Duavive
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 
DUAVIVE 0.45 mg/20 mg modified-release tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate 
equivalent to 20 mg bazedoxifene. 
 
Excipients with known effect 
Each modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as sucrose 
monopalmitate), 62.9 mg lactose (as monohydrate), 0.2 mg maltitol liquid, 0.0176 mg glucose, and 
0.0088 mg sorbitol 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Modified-release tablet. 
 
Pink, oval-shaped, modified-release tablet of 12 mm printed on one side with “0.45/20”. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women 
with a uterus (with at least 12 months since the last menses) for whom treatment with 
progestin-containing therapy is not appropriate.   
 
The experience treating women older than 65 years is limited. 
 
4.2 Posology and method of administration 
 
Posology 
 
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose 
for the shortest duration should be used (see section 4.4). 
 
The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken 
as a single oral tablet, once daily. 
 
If a tablet is forgotten, it should be taken as soon as the patient remembers. Therapy should then be 
continued as before. If more than one tablet has been forgotten, only the most recent tablet should be 
taken, the patient should not take double the usual dose to make up for missed tablets. 
 
Special populations  
 
Elderly 
 
CE/BZA has not been studied in women over 75 years of age. Based on available data no dosage 
adjustment is necessary based on age (see section 5.2). The experience treating women older than 
65 years is limited. 



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Renal impairment 
 
The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment. Use in 
this population is therefore not recommended (see sections 4.4 and 5.2). 
 
Hepatic impairment  
 
The safety and efficacy of CE/BZA have not been evaluated in patients with hepatic impairment. Use 
in this population is contraindicated (see sections 4.3, 4.4 and 5.2). 
 
Paediatric population  
 
There is no relevant use of CE/BZA in the paediatric population.  
 
Method of administration  
 
Oral use. 
 
CE/BZA may be taken at any time of day, without regard to meals (see section 5.2). Tablets should be 
swallowed whole.  
 
4.3 Contraindications 
 

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.  
- Known, suspected, or past history of breast cancer. 
- Known, past or suspected oestrogen-dependent malignant tumours (e.g., endometrial 

cancer). 
- Undiagnosed genital bleeding. 
- Untreated endometrial hyperplasia. 
- Active or past history of venous thromboembolism (e.g., deep venous thrombosis, 

pulmonary embolism, and retinal vein thrombosis). 
- Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency, see 

section 4.4). 
- Active or past history of arterial thromboembolic disease (e.g., myocardial infarction, 

stroke). 
- Acute liver disease or a history of liver disease as long as liver function tests have failed 

to return to normal. 
- CE/BZA must not be taken by women of childbearing potential, or breast-feeding women 

(see sections 4.6 and 5.3).  
- Porphyria. 

 
4.4 Special warnings and precautions for use 
 
For the treatment of postmenopausal symptoms, CE/BZA should only be initiated for symptoms that 
adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be 
undertaken at least annually, and treatment should only be continued as long as the benefit outweighs 
the risk. 
 
Women taking CE/BZA should not be taking progestins, additional oestrogens or selective oestrogen 
receptor modulators (SERMs).  
 
DUAVIVE (CE/BZA) has not been studied in the treatment of premature menopause.  
 
Medical examination/follow-up 
 
Before initiating or reinstituting treatment with CE/BZA, a complete personal and family medical 



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history should be taken. Physical (including pelvic and breast) examination should be guided by this 
and by the contraindications and precautions for use. During treatment, periodic check-ups are 
recommended of a frequency and nature adapted to the individual woman. Women should be advised 
what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below). 
Investigations, including appropriate imaging tools, e.g., mammography, should be carried out in 
accordance with currently accepted screening practices, modified to the clinical needs of the 
individual. 
 
Conditions which need supervision 
 
If any of the following conditions are present, have occurred previously, and/or have been aggravated 
during pregnancy or previous hormone treatment, the patient should be closely supervised. It should 
be taken into account that these conditions may recur or be aggravated during treatment with CE/BZA, 
in particular: 
 

 Leiomyoma (uterine fibroids) or endometriosis 
 Risk factors for thromboembolic disorders (see below) 
 Risk factors for oestrogen-dependent tumours, e.g., 1st degree heredity for breast cancer 
 Hypertension 
 Liver disorders (e.g., liver adenoma) 
 Diabetes mellitus with or without vascular involvement 
 Cholelithiasis 
 Migraine or (severe) headache 
 Systemic lupus erythematosus 
 A history of endometrial hyperplasia (see below) 
 Epilepsy 
 Asthma 
 Otosclerosis 

 
Reasons for immediate withdrawal of therapy 
 
Therapy should be discontinued in case a contraindication is discovered (e.g., venous 
thromboembolism, stroke, and pregnancy) and in the following situations: 
 

- Jaundice or deterioration in liver function 
- Significant increase in blood pressure 
- New onset of migraine-type headache 

 
Endometrial hyperplasia and carcinoma 
 
In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when 
oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer 
risk among oestrogen-only users varies from 2- to 12-fold greater compared with non-users, depending 
on duration of treatment and oestrogen dose. After stopping treatment, risk may remain elevated for at 
least 10 years. Women taking CE/BZA should not take additional oestrogens as this may increase the 
risk of endometrial hyperplasia and endometrial carcinoma.  
 
The addition of bazedoxifene in CE/BZA reduces the risk of endometrial hyperplasia, which may be a 
precursor of endometrial carcinoma. 
 
Break-through bleeding and spotting may occur during treatment. If break-through bleeding or 
spotting appears after some time on therapy, or continues after treatment has been discontinued, the 
reason should be investigated, which may include endometrial biopsy to exclude endometrial 
malignancy.  
 



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Breast cancer 
 
The overall evidence suggests a possible increased risk of breast cancer in women taking 
oestrogen-only therapy that is dependent on the duration of therapy.  
 
The Women’s Health Initiative (WHI) trial found no increase in the risk of breast cancer in 
hysterectomised women using oestrogen-only therapy.  
 
Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed 
that is substantially lower than that found in users of oestrogen-progestagen combinations (see 
section 4.8). The excess risk becomes apparent within a few years of use but returns to baseline within 
a few (at most five) years after stopping treatment.  
 
The effect of CE/BZA on the risk of breast cancer is unknown. 
 
Ovarian cancer 
 
Ovarian cancer is much rarer than breast cancer.   
 
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women 
taking oestrogen-only Hormone Replacement Therapy (HRT), which becomes apparent within 5 years 
of use and diminishes over time after stopping. 
 
Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated 
with a similar or slightly smaller risk (see section 4.8). 
 
The effect of CE/BZA on the risk of ovarian cancer is unknown. 
 
Venous thromboembolism (VTE) 
 
In clinical trials of up to 2 years duration in postmenopausal women with CE/BZA, cases of VTE have 
been reported (see section 4.8). Should a VTE event occur or be suspected, CE/BZA should be 
discontinued immediately. 
 
SERMs (including bazedoxifene) and oestrogens individually increase the risk of VTE (see 
section 4.8). 
 
Hormone therapy is associated with a 1.3-3 fold risk of developing VTE. The occurrence of such an 
event is more likely in the first year of HRT than later (see section 4.8).  
 
Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may 
add to this risk. CE/BZA is contraindicated in these patients (see section 4.3). 
 
Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, 
prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus 
erythematosus (SLE), and cancer. There is no consensus about the possible role of varicose veins in 
VTE. As in all postoperative patients, prophylactic measures need be considered to prevent VTE 
following surgery. If prolonged immobilisation is to follow elective surgery temporarily stopping 
CE/BZA 4 to 6 weeks earlier is recommended. Treatment should not be restarted until the woman is 
completely mobilised. In addition, women taking CE/BZA should be advised to move about 
periodically during travel involving prolonged immobilisation. 
 
In women with no personal history of VTE but with a first-degree relative with a history of thrombosis 
at young age, screening may be offered after careful counselling regarding its limitations (only a 
proportion of thrombophilic defects are identified by screening). If a thrombophilic defect is identified 
which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g., antithrombin, 
protein S, or protein C deficiencies or a combination of defects) hormone therapy is contraindicated. 



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Women already on chronic anticoagulant treatment require careful consideration of the benefit risk of 
use of hormone therapy. 
 
If VTE develops after initiating therapy, or is suspected, CE/BZA should be discontinued 
immediately. Women should be told to contact their doctors immediately when they are aware of a 
potential thromboembolic symptom (e.g., painful swelling of a leg, sudden pain in the chest, 
dyspnoea). 
 
Coronary artery disease (CAD) 
 
There is no evidence from randomised controlled trials of protection against myocardial infarction in 
women with or without existing CAD who received oestrogen-only therapy. Randomised controlled 
data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.  
 
Ischaemic stroke 
 
Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke. The 
relative risk does not change with age or time since menopause. However, as the baseline risk of 
stroke is strongly age-dependent, the overall risk of stroke in women who use hormone therapy will 
increase with age (see section 4.8). 
 
The effect of CE/BZA on the risk of stroke is unknown. 
 
Should a stroke occur or be suspected, CE/BZA should be discontinued immediately (see section 4.3). 
 
Other conditions 
 
- Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction 

should be carefully monitored when being treated with CE/BZA.  
- Patients with terminal renal insufficiency should be closely monitored, since it is expected that 

the level of circulating oestrogens components of CE/BZA will be increased. Use in this 
population is not recommended (see sections 4.2 and 5.2).  

- Women with pre-existing hypertriglyceridaemia should be followed closely during treatment 
with oestrogens, since rare cases of large increases of plasma triglycerides leading to 
pancreatitis have been reported with oestrogen therapy in this condition. CE/BZA has not been 
studied in women with baseline triglyceride levels >300 mg/dL (>3.4 mmol/L). In clinical trials 
of up to 2 years duration, CE/BZA was associated with an increase from baseline in the 
concentration of serum triglycerides of approximately 16% at month 12 and 20% at month 24. 
Annual monitoring of serum triglyceride levels should therefore be considered. 

- CE/BZA has not been studied in patients with impaired liver function (see sections 4.2 and 5.2) 
or history of cholestatic jaundice. Oestrogens may be poorly metabolised in women with 
impaired liver function. For women with a history of cholestatic jaundice associated with past 
oestrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, 
CE/BZA should be discontinued. 

- A 2 to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal 
women receiving oestrogens has been reported (see section 4.8). Patients treated with CE/BZA 
should be monitored carefully for signs of development of gallbladder disease. 

- Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total 
thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by 
radioimmunoassay) or T3 levels (by radio-immunoassay). T3 resin uptake is decreased, 
reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Other binding 
proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding 
globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. 
Free or biological active hormone concentrations are unchanged. Other plasma proteins may be 
increased (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin). 

 



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Oestrogen therapy use does not improve cognitive function. There is some evidence of increased risk 
of probable dementia in women who start using continuous oestrogen-only therapy after the age of 65. 
 
The effect of CE/BZA on the risk of dementia is unknown. 
 
Excipients content 
 
This medicinal product contains lactose, sucrose, glucose (in polydextrose and maltitol liquid) and 
sorbitol (in polydextrose).  
 
Lactose, sucrose and glucose 
 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, fructose 
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this 
medicinal product. 
 
Sorbitol 
 
This medicinal product contains sorbitol which may affect the bioavailability of other concomitantly 
administered medicinal products. The additive effect of all sources of sorbitol from other 
concomitantly administered medicinal products and dietary sources should be taken into account. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Results from a clinical drug-drug interaction study conducted with CE/BZA and from interaction 
studies with CE or bazedoxifene monotherapy are summarised below. 
 
Conjugated oestrogens 
 
In vitro and in vivo studies have shown that oestrogens are partially metabolised by cytochrome 
P450 enzymes, including CYP3A4. However, in a clinical drug-drug interaction study, repeat 
administration of 200 mg itraconazole, a strong CYP3A4 inhibitor, had minimal impact on the 
pharmacokinetics of CE (as measured by estrone and equilin) and bazedoxifene when administered 
with a single dose of CE 0.45 mg/BZA 20 mg. 
 
The metabolism of oestrogens may be increased by concomitant use of substances known to induce 
drug-metabolising enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) 
and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz). Ritonavir and nelfinavir, 
although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly 
with steroid hormones. Herbal preparations containing St John’s wort (Hypericum perforatum) may 
induce the metabolism of oestrogens. Clinically, an increased metabolism of oestrogens may lead to 
decreased effect and changes in the uterine bleeding profile. 
 
Bazedoxifene  
 
The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce 
uridine diphosphate glucuronosyltransferases (UGTs), such as rifampicin, phenobarbital, 
carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of 
bazedoxifene. A reduction in bazedoxifene exposure may be associated with an increased risk of 
endometrial hyperplasia (see section 4.4).  
 
Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism. Bazedoxifene 
does not induce or inhibit the activities of major CYP isoenzymes, and is unlikely to interact with 
co-administered medicinal products via CYP-mediated metabolism.  
 



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There were no significant pharmacokinetic interactions between bazedoxifene and the following 
medicinal products: ibuprofen, atorvastatin and azithromycin or an antacid containing aluminium and 
magnesium hydroxide.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
CE/BZA is only for use in postmenopausal women, and is contraindicated in women who are or may 
become pregnant (see section 4.3). There are no data from the use of CE/BZA in pregnant women. If 
pregnancy occurs during treatment with CE/BZA, it should be withdrawn immediately. 
 
The results of most epidemiological studies to date relevant to inadvertent foetal exposure to 
oestrogens indicate no teratogenic or foetotoxic effects. 
 
In studies conducted in rabbits, bazedoxifene alone has shown reproductive toxicity (see section 5.3). 
The potential risk for humans is unknown. 
 
Breast-feeding 
 
CE/BZA is contraindicated during breast-feeding (see section 4.3). It is not known whether 
bazedoxifene is excreted in human milk. Detectable amounts of oestrogens have been identified in the 
milk of mothers receiving CE. Oestrogen administration to breast-feeding mothers has been shown to 
decrease the quantity and quality of the milk. 
 
Fertility 
 
No studies were performed on animals to evaluate the effects on reproduction with the CE/BZA 
combination.  
 
Studies in rats with bazedoxifene have shown adverse effects on fertility (see section 5.3). The 
potential risk for humans is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
CE/BZA has a minor influence on the ability to drive and use machines.  
 
In clinical trials with bazedoxifene monotherapy, somnolence was reported as an adverse reaction, and 
patients should be advised on the potential effect on driving and using machines. 
 
In patients receiving bazedoxifene monotherapy there have been post-marketing reports of visual 
symptoms such as visual acuity disturbance or blurred vision. If such symptoms occur, patients should 
avoid driving or use of machines that requires accurate visual perception until symptoms have 
resolved, or until they have received medical advice that it is safe to do so.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most commonly reported adverse reaction is abdominal pain, occurring in more than 10% of 
patients in clinical trials.  
 
Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients). 
 



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Tabulated list of adverse reactions 
 
The table below lists the adverse reactions observed with CE/BZA (n = 3,168) in placebo-controlled 
clinical trials. Adverse reactions were categorised as very common ( 1/10), common 
( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) or rare ( 1/10,000 to < 1/1,000). 
 
System organ 
class 

Frequency of occurrence of adverse reactions 
Very common Common Uncommon Rare 

Infections and 
infestations 

 Vulvovaginal 
candidiasis

  

Vascular disorders    Venous 
thromboembolic 
events (including, 
pulmonary 
embolism, retinal 
vein thrombosis, 
deep vein 
thrombosis and 
thrombophlebitis)

Gastrointestinal 
disorders 

Abdominal pain Constipation; 
diarrhoea; nausea 

  

Hepatobiliary 
disorders 

  Cholecystitis  

Musculoskeletal 
and connective 
tissue disorders 

 Muscle spasms   

Investigations  Blood triglycerides 
increased

  

 
Description of selected adverse reactions 
 
Breast cancer risk 
 
Breast cancer risk associated with the use of oestrogens alone is represented by several studies. Any 
increased risk to users of oestrogen-only therapy is substantially lower than that seen in users of 
oestrogen–progestagen combinations. The level of risk is dependent on duration of use (see 
section 4.4). Results of the largest randomised placebo-controlled trial (WHI-study) and largest 
epidemiological study (MWS) are presented.  
 
US WHI Oestrogen only (ET) arm – additional risk of breast cancer after 5 years use 
 

Age range 
(years) 

Incidence per 1,000 
women in placebo arm 
over 5 years 

 
Risk ratio & 95% CI 

Additional cases per 
1,000 ET users over 

5 years (95% CI)
CE Oestrogen only

50-79 21 0.8 (0.7-1.0) -4 (-6 – 0)* 
*WHI study in women with no uterus, which did not show an increase in risk of breast cancer 

 
Million women study (Estradiol only arm) – estimated additional risk of breast cancer after 5 years use 
 

Age range 
(years) 

Additional cases per 
1,000 never-users of HRT 
over a 5 year period* 

 
Risk ratio#  

 

Additional cases per 
1,000 ET users over 
5 years (95%CI) 

Estradiol only 
50-65 9-12 1.2 1-2 (0-3) 

* Taken from baseline incidence rates in developed countries 
#Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use. 



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Endometrial cancer risk 
 
Postmenopausal women with a uterus  
The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT.  
 
In women with a uterus, use of oestrogen-only HRT is not recommended because it increases the risk 
of endometrial cancer (see section 4.4). Depending on the duration of oestrogen-only use and 
oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from 
5 to 55 extra cases diagnosed in every 1,000 women between the ages of 50 and 65 years. 
 
CE/BZA contains bazedoxifene, which reduces the risk of endometrial hyperplasia that can occur with 
oestrogen-only use (see section 4.4). Endometrial hyperplasia may be a precursor to endometrial 
cancer. 
 
Ovarian cancer 
 
Use of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer 
diagnosed (see section 4.4).  
 
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in 
women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 
1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case 
per 2,000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be 
diagnosed with ovarian cancer over a 5-year period. 
 
Risk of venous thromboembolism 
 
In the bazedoxifene osteoporosis treatment trial (mean age = 66.5 years), the VTE rate per 
1,000 women-years through the 3-year study period was 2.86 in the bazedoxifene (20 mg) group and 
1.76 in the placebo group and through the 5-year study period was 2.34 in the bazedoxifene 20 mg 
group and 1.56 in the placebo group. After 7 years, the VTE rate per 1,000 women-years was 2.06 in 
the bazedoxifene 20 mg group and 1.36 in the placebo group. 
 
Oestrogens are known to increase the risk of VTE (see section 4.4). The occurrence of such a reaction 
is more likely in the first year of treatment. The data from the largest randomised trial are summarised 
below: 
 
WHI studies oestrogen only arm – additional risk of VTE over 5 years’ use 

Age range (years) Incidence per 1,000 women 
in placebo arm over 5 years 

Risk ratio & 95%CI Additional cases per 
1,000 ET users  

Oral oestrogen-only* 
50-59 7 1.2 (0.6-2.4) 1 (-3-10) 

*study in women with no uterus 
 
Risk of ischaemic stroke 
 
The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of 
ischaemic stroke. This relative risk is not dependent on age or on duration of use, but as the baseline 
risk is strongly age-dependent, the overall risk of stroke in women who use oestrogen therapy will 
increase with age (see section 4.4). The additional risk of ischaemic stroke over five years of use was 
assessed in the largest randomised trial in women without a uterus (WHI) from 50-59 years of age.  
 



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WHI Studies combined – Additional risk of ischaemic stroke* over 5 years use 
Age range (years) Incidence per 1,000 women 

in placebo arm over 5 years 
Risk ratio & 95%CI Additional cases per 

1,000 HRT users 
over 5 years 

50-59 8 1.3 (1.1-1.6) 3 (1-5) 
*no differentiation was made between ischaemic and haemorrhagic stroke.  
 
Adverse reactions reported with CE and/or bazedoxifene monotherapy 
 
Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), 
uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known 
(cannot be estimated from available data). 
 
Adverse reactions that have been observed with CE monotherapy 
 
System organ class Frequency of occurrence of adverse reactions 

Common Uncommon Rare Very rare 
Infections and 
infestations 

 Vaginitis    

Neoplasms benign, 
malignant and 
unspecified (incl. 
cysts and polyps) 

  Growth 
potentiation of 
benign 
meningioma; 
fibrocystic 
breast disease 

Enlargement of 
hepatic 
haemangiomas 

Immune system 
disorders 

 Hypersensitivity  Angioedema; 
anaphylactic/ana
phylactoid 
reactions; 
urticaria 

 

Metabolism and 
nutrition disorders 

  Glucose 
intolerance 

Exacerbation of 
porphyria; 
hypocalcaemia (in 
patients with 
disease that can 
predispose to 
severe 
hypocalcaemia) 

Psychiatric disorders  Dementia; 
depression; mood 
altered; changes 
in libido 

Irritability  

Nervous system 
disorders 

 Migraine; 
headache; 
dizziness; 
nervousness 

Exacerbation of 
epilepsy 

Exacerbation of 
chorea 

Eye disorders 
 

 Intolerance to 
contact lenses 

  

Cardiac disorders   Myocardial 
infarction 

 

Respiratory, thoracic 
and mediastinal 
disorders 

  Exacerbation of 
asthma 

 



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System organ class Frequency of occurrence of adverse reactions 
Common Uncommon Rare Very rare 

Gastrointestinal 
disorders 

 Nausea Pancreatitis; 
ischaemic 
colitis; vomiting 

 

Skin and 
subcutaneous tissue 
disorders 

Alopecia 
 

Hirsutism; rash; 
pruritus; 
chloasma 

 Erythema 
multiforme; 
erythema 
nodosum 

Musculoskeletal and 
connective tissue 
disorders 

Arthralgia; leg 
cramps 

   

Reproductive system 
and breast disorders 

Breast pain, 
tenderness, 
enlargement, 
discharge; 
leucorrhoea  

Change in 
cervical ectropion 
and secretion 

Pelvic pain  

Investigations Changes in 
weight (increase 
or decrease)  

  Increases in blood 
pressure 

 
Adverse reactions that have been observed with bazedoxifene monotherapy 
 
System organ class Frequency of occurrence of adverse reactions 

Very common Common Uncommon Not known 

Immune system 
disorders 

 Hypersensitivity   

Nervous system 
disorders 

 Somnolence   

Eye disorders 
 

  Retinal vein 
thrombosis 

Visual acuity 
reduced, blurred 
vision, photopsia, 
visual field defect, 
visual impairment, 
dry eye, eyelid 
oedema, 
blepharospasm, eye 
pain and eye 
swelling 

Cardiac disorders    Palpitations 
Vascular disorders Hot flush  Deep vein 

thrombosis, 
thrombophlebitis 
superficial 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

  Pulmonary 
embolism 

 

Gastrointestinal 
disorders 

 Dry mouth   

Skin and 
subcutaneous tissue 

 Urticaria, rash, 
pruritus 

  



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System organ class Frequency of occurrence of adverse reactions 

Very common Common Uncommon Not known 

disorders 

Musculoskeletal 
and connective 
tissue disorders 

Muscle 
spasms 
(includes leg 
cramps)  

   

General disorders 
and administration 
site conditions 

Oedema 
peripheral 

   

Investigations  Blood triglycerides 
increased, alanine 
aminotransferase 
increased; aspartate 
aminotransferase 
increased 

  

 
Reporting of suspected adverse reactions  
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is no specific antidote. In case of overdose it is recommended that the patient be monitored for 
any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted 
immediately. 
 
Symptoms of overdose of oestrogen-containing medicinal products in adults and children may include 
nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal 
bleeding may occur in females. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; estrogens, 
combinations with other drugs; ATC code: G03CC07 
 
Mechanism of action 
 
CE/BZA pairs CE with the selective oestrogen receptor modulator (SERM), BZA, which is defined as 
a tissue selective oestrogen complex (TSEC). The active ingredients of CE are primarily the sulphate 
esters of estrone, equilin sulphates and 17α/β-estradiol. These substitute for the loss of oestrogen 
production in menopausal women, and alleviate menopausal symptoms. As oestrogens promote the 
growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and 
cancer. The addition of bazedoxifene, acting as an oestrogen receptor antagonist in the uterus, greatly 
reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women. 
 



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Clinical efficacy and safety 
 
CE/BZA was evaluated in 4,868 postmenopausal women who participated in 5 phase 3 trials. Among 
these, 1,585 women were treated with CE 0.45 mg/BZA 20 mg and 1,241 received placebo. Long-
term exposure to CE/BZA for up to 2 years was evaluated; 3,322 women were exposed to CE/BZA for 
at least 1 year, and 1,999 women were exposed for 2 years. 
 
Relief of oestrogen-deficiency symptoms and bleeding patterns 
 
Relief of menopausal symptoms was achieved during the first few weeks of treatment. In a 12-week 
study, CE 0.45 mg/BZA 20 mg significantly reduced the number and severity of hot flushes compared 
to placebo at weeks 4 and 12.  
 
In one study, amenorrhea was reported in 97% of the women who received CE 0.45 mg/BZA 20 mg 
during months 10 to 12. Irregular bleeding and/or spotting was reported in the CE 0.45 mg/BZA 
20 mg group by 7% of women during the first 3 months of treatment and by 3% of women during 
months 10 to 12. 
 
In another study, amenorrhea was reported in 96% of the women who received CE 0.45 mg/BZA 
20 mg during months 10 to 12. Irregular bleeding and/or spotting was reported in the CE 
0.45 mg/BZA 20 mg group by 8% of women during the first 3 months and by 4% of women during 
months 10 to 12. 
 
Breast density 
 
CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to 
placebo over 1 year of treatment. 
 
Effects on bone mineral density (BMD) 
 
In a 1 year study, CE 0.45 mg/BZA 20 mg showed a significant difference from baseline in lumbar 
spine BMD (+1.52%) at month 12 compared to placebo. This change in BMD was similar to that 
shown with bazedoxifene 20 mg alone (+1.35%) and less than that seen with CE 0.45 mg/ 
medroxyprogesterone 1.5 mg (+2.58%) in the same study.  
 
Elderly 
 
Of the total number of women in phase 3 clinical trials who received CE/BZA 20 mg, 2.4% (n=77) 
were aged ≥65 years. No overall differences in safety or efficacy were observed between women aged 
>65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out. 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
CE/BZA in all subsets of the paediatric population in the ‘treatment of oestrogen deficiency symptoms 
in postmenopausal women’ (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic studies for CE/BZA were conducted in healthy postmenopausal women who were 
naturally postmenopausal or who had undergone bilateral oophorectomy. 
 
Following multiple doses of CE 0.45 mg/BZA 20 mg, the mean steady state pharmacokinetic 
parameters for CE and bazedoxifene (baseline adjusted for total estrone) are summarised below. 
 



15 

Mean ± SD Steady-State Pharmacokinetic Parameters (n=24) 
 Cmax 

(ng/mL) 
Tmax 
(hr) 

AUCss 
(nghr/mL)

Bazedoxifene 6.9 ± 3.9 2.5 ± 2.1 71 ± 34 
Baseline-adjusted total estrone 2.6 ± 0.8 6.5 ± 1.6 35 ± 12 

 
Absorption 
 
After a single dose of CE/BZA, bazedoxifene and baseline-adjusted total estrone were absorbed with a 
tmax of approximately 2 hours and 8.5 hours, respectively. When single doses of CE 0.625 mg/BZA 
20 mg were administered with a high-fat meal, bazedoxifene Cmax was unaffected, but Area Under 
Curve (AUC) increased by approximately 25%. Food had little or no effect on the exposure of CE. 
 
CE/BZA can be administered with or without food. 
 
Following administration of BZA alone, a linear increase in plasma concentrations for single doses 
from 0.5 mg up to 120 mg and multiple daily doses from 1 mg to 80 mg was observed. The absolute 
bioavailability of BZA is approximately 6%.  
 
CE are soluble in water and are well-absorbed from the gastrointestinal tract after release from the 
medicinal product formulation. Oestrogen dose proportionality was assessed in two studies of CE. 
Dose-proportional increases in both AUC and Cmax were observed across the dose range from 
0.3 mg to 0.625 mg of CE for total (conjugated plus unconjugated) equilin, total estrone adjusted for 
baseline, and unconjugated estrone adjusted for baseline. 
 
Distribution 
 
The distribution of CE and bazedoxifene after administration of CE/BZA has not been studied.  
 
Following intravenous administration of a 3 mg dose of BZA alone, the volume of distribution is 14.7 
3.9 l/kg. BZA is highly bound (98% - 99%) to plasma proteins in vitro, but does not bind to sex 
hormone binding globulin (SHBG).  
 
The distribution of exogenous oestrogens is similar to that of endogenous oestrogens. Oestrogens are 
widely distributed in the body and are generally found in higher concentrations in the sex hormone 
target organs. Oestrogens circulate in the blood largely bound to SHBG and albumin.  
 
Biotransformation 
 
The metabolic disposition of CE and BZA, after administration of CE/BZA, has not been studied.  
 
Circulating oestrogens exist in a dynamic equilibrium of metabolic interconversions. 17β-estradiol is 
converted reversibly to estrone, and both can be converted to estriol, which is the major urinary 
metabolite. In postmenopausal women, a significant proportion of the circulating oestrogens exists as 
sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation 
of more active oestrogens. 
 
The metabolic disposition of bazedoxifene in postmenopausal women has been determined following 
oral administration of 20 mg of radiolabeled BZA. BZA is extensively metabolised in women. 
Glucuronidation is the major metabolic pathway. Little or no cytochrome P450-mediated metabolism 
is evident. Bazedoxifene-5-glucuronide is the major circulating metabolite. The concentrations of this 
glucuronide are approximately 10-fold higher than those of unchanged BZA in plasma.  
 



16 

Elimination 
 
After a single dose of CE/BZA, baseline-adjusted total estrone (representing CE) is eliminated with a 
half-life of approximately 17 hours. BZA is eliminated with a half-life of approximately 30 hours. 
Steady-state concentrations are achieved by the second week of once-daily administration.  
 
CE components, 17β-estradiol, estrone, and estriol are excreted in the urine, along with glucuronide 
and sulfate conjugates. 
 
The clearance of BZA is 0.4 ±0.1 L/h/kg based on intravenous administration. The major route of 
excretion of radiolabeled BZA is the faeces, and less than 1% of the dose is eliminated in urine. 
 
Special populations 
 
Elderly 
The pharmacokinetics of CE/BZA have not been evaluated in women over 75 years of age. 
The pharmacokinetics of a 20 mg single dose of BZA were evaluated in a study in 26 healthy 
postmenopausal women. On average, compared to women 51 to 64 years of age (n=8), women 
65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) 
showed a 2.6-fold increase in AUC. This increase is most likely attributable to age-related changes in 
hepatic function.  
 
Renal impairment 
The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment. 
Limited clinical data (n=5) for bazedoxifene monotherapy are available in subjects with moderate 
renal impairment (creatinine clearance 50 ml/min). A single 20 mg dose of BZA was administered to 
these subjects. Negligible (1%) amounts of BZA are eliminated in urine. Impaired renal function 
showed little or no influence on bazedoxifene pharmacokinetics. 
 
Hepatic impairment  
The pharmacokinetics of CE/BZA have not been evaluated in women with hepatic impairment.  
 
The disposition of a single 20 mg dose of bazedoxifene was compared in women with hepatic 
impairment (Child-Pugh Class A [n=6], B [n=6], and C [n=6]) and subjects with normal hepatic 
function (n=18). On average, women with hepatic impairment showed a 4.3-fold increase in AUC 
compared with controls. Safety and efficacy have not been evaluated further in women with hepatic 
insufficiency. Use of CE/BZA in this population is contraindicated (see sections 4.2, 4.3 and 4.4). 
 
Body mass index (BMI)  
In a pharmacokinetic study (n=24) BMI appeared to have little impact on systemic exposure to CE and 
BZA. 
 
5.3 Preclinical safety data 
 
Carcinogenicity, mutagenicity, and impairment of fertility studies with CE/BZA have not been 
conducted. The following data are based on the findings in studies with bazedoxifene. 
 
In 6-month carcinogenicity studies in transgenic mice, there was an increased incidence of benign, 
ovarian granulosa-cell tumours in female mice given 150 or 500 mg/kg/day. Systemic exposure 
(AUC) to bazedoxifene in these groups was 35 and 69 times that in postmenopausal women 
administered 20 mg/day for 14 days. 
 
In a 2-year carcinogenicity study in rats, an increased incidence of benign, ovarian granulosa-cell 
tumours was observed in female rats at dietary concentrations of 0.03% and 0.1%. Systemic exposure 
(AUC) of bazedoxifene in these groups was 2.6 and 6.6 times that observed in postmenopausal women 
administered 20 mg/day for 14 days. 
 



17 

The observation of benign, ovarian granulosa-cell tumours in female mice and rats administered 
bazedoxifene is a class effect of SERMs related to its pharmacology in rodents when treated during 
their reproductive lives, when their ovaries are functional and responsive to hormonal stimulation. 
 
Bazedoxifene elicited male rat-specific nephropathies (corticomedullar nephrocalcinosis and enhanced 
spontaneous chronic progressive nephropathy) and associated adenomas and carcinomas at exposure 
ratios of 0.05 to 4 times, and dose ratios, based on surface area (mg/m2), of approximately 
0.6 to 22 times the clinical dose of 20 mg. These findings are considered rat-specific and presumably 
not relevant in humans. Renal cell carcinomas were observed in an 18-month bone efficacy study in 
aged ovariectomised cynomolgus monkeys at exposure ratios of 0.05 to 16.3 times, and dose ratios, 
based on surface area (mg/m2), of approximately 0.2 to 24 times the clinical dose of 20 mg. These 
tumours are known to occur in aged nonhuman primates and were considered spontaneous in the aged 
monkeys and irrelevant to humans. 
 
BZA was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation 
assay, in vitro mammalian cell forward mutation assay at the thymidine kinase (TK/-) locus in 
L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary 
(CHO) cells, and in vivo mouse micronucleus assay. 
 
Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted. The 
following data are based on the findings in studies with BZA. 
 
In rabbit studies with BZA, abortion and an increased incidence of heart (ventricular septal defect) and 
skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) 
anomalies in the fetuses were present at maternally toxic dosages of  0.5 mg/kg/day (1.5 times the 
human exposure). Treatment of rats with BZA at maternally toxic dosages  1 mg/kg/day ( 0.4 times 
the human dose based on body surface area) resulted in reduced numbers of live foetuses and/or 
reductions in foetal body weights. No foetal developmental anomalies were observed. 
 
Female rats were administered daily dosages of 0.3 to 30 mg/kg (0.15 to 14.6 times the human dose 
based on body surface area, mg /m2 [20 mg/kg dosage in humans is 12.3 mg/m2]) prior to and during 
mating with untreated males. Oestrous cycles and fertility were adversely affected in all 
bazedoxifene-treated female groups. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Conjugated oestrogens tablet core 
 
Lactose monohydrate 
Microcrystalline cellulose 
Powdered cellulose 
Hypromellose 2208 (100,000 mPa•s) (E464) 
Magnesium stearate 
Calcium phosphate  
 
Inert filler coating 
 
Sucrose 
Microcrystalline cellulose 
Hydroxypropylcellulose 
Hypromellose 2910 (6 mPa•s) (E464) 
Hypromellose 2910 (15 mPa•s) (E464) 
Macrogol (400) 
 



18 

Bazedoxifene active coating 
 
Sucrose 
Hypromellose 2910 (3 mPa•s) (E464) 
Sucrose monopalmitate 
Ascorbic acid 
 
Colour coating 
 
Hypromellose 2910 (6 mPa•s) (E464) 
Titanium dioxide (E171) 
Macrogol (400)  
Red Iron oxide (E172) 
 
Clear coating 
 
Hydroxyethylcellulose 
Povidone (E1201) 
Polydextrose (E1200) (contains glycerol and glucose) 
Maltitol liquid  
Poloxamer 188 
 
Printing ink 
 
Black Iron oxide (E172) 
Propylene glycol (E1520) 
Hypromellose 2910 (6 mPa•s) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years   
 
After opening the blister pouch, use within 60 days. 
 
6.4 Special precautions for storage 
 
Do not store above 25ºC.  
 
Store in the original package in order to protect from moisture.  
 
6.5  Nature and contents of container 
 
PVC/Aclar/PVC blister packs containing 28 modified-release tablets.  
 
6.6 Special precautions for disposal  
 
No special requirements for disposal. 
 
 



19 

7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/960/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 December 2014 
Date of latest renewal: 11 November 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 



21 

 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Pfizer Ireland Pharmaceuticals 
Little Connell 
Newbridge 
County Kildare 
Ireland 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
Medicinal product subject to medical prescription.  
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 
 Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 
 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
DUAVIVE 0.45 mg/20 mg modified-release tablets  
conjugated oestrogens/bazedoxifene 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate 
equivalent to 20 mg bazedoxifene 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose, sucrose, polydextrose and maltitol liquid. See package leaflet for further 
information.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 modified-release tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Swallow tablet whole. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
After opening the blister pouch, use within 60 days. 



25 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25ºC.  
 
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/960/001 28 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
DUAVIVE 0.45/20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN:  
NN:  
 
 



26 

 
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING  
 
BLISTER POUCH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
DUAVIVE 0.45 mg/20 mg modified-release tablets  
conjugated oestrogens/bazedoxifene 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate 
equivalent to 20 mg bazedoxifene 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose, sucrose, polydextrose and maltitol liquid. See package leaflet for further 
information.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 modified-release tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Swallow tablet whole. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
After opening the blister pouch, use within 60 days. 
 



27 

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25ºC.  
 
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/960/001 28 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



28 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS AND STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
DUAVIVE 0.45 mg/20 mg modified-release tablets 
conjugated oestrogens/bazedoxifene 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 



30 

Package leaflet: Information for the patient 
 

DUAVIVE 0.45 mg/20 mg modified-release tablets 
conjugated oestrogens/bazedoxifene 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What DUAVIVE is and what it is used for  
2. What you need to know before you take DUAVIVE 
3. How to take DUAVIVE 
4. Possible side effects  
5. How to store DUAVIVE 
6. Contents of the pack and other information 
 
 
1. What DUAVIVE is and what it is used for 
 
DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and 
bazedoxifene. Conjugated oestrogens is a medicine that belongs to a group of medicines called 
hormone replacement therapy (HRT). Bazedoxifene belongs to a group of non-hormonal medicines 
called selective estrogen receptor modulators (SERMs).  
 
DUAVIVE is used in postmenopausal women who still have their uterus (womb) and have not had a 
natural period in the last 12 months. 
 
DUAVIVE is used for: 
 
Relief of symptoms occurring after menopause 
 
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can 
cause symptoms such as hot face, neck and chest ("hot flushes"). DUAVIVE alleviates these 
symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously 
hinder your daily life and your doctor determines that other types of HRT are not appropriate for you. 
 
 
2. What you need to know before you take DUAVIVE 
 
Medical history and regular check-ups 
 
The use of DUAVIVE carries risks, which need to be considered when deciding whether to start 
taking it, or whether to carry on taking it.  
 
There is no experience in treating women with a premature menopause (due to ovarian failure or 
surgery) with DUAVIVE. 
 



31 

Before you start taking this medicine, your doctor will ask you about your own and your family’s 
medical history. Your doctor may decide to perform a physical examination. This may include an 
examination of your breasts and/or an internal examination, if necessary, or if you have any special 
concerns. Tell your doctor if you have any medical problems or illnesses. 
 
Once you have started this medicine you should see your doctor for regular check-ups (at least once a 
year). During these check-ups, discuss with your doctor the benefits and risks of continuing with 
DUAVIVE. You are advised to: 

 go for regular breast screening and cervical smear tests, as recommended by your doctor. 
 regularly check your breasts for any changes such as dimpling of the skin, changes in the 

nipple, or any lumps you can see or feel. 
 
Do not take DUAVIVE  

- If you are allergic to conjugated estrogens, bazedoxifene or any of the other ingredients of 
this medicine (listed in section 6).  

- If you have or have ever had breast cancer, or if you are suspected of having it. 
- If you have or have had cancer which is sensitive to oestrogens, such as cancer of the 

womb lining (endometrium), or if you are suspected of having it. 
- If you have recently had any unexplained vaginal bleeding. 
- If you have excessive thickening of the womb lining (endometrial hyperplasia) that is 

not being treated. 
- If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs 

(deep venous thrombosis), the lungs (pulmonary embolism) or eyes (retinal vein 
thrombosis). 

- If you have a blood clotting disorder (such as protein C, protein S, or antithrombin 
deficiency). 

- If you have or recently have had a disease caused by blood clots in the arteries, such as a 
heart attack, stroke or angina.  

- If you have or have ever had liver disease and your liver function tests have not returned 
to normal. 

- If you are pregnant or could still become pregnant or you are breast-feeding. 
- If you have a rare blood problem called porphyria, which is passed down in families 

(inherited).  
 
If you are not sure about any of the points above, talk to your doctor before taking this medicine.  
If any of the above conditions appear for the first time while taking this medicine, stop taking it at 
once and consult your doctor immediately. 
 
Warnings and precautions 
 
Talk to your doctor before taking this medicine if you have ever had any of the following problems, as 
these may return or become worse during treatment with DUAVIVE. If so, you should see your doctor 
more often for check-ups: 

 fibroids inside your womb 
 growth of womb lining outside your womb (endometriosis) or a history of excessive 

growth of the womb lining (endometrial hyperplasia) 
 increased risk of developing blood clots [see “Blood clots in a vein (thrombosis)”] 
 increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or 

grandmother who has had breast cancer)  
 high blood pressure 
 a liver disorder, such as a benign liver tumour 
 diabetes  
 gallstones  
 migraine or severe headaches 
 a rare disease of the immune system that affects many organs of the body (systemic lupus 

erythematosus, SLE) 
 seizures (epilepsy) 



32 

 asthma 
 a disease affecting the eardrum and hearing (otosclerosis) 
 a high level of fat in your blood (triglycerides) 
 fluid retention due to cardiac or kidney problems 

 
Stop taking DUAVIVE and see a doctor immediately 
 
If you notice any of the following: 

 any of the conditions mentioned under ‘Do not take DUAVIVE’ 
 yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a 

liver disease 
 a large increase in your blood pressure (symptoms may be headache, tiredness, dizziness) 
 migraine-like headaches which happen for the first time 
 if you become pregnant 
 you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden 

chest pain, or difficulty in breathing. For more information, see ‘Blood clots in a vein 
(thrombosis)’ 

 
DUAVIVE and cancer  
 
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining 
of the womb (endometrial cancer) 
This medicine contains conjugated oestrogens and bazedoxifene and is used to treat women with a 
uterus (womb). 
 
When you take DUAVIVE do not take additional oestrogens as this may increase the risk of 
endometrial hyperplasia. 
 
If you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible. 
 
Breast cancer  
Evidence suggests that taking oestrogen-only HRT possibly increases the risk of breast cancer. The 
extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. 
However, it returns to normal within a few years (at most 5) after stopping treatment. For women who 
are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown. 
 
The effect of DUAVIVE on the risk of breast cancer is unknown. 
 
Regularly check your breasts. See your doctor as soon as possible if you notice any changes, such 
as: 

 dimpling of the skin 
 changes in the nipple 
 any lumps you can see or feel 

 
Ovarian cancer 
Ovarian cancer is rare-much rarer than breast cancer. The use of oestrogen-only HRT has been 
associated with a slightly increased risk of ovarian cancer. 
 
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking 
HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women 
who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra 
case). Talk to your doctor if you have any concerns.  
 
The effect of DUAVIVE on the risk of ovarian cancer is unknown. 
 



33 

DUAVIVE and your heart or circulation 
 
Blood clots in a vein (thrombosis) 
DUAVIVE may increase the risk of blood clots. 
 
Oestrogen-only and bazedoxifene monotherapy increase the risk of blood clots in the veins (also called 
deep vein thrombosis, or DVT), especially during the first year of taking these medicines.  
 
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, 
collapse or even death. 
 
Since you are more likely to get a blood clot in your veins as you get older and if any of the following 
applies to you, inform your doctor promptly: 

 if you are unable to walk for a long time because of major surgery, injury or illness (see 
also section 3, if you need to have surgery) 

 if you are seriously overweight (BMI >30 kg/m2) 
 if you have any blood clotting problem that needs long-term treatment with a medicine 

used to prevent blood clots 
 if any of your close relatives has ever had a blood clot in the leg, lung or another organ 
 if you have systemic lupus erythematosus (SLE). 
 if you have cancer. 

 
If any of these conditions apply to you, talk to your doctor before you take this medicine. 
 
Heart disease (heart attack) 
There is no evidence that HRT will prevent a heart attack. Randomised controlled data found no 
increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy.  
 
Stroke 
The risk of having a stroke is about 1.5 times higher in HRT users than in non-users. The number of 
extra cases of stroke due to use of HRT will increase with age.  
  
For women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a 
stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 
1,000 users, over 5 years (i.e., 3 extra cases). 
 
The effect of DUAVIVE on the risk of stroke is unknown. 
 
Other things that can increase the risk of stroke include: 

 getting older 
 high blood pressure 
 smoking 
 drinking too much alcohol 
 an irregular heartbeat 

 
If you are having an operation  
 
If you are going to have surgery, tell the surgeon you are taking DUAVIVE. You may need to stop 
taking DUAVIVE about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see 
Blood clots in a vein). Ask your doctor when you can start taking this medicine again. 
 
In case of doubt, talk to your doctor before you take this medicine. 
 
Other conditions 
 
If you have any of the following your doctor should monitor you: 



34 

- kidney problems 
- pre-existing high level of fat in your blood (triglycerides) 
- liver problems 
- asthma 
- seizures (epilepsy) 
- migraine  
- systemic lupus erythematosus (SLE – a rare disease of the immune system that affects 

many organs of the body) 
- fluid retention 

 
Oestrogen therapy will not prevent memory loss. There is some evidence of a higher risk of memory 
loss in women who start using oestrogen therapy after the age of 65. Speak to your doctor for advice. 
 
Children and adolescents 
 
This medicine is not for use in children and adolescents below 18 years old. 
 
Other medicines and DUAVIVE 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Some medicines may interfere with the effect of DUAVIVE. This might lead to irregular bleeding. 
This applies to the following medicines: 

 Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine); 
 Medicines for tuberculosis (such as rifampicin, rifabutin); 
 Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir); 
 Herbal remedies containing St John’s Wort (Hypericum perforatum) 

 
Pregnancy and breast-feeding 
 

This medicine is for use only by postmenopausal women. Do not take this medicine if you are 
pregnant, or if you think you might be pregnant. Do not take this medicine if you are breast-feeding. 
 
Driving and using machines 
 
DUAVIVE has a minor effect on the ability to drive or use machines. 
 
If you feel drowsy after taking this medicine, you should avoid driving or operating machines.  
 
The bazedoxifene component of this medicine has been reported to cause problems with eyesight such 
as blurred vision. If this happens, you should avoid driving or operating machines until your doctor 
tells you that it is safe to do so. 
 
DUAVIVE contains lactose, sucrose, maltitol liquid, glucose and sorbitol 
 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before using this medicinal product. 
This medicine contains 0.0088 mg sorbitol in each tablet. 
 
 
3. How to take DUAVIVE  
 
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. 
Speak to your doctor if you think this dose is too strong or not strong enough.  
 



35 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet once daily.  
Swallow the tablet whole with a glass of water. 
 
You can take the tablet at any time of the day, with or without food; however, it is advisable to take 
your tablet at the same time each day as this will help to remind you to take your medicine. 
 
You should continue taking this medicine for as long as your doctor tells you. In order for this 
medicine to work, it should be taken daily as prescribed. 
 
If you take more DUAVIVE than you should 
 
Call your doctor or pharmacist. 
If you take too many tablets you may have nausea (feel sick) or vomit. You may experience breast 
tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal 
bleeding.  
 
If you forget to take DUAVIVE 
 
If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take 
your next tablet, skip the tablet you missed and only take your next scheduled tablet. Do not take a 
double dose to make up for a forgotten tablet. 
 
If you stop taking DUAVIVE 
 
If you decide to stop taking this medicine before finishing the prescribed course of treatment, you 
should talk to your doctor first. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Stop taking DUAVIVE and see a doctor immediately if you get any of the following serious side 
effects: 
 
Uncommon: may affect 1 in 100 people 

 If you begin to get migraine-like headaches, or severe headaches 
 
Rare: may affect up to 1 in 1,000 people 

 Signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain 
or difficulty in breathing.  

 Signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance 
including loss of vision, pain and swelling of the eye especially if sudden. 

 A severe allergic reaction - symptoms may include sudden wheezing and chest pain or 
tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, 
collapse 

 Swelling of the eyes, nose, lips, mouth, tongue or throat, difficulty in breathing, severe 
dizziness or fainting, skin rash (symptoms of angioedema) 

 Symptoms of pancreatitis which may include severe upper abdominal pain which may 
spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting  

 Abrupt onset of abdominal pain and passage of bright red blood in the stool, with or 
without diarrhoea due to sudden blockage of an artery supplying the intestines (ischaemic 



36 

colitis)  
 A heart attack - symptoms will usually include pain, including chest pain spreading to the 

jaw, neck and upper arm. You may feel sweaty, breathless, fatigued, nauseous and faint in 
addition to the pain 

 
Very rare: may affect up to 1 in 10,000 people 

 A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)  
 Erythema multiforme: symptoms may include skin rash with pink-red blotches especially 

on palms of hands or soles of feet which may blister. You may also have ulcers in the 
mouth, eyes or genitals and have a fever  

 
Not known: frequency cannot be estimated from the available data 

 Other ocular reactions (seeing sparks or flashes of light, narrowing of visual field, and 
swelling of eye or eye lid)  

 
Other side effects 
 
Very common: may affect more than 1 in 10 people 

 Abdominal pain (stomach ache) 
 
Common: may affect 1 in 10 people 

 Muscle spasms (including leg cramps) 
 Constipation 
 Diarrhoea 
 Nausea 
 Thrush (vaginal yeast infection) 
 Increases in your triglyceride levels (fatty substances in the blood) 

 
Uncommon: may affect 1 in 100 people 

 Gall bladder disease (e.g. gallstones, inflammation of the gall bladder (cholecystitis))  
 
The following side effects have been observed when either conjugated oestrogens and/or bazedoxifene 
(the active ingredients in this medicine) has been used alone and may occur also with this medicine: 
 
Very common: may affect more than 1 in 10 people 

 Hot flushes 
 Muscle cramps 
 Visible swelling of the face, hands, legs, feet or ankles (peripheral oedema) 

 
Common: may affect 1 in 10 people 

 Breast pain, breast tenderness, swollen breasts 
 Discharge from the nipples 
 Joint pain 
 Alopecia (hair loss) 
 Changes in weight (increase or decrease) 
 Increases in liver enzymes (identified in routine liver function testing) 
 Dry mouth 
 Drowsiness 
 Hives (urticaria) 
 Rash 
 Itching 

 
Uncommon: may affect up to 1 in 100 people 

 Vaginal inflammation 
 Vaginal discharge  



37 

 Cervical erosion found on medical examination  
 Blood clot in the leg veins 
 Blood clot in the lungs 
 Blood clot in a vein at the back of the eye (retinal vein) which may lead to loss of vision 
 Nausea (feeling sick) 
 Headache 
 Migraine 
 Dizziness 
 Changes in mood  
 Feeling nervous 
 Depression  
 Memory loss (dementia) 
 Changes in your interest in sex (increased or decreased libido) 
 Discolouration of the skin on the face or other parts of the body 
 Increase in hair growth 
 Difficulty wearing contact lenses  

 
Rare: may affect up to 1 in 1,000 people 

 Pelvic pain 
 Changes in breast tissue 
 Vomiting 
 Feeling irritable  
 An effect on the way in which your blood sugar (glucose) levels are controlled including 

increased glucose levels in the blood 
 A worsening of asthma 
 A worsening of epilepsy (seizures) 
 Growth of benign meningioma, a non-cancerous tumour of the membranes around the 

brain or spinal cord 
 
Very rare: may affect up to 1 in 10,000 people 

 Painful red bumps on the skin 
 A worsening of chorea (an existing neurological disorder characterised by involuntary 

spasmodic movements of the body) 
 Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver 
 Low levels of blood calcium (hypocalcaemia); frequently there will be no symptoms to 

suggest that your blood calcium is low, but when hypocalcaemia is severe you may feel 
tired, generally unwell, depressed and become dehydrated. This may be accompanied by 
bone pain and abdominal pain. Kidney stones may develop and cause severe pain in the 
mid-back region (renal colic).  

 Worsening of porphyria, a rare blood disorder which is passed down in families 
(inherited). 

 
Not known: frequency cannot be estimated from the available data 

 Palpitations (awareness of your heart beat) 
 Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, 

involuntary blinking or spasm of the eyelids)  
 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 



38 

 
5. How to store DUAVIVE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last date of that month. 
 
Do not store above 25C. 
  
Store in the original package in order to protect from moisture.  
  
After opening the blister pouch, use within 60 days. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What DUAVIVE contains  
 
The active substances are conjugated oestrogens and bazedoxifene. Each tablet contains 0.45 mg of 
conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene. 

 
The other ingredients are: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, 
containing glucose and sorbitol) and maltitol liquid (see section 2), microcrystalline cellulose, 
powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic 
acid, hypromellose (E464), povidone (E1201), poloxamer 188, calcium phosphate, titanium dioxide 
(E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) and propylene glycol (E1520).  
 
What DUAVIVE looks like and contents of the pack 
 
The DUAVIVE 0.45 mg/20 mg modified-release tablet is a pink, oval-shaped, tablet marked on one 
side with “0.45/20”. 
 
The modified-release tablets are provided in PVC/Aclar/PVC blister packs containing 28 tablets.  
 
Marketing Authorisation Holder 
 
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. 
 
Manufacturer 
  
Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België / Belgique / Belgien 
Pfizer SA/NV 
Tél/Tel: +32 (0)2 554 62 11  
 
 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 
 



39 

България 
Пфайзер Люксембург САРЛ,  
Клон България 
Ten: +359 2 970 4333 
 

Luxembourg / Luxemburg 
Pfizer SA/NV 
Tél/Tel: +32 (0)2 554 62 11  
 
 

Česká Republika 
Pfizer s.r.o.  
Tel: +420-283-004-111 
 

Magyarország 
Pfizer Kft 
Tel: +36 1 488 3700 

Danmark 
Pfizer ApS  
Tlf: +45 44 201 100  
 

Malta 
Vivian Corporation Ltd. 
Tel: +35621 344610 
 

Deutschland 
Pfizer Pharma PFE GmbH 
Tel: +49 (0)800 8535555 
 

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01 
 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal 
Tel.: +372 666 7500 
 

Norge 
Pfizer AS 
Tlf: +47 67 526 100  
 

Ελλάδα 
Pfizer Hellas A.E. 
Τηλ.: +30 210 6785 800 
 

Österreich 
Pfizer Corporation Austria Ges.m.b.H. 
Tel: +43 (0)1 521 15-0 
 

España 
Merck Sharp & Dohme de España, S.A. 
Télf.: +34 91 321 06 00 
 

Polska 
Pfizer Polska Sp. z o.o.  
Tel:+48 22 335 61 00  
 

France 
Pfizer  
Tel +33 (0)1 58 07 34 40 
 

Portugal 
Merck Sharp & Dohme, Lda 
Tel: + 351 21 4465700 
clic@merck.com 
 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: + 385 1 3908 777 

România 
Pfizer Romania S.R.L 
Tel: +40 (0) 21 207 28 00 
 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 
 
 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0) 1 52 11 400 
 

Ísland 
Icepharma hf 
Simi: +354 540 8000 
 

Slovenská Republika 
Pfizer Luxembourg SARL,  
organizačná zložka  
Tel: + 421 2 3355 5500 
 

Italia 
MSD Italia S.r.l. 
Tel: +39 06 361911 
medicalinformation.it@merck.com 
 

Suomi/Finland 
Pfizer Oy  
Puh/Tel: +358 (0)9 430 040 
 



40 

Kύπρος 
Pfizer Hellas (Cyprus Branch) A.E.  
Τηλ: +357 22 817690 
 

Sverige  
Pfizer AB  
Tel:+46 (0)8 550 520 00  

Latvijā 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 

United Kingdom 
Pfizer Limited,  
Tel: +44 (0) 1304 616161 
 

 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVEUSE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take duavive', 'Section_Content': 'medical history and regular check-ups the use of duavive carries risks, which need to be considered when deciding whether to start taking it, or whether to carry on taking it. there is no experience in treating women with a premature menopause (due to ovarian failure or surgery) with duavive. before you start taking this medicine, your doctor will ask you about your own and your family\'s medical history. your doctor may decide to perform a physical examination. this may include an examination of your breasts and/or an internal examination, if necessary, or if you have any special concerns. tell your doctor if you have any medical problems or illnesses. once you have started this medicine you should see your doctor for regular check-ups (at least once a year). during these check-ups, discuss with your doctor the benefits and risks of continuing with duavive. you are advised to: go for regular breast screening and cervical smear tests, as recommended by your doctor. regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. do not take duavive - if you are allergic to conjugated estrogens, bazedoxifene or any of the other ingredients of this medicine (listed in section 6). - if you have or have ever had breast cancer, or if you are suspected of having it. - if you have or have had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it. - if you have recently had any unexplained vaginal bleeding. - if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated. - if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis), the lungs (pulmonary embolism) or eyes (retinal vein thrombosis). - if you have a blood clotting disorder (such as protein c, protein s, or antithrombin deficiency). - if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina. - if you have or have ever had liver disease and your liver function tests have not returned to normal. - if you are pregnant or could still become pregnant or you are breast-feeding. - if you have a rare blood problem called porphyria, which is passed down in families (inherited). if you are not sure about any of the points above, talk to your doctor before taking this medicine. if any of the above conditions appear for the first time while taking this medicine, stop taking it at once and consult your doctor immediately. warnings and precautions talk to your doctor before taking this medicine if you have ever had any of the following problems, as these may return or become worse during treatment with duavive. if so, you should see your doctor more often for check-ups: fibroids inside your womb growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) increased risk of developing blood clots [see "blood clots in a vein (thrombosis)"] increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer) high blood pressure a liver disorder, such as a benign liver tumour diabetes gallstones migraine or severe headaches a rare disease of the immune system that affects many organs of the body (systemic lupus erythematosus, sle) seizures (epilepsy) 32 asthma a disease affecting the eardrum and hearing (otosclerosis) a high level of fat in your blood (triglycerides) fluid retention due to cardiac or kidney problems stop taking duavive and see a doctor immediately if you notice any of the following: any of the conditions mentioned under \'do not take duavive\' yellowing of your skin or the whites of your eyes (jaundice). these may be signs of a liver disease a large increase in your blood pressure (symptoms may be headache, tiredness, dizziness) migraine-like headaches which happen for the first time if you become pregnant you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing. for more information, see \'blood clots in a vein (thrombosis)\' duavive and cancer excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) this medicine contains conjugated oestrogens and bazedoxifene and is used to treat women with a uterus (womb). when you take duavive do not take additional oestrogens as this may increase the risk of endometrial hyperplasia. if you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible. breast cancer evidence suggests that taking oestrogen-only hrt possibly increases the risk of breast cancer. the extra risk depends on how long you take hrt. the additional risk becomes clear within a few years. however, it returns to normal within a few years (at most 5) after stopping treatment. for women who are using oestrogen-only hrt for 5 years, little or no increase in breast cancer risk is shown. the effect of duavive on the risk of breast cancer is unknown. regularly check your breasts. see your doctor as soon as possible if you notice any changes, such as: dimpling of the skin changes in the nipple any lumps you can see or feel ovarian cancer ovarian cancer is rare-much rarer than breast cancer. the use of oestrogen-only hrt has been associated with a slightly increased risk of ovarian cancer. the risk of ovarian cancer varies with age. for example, in women aged 50 to 54 who are not taking hrt, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. for women who have been taking hrt for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case). talk to your doctor if you have any concerns. the effect of duavive on the risk of ovarian cancer is unknown. duavive and your heart or circulation blood clots in a vein (thrombosis) duavive may increase the risk of blood clots. oestrogen-only and bazedoxifene monotherapy increase the risk of blood clots in the veins (also called deep vein thrombosis, or dvt), especially during the first year of taking these medicines. blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. since you are more likely to get a blood clot in your veins as you get older and if any of the following applies to you, inform your doctor promptly: if you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, if you need to have surgery) if you are seriously overweight (bmi >30 kg/m2) if you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots if any of your close relatives has ever had a blood clot in the leg, lung or another organ if you have systemic lupus erythematosus (sle). if you have cancer. if any of these conditions apply to you, talk to your doctor before you take this medicine. heart disease (heart attack) there is no evidence that hrt will prevent a heart attack. randomised controlled data found no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy. stroke the risk of having a stroke is about 1.5 times higher in hrt users than in non-users. the number of extra cases of stroke due to use of hrt will increase with age. for women in their 50s who are not taking hrt, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. for women in their 50s who are taking hrt, there will be 11 cases in 1,000 users, over 5 years (i.e., 3 extra cases). the effect of duavive on the risk of stroke is unknown. other things that can increase the risk of stroke include: getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat if you are having an operation if you are going to have surgery, tell the surgeon you are taking duavive. you may need to stop taking duavive about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see blood clots in a vein). ask your doctor when you can start taking this medicine again. in case of doubt, talk to your doctor before you take this medicine. other conditions if you have any of the following your doctor should monitor you: 34 - kidney problems - pre-existing high level of fat in your blood (triglycerides) - liver problems - asthma - seizures (epilepsy) - migraine - systemic lupus erythematosus (sle a rare disease of the immune system that affects many organs of the body) - fluid retention oestrogen therapy will not prevent memory loss. there is some evidence of a higher risk of memory loss in women who start using oestrogen therapy after the age of 65. speak to your doctor for advice. children and adolescents this medicine is not for use in children and adolescents below 18 years old. other medicines and duavive tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. some medicines may interfere with the effect of duavive. this might lead to irregular bleeding. this applies to the following medicines: medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine); medicines for tuberculosis (such as rifampicin, rifabutin); medicines for hiv infection (such as nevirapine, efavirenz, ritonavir and nelfinavir); herbal remedies containing st john\'s wort (hypericum perforatum) pregnancy and breast-feeding this medicine is for use only by postmenopausal women. do not take this medicine if you are pregnant, or if you think you might be pregnant. do not take this medicine if you are breast-feeding. driving and using machines duavive has a minor effect on the ability to drive or use machines. if you feel drowsy after taking 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{'Title': '3. how to take duavive', 'Section_Content': 'your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. speak to your doctor if you think this dose is too strong or not strong enough. always take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. the recommended dose is one tablet once daily. swallow the tablet whole with a glass of water. you can take the tablet at any time of the day, with or without food; however, it is advisable to take your tablet at the same time each day as this will help to remind you to take your medicine. you should continue taking this medicine for as long as your doctor tells you. in order for this medicine to work, it should be taken daily as prescribed. if you take more duavive than you should call your doctor or pharmacist. if you take too many tablets you may have nausea (feel sick) or vomit. you may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding. if you forget to take duavive if you forget to take a tablet, take it as soon as you remember. however, if it is almost time to take your next tablet, skip the tablet you missed and only take your next scheduled tablet. do not take a double dose to make up for a forgotten tablet. if you stop taking duavive if you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'duavive', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'the lowest dose', 'Type': 'TREATMENT', 'BeginOffset': 34, 'EndOffset': 49}, {'Text': 'your symptom', 'Type': 'PROBLEM', 'BeginOffset': 59, 'EndOffset': 71}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 191, 'EndOffset': 204}, {'Text': 'swallow', 'Type': 'TREATMENT', 'BeginOffset': 347, 'EndOffset': 354}, {'Text': 'your medicine', 'Type': 'TREATMENT', 'BeginOffset': 576, 'EndOffset': 589}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 618, 'EndOffset': 631}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 683, 'EndOffset': 696}, {'Id': 3, 'BeginOffset': 861, 'EndOffset': 867, 'Score': 0.9981343150138855, 'Text': 'nausea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7829316854476929}]}, {'Id': 4, 'BeginOffset': 874, 'EndOffset': 878, 'Score': 0.8555838465690613, 'Text': 'sick', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7594865560531616}]}, {'Id': 5, 'BeginOffset': 883, 'EndOffset': 888, 'Score': 0.9673618674278259, 'Text': 'vomit', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9129271507263184}]}, {'Id': 6, 'BeginOffset': 909, 'EndOffset': 926, 'Score': 0.8649118542671204, 'Text': 'breast tenderness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9749660491943359}]}, {'Id': 7, 'BeginOffset': 928, 'EndOffset': 937, 'Score': 0.9995672106742859, 'Text': 'dizziness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9826013445854187}]}, {'Id': 8, 'BeginOffset': 939, 'EndOffset': 953, 'Score': 0.9816498160362244, 'Text': 'abdominal pain', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9762015342712402}]}, {'Id': 9, 'BeginOffset': 955, 'EndOffset': 965, 'Score': 0.9984373450279236, 'Text': 'drowsiness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9818175435066223}]}, {'Id': 10, 'BeginOffset': 966, 'EndOffset': 973, 'Score': 0.9995730519294739, 'Text': 'fatigue', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9712576866149902}]}, {'Id': 11, 'BeginOffset': 1006, 'EndOffset': 1022, 'Score': 0.9445071220397949, 'Text': 'vaginal bleeding', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8499873280525208}]}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1256, 'EndOffset': 1269}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1361, 'EndOffset': 1374}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 1417, 'EndOffset': 1426}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1514, 'EndOffset': 1527}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. stop taking duavive and see a doctor immediately if you get any of the following serious side effects: uncommon: may affect 1 in 100 people if you begin to get migraine-like headaches, or severe headaches rare: may affect up to 1 in 1,000 people signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain or difficulty in breathing. signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance including loss of vision, pain and swelling of the eye especially if sudden. a severe allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse swelling of the eyes, nose, lips, mouth, tongue or throat, difficulty in breathing, severe dizziness or fainting, skin rash (symptoms of angioedema) symptoms of pancreatitis which may include severe upper abdominal pain which may spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting abrupt onset of abdominal pain and passage of bright red blood in the stool, with or without diarrhoea due to sudden blockage of an artery supplying the intestines (ischaemic 36 colitis) a heart attack - symptoms will usually include pain, including chest pain spreading to the jaw, neck and upper arm. you may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain very rare: may affect up to 1 in 10,000 people a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) erythema multiforme: symptoms may include skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister. you may also have ulcers in the mouth, eyes or genitals and have a fever not known: frequency cannot be estimated from the available data other ocular reactions (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eye lid) other side effects very common: may affect more than 1 in 10 people abdominal pain (stomach ache) common: may affect 1 in 10 people muscle spasms (including leg cramps) constipation diarrhoea nausea thrush (vaginal yeast infection) increases in your triglyceride levels (fatty substances in the blood) uncommon: may affect 1 in 100 people gall bladder disease (e.g. gallstones, inflammation of the gall bladder (cholecystitis)) the following side effects have been observed when either conjugated oestrogens and/or bazedoxifene (the active ingredients in this medicine) has been used alone and may occur also with this medicine: very common: may affect more than 1 in 10 people hot flushes muscle cramps visible swelling of the face, hands, legs, feet or ankles (peripheral oedema) common: may affect 1 in 10 people breast pain, breast tenderness, swollen breasts discharge from the nipples joint pain alopecia (hair loss) changes in weight (increase or decrease) increases in liver enzymes (identified in routine liver function testing) dry mouth drowsiness hives (urticaria) rash itching uncommon: may affect up to 1 in 100 people vaginal inflammation vaginal discharge 37 cervical erosion found on medical examination blood clot in the leg veins blood clot in the lungs blood clot in a vein at the back of the eye (retinal vein) which may lead to loss of vision nausea (feeling sick) headache migraine dizziness changes in mood feeling nervous depression memory loss (dementia) changes in your interest in sex (increased or decreased libido) discolouration of the skin on the face or other parts of the body increase in hair growth difficulty wearing contact lenses rare: may affect up to 1 in 1,000 people pelvic pain changes in breast tissue vomiting feeling irritable an effect on the way in which your blood sugar (glucose) levels are controlled including increased glucose levels in the blood a worsening of asthma a worsening of epilepsy (seizures) growth of benign meningioma, a non-cancerous tumour of the membranes around the brain or spinal cord very rare: may affect up to 1 in 10,000 people painful red bumps on the skin a worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body) enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver low levels of blood calcium (hypocalcaemia); frequently there will be no symptoms to suggest that your blood calcium is low, but when hypocalcaemia is severe you may feel tired, generally unwell, depressed and become dehydrated. this may be accompanied by bone pain and abdominal pain. kidney stones may develop and cause severe pain in the mid-back region (renal colic). worsening of porphyria, a rare blood disorder which is passed down in families (inherited). not known: frequency cannot be estimated from the available data palpitations (awareness of your heart beat) dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids) reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'duavive', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 38, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.964139461517334, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7832028269767761}]}, {'Id': 39, 'BeginOffset': 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{'Title': '5. how to store duavive', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton and blister after exp. the expiry date refers to the last date of that month. do not store above 25c. store in the original package in order to protect from moisture. after opening the blister pouch, use within 60 days. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'duavive', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'opening the blister pouch', 'Type': 'TREATMENT', 'BeginOffset': 309, 'EndOffset': 334}, {'Text': '60', 'Type': 'NUMBER', 'BeginOffset': 347, 'EndOffset': 349}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what duavive contains the active substances are conjugated oestrogens and bazedoxifene. each tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene. the other ingredients are: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (e1200, containing glucose and sorbitol) and maltitol liquid (see section 2), microcrystalline cellulose, powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, hypromellose (e464), povidone (e1201), poloxamer 188, calcium phosphate, titanium dioxide (e171), macrogol (400), red iron oxide (e172), black iron oxide (e172) and propylene glycol (e1520). what duavive looks like and contents of the pack the duavive 0.45 mg/20 mg modified-release tablet is a pink, oval-shaped, tablet marked on one side with "0.45/20". the modified-release tablets are provided in pvc/aclar/pvc blister packs containing 28 tablets.', 'Entity_Recognition': [{'Text': 'duavive', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 48, 'EndOffset': 69, 'Score': 0.591627299785614, 'Text': 'conjugated oestrogens', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 74, 'EndOffset': 86, 'Score': 0.993885338306427, 'Text': 'bazedoxifene', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9145087003707886, 'RelationshipScore': 0.9967343807220459, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 93, 'EndOffset': 99, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9116767048835754, 'RelationshipScore': 0.6944180130958557, 'RelationshipType': 'DOSAGE', 'Id': 3, 'BeginOffset': 109, 'EndOffset': 116, 'Text': '0.45 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '0.45', 'Type': 'NUMBER', 'BeginOffset': 109, 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