Senshio
1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Senshio 60 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each film-coated tablet contains 60 mg ospemifene. 

 

Excipient with known effect 

 

Each film-coated tablet contains 1.82 mg lactose as monohydrate. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet (tablet). 

Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed 

with “60” on one side. 
 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy 

(VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.  

 

4.2 Posology and method of administration 

 

Posology 

 

The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.  

 

If a dose is missed it should be taken with food as soon as the patient remembers. A double dose 

should not be taken in the same day.  

 

Special populations 

 

Elderly (>65 years old) 

No dose adjustment is necessary in patients above the age of 65 years (see section 5.2). 

 

Renal impairment 

No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see 

section 5.2).  

 



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Hepatic impairment 

No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Ospemifene 

has not been studied in patients with severe hepatic impairment, therefore Senshio is not 

recommended for use in such patients (see section 5.2).  

 

Paediatric population 

There is no relevant use of ospemifene in the paediatric population for the indication of the treatment 

of moderate to severe symptomatic VVA in post-menopausal women. 

 

Method of administration 

 

Oral use. 

 

One tablet should be swallowed whole once daily with food and should be taken at the same time each 

day.  

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, 

pulmonary embolism and retinal vein thrombosis. 

Unexplained vaginal bleeding. 

Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant 

therapy) for breast cancer (see section 4.4). 

Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer). 

Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been 

studied. 

 

4.4 Special warnings and precautions for use 

 

For the treatment of vulvar and vaginal atrophy, ospemifene should only be initiated for symptoms 

that adversely affect quality of life e.g. dyspareunia and vaginal dryness. In all cases, a careful 

appraisal of the risks and benefits should be undertaken at least annually taking into consideration 

other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and 

cerebrovascular risks. Ospemifene should only be continued as long as the benefit outweighs the risk. 

 

Endometrial findings 

 

In clinical studies, a mean increase of 0.8 mm in endometrial thickness after 12 months (as assessed by 

protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or 

spotting in the ospemifene-treated group compared to the placebo-treated group. If bleeding or 

spotting occurs on therapy, or continues after treatment has been discontinued, this should always be 

investigated, which may include an endometrial biopsy to exclude endometrial malignancy. The 

incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment 

with an upper 95% confidence limit of 1.74% (see section 5.1). In post-menopausal women who 

received ospemifene treatment up to 1 year, benign endometrial polyps were reported in 0.4% 

compared to 0.2% in women who received placebo treatment.  

 

Venous thromboembolic events (VTEs) 

 

The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective 

estrogen receptor modulators (SERMs). The risk of VTE associated with ospemifene cannot be 

excluded. Generally recognised risk factors for VTE include advanced age, a family history, severe 

obesity (BMI>30 kg/m
2
) and systemic lupus erythematosus (SLE). The risk of VTE is temporarily 

increased with prolonged immobilisation, major trauma or major surgery. Ospemifene should be 

discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation (e.g., post-surgical 

recovery, prolonged bed rest). Treatment should be resumed only after the patient is mobilised.  



4 

 

If VTE develops after initiating therapy, the treatment should be discontinued. Patients should be 

advised to contact their doctors immediately when they experience a potential thromboembolic 

symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea). 

 

Cerebro-vascular events 

 

The risk of cerebrovascular events is possibly increased with other SERMs. The risk of 

cerebrovascular events associated with ospemifene cannot be excluded. This should be considered 

when prescribing ospemifene for postmenopausal women with a history of stroke or other significant 

stroke risk factors.  

 

Pre-existing gynaecological pathology other than signs of vaginal atrophy 

 

There are limited clinical trial data on the use of ospemifene in patients with other gynaecological 

conditions. It is recommended that any additional pathology be investigated and treated appropriately 

before starting ospemifene. 

 

Breast cancer 

 

Ospemifene has not been formally studied in women with a prior history of breast cancer. No data are 

available on its concomitant use with medicinal products used in the treatment of early or advanced 

breast cancer. Therefore ospemifene should be used for the treatment of VVA only after the treatment 

of breast cancer, including adjuvant therapy, has been completed. 

 

Hot flushes 

 

Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes 

associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon 

beginning therapy. About 1% of subjects discontinued in the Phase 2/3 clinical programme due to hot 

flushes. 

 

Co-administration with fluconazole 

 

Caution is recommended when co-administering ospemifene with fluconazole (see section 4.5). If 

necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with 

fluconazole lasts. 

 

Lactose content 

 

Senshio contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase 

deficiency or glucose-galactose malabsorption should not take this medicinal product. 

 

Sodium content 

 

Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 
 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Effects of other medicinal products on ospemifene 

 

Fluconazole, a moderate CYP3A / moderate CYP2C9 / strong CYP2C19 inhibitor, increased the AUC 

of ospemifene by 2.7-fold. These results suggest that co-administration of ospemifene with any 

medicinal product that inhibits both CYP3A4 and CYP2C9 activity (e.g. fluconazole) would be 

expected to increase the exposure of ospemifene in a similar way. Therefore, caution is recommended 



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when co-administering ospemifene with fluconazole. In case of impaired tolerance of ospemifene, the 

latter should be stopped as long as treatment with fluconazole lasts. 

 

Ketoconazole, a strong CYP3A4 inhibitor and moderate P-glycoprotein inhibitor, increased the AUC 

of ospemifene by 1.4-fold. This increase is not considered to be clinically significant given the 

inherent pharmacokinetic variability of ospemifene. There is therefore no reason to expect that strong 

CYP3A4 inhibitors would cause a clinically meaningful change in ospemifene exposure. Co-

administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients 

who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous 

history/experience with other CYP2C9 substrates. 

 

Rifampicin, a strong CYP3A / CYP2C9 enzyme inducer, decreased the AUC of ospemifene by 58%. 

Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, 

phenytoin, St John’s wort and rifabutin would be expected to decrease the exposure of ospemifene, 
which may decrease the clinical effect.  

 

Inhibition of UGT1A3, UGT2B7, UGT1A1, or UGT1A8 may potentially affect the glucuronidation of 

ospemifene and/or 4-hydroxyospemifene. 

 

In healthy subjects, the absorption of ospemifene is not affected by co-administration of oral 

omeprazole, a medicinal product that increases gastric pH. 

 

Effects of ospemifene on other medicinal products 

 

Interaction studies were performed with probe substrates for CYP2C9 (warfarin), CYP3A4 

(midazolam), CYP2C19, and CYP3A4 (omeprazole) and CYP2B6 (bupropion). Ospemifene did not 

cause a clinically meaningful change in the exposure to the substrates, indicating that ospemifene does 

not affect those enzyme activities in vivo to a clinically significant extent. 

 

Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter 

(OCT)1 in vitro at clinically relevant concentrations. Therefore, ospemifene may increase 

concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, 

ganciclovir and oxaliplatin). 

 

In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation mainly via UGT1A3 and 

UGT1A9 at clinically relevant concentrations. The pharmacokinetics of medicinal products that are 

mainly metabolised by UGT1A3 and UGT1A9 could be affected when administered concomitantly 

with ospemifene and co-administration should be made with caution. 

 

The safety of using ospemifene concomitantly with oestrogens or other SERMS, such as tamoxifen, 

toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not 

recommended. 

 

Due to its lipophilic nature and absorption characteristics, an interaction between ospemifene and 

medicinal products like orlistat, cannot be ruled out. Therefore, caution is recommended when 

ospemifene is combined with orlistat. A clinical monitoring of a decrease in the efficacy of 

ospemifene should be made. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

Senshio is only for use in postmenopausal women and should not be used in women of child-bearing 

potential. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn 

immediately.  

There are no data on the use of ospemifene in pregnant women. Studies in animals have shown 

reproductive toxicity (see section 5.3). The potential risk in humans is unknown. 



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Breast-feeding 

 

Senshio is not indicated during breast-feeding. 

 

Fertility 

 

Ospemifene is not indicated for fertile women. 

 

4.7 Effects on ability to drive and use machines 

 

Senshio has no or negligible influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most frequently reported adverse reactions are hot flushes (7.5%). 

 

Tabulated list of adverse reactions 

 

Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency. 

Frequencies are defined 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); not known (cannot be estimated from 
available data).  

 

Adverse reactions  

MedDRA system organ class Common Uncommon 

Infections and infestations Vulvovaginal candidiasis / 

mycotic infections 
- 

Immune system disorders 

- 

Drug hypersensitivity
b
,  

Hypersensitivity
b
,  

Swollen tongue 

Nervous system disorders Headache
c
  

Vascular disorders Hot flush - 

Skin and subcutaneous tissue 

disorders 

Rash (includes rash 

erythematous, rash generalised) 

Pruritus 

Urticaria 

Musculoskeletal and connective 

tissue disorders 

Muscle spasms 
- 

Reproductive system and breast 

disorders 

Vaginal discharge,  

Genital discharge, Vaginal 

haemorrhage 

Endometrial hypertrophy
a
 

(sonographic endometrial 

thickness) 

a
 Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial 

thickness findings. 

b
 Hypersensitivity reactions including adverse reactions listed under skin and subcutaneous tissue 

disorders, swollen tongue, pharyngeal oedema and throat tightening were reported. 

c 
The frequency of headache reported in the table is that calculated from the Phase 2/3 clinical trials, 

where the frequency was comparable between 60 mg ospemifene (5.4%) and placebo (5.9%) groups. 

 

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. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 

 

Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses 

up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks. There is no specific antidote for 

ospemifene. In the event of overdose, general supportive measures should be initiated based on the 

patient’s signs and symptoms. 
 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, selective estrogen 

receptor modulators, ATC code: G03XC05. 

 

Pharmacodynamic effects 

 

Decreases in oestrogen levels that occur after the menopause lead to VVA, characterised by decreased 

maturation of vaginal epithelial cells, a progressive decrease in the vascularity of the vaginal tissues, 

and decreased lubrication. The glycogen content of vaginal epithelial cells also decreases, resulting in 

reduced colonisation by lactobacilli and increased vaginal pH. These changes result in clinical signs 

which include vaginal dryness, redness, petechiae, pallor, and friability in the mucosa. In addition, 

these changes can result in chronic symptoms associated with VVA, the most common of which are 

vaginal dryness and dyspareunia.  

 

Ospemifene’s biological actions are mediated through the binding of ospemifene and its major 
metabolite to oestrogen receptors. The relative contribution of the metabolite to the pharmacological 

effect is estimated to be approximately 40%. This binding results in activation of some oestrogenic 

pathways (agonism) and blockade of other oestrogenic pathways (antagonism). The biological activity 

profile in humans is predominantly due to the parent compound. 

 

Nonclinical findings show that ospemifene and its major metabolite have an oestrogen like effect in 

the vagina increasing the cellular maturation and mucification of the vaginal epithelium. In the 

mammary gland, they have a predominantly oestrogen antagonist effect. In bone, ospemifene has 

agonist-like activity. In the uterus ospemifene and its major metabolite have weak partial 

agonist/antagonist effects. These non-clinical findings are consistent with findings from clinical trials, 

in which ospemifene demonstrated benefits on vaginal physiology without apparent oestrogen-like 

effects on breast tissue (see subheading Clinical safety). 

 

Clinical efficacy and safety  

 

The clinical efficacy and safety of ospemifene was determined primarily from two multi-centre, 

placebo-controlled trials of 12 weeks duration (trials 1 and 2) and a third long-term safety trial of 

52 weeks duration (trial 3) in post-menopausal patients with VVA. In those trials, a total of 

1,102 subjects received 60 mg of ospemifene and 787 subjects received placebo. 

In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients 

received placebo. All patients received non-hormonal vaginal lubricant for use as needed; therefore, 

the effects on efficacy endpoints in the ospemifene treatment group were in addition to those achieved 

with lubricant use alone. The study population consisted of generally healthy post-menopausal women 

between 41 to 80 years of age (mean age = 59 years), who at baseline had ≤ 5.0% superficial cells in 
the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA 

symptom, where patients had to choose the symptom that was the most bothersome (MBS). There 

were four co-primary endpoints for which change from baseline was assessed: percentage parabasal 

cells and superficial cells in the vaginal smear, vaginal pH, and MBS of VVA (dryness or 

dyspareunia).  

 



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The long-term study (trial 3) was a 52-week, randomised, double-blind, placebo-controlled safety and 

efficacy study in 426 postmenopausal women with an intact uterus. Of the 426 subjects enrolled in the 

study, 363 (85.2%) subjects were randomised to once-daily oral doses of ospemifene 60 mg and 

63 (14.8%) subjects were randomised to placebo. The mean age of participants was 61.7 years in the 

ospemifene 60 mg group and 62.9 years in the placebo group. 

 

Clinical efficacy 

 

Physiological responses (objective measures) 

Ospemifene (OSP) improved post-menopausal physiologic changes. In two separate 12 week pivotal 

trials (trials 1 and 2), ospemifene was associated with a statistically significant mean decrease from 

baseline in the percentage of parabasal cells and vaginal pH and a statistically significant mean 

increase from baseline in the percentage of superficial cells, compared with placebo (P<0.001 for each 

parameter) at weeks 4 and 12. This improvement in objective measures (superficial and parabasal cells 

and pH) were sustained in ospemifene treated women in a long-term study of up to 52 weeks. The 

magnitude of effect was similar in all three trials.  

 

Symptoms (subjective measures) 

The most bothersome symptom (MBS) was assessed at baseline, 4 and 12 weeks with the severity 

scored as follows: None=0, Mild=1, Moderate=2, Severe=3. Table 1 shows the mean change in 

severity score in MBS after 12 weeks with the associated statistical testing for the difference vs. 

placebo for trials 1 and 2.  

 

Table 1: Primary efficacy analysis - change from baseline to week 12 in most bothersome 

symptom (ITT, LOCF) 

 

Study Dryness Dyspareunia 

 60 mg OSP Placebo p-value 60 mg OSP Placebo p-value 

Trial 1 -1.26 -0.84 0.021 -1.19 -0.89 0.023 

Trial 2 -1.3 -1.1 0.0803 -1.5 -1.2 0.0001 

 

Table 2 shows the percentage of subjects who reported a change in their MBS at week 12.  

“Improvement” was defined as a reduction in the severity score of 1 or more.  
“Relief” was defined as no or only mild symptoms at week 12.  
“Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and 
changed from severe to mild or severe or moderate to none. 

 

Table 2. Percentage of patients with improvement, relief or substantial improvement of MBS 

after 12 weeks on ospemifene vs. placebo (ITT, LOCF) 

 

 
Improvement Relief 

Substantial 

improvement 

60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo 

Trial 1 

Dryness 

74.6% 57.7% 66.1% 49.0% 42.4% 26.9% 

P=0.0101 P=0.0140 P=0.0172 

Trial 2 

Dryness 

70.6% 68.2% 61.9% 53.2% 46.3% 34.3% 

P=0.7134 P=0.1380 P=0.0385 

Trial 1 

Dyspareunia 

68.3% 54.1% 57.5% 41.8% 40.8% 29.5% 

P=0.0255 P=0.0205 P=0.0799 

Trial 2 

Dyspareunia 

79.9% 63.9% 63.0% 47.4% 52.8% 38.7% 

P=0.0000 P=0.0001 P=0.0006 

 

A trend was observed in both trials in the improvement of MBS from baseline to week 4 in favour of 

ospemifene compared to placebo, although the difference was not statistically significant.  

 



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Clinical Safety 

Across all placebo-controlled clinical trials of ospemifene, deep vein thrombosis occurred at a 

frequency of approximately 3.65 cases per 1,000 patient years on 60 mg ospemifene (95% confidence 

interval of 0.44 to 13.19) versus 3.66 cases per 1,000 patient years for placebo (95% confidence 

interval of 0.09 to 20.41; relative risk is 1.0). 

 

Endometrial safety in women was assessed at baseline and 12 weeks in the two 12-week phase III 

studies (trials 1 and 2: ospemifene, n=302; placebo, n= 301). For subjects completing the trial 1 

extension study (ospemifene, n=41; placebo, n= 18) and for subjects in the long-term 52-week safety 

study (trial 3: ospemifene, n=276; placebo, n=46), endometrial safety was assessed by endometrial 

biopsy at baseline and at 12 months. In total, there were 317 subjects on ospemifene and 64 subjects 

on placebo who had a baseline as well as a week 52 biopsy. No cases of endometrial hyperplasia were 

reported at either time point.  

 

There was a single subject (0.3%) who developed endometrial hyperplasia in the ospemifene group 

(simple hyperplasia without atypia) 88 days after the last dose of study drug. No subjects in either 

group developed endometrial cancer or breast cancer during the trials. Across all placebo controlled 

clinical trials, there was no significant difference in breast related adverse events between ospemifene 

and placebo. The incidence of abnormal, but not clinically significant, findings on breast palpation and 

mammography decreased in the ospemifene 60 mg population during the 1-year study (trial 3) from 

1.6% to 0.6% and from 11.8% to 8.1% respectively. In contrast, abnormal, not clinically significant, 

findings on mammography increased in the placebo population from 6.5% to 8.3%. There were no 

abnormal breast palpation findings in the placebo group at baseline or at study end. 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

ospemifene in all subsets of the paediatric population in VVA (see section 4.2 for information on 

paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Ospemifene is absorbed rapidly after oral administration, with a Tmax of approximately 3 - 4 hours 

post-dose in the fed state. The absolute bioavailability of ospemifene has not been established. Mean 

ospemifene Cmax and AUC0-24hr were 785 ng/mL and 5,448 ng•hr/mL, respectively, after repeat doses 
of 60 mg ospemifene once daily in the fed state.  

 

When ospemifene is administered with a high fat meal, the Cmax and AUC are 2.5-fold and 1.9-fold 

higher, respectively, with lower variability relative to the fasting state. A low fat meal resulted in 

approximately a two-fold increase in exposure of ospemifene and a high fat meal resulted in 

approximately a three-fold increase in exposure of ospemifene in two food effect studies with tablet 

formulations different from the commercial formulation. It is recommended that ospemifene should be 

taken with food at the same time each day. 

 

 

Distribution 

 

Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins. Plasma/blood 

cell partitioning of [
14

C]-Ospemifene (< 3%) and [
14

C]-4-hydroxyospemifene (< 2%) is low. The 

apparent volume of distribution is 448 l. 

 

Biotransformation 

 

Ospemifene and its major metabolite, 4-hydroxyospemifene, are metabolised by multiple metabolic 

pathways, the main enzymes involved are UGT1A3, UGT2B7, UGT1A1 and UGT1A8, and CYP2C9, 



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CYP3A4 and CYP2C19. The major metabolite, 4-hydroxyospemifene, was seen to undergo formation 

rate-limited elimination (with t1/2 similar to the parent compound) in a human mass balance study. The 

principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4-

hydroxyospemifene. Ospemifene and 4-hydroxyospemifene accounted for approximately 20% and 

14% of the total radioactivity in serum, respectively. The apparent total body clearance is 9.16 l/hr 

using a population approach.  

 

In vitro, ospemifene and 4-hydroxyospemifene did not inhibit or induce the activity of CYP450 

enzymes at clinically relevant concentrations. In vitro, ospemifene and 4-hydroxyospemifene inhibited 

glucuronidation via UGT1A3 and UGT1A9 at clinically relevant concentrations. In in vitro studies 

ospemifene is a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6. 

Furthermore in vitro studies have shown that ospemifene is a weak inducer for CYP2B6 and CYP3A4. 

In in vitro studies, ospemifene and 4-hydroxyospemifene did not inhibit P-glycoprotein (P-gp), breast 

cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, 

OCT2, organic anion transporter (OAT)1, OAT3, or bile salt export pump (BSEP) transporters at 
clinically relevant concentrations. It is unknown if ospemifene is a substrate for BCRP in the intestine. 

Therefore care should be taken if ospemifene is administered with a BCRP inhibitor. 

 

Elimination 

 

The apparent terminal half-life of ospemifene in post-menopausal women is approximately 25 hours. 

Following oral administration of [
3
-H]-ospemifene in the fasted state, approximately 75% and 7% of 

the dose was excreted in faeces and urine respectively. Less than 0.2% of the ospemifene dose was 

excreted unchanged in urine. Following a single oral administration of 60 mg ospemifene in the fed 

state, 17.9%, 10.0% and 1.4% of the administered dose was excreted in faeces as ospemifene, 4-

hydroxyospemifene and 4’-hydroxyospemifene, respectively. The fate of remaining fraction is 
unknown but can probably be explained by formation of glucuronide metabolites. 

 

Linearity/non-linearity 

 

Ospemifene exhibits linear pharmacokinetics in the fed state within the dose range of 60 mg to 240 mg. 

 

Pharmacokinetics in subpopulations 

 

Age 

No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age 

range studied (40-80) years of age. No dose adjustment is necessary in elderly patients. 

 

Paediatric population 

Pharmacokinetic studies have not been performed with ospemifene in the paediatric population. 

 

Renal impairment 

Renal clearance of unchanged active substance is a minor pathway of elimination, less than 0.2% of 

the ospemifene dose is excreted unchanged in urine. In patients with severe renal impairment the 

ospemifene exposure was increased by approximately 20%, when compared to healthy matched 

subjects. No clinically important pharmacokinetic differences between subjects with severe renal 

impairment and healthy subjects were observed. This difference is not considered clinically relevant 

and no dose adjustment is necessary in patients with renal impairment. 

 

Hepatic impairment 

Ospemifene is primarily metabolised by the liver. The pharmacokinetics of ospemifene is only mildly 

affected by mild and moderate hepatic impairment (Child Pugh scores 5-9) when compared to healthy 

matched controls. In patients with moderate hepatic impairment the exposure of ospemifene and 

4-hydroxyospemifene was approximately 30% and 70% higher. These changes in pharmacokinetics of 

ospemifene by moderate hepatic impairment are not considered to be clinically significant in 

consideration of inherent pharmacokinetic variability of ospemifene. No dose adjustment is necessary 



11 

in patients with mild or moderate hepatic impairment. The pharmacokinetics of ospemifene has not 

been evaluated in patients with severe hepatic impairment (Child-Pugh Class score >9). 

 

Other special populations 

 

Gender  

Senshio is indicated for use only in postmenopausal women.  

 

Race 

Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 

93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials. There were no discernible 

differences in ospemifene plasma concentrations among these groups; however, the influence of race 

cannot be conclusively determined. 

 

CYP2C9 poor metabolisers 

 

Both CYP2C9 and CYP3A4 are involved in the metabolism of ospemifene. Co-administration of 

ketoconazole, a strong CYP3A4 inhibitor, increased the AUC of ospemifene by 1.4-fold. In CYP2C9 

poor metabolizers, co-administration of CYP3A4 inhibitors may increase systemic concentration of 

ospemifene to a larger extent. Therefore, co-administration of ospemifene with strong/moderate 

CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor 

metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates. 

 

5.3 Preclinical safety data 

 

In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of 

toxicity were the ovary, uterus and the liver. Ospemifene-related changes included ovarian follicular 

cysts, endometrial stromal atrophy and endometrial hypertrophy/hyperplasia which are consistent with 

the pharmacologic activity of ospemifene in the intact, normally cycling animal. In the liver 

hepatocyte hypertrophy or increased glycogen storage, increase in alanine aminotransferase (ALT) and 

alkaline phosphatase (ALP) were observed. Overall, these findings are characteristic for an induction 

of CYP isoenzymes and are regarded as adaptive responses without any histopathological signs of 

liver injury. No changes in blood biochemical parameters such as ALT or ALP were determined in 

postmenopausal women treated with Ospemifene in clinical studies. Taken together, the liver changes 

observed in experimental animals in repeat dose toxicity studies are regarded as adaptive changes due 

to enzyme induction and given the lack of any clinical signs are unlikely to represent a safety concern 

for humans. 

 

Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in 

vivo tests. 

 

In a 2-year carcinogenicity study in female mice, ospemifene caused treatment related increases in 

neoplastic findings in the adrenal gland and ovary. Systemic exposure (AUC) at these doses was 2.1-, 

4.0- and 4.7-times the AUC in postmenopausal woman administered 60 mg/day. In the adrenal gland, 

there was an increased incidence of adrenal subcapsular cell and adrenal cortical tumours in animals 

dosed at high dose. In the ovary, there was an increase in sex-cord stromal tumours, tubulostromal 

tumours, granulosa cell tumours and luteomas in all treatment groups. 

 

In a 2-year carcinogenicity study in rats, a clear increase in mostly benign thymic tumours was 

recorded at all ospemifene dose levels. This effect was likely due to the anti-oestrogenic effect of 

ospemifene in this target tissue, which was attenuating the physiological thymic involution (atrophy) 

process induced by oestrogens starting during puberty. In the liver, an increase in hepatocellular 

tumours were recorded at all ospemifene dose levels. Systemic exposure (AUC) at the administered 

doses was 0.3-, 1.0- and 1.2-times the AUC in postmenopausal woman administered 60 mg/day. 

 



12 

Overall, tumour development in these studies is believed to be the result of rodent specific hormonal 

mechanisms when treated during their reproductive lives; these findings are unlikely to have any 

clinical relevance in postmenopausal women. 

 

Ospemifene was not teratogenic in rats or rabbits. In a two-generation reproductive study on pre-and 

postnatal development ospemifene induced an increased post-implantation loss, an increased number 

of dead pups at birth as well as an increased incidence of postnatal loss of pups in the F1 generation. 

In the F0 maternal generation, a significant prolonged gestation was observed. However, all exposures 

were far below the intended human exposure. The reproductive effects observed are considered to be 

related to oestrogen receptor activity of ospemifene. Fertility studies were not conducted. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core: 

 

Colloidal silicon dioxide (E 551) 

Magnesium stearate (E 578) 

Mannitol (E 421) 

Microcrystalline cellulose (E 460) 

Povidone (E 1201) 

Pregelatinised starch (maize) 

Sodium starch glycolate (type A) 

 

Film coating: 

 

Hypromellose (E 464) 

Lactose monohydrate 

Titanium dioxide (E 171) 

Triacetin (E 1518) 

Macrogols (E 1521) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

5 years. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 

PVC/PVdC-Aluminium blister. Pack sizes of 7, 28 or 84 film-coated tablets.  

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 



13 

7. MARKETING AUTHORISATION HOLDER

Shionogi B.V. 

Kingsfordweg 151  

1043GR Amsterdam 

Netherlands 

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/978/001 

EU/1/14/978/002 

EU/1/14/978/003 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2015 

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. 



14 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) 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 

 

 



15 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

Penn Pharmaceutical Services Ltd  

23-24 Tafarnaubach Industrial Estate  

Tredegar, Gwent, South Wales  

NP22 3AA 

United Kingdom 

 

Manufacturing Packaging Farmaca (MPF) B.V. 

Appelhof 13 

8465RX  

Oudehaske 

The Netherlands  

 

Shionogi B.V. 

Kingsfordweg 151  

1043GR Amsterdam 

Netherlands 

 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

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 THE 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.  

 

 



16 

 Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures: 

Description Due date 

Non-interventional post-authorisation safety study (PASS): An observational 

retrospective cohort study of ospemifene to assess the incidence of venous 

thromboembolism and other safety concerns as agreed in the risk management plan, in 

VVA patients treated with ospemifene compared to 1) patients newly prescribed 

SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the 

incidence in untreated VVA patients. 

28 Feb 2021 



17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



18 

A. LABELLING 



19 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON 

1. NAME OF THE MEDICINAL PRODUCT

Senshio 60 mg film-coated tablets 

ospemifene 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 60 mg ospemifene. 

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

7 film-coated tablets 

28 film-coated tablets 

84 film-coated tablets 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 

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 

9. SPECIAL STORAGE CONDITIONS



20 

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 

 

Shionogi B.V. 

Kingsfordweg 151  

1043GR Amsterdam 

Netherlands 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/978/001   7 film-coated tablets 

EU/1/14/978/002   28 film-coated tablets 

EU/1/14/978/003   84 film-coated tablets 

 

 

13. BATCH NUMBER 

 

BN 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Senshio 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 

PC  

SN  

NN  

 



21 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER 

1. NAME OF THE MEDICINAL PRODUCT

Senshio 60 mg tablets 

ospemifene 

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Shionogi 

3. EXPIRY DATE

EXP 

4. BATCH NUMBER

BN 

5. OTHER

Mon. 

Tue. 

Wed. 

Thu. 

Fri. 

Sat. 

Sun. 



22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 

 



23 

Package leaflet: Information for the patient 

Senshio 60 mg film-coated tablets 

ospemifene 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

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 Senshio is and what it is used for

2. What you need to know before you take Senshio

3. How to take Senshio

4. Possible side effects

5. How to store Senshio

6. Contents of the pack and other information

1. What Senshio is and what it is used for

Senshio contains the active substance ospemifene. Ospemifene belongs to a group of medicines that 

do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).  

Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside 

the vagina, such as itching, dryness, burning and pain during sex (dyspareunia) if local oestrogen 

therapy is not suitable. This is known as vulvar and vaginal atrophy. It is caused by a lowering in the 

levels of the female hormone oestrogen in your body. When this happens, the vaginal walls can 

become thinner. This happens naturally after menopause (post-menopause). 

Senshio works in a similar way to some of the helpful effects of oestrogen, helping to improve these 

symptoms and the underlying causes of vulvar and vaginal atrophy. 

2. What you need to know before you take Senshio

Do not take Senshio 

- If you are allergic to ospemifene or any of the other ingredients of this medicine (listed in 

section 6). 

- If you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep 

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

- If you have unexplained vaginal bleeding.  

- If your doctor thinks you might have breast cancer or you are being treated for breast cancer. 

- If your doctor thinks you might have or you are being treated for cancer which is sensitive to 

oestrogens, such as cancer of the womb. 

- If you have excessive thickening of the womb lining, such as endometrial hyperplasia. 



24 

Warnings and precautions  

Once you have started on Senshio you should see your doctor for regular check-ups (at least once a 

year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Senshio. 

Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.  

- Any of your close relatives has ever had a blood clot in the leg, lung or other organ. 

- You are seriously overweight (BMI >30 kg/m
2
). 

- You have an autoimmune condition called systemic lupus erythematosus (SLE).  

- If you have had a stroke (a cerebrovascular accident), or if your doctor has told you that you are at 

high risk of having one. 

- If you are suffering from any gynaecological illness other than vulvar and vaginal atrophy. 

- If you have had breast cancer.  

While taking Senshio: 

- If you are unable to walk for a long time or are sitting for a long time in the same position because 

of major surgery, injury or illness, it may prevent good blood circulation and may temporarily 

increase your risk of blood clots. You should therefore speak to your doctor immediately. Your 

doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or 

during a long period of bed rest e.g. injury or illness. Treatment with Senshio can be restarted as 

soon as you regain your mobility and in consultation with your doctor. 

- If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you 

should speak to your doctor. 

- If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden 

chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see 

a doctor immediately. 

Children and adolescents 

Do not give this medicine to children or adolescents. This medicine is only intended for use in post-

menopausal women. 

Other medicines and Senshio 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines.  

Do not take Senshio with any of these medicines: 

 Oestrogens.
 Any other medicine belonging to the group called SERMs, such as tamoxifen, toremifene,

bazedoxifene and raloxifene.

Talk to your doctor
 
before taking Senshio with: 

 Fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount
of ospemifene in your blood. Your doctor may consider stopping treatment with Senshio while 

you are taking fluconazole. 

 Any of the following medicines, which may lead to a reduced effect of Senshio:
o Rifampicin and rifabutin commonly used to treat tuberculosis.

o Carbamazepine and phenytoin used to treat convulsions/seizures (anticonvulsants).

o St John’s wort, a herbal medicine sometimes used to treat depression.
o Orlistat sometimes used to treat obesity.

 Any of the following medicines, as their concentrations may be increased while taking Senshio:
o Metformin used to treat Type II diabetes.

o Aciclovir used to treat cold sores and genital herpes.

o Ganciclovir used to treat infections caused by a virus called cytomegalovirus.

o Oxaliplatin, an anti-cancer medicine for advanced (metastatic) cancer of the large bowel

(colon) or back passage (rectum).



25 

Pregnancy, breast-feeding and fertility 

Senshio is for use only in postmenopausal women. It must not be taken by women who are pregnant, 

who could still have a baby or are breast-feeding. This is because there are no data on the use of 

Senshio in pregnant or pre-menopausal women or those who are breast-feeding. 

Tell your doctor immediately if you become pregnant while taking Senshio; treatment should be 

stopped immediately. 

Driving and using machines 

Senshio has no known or very little influence on the ability to drive and use machines. 

Senshio contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 

before taking this medicine. 

Senshio contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 

3. How to take Senshio

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

The recommended dose is one tablet taken orally at the same time each day. Senshio should be taken 

with food. The tablets should be swallowed whole with food.  

Senshio must be taken every day for as long as your doctor tells you to. 

Patients with liver disease 

This medicine is not recommended if you have severely reduced liver function. 

If you take more Senshio than you should 

If you take more tablets than you should, tell your doctor or pharmacist. 

If you forget to take Senshio 

If you forget to take a tablet you should take the missed tablet (with food) as soon as you remember 

within the same day. Do not take two tablets in one day to make up for a forgotten tablet. 

If you stop using Senshio 

You will not benefit from the effects of Senshio if you stop using it without talking to your doctor. 

Your doctor will explain the effects of stopping treatment and will also discuss other possibilities for 

treatment with you. 

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. 

Common side effects (may affect up to 1 in 10 people): 

- An infection of the genitals caused by a fungus (thrush) 

- Hot flushes 

- Muscle cramps 

- Vaginal or genital discharge 

- Rash 



26 

- Headache 

- Vaginal bleeding 

Uncommon side effects (may affect up to 1 in 100 people): 

- Thickening of the womb lining (endometrium) as seen on ultrasound scan (endometrial 

hypertrophy). 

- An allergic reaction. Symptoms of an allergic reaction may include rash, itchy skin, raised patches 

on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing 

or swallowing. 

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. 

5. How to store Senshio

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 day of that month. 

This medicine does not require any special storage conditions. 

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 Senshio contains  

- The active substance is ospemifene. Each film-coated tablet contains 60 mg ospemifene. 

- The other ingredients are: 

Tablet core: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), 

microcrystalline cellulose (E 460), povidone (E 1201), pregelatinised starch (maize), 

sodium starch glycolate (type A). 

Film coating: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin 

(E 1518), polyethylene glycol (E 1521). 

What Senshio looks like and contents of the pack 

Senshio tablets are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long 

by 6.45 mm wide) debossed with “60” on one side.  
They are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets.  

Not all pack sizes may be marketed. 

Marketing Authorisation Holder 

Shionogi B.V. 

Kingsfordweg 151  

1043GR Amsterdam 

Netherlands 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


27 

Manufacturer 

Penn Pharmaceutical Services Ltd  

23-24 Tafarnaubach Industrial Estate 

Tredegar, Gwent, South Wales  

NP22 3AA  

United Kingdom  

Manufacturing Packaging Farmaca (MPF) B.V. 

Appelhof 13  

8465RX  

Oudehaske  

Netherlands 

Shionogi B.V. 

Kingsfordweg 151  

1043GR Amsterdam 

Netherlands 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, 

IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK 

Shionogi B.V. 

Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: 
+ 31 (0)20 703 8327 
contact@shionogi.eu 

DE 

Shionogi GmbH 

Tel: +49 (0)89 2109 3049 

kontakt@shionogi.eu 

ES 

Shionogi SLU 

Tel: +34 911 239 258 

contacta@shionogi.eu 

IT 

Shionogi Srl 

Tel: +39 06 94 805 118 

contattaci@shionogi.eu 

UK 

Shionogi B.V. 

Tel +44 (0)20 3053 4190 

contact@shionogi.eu 

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(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take senshio', 'Section_Content': "do not take senshio - if you are allergic to ospemifene or any of the other ingredients of this medicine (listed in section 6). - if you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis). - if you have unexplained vaginal bleeding. - if your doctor thinks you might have breast cancer or you are being treated for breast cancer. - if your doctor thinks you might have or you are being treated for cancer which is sensitive to oestrogens, such as cancer of the womb. - if you have excessive thickening of the womb lining, such as endometrial hyperplasia. warnings and precautions once you have started on senshio you should see your doctor for regular check-ups (at least once a year). at these check-ups, discuss with your doctor the benefits and risks of continuing with senshio. talk to your doctor or pharmacist before taking senshio if any of the following apply to you. - any of your close relatives has ever had a blood clot in the leg, lung or other organ. - you are seriously overweight (bmi >30 kg/m 2 ). - you have an autoimmune condition called systemic lupus erythematosus (sle). - if you have had a stroke (a cerebrovascular accident), or if your doctor has told you that you are at high risk of having one. - if you are suffering from any gynaecological illness other than vulvar and vaginal atrophy. - if you have had breast cancer. while taking senshio: - if you are unable to walk for a long time or are sitting for a long time in the same position because of major surgery, injury or illness, it may prevent good blood circulation and may temporarily increase your risk of blood clots. you should therefore speak to your doctor immediately. your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness. treatment with senshio can be restarted as soon as you regain your mobility and in consultation with your doctor. - if any vaginal bleeding occurs while taking senshio or soon after you have stopped taking it, you should speak to your doctor. - if you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking senshio, stop taking senshio and see a doctor immediately. children and adolescents do not give this medicine to children or adolescents. this medicine is only intended for use in post- menopausal women. other medicines and senshio tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. do not take senshio with any of these medicines: oestrogens. any other medicine belonging to the group called serms, such as tamoxifen, toremifene, bazedoxifene and raloxifene. talk to your doctor before taking senshio with: fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount of ospemifene in your blood. your doctor may consider stopping treatment with senshio while you are taking fluconazole. any of the following medicines, which may lead to a reduced effect of senshio: o rifampicin and rifabutin commonly used to treat tuberculosis. o carbamazepine and phenytoin used to treat convulsions/seizures (anticonvulsants). o st john's wort, a herbal medicine sometimes used to treat depression. o orlistat sometimes used to treat obesity. any of the following medicines, as their concentrations may be increased while taking senshio: o metformin used to treat type ii diabetes. o aciclovir used to treat cold sores and genital herpes. o ganciclovir used to treat infections caused by a virus called cytomegalovirus. o oxaliplatin, an anti-cancer medicine for advanced (metastatic) cancer of the large bowel (colon) or back passage (rectum). pregnancy, breast-feeding and fertility senshio is for use only in postmenopausal women. it must not be taken by women who are pregnant, who could still have a baby or are breast-feeding. this is because there are no data on the use of senshio in pregnant or pre-menopausal women or those who are breast-feeding. tell your doctor immediately if you become pregnant while taking senshio; treatment should be stopped immediately. driving and using machines senshio has no known or very little influence on the ability to drive and use machines. senshio contains lactose if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. senshio contains sodium this medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free'.", 'Entity_Recognition': [{'Text': 'senshio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 33, 'EndOffset': 41}, {'Id': 11, 'BeginOffset': 45, 'EndOffset': 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{'Title': '3. how to take senshio', 'Section_Content': 'always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended dose is one tablet taken orally at the same time each day. senshio should be taken with food. the tablets should be swallowed whole with food. senshio must be taken every day for as long as your doctor tells you to. patients with liver disease this medicine is not recommended if you have severely reduced liver function. if you take more senshio than you should if you take more tablets than you should, tell your doctor or pharmacist. if you forget to take senshio if you forget to take a tablet you should take the missed tablet (with food) as soon as you remember within the same day. do not take two tablets in one day to make up for a forgotten tablet. if you stop using senshio you will not benefit from the effects of senshio if you stop using it without talking to your doctor. your doctor will explain the effects of stopping treatment and will also discuss other possibilities for treatment with you. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'senshio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': 'senshio', 'Type': 'TREATMENT', 'BeginOffset': 210, 'EndOffset': 217}, {'Text': 'the tablets', 'Type': 'TREATMENT', 'BeginOffset': 245, 'EndOffset': 256}, {'Text': 'senshio', 'Type': 'TREATMENT', 'BeginOffset': 294, 'EndOffset': 301}, {'Id': 5, 'BeginOffset': 381, 'EndOffset': 394, 'Score': 0.867469310760498, 'Text': 'liver disease', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.961922287940979}]}, {'Text': 'severely reduced liver function', 'Type': 'PROBLEM', 'BeginOffset': 440, 'EndOffset': 471}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 987, 'EndOffset': 996}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 1043, 'EndOffset': 1052}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1111, 'EndOffset': 1124}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. common side effects (may affect up to 1 in 10 people): - an infection of the genitals caused by a fungus (thrush) - hot flushes - muscle cramps - vaginal or genital discharge - rash 26 - headache - vaginal bleeding uncommon side effects (may affect up to 1 in 100 people): - thickening of the womb lining (endometrium) as seen on ultrasound scan (endometrial hypertrophy). - an allergic reaction. symptoms of an allergic reaction may include rash, itchy skin, raised patches on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing or swallowing. 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': 'senshio', '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': 10, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9673774838447571, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6773808598518372}]}, {'Text': 'common side effects', 'Type': 'PROBLEM', 'BeginOffset': 92, 'EndOffset': 111}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 130, 'EndOffset': 131}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 135, 'EndOffset': 137}, {'Text': 'an infection of the genitals', 'Type': 'PROBLEM', 'BeginOffset': 149, 'EndOffset': 177}, {'Text': 'a fungus (thrush', 'Type': 'PROBLEM', 'BeginOffset': 188, 'EndOffset': 204}, 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{'Title': '5. how to store senshio', '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 day of that month. this medicine does not require any special storage conditions. 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': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what senshio contains - the active substance is ospemifene. each film-coated tablet contains 60 mg ospemifene. - the other ingredients are: tablet core: colloidal silicon dioxide (e 551), magnesium stearate (e 578), mannitol (e 421), microcrystalline cellulose (e 460), povidone (e 1201), pregelatinised starch (maize), sodium starch glycolate (type a). film coating: hypromellose (e 464), lactose monohydrate, titanium dioxide (e 171), triacetin (e 1518), polyethylene glycol (e 1521). what senshio looks like and contents of the pack senshio tablets are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long by 6.45 mm wide) debossed with "60" on one side. they are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'senshio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, 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'RelationshipScore': 0.9999942779541016, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 93, 'EndOffset': 98, 'Text': '60 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 4, 'BeginOffset': 153, 'EndOffset': 178, 'Score': 0.9326717257499695, 'Text': 'colloidal silicon dioxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 180, 'EndOffset': 185, 'Score': 0.8939799666404724, 'Text': 'e 551', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 6, 'BeginOffset': 188, 'EndOffset': 206, 'Score': 0.9968239068984985, 'Text': 'magnesium stearate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 7, 'BeginOffset': 208, 'EndOffset': 213, 'Score': 0.8962604403495789, 'Text': 'e 578', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 216, 'EndOffset': 224, 'Score': 0.8678197860717773, 'Text': 'mannitol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 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