Tandemact
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 30 mg/2 mg tablets 
Tandemact 30 mg/4 mg tablets 
Tandemact 45 mg/4 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Tandemact 30 mg/2 mg tablets 
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.  
 
Excipient with known effect 
Each tablet contains approximately 125 mg lactose monohydrate (see section 4.4). 
 
Tandemact 30 mg/4 mg tablets 
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.  
 
Excipient with known effect 
Each tablet contains approximately 177 mg lactose monohydrate (see section 4.4). 
 
Tandemact 45 mg/4 mg tablets 
Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.  
 
Excipient with known effect 
Each tablet contains approximately 214 mg lactose monohydrate (see section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Tandemact 30 mg/2 mg tablets 
White to off-white, round, convex and debossed ‘4833 G’ on one face and ‘30/2’ on the other. 
 
Tandemact 30 mg/4 mg tablets 
White to off-white, round, convex and debossed ‘4833 G’ on one face and ‘30/4’ on the other. 
 
Tandemact 45 mg/4 mg tablets 
White to off-white, round, flat and debossed ‘4833 G’ on one face and ‘45/4’ on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who 
show intolerance to metformin or for whom metformin is contraindicated and who are already treated 
with a combination of pioglitazone and glimepiride. 
 
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess 
adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate 
response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, 
prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained 
(see section 4.4). 



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4.2 Posology and method of administration 
 
Posology 
 
The recommended dose of Tandemact is one tablet taken once daily.  
 
If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination 
therapy should be considered.  
 
If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, 
patients should be stabilised with concomitant pioglitazone and glimepiride before switching to 
Tandemact. 
 
Special populations  

Elderly 
Physicians should start treatment with the lowest available dose and increase the dose gradually, 
particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and 
cardiac failure). 
 
Renal impairment 
Tandemact should not be used in patients with severe renal function disorders (creatinine clearance 
< 30 ml/min, see section 4.3). 
 
Hepatic impairment 
Tandemact should not be used in patients with hepatic impairment (see section 4.3 and 4.4). 
 
Paediatric population 
The safety and efficacy of Tandemact in children and adolescents under 18 years of age have not been 
established. No data are available. 
 
Method of administration 
 
The tablets are taken orally shortly before or with the first main meal. The tablets should be swallowed 
with a glass of water. 
 
4.3 Contraindications 
 
Tandemact is contraindicated in patients with: 
 
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or other 

sulphonylureas or sulphonamides 
- Cardiac failure or history of cardiac failure (NYHA stages I to IV) 
- Current bladder cancer or a history of bladder cancer 
- Uninvestigated macroscopic haematuria 
- Hepatic impairment 
- Type 1 diabetes mellitus  
- Diabetic coma 
- Diabetic ketoacidosis  
- Severe renal function disorders (creatinine clearance < 30 ml/min) 
- Pregnancy 
- Breast-feeding (see section 4.6) 
 
4.4 Special warnings and precautions for use 
 
There is no clinical trial experience of other oral anti-hyperglycaemic medicinal products added to 
treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.  



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Hypoglycaemia 
 
When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to 
hypoglycaemia due to the sulphonylurea component. Symptoms can almost always be promptly 
controlled by immediate intake of carbohydrates (sugar). Artificial sweeteners have no effect. 
 
It is known from other sulphonylureas that, despite initially successful countermeasures, 
hypoglycaemia may recur. Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily 
controlled by the usual amounts of sugar, require immediate medical treatment and occasionally 
hospitalisation. 
 
Treatment with Tandemact requires regular monitoring of glycaemic control. 
 
Fluid retention and cardiac failure 
 
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. When 
treating patients who have at least one risk factor for development of congestive heart failure 
(e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians 
should start with the lowest available dose of pioglitazone and increase the dose gradually. Patients 
should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those 
with reduced cardiac reserve. There have been post-marketing cases of cardiac failure reported when 
pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. Since 
insulin and pioglitazone are both associated with fluid retention, concomitant administration may 
increase the risk of oedema. Post marketing cases of peripheral oedema and cardiac failure have also 
been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory 
drugs, including selective COX-2 inhibitors. Tandemact should be discontinued if any deterioration in 
cardiac state occurs. 
 
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with 
type 2 diabetes mellitus and pre-existing major macrovascular disease. Pioglitazone or placebo was 
added to existing antidiabetic and cardiovascular therapy for up to 3.5 years. This study showed an 
increase in reports of heart failure; however this did not lead to an increase in mortality in this study.  
 
Elderly 
 

Combination use with insulin should be considered with caution in the elderly because of increased 
risk of serious heart failure. 
 
In light of age-related risks (especially bladder cancer, fractures and heart failure), the balance of 
benefits and risks should be considered carefully both before and during treatment in the elderly. 
 
Bladder cancer 
 
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials 
with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 
10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029). After excluding patients in whom 
exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 
7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups. Epidemiological studies have 
also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, 
although not all studies identified a statistically significant increased risk. 
 
Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks 
include age, smoking history, exposure to some occupational or chemotherapy agents 
e.g. cyclophosphamide or prior radiation treatment in the pelvic region). Any macroscopic haematuria 
should be investigated before starting pioglitazone therapy.  
 



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Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria 
or other symptoms such as dysuria or urinary urgency develop during treatment. 
 
Liver function 
 
There have been rare reports of elevated liver enzymes and hepatocellular dysfunction during 
post-marketing experience with pioglitazone and glimepiride (see section 4.8). Although in very rare 
cases fatal outcome has been reported, causal relationship has not been established. 
It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of 
liver enzymes. Liver enzymes should be checked prior to the initiation of therapy with Tandemact in 
all patients. Therapy with Tandemact should not be initiated in patients with increased baseline liver 
enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.  
 
Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored 
periodically based on clinical judgement. If ALT levels are increased to 3 x upper limit of normal 
during Tandemact therapy, liver enzyme levels should be reassessed as soon as possible. If ALT levels 
remain > 3 x the upper limit of normal, therapy should be discontinued. If any patient develops 
symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, 
abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision 
whether to continue the patient on therapy with Tandemact should be guided by clinical judgement 
pending laboratory evaluations. If jaundice is observed, the medicinal product should be discontinued. 
 
Weight gain 
 
In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was 
evidence of dose related weight gain, which may be due to fat accumulation and in some cases 
associated with fluid retention. In some cases weight increase may be a symptom of cardiac failure 
therefore weight should be closely monitored. Part of the treatment of diabetes is dietary control. 
Patients should be advised to adhere strictly to a calorie-controlled diet. 
 
Haematology 
 
Rare changes in haematology have been observed with glimepiride treatment (see section 4.8). 
Treatment with Tandemact therefore requires regular haematological monitoring (especially 
leucocytes and platelets). 
 
During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative 
reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution. Similar changes 
were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a 
lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative 
reductions) treated patients in comparative controlled trials with pioglitazone. 
 
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. 
Since glimepiride belongs to the chemical class of sulfonylurea medicinal products, caution should be 
used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered. 
 
Eye disorders 
 
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual 
acuity have been reported with thiazolidinediones, including pioglitazone. Many of these patients 
reported concurrent peripheral oedema. It is unclear whether or not there is a direct association 
between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular 
oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should 
be considered. 
 



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Polycystic ovarian syndrome 
 
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic 
ovarian syndrome may result in resumption of ovulation. These patients may be at risk of pregnancy. 
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if 
pregnancy occurs, the treatment should be discontinued (see section 4.6). 
 
Others 
 
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions 
reports of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8). 
 
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with 
pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator. The observed 
excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 
100 patient years of use. 
 
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and 
women. 
 
The risk of fractures should be considered in the long term care of patients treated with pioglitazone 
(see section 4.8). 
 
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 
inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). Glycaemic control should be monitored 
closely. Pioglitazone dose adjustment within the recommended posology or changes in diabetic 
treatment should be considered (see section 4.5). 
 
The tablets contain lactose monohydrate and therefore should not be administered to patients with rare 
hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose 
malabsorption. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
There have been no formal interaction studies for Tandemact, however, the concomitant use of the 
active substances in patients in clinical use has not resulted in any unexpected interactions. The 
following statements reflect the information available on the individual active substances (pioglitazone 
and glimepiride). 
 
Pioglitazone 
 
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported 
to result in a 3-fold increase in AUC of pioglitazone. A decrease in the dose of pioglitazone may be 
needed when gemfibrozil is concomitantly administered. Close monitoring of glycaemic control 
should be considered (see section 4.4). Co-administration of pioglitazone with rifampicin (an inducer 
of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone. The 
pioglitazone dose may need to be increased when rifampicin is concomitantly administered. Close 
monitoring of glycaemic control should be considered (see section 4.4). 
 
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics 
or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Co-administration of 
pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea. 
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4. 
In vitro studies have shown no inhibition of any subtype of cytochrome P450. Interactions with 
substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel 
blockers, and HMGCoA reductase inhibitors are not to be expected.  
 



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Glimepiride 
 
If glimepiride is taken simultaneously with certain other medicinal products, both undesired increases 
and decreases in the hypoglycaemic action of glimepiride can occur. For this reason, other medicinal 
products should only be taken with Tandemact with the knowledge (or at the prescription) of the 
doctor. 
 
Based on the experience with glimepiride and with other sulphonylureas the following interactions 
have to be mentioned. 
 
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may 
occur when one of the following active substances is taken, for example: 
 
phenylbutazone, azapropazone and oxyfenbutazone 
insulin and oral antidiabetic products 
metformin 
salicylates and p-amino-salicylic acid 
anabolic steroids and male sex hormones 
chloramphenicol 
clarithromycin 
coumarin anticoagulants 
disopyramide 
fenfluramine 
fibrates 
angiotensin-converting enzyme (ACE) inhibitors 
fluoxetine 
allopurinol 
sympatholytics 
cyclo-, tro- and iphosphamides 
sulphinpyrazone 
certain long-acting sulphonamides 
tetracyclines 
MAO-inhibitors 
quinolone antibiotics 
probenecid 
miconazole 
pentoxyfylline (high dose parenteral) 
tritoqualine 
fluconazole 
 
Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when 
one of the following active substances is taken, for example: 
 
oestrogens and progestagens, 
saluretics, thiazide diuretics, 
thyroid stimulating agents, glucocorticoids, 
phenothiazine derivatives, chlorpromazine, 
adrenaline and sympathicomimetics, 
nicotinic acid (high doses) and nicotinic acid derivatives, 
laxatives (long-term use), 
phenytoin, diazoxide, 
glucagon, barbiturates and rifampicin. 
acetozolamide 
 
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of 
the blood glucose lowering effect. 
 



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Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine 
and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent. 
 
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable 
fashion. 
 
Glimepiride may either potentiate or weaken the effects of coumarin derivatives. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential / Contraception in males and females 
 

Tandemact is not recommended in women of childbearing potential not using contraception. If a 
patient wishes to become pregnant, treatment with Tandemact should be discontinued. 
 
Pregnancy 
 
Risk related to pioglitazone 

There are no adequate data from the use of pioglitazone in pregnant women. Studies of pioglitazone in 
animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.  
 
Risk related to glimepiride 
There are no adequate data from the use of glimepiride in pregnant women. Animal studies have 
shown reproductive toxicity which was most likely related to the pharmacological action 
(hypoglycaemia) of glimepiride.  
 
Tandemact is contraindicated during pregnancy (see section 4.3). If a pregnancy occurs, treatment 
with Tandemact should be discontinued. 
 
Breast-feeding 
 
Sulphonylurea-derivatives like glimepiride pass into the breast milk. Pioglitazone has been shown to 
be present in the milk of lactating rats. It is not known whether pioglitazone is secreted in human milk.  
 
Tandemact is contra-indicated during breast-feeding (see section 4.3). 
 
Fertility 
 

In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or 
fertility index. 
 
4.7 Effects on ability to drive and use machines 
 
Tandemact has minor influence on the ability to drive and use machines. The patient’s ability to 
concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia from 
glimepiride or, for example, as a result of visual impairment. This may constitute a risk in situations 
where these abilities are of special importance (e.g. driving a car or using machines). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is 
particularly important in those who have reduced or absent awareness of the warnings of 
hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is 
advisable to drive or use machines in these circumstances. 
 
Patients who experience visual disturbance should be cautious when driving or using machines. 
 



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4.8 Undesirable effects 
 
Summary of the safety profile 
 
Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see 
section 5.1). Hypoglycaemic reactions mostly occur immediately due to the sulphonylurea component 
of Tandemact. Symptoms can almost always be promptly controlled by immediate intake of 
carbohydrates (sugar). This is a serious reaction which may occur uncommonly (≥ 1/1,000 to < 1/100) 
(see section 4.4). Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, 
granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia may occur rarely 
(≥ 1/10,000 to < 1/1,000) (see section 4.4). Other reactions such as bone fracture, weight increase and 
oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4). 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported in double-blind studies and post marketing experience are listed below as 
MedDRA preferred term by system organ class and absolute 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 the available 
data). Within each system organ class, adverse reactions are presented in order of decreasing incidence 
followed by decreasing seriousness. 
 

Adverse reaction Frequency of adverse reactions 
 Pioglitazone Glimepiride Tandemact 
Infections and infestations    
upper respiratory tract infection common  common 
sinusitis uncommon  uncommon 
Neoplasms benign, malignant and unspecified 
(including cysts and polyps) 

   

bladder cancer uncommon  uncommon 
Blood and lymphatic system disorders    
changes in haematology1  rare rare 
Immune system disorders     
allergic shock2  very rare very rare 
allergic vasculitis2  very rare very rare 
hypersensitivity and allergic reactions3 not known  not known 
Metabolism and nutrition disorders    
hypoglycaemia   uncommon 
appetite increased   uncommon 
Nervous system disorders    
dizziness   common 
hypo-aesthesia common  common 
headache   uncommon 
insomnia uncommon  uncommon 
Eye disorders    
visual disturbance4 common  uncommon 
macular oedema not known  not known 
Ear and labyrinth disorders    
vertigo   uncommon 
Gastrointestinal disorders5    
flatulence   common 
vomiting  very rare very rare 
diarrhoea  very rare very rare 
nausea  very rare very rare 
abdominal pain  very rare very rare 
abdominal pressure  very rare very rare 



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Adverse reaction Frequency of adverse reactions 
 Pioglitazone Glimepiride Tandemact 
feeling of fullness in the stomach  very rare very rare 
Hepatobiliary disorders6    
hepatitis  very rare very rare 
impairment of liver function (with cholestasis and 
jaundice) 

 very rare very rare 

Skin and subcutaneous tissue disorders    
sweating   uncommon 
hypersensitivity to light  very rare very rare 
urticaria2  not known not known 
itching2  not known not known 
rash2  not known not known 
Musculoskeletal and connective tissue disorders    
bone fracture7 common  common 
Renal and urinary disorders    
glycosuria   uncommon 
proteinuria   uncommon 
General disorders and administration site 
conditions 

   

oedema8   common 
fatigue   uncommon 
Investigations    
weight increased9 common common common 
increased lactic dehydrogenase    uncommon 
decrease in sodium serum concentrations  very rare very rare 
alanine aminotransferase increase10 not known  not known 

 
Description of selected adverse reactions 
 
1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, 
agranulocytosis, haemolytic anaemia and pancyto-penia may occur. These are in general reversible 
upon discontinuation of treatment. 
 
2 In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea, 
fall in blood pressure and sometimes shock. Hypersensitivity reactions of the skin may occur as 
itching, rash, and urticaria. Cross allergenicity with sulphonylureas, sulphonamides or related 
substances is possible. 
 
3 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been 
reported. These reactions include anaphylaxis, angioedema, and urticaria.  
 
4 Visual disturbance has been reported mainly early in treatment and is related to changes in blood 
glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other 
hypoglycaemic medicinal products. 
 
5 Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy. 
 
6 Elevation of liver enzymes may occur. In very rare cases, impairment of liver function (e.g. with 
cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure. 
 

7 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, 
comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated 
groups and 7,400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of 
fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in 
fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%). 



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In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of 
pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 
100 patient years) of female patients treated with comparator. The observed excess risk of fractures for 
women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use. No increase 
in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). 
Post-marketing, bone fractures have been reported in both male and female patients (see section 4.4). 
 
8 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled 
clinical trials. The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%. The 
reports of oedema were generally mild to moderate and usually did not require discontinuation of 
treatment. 
 
9 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy 
was 2 – 3 kg over one year. This is similar to that seen in a sulphonylurea active comparator group. In 
combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one 
year of 2.8 kg.  
 
10 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the 
upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea 
comparator groups. Mean levels of liver enzymes decreased with treatment with pioglitazone.  
 
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the 
same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in 
combination therapy with insulin. In an outcome study of patients with pre-existing major 
macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than 
with placebo, when added to therapy that included in insulin. However, this did not lead to an increase 
in mortality in this study. In this study in patients receiving pioglitazone and insulin, a higher 
percentage of patients with heart failure was observed in patients aged ≥ 65 years compared with those 
less than 65 years (9.7% compared to 4.0%). In patients on insulin with no pioglitazone the incidence 
of heart failure was 8.2% in those ≥ 65 years compared to 4.0% in patients less than 65 years. Heart 
failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone 
was used in combination with insulin or in patients with a history of cardiac failure (see section 4.4). 
 
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 
 
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 
45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven 
days was not associated with any symptoms. 
 
After ingestion of an overdose of glimepiride, hypoglycaemia may occur, lasting from 12 to 72 hours, 
and may recur after initial recovery. Symptoms may not be present for up to 24 hours after ingestion. 
In general observation in hospital is recommended. Nausea, vomiting and epigastric pain may occur. 
The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, 
tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions. 
 
Treatment of overdose of Tandemact primarily consists of preventing absorption of glimepiride by 
inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and 
sodium-sulphate (laxative). If large quantities have been ingested, gastric lavage is indicated, followed 
by activated charcoal and sodium-sulphate. In case of (severe) overdose hospitalisation in an intensive 
care department is indicated. Start the administration of glucose as soon as possible, if necessary by a 



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bolus intravenous injection of 50 ml of a 50% solution, followed by an infusion of a 10% solution with 
strict monitoring of blood glucose. Further treatment should be symptomatic. 
 
In particular when treating hypoglycaemia due to accidental intake of Tandemact in infants and young 
children, the dose of glucose given must be carefully controlled to avoid the possibility of producing 
dangerous hyperglycaemia. Blood glucose should be closely monitored. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering 
drugs; ATC code: A10BD06. 
 
Tandemact combines two antihyperglycaemic active substances with complementary mechanisms of 
action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member 
of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class. 
Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas primarily by 
inducing insulin release from pancreatic beta cells. 
 
Pioglitazone 
 
Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone appears to act 
via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading 
to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with 
pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose 
disposal in the case of insulin resistance. 
 
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus. The 
improved glycaemic control is associated with a reduction in both fasting and postprandial plasma 
insulin concentrations. A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to 
two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the 
first six months of therapy). Kaplan-Meier analysis showed shorter time to treatment failure in patients 
treated with gliclazide, compared with pioglitazone. At two years, glycaemic control (defined as 
HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of 
patients on gliclazide. In a two-year study of combination therapy comparing pioglitazone with 
gliclazide when added to metformin, glycaemic control measured as mean change from baseline in 
HbA1c was similar between treatment groups after one year. The rate of deterioration of HbA1c during 
the second year was less with pioglitazone than with gliclazide. 
 
In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin 
optimisation period were randomised to pioglitazone or placebo for 12 months. Patients receiving 
pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin 
alone, and a reduction of insulin dose in the pioglitazone treated group. 
 
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin 
sensitivity. Two-year clinical studies have shown maintenance of this effect. 
 
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the 
albumin/creatinine ratio compared to baseline. 
 
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in 
type 2 diabetics. Pioglitazone was associated with significant weight gain. Visceral fat was 
significantly decreased, while there was an increase in extra-abdominal fat mass. Similar changes in 
body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity. 
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased 



13 

HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically 
significant increases in LDL-cholesterol levels. In clinical trials of up to two years duration, 
pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol 
levels, compared with placebo, metformin or gliclazide. Pioglitazone did not cause statistically 
significant increases in LDL-cholesterol levels compared with placebo, whilst reductions were 
observed with metformin and gliclazide. In a 20-week study, as well as reducing fasting triglycerides, 
pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and 
hepatically synthesised triglycerides. These effects were independent of pioglitazone’s effects on 
glycaemia and were statistically significantly different to glibenclamide. 
 
In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and 
pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to 
existing antidiabetic and cardiovascular therapy, for up to 3.5 years. The study population had an 
average age of 62 years; the average duration of diabetes was 9.5 years. Approximately one third of 
patients were receiving insulin in combination with metformin and/or a sulphonylurea. To be eligible 
patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous 
cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, 
or peripheral arterial obstructive disease. Almost half of the patients had a previous myocardial 
infarction and approximately 20% had had a stroke. Approximately half of the study population had at 
least two of the cardiovascular history entry criteria. Almost all subjects (95%) were receiving 
cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium 
channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates). 
 
Although the study failed regarding its primary endpoint, which was a composite of all-cause 
mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, 
coronary revascularisation and leg revascularisation, the results suggest that there are no long-term 
cardiovascular concerns regarding use of pioglitazone. However, the incidence of oedema, weight gain 
and heart failure were increased. No increase in mortality from heart failure was observed. 
 
Glimepiride 
 
Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells. 
As with other sulphonylureas this effect is based on an increase of responsiveness of the pancreatic 
beta cells to the physiological glucose stimulus. In addition, glimepiride seems to have pronounced 
extrapancreatic effects also postulated for other sulphonylureas. 
 
Insulin release 

Sulphonylureas regulate insulin secretion by closing the ATP-sensitive potassium channel in the beta 
cell membrane. Closing the potassium channel induces depolarisation of the beta cell and results – by 
opening of calcium channels – in an increased influx of calcium into the cell. This leads to insulin 
release through exocytosis. Glimepiride binds with a high exchange rate to a beta cell membrane 
protein which is associated with the ATP-sensitive potassium channel but which is different from the 
usual sulphonylurea binding site. 
 
Extrapancreatic activity 

The extrapancreatic effects are for example an improvement of the sensitivity of the peripheral tissue 
for insulin and a decrease of the insulin uptake by the liver.  
 
The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport 
proteins, located in the cells membrane. The transport of glucose in these tissues is the rate limiting 
step in the use of glucose. Glimepiride increases very rapidly the number of active glucose transport 
molecules in the plasma membranes of muscle and fat cells, resulting in stimulated glucose uptake. 
Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which 
may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.  
Glimepiride inhibits the glucose production in the liver by increasing the intracellular concentration of 
fructose-2,6-bisphosphate, which in turn inhibits the gluconeogenesis. 
 



14 

General 

In healthy persons, the minimum effective oral dose is approximately 0.6 mg. The effect of 
glimepiride is dose-dependent and reproducible. The physiological response to acute physical 
exercise, reduction of insulin secretion, is still present under glimepiride. 
 
There was no significant difference in effect regardless of whether glimepiride was given 30 minutes 
or immediately before a meal. In diabetic patients, good metabolic control over 24 hours can be 
achieved with a single daily dose. 
 
Although the hydroxy metabolite of glimepiride caused a small but significant decrease in serum 
glucose in healthy persons, it accounts for only a minor part of the total effect. 
 
Paediatric population 
 

The European Medicines Agency has waived the obligation to submit the results of studies with 
Tandemact in all subsets of the paediatric population in type 2 diabetes mellitus. See section 4.2 for 
information on paediatric use. 
 
5.2 Pharmacokinetic properties 
 
Tandemact  
 
Studies in human volunteers have shown Tandemact to be bioequivalent to the administration of 
pioglitazone and glimepiride given as separate tablets.  
 
The following statements reflect the pharmacokinetic properties of the individual active substances of 
Tandemact. 
 
Pioglitazone 
 
Absorption 

Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of 
unchanged pioglitazone are usually achieved 2 hours after administration. Proportional increases of 
the plasma concentration were observed for doses from 2-60 mg. Steady state is achieved after 
4-7 days of dosing. Repeated dosing does not result in accumulation of the compound or metabolites. 
Absorption is not influenced by food intake. Absolute bioavailability is greater than 80%. 
 
Distribution 

The estimated volume of distribution in humans is 0.25 L/kg. 
 
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%). 
 
Biotransformation 

Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups. 
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser 
degree. Three of the six identified metabolites are active (M-II, M-III, and M-IV). When activity, 
concentrations and protein binding are taken into account, pioglitazone and metabolite M-III 
contribute equally to efficacy. On this basis M-IV contribution to efficacy is approximately three-fold 
that of pioglitazone, whilst the relative efficacy of M-II is minimal. 
 
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450. 
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man. 
 
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics 
or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Concomitant 
administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with 



15 

rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the 
plasma concentration of pioglitazone (see section 4.5). 
 

Elimination 

Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in 
faeces (55%) and a lesser amount in urine (45%). In animals, only a small amount of unchanged 
pioglitazone can be detected in either urine or faeces. The mean plasma elimination half-life of 
unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.  
 
Linearity/non-linearity 

Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range. 
 
Elderly 

Steady state pharmacokinetics are similar in patients age 65 and over and young subjects. 
 
Patients with renal impairment 

In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower 
than those seen in subjects with normal renal function, but oral clearance of parent substance is 
similar. Thus free (unbound) pioglitazone concentration is unchanged. 
 
Patients with hepatic impairment 

Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution. 
Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone. 
 
Glimepiride 
 
Absorption 

The bioavailability of glimepiride after oral administration is complete. Food intake has no relevant 
influence on absorption, only absorption rate is slightly diminished. Maximum serum concentrations 
(Cmax) are reached approximately 2.5 hours after oral intake (mean 0.3 µg/mL during multiple dosing 
of 4 mg daily).  
 
Distribution 

Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to 
the albumin distribution space, high protein binding (> 99%), and a low clearance (approximately 
48 mL/min).  
 
In animals, glimepiride is excreted in milk. Glimepiride is transferred to the placenta. Passage of the 
blood brain barrier is low. 
 
Biotransformation and elimination 

Mean dominant serum half-life, which is of relevance for the serum concentrations under 
multiple-dose conditions, is about 5 to 8 hours. After high doses, slightly longer half-lives were noted. 
 
After a single dose of radiolabelled glimepiride, 58% of the radioactivity was recovered in the urine, 
and 35% in the faeces. No unchanged substance was detected in the urine. Two metabolites – most 
probably resulting from hepatic metabolism (major enzyme is CYP2C9) – were identified both in 
urine and faeces: the hydroxy derivative and the carboxy derivative. After oral administration of 
glimepiride, the terminal half-lives of those metabolites were 3 to 6 and 5 to 6 hours respectively. 
 
Comparison of single and multiple once-daily dosing revealed no significant differences in 
pharmacokinetics, and the intra-individual variability was very low. There was no relevant 
accumulation. 
 
Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) 
patients. In patients with low creatinine clearance, there was a tendency for glimepiride clearance to 



16 

increase and for average serum concentrations to decrease, most probably resulting from a more rapid 
elimination because of lower protein binding. Renal elimination of the two metabolites was impaired. 
Overall no additional risk of accumulation is to be assumed in such patients. 
 
Pharmacokinetics in five non-diabetic patients after bile duct surgery were similar to those in healthy 
persons. 
 
Linearity/non-linearity 

There is a linear relationship between dose and both Cmax and AUC (area under the time/concentration 
curve).  
 
5.3 Preclinical safety data 
 
No animal studies have been conducted with the combined products of Tandemact. The following data 
are findings in studies performed with pioglitazone or glimepiride individually. 
 
Pioglitazone 
 
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric 
cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys. 
In addition, increased fatty deposition and infiltration were observed. These findings were observed 
across species at plasma concentrations  4 times the clinical exposure. Foetal growth restriction was 
apparent in animal studies with pioglitazone. This was attributable to the action of pioglitazone in 
diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during 
pregnancy thereby reducing the availability of metabolic substrates for foetal growth.  
 
Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro 
genotoxicity assays. An increased incidence of hyperplasia (males and females) and tumours (males) 
of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.  
 
The formation and presence of urinary calculi with subsequent irritation and hyperplasia was 
postulated as the mechanistic basis for the observed tumourigenic response in the male rat. A 
24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in 
an increased incidence of hyperplastic changes in the bladder. Dietary acidification significantly 
decreased but did not abolish the incidence of tumours. The presence of microcrystals exacerbated the 
hyperplastic response but was not considered to be the primary cause of hyperplastic changes. The 
relevance to humans of the tumourigenic findings in the male rat cannot be excluded.  
 
There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not 
seen in dogs or monkeys treated with pioglitazone for up to 12 months. 
 
In an animal model of familial adenomatous polyposis (FAP), treatment with two other 
thiazolidinediones increased tumour multiplicity in the colon. The relevance of this finding is 
unknown. 
 
Glimepiride 
 
Preclinical effects observed occurred at exposures sufficiently in excess of the maximum human 
exposure as to indicate little relevance to clinical use, or were due to the pharmacodynamic action 
(hypoglycaemia) of the compound. This finding is based on conventional safety pharmacology, 
repeated dose toxicity, genotoxicity, carcinogenicity, and reproduction toxicity studies. In the latter 
(covering embryotoxicity, teratogenicity and developmental toxicity), undesirable effects observed 
were considered to be secondary to the hypoglycaemic effects induced by the compound in dams and 
in offspring. 
 
 



17 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Cellulose microcrystalline 
Croscarmellose sodium 
Hydroxypropylcellulose 
Lactose monohydrate 
Magnesium stearate 
Polysorbate 80 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Aluminium/aluminium blisters; packs of 14, 28, 30, 50, 90 or 98 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/366/005 
EU/1/06/366/006 
EU/1/06/366/007 
EU/1/06/366/008 
EU/1/06/366/009 
EU/1/06/366/010 
EU/1/06/366/011 
EU/1/06/366/012 
EU/1/06/366/013 
EU/1/06/366/014 
EU/1/06/366/015 
EU/1/06/366/016 
EU/1/06/366/017 



18 

EU/1/06/366/018 
EU/1/06/366/019 
EU/1/06/366/020 
EU/1/06/366/021 
EU/1/06/366/022 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 08 January 2007 
Date of latest renewal: 09 September 2016 
 
 
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 
 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS 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 

 



20 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Takeda Ireland Limited 
Bray Business Park 
Kilruddery 
County Wicklow 
Ireland 
 
Delpharm Novara S.r.l. 
Via Crosa 86,  
28065 Cerano (NO) 
Italy 
 
Takeda GmbH 
Production Site Oranienburg 
Lehnitzstrasse 70 – 98 
16515 Oranienburg, 
Germany 
 
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 
 
The requirements for submission of periodic safety update reports 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 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. 

 



21 

 Additional risk minimisation measures  
 
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use 
Pioglitazone. Prior to distribution of the prescriber guide in each Member State, the MAH agreed the 
content and format of the educational material, together with a communication plan, with the national 
competent authority. 
 
• This educational pack is aimed at strengthening awareness of important identified risks of 

bladder cancer and heart failure and the overall recommendations intended to optimise the 
benefit-risk margin at the patient level.  

• The physician educational pack should contain: The Summary of Product Characteristics, 
package leaflet, and a Prescriber Guide. 

 
The Prescriber Guide highlights the following: 
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and 

emphasising the need for regular review of treatment benefit. 
• The risk of bladder cancer and relevant risk minimisation advice. 
• The risk of heart failure and relevant risk minimisation advice. 
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures 

and heart failure). 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 30 mg/2 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
50 tablets 
90 tablets 
98 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 
 



25 

 
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 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/366/017 14 tablets 
EU/1/06/366/018 28 tablets 
EU/1/06/366/019 30 tablets 
EU/1/06/366/020 50 tablets 
EU/1/06/366/021 90 tablets 
EU/1/06/366/022 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Tandemact 30 mg/2 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 OUTER PACKAGING  
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 30 mg/4 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
50 tablets 
90 tablets 
98 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 
 
 



27 

9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/366/005 14 tablets 
EU/1/06/366/006 28 tablets 
EU/1/06/366/007 30 tablets 
EU/1/06/366/008 50 tablets 
EU/1/06/366/009 90 tablets 
EU/1/06/366/010 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Tandemact 30 mg/4 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  
 



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 45 mg/4 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
50 tablets 
90 tablets 
98 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 
 



29 

 
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 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/366/011 14 tablets 
EU/1/06/366/012 28 tablets 
EU/1/06/366/013 30 tablets 
EU/1/06/366/014 50 tablets 
EU/1/06/366/015 90 tablets 
EU/1/06/366/016 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Tandemact 45 mg/4 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  
 



30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 30 mg/2 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda (logo)  
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
FOR CALENDARISED PACKS: 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 
 



31 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 30 mg/4 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
FOR CALENDARISED PACKS: 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 



32 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tandemact 45 mg/4 mg tablets 
 
pioglitazone/glimepiride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
FOR CALENDARISED PACKS: 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 



33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



34 

Package leaflet: Information for the patient 
 

Tandemact 30 mg/2 mg tablets 
Tandemact 30 mg/4 mg tablets 
Tandemact 45 mg/4 mg tablets 

pioglitazone/glimepiride 
 
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 Tandemact is and what it is used for 
2. What you need to know before you take Tandemact 
3. How to take Tandemact 
4. Possible side effects 
5. How to store Tandemact 
6. Contents of the pack and other information 
 
 
1. What Tandemact is and what it is used for  
 
Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control 
blood sugar level.  
 
It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes 
mellitus. This type 2 diabetes usually develops in adulthood where the body either does not produce 
enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it 
produces. 
 
Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing 
the amount of insulin available and helping your body make better use of it. Your doctor will check 
whether Tandemact is working 3 to 6 months after you start taking it. 
 
 
2. What you need to know before you take Tandemact 
 
Do not take Tandemact: 
- if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, or any 

of the other ingredients of this medicine (listed in section 6) 
- if you have heart failure or have had heart failure in the past 
- if you have liver disease 
- if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or 

vomiting) 
- if you have severe problems with your kidneys 
- if you have or have ever had bladder cancer 
- if you have blood in your urine that your doctor has not checked 
- if you have insulin dependent diabetes (type 1) 
- if you are in a diabetic coma 
- if you are pregnant 
- if you are breast-feeding 



35 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Tandemact (see also section 4) 
- if you have a problem with your heart. Some patients with long-standing type 2 diabetes 

mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin 
together experienced the development of heart failure. Inform your doctor as soon as possible if 
you experience signs of heart failure such as unusual shortness of breath or rapid increase in 
weight or localised swelling (oedema).  

- if you retain water (fluid retention) or have heart failure problems in particular if you are over 
75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and 
swelling, you must also tell your doctor. 

- if you have a special type of diabetic eye disease called macular oedema (swelling of the back 
of the eye), talk to your doctor if you notice any change to your vision.  

- if you have a problem with your liver. Before you start taking Tandemact you will have a blood 
sample taken to check your liver function. This check should be repeated at intervals. Inform 
your doctor as soon as possible if you develop symptoms suggesting a problem with your liver 
(like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite 
and/or dark urine) as your liver function should be checked.  

- if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased 
possibility of becoming pregnant because you may ovulate again when you take Tandemact. If 
this applies to you, use appropriate contraception to avoid the possibility of an unplanned 
pregnancy. 

- if you are already taking other medicines for the treatment of diabetes. 
- if you have problems with your enzyme called Glucose-6-phosphodehydrogenase since it can 

decrease your red cells. 
 

You may also experience a reduction in blood count (anaemia). Your doctor may take blood tests to 
monitor your blood cell levels and liver function. 
 
Hypoglycaemia 
When you take Tandemact, your blood sugar could fall below the normal level (hypoglycaemia). If 
you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, 
hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood 
sugar level again. Ask your doctor or pharmacist for more information if you are not sure how to 
recognise this. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit 
juice. 
 
Broken bones 
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your 
doctor will take this into account when treating your diabetes. 
 
Children and adolescents 
Use in children and adolescents under 18 years is not recommended. 
 
Other medicines and Tandemact 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because some medicines can weaken or strengthen the effect of Tandemact on the 
level of sugar in your blood. 
 
The following medicines can increase the blood sugar lowering effect of Tandemact. This can lead to 
a risk of hypoglycaemia (low blood sugar):  
- gemfibrozil and fibrates (to lower high cholesterol level) 
- insulin, metformin or other medicines to treat diabetes mellitus  
- phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and 

inflammation) 
- long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, 

quinolones, clarithromycin (to treat bacterial or fungal infections) 



36 

- anabolic steroids (supporting muscle build up) or male sex hormone replacement therapy  
- fluoxetine, MAO-inhibitors (to treat depression) 
- angiotensin-converting enzyme (ACE) inhibitors, sympatholytics, disopyramide, pentoxifylline, 

coumarin derivatives such as warfarin (to treat heart or blood problems) 
- allopurinol, probenecid, sulfinpyrazone (to treat gout) 
- cyclophosphamide, ifosfamide, trofosfamide (to treat cancer) 
- fenfluramine (to reduce weight) 
- tritoqualine (to treat allergies) 
 
The following medicines may decrease the blood sugar lowering effect of Tandemact. This can lead to 
a risk of hyperglycaemia (high blood sugar level): 
- oestrogens, progestogens (female sex hormones) 
- thiazide diuretics and saluretics also called water tablets (to treat high blood pressure) 
- levothyroxine (to stimulate the thyroid gland) 
- glucocorticoids (to treat allergies and inflammation)  
- chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders) 
- adrenaline and sympathicomimetics (to increase heart beat, to treat asthma or nasal congestion, 

coughs and colds or used in life-threatening emergencies)  
- nicotinic acid (to treat high cholesterol level)  
- long-term use of laxatives (to treat constipation) 
- phenytoin (to treat fits) 
- barbiturates (to treat nervousness and sleep problems) 
- azetazolamide (to treat increased pressure in the eye also called glaucoma) 
- diazoxide (to treat high blood pressure or low blood sugar) 
- rifampicin (to treat infections, tuberculosis) 
- glucagon (to treat severe low blood sugar levels) 
 
The following medicines can increase or decrease the blood sugar lowering effect of Tandemact: 
- H2 antagonists (to treat stomach ulcers) 
- beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart 

failure). These can also hide the signs of hypoglycaemia, so special care is needed when taking 
these medicines  

 
Tandemact may either increase or weaken the effects of the following medicines:  
- coumarin derivatives such as warfarin (to slow down or stop blood clotting)  
 
Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and 
your dose of Tandemact may need to be changed. 
 
Tandemact with alcohol 
Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar 
lowering action of Tandemact in an unpredictable way. 
 
Pregnancy and breast-feeding 
Do not use Tandemact if you are pregnant. You must tell your doctor if you are, you think you may be 
pregnant or are planning to have a baby. Your doctor will advise you to discontinue this medicine. 
Do not use Tandemact if you are breastfeeding or are planning to breast-feed (see section “Do not take 
Tandemact”). 
 
Driving and using machines 
Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, 
especially when beginning or after altering treatment, or when Tandemact is not taken regularly. This 
may affect your ability to drive or use machines.  
Take care if you experience abnormal vision. 
 



37 

Tandemact contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking Tandemact.  
 
 
3. How to take Tandemact 
 
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 once daily shortly before or with the first main meal. Your 
doctor will tell you the dose to take or if necessary to change to a different dose. You should swallow 
the tablets with a glass of water. 
 
If you have the impression that the effect of Tandemact is too weak, talk to your doctor. 
 
If you are following a special diet for diabetes, you should continue with this while you are taking 
Tandemact. 
 
Your weight should be checked at regular intervals; if your weight increases, inform your doctor. 
 
Your doctor will ask you to have blood tests periodically during treatment with Tandemact. 
 
If you take more Tandemact than you should 
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a 
doctor or pharmacist immediately. Your blood sugar could fall below the normal level. The symptoms 
may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness, 
nausea, coma or convulsion. Your blood sugar level can be increased by taking sugar. It is 
recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice. 
 
If you forget to take Tandemact 
Take Tandemact daily as prescribed. However if you miss a dose, skip the missed dose and just carry 
on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.  
 
If you stop taking Tandemact 
Tandemact should be used every day to work properly. If you stop using Tandemact, your blood sugar 
may go up. Talk to your doctor before stopping this treatment. 
 
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. 
 
In particular, patients have experienced the following serious side effects: 
 
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients 
taking Tandemact. Signs and symptoms include blood in your urine, pain when urinating or a sudden 
need to urinate. If you experience any of these, talk to your doctor as soon as possible. 
 
Hypoglycaemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) 
in patients taking Tandemact. The symptoms may include cold sweat, tiredness, headache, rapid 
heartbeat, hunger pangs, irritability, nervousness or nausea. It is important to know what symptoms to 
expect when hypoglycaemia (low blood sugar) occurs. Ask your doctor or pharmacist for more 
information if you are not sure how to recognise this and what you should do if you experience the 
symptoms.  



38 

 
Decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which 
makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes 
infections more likely) have been reported in patients taking Tandemact rarely (may affect up to 
1 in 1,000 people). If you experience this side effect, talk to your doctor as soon as possible. These 
problems generally get better after you stop taking Tandemact. 
 
Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in 
patients taking Tandemact in combination with insulin. If you experience this side effect, talk to your 
doctor as soon as possible. 
 
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients 
taking Tandemact and have also been reported in male patients (frequency cannot be estimated from 
the available data) taking Tandemact. If you experience this side effect, talk to your doctor as soon as 
possible. 
 
Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been 
reported in patients taking Tandemact (frequency cannot be estimated from the available data). If you 
experience this symptom for the first time, talk to your doctor as soon as possible. Also, if you already 
have blurred vision and the symptom gets worse, talk to your doctor as soon as possible. 
 
Allergic reactions have been reported with frequency not known (cannot be estimated from the 
available data) in patients taking Tandemact. If you have a serious allergic reaction, including hives 
and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing 
stop taking this medicine and talk to your doctor immediately. 
 
Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, 
including glimepiride: 
 
Common (may affect up to 1 in 10 people) 
 
- weight gain 
- dizziness 
- gas 
- respiratory infection 
- numbness 
 
Uncommon (may affect up to 1 in 100 people) 
 
- headache 
- inflammation of the sinuses (sinusitis) 
- vertigo 
- abnormal vision 
- sweating 
- tiredness 
- difficulty sleeping (insomnia) 
- decreased blood sugar 
- sugar in urine 
- proteins in urine 
- increased appetite 
- increase of an enzyme called lactic dehydrogenase (LDH) 
 
Rare (may affect up to 1 in 1,000 people) 
- noticeable changes in blood 
 
Very rare (may affect up to 1 in 10,000 people) 
- liver disease 



39 

- allergic reactions including allergic shock 
- feeling sick (nausea), vomiting and diarrhoea 
- stomach ache 
- abdominal pressure 
- feeling of fullness in the stomach 
- sensitivity to light 
- decrease in salt (sodium) concentrations in the blood 
 
Not known (frequency can not be estimated from the available data) 
- increase in liver enzymes 
- itchy skin 
- raised and itchy rash (hives) 
 
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 Tandemact 
 
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 the 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 waste water or household waste. Ask you 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 Tandemact contains 
- The active substances are pioglitazone and glimepiride.  

Each Tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg 
glimepiride. 
Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg 
glimepiride. 
Each Tandemact 45 mg/4 mg tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg 
glimepiride. 

- The other ingredients are cellulose microcrystalline, croscarmellose sodium, 
hydroxypropylcellulose, lactose monohydrate (see section 2 ‘Tandemact contains lactose 
monohydrate’), magnesium stearate and polysorbate 80. 

 
What Tandemact looks like and contents of the pack 
- Tandemact 30 mg/2 mg tablets are white to off-white, round, convex and debossed ‘4833 G’ on 

one face and ‘30/2’ on the other.  
- Tandemact 30 mg/4 mg tablets are white to off-white, round, convex and debossed ‘4833 G’ on 

one face and ‘30/4’ on the other. 
- Tandemact 45 mg/4 mg tablets are white to off-white, round, flat and debossed ‘4833 G’ on one 

face and ‘45/4’ on the other. 
The tablets are supplied in aluminium/aluminium blister packs containing either 14, 28, 30, 50, 90 or 
98 tablets. 
 



40 

Not all pack sizes may be marketed. 
 
Marketing authorisation holder 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
Manufacturer 
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland 
Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italy 
Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 – 98, 16515 Oranienburg, Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Takeda Belgium 
Tél/Tel: +32 2 464 06 11 
takeda-belgium@takeda.com  
 

Lietuva 
Takeda UAB 
Tel: +370 521 09 070 
lt-info@takeda.com 
 

България 
Такеда България 
Тел.: + 359 2 958 27 36;   + 359 2 958 15 29 
 

Luxembourg/Luxemburg 
Takeda Belgium 
Tél/Tel: +32 2 464 06 11 
takeda-belgium@takeda.com  
 

Česká republika 
Takeda Pharmaceuticals Czech Republic s.r.o. 
Tel: + 420 234 722 722  

Magyarország 
Takeda Pharma Kft. 
Tel: +361 2707030 
 

Danmark 
Takeda Pharma A/S 
Tlf: +45 46 77 11 11 
 

Malta 
Takeda Italia S.p.A. 
Tel: +39 06 502601 
 

Deutschland 
Takeda GmbH 
Tel: 0800 825 3325 
medinfo@takeda.de  
 

Nederland 
Takeda Nederland bv 
Tel: +31 23 56 68 777 
 

Eesti 
Takeda Pharma AS 
Tel: +372 617 7669 
 

Norge 
Takeda AS 
Tlf: +47 6676 3030 
infonorge@ takeda.com  
 

Ελλάδα 
TAKEDA ΕΛΛΑΣ Α.Ε 
Τηλ: +30 210 6387800 
gr.info@takeda.com  
 

Österreich 
Takeda Pharma Ges.m.b.H 
Tel: +43(0)800 20 80 50 
 

España 
Takeda Farmacéutica España S.A. 
Tel: +34 917 14 99 00 
spain@takeda.com 
 

Polska 
Takeda Pharma sp. z o.o. 
Tel.: +48 22 608 13 00 
 

France 
Takeda France 
Tél: +33 1 46 25 16 16 

Portugal 
Takeda - Farmacêuticos Portugal, Lda. 
Tel: + 351 21 120 1457 



41 

  
Hrvatska 
Takeda Pharmaceuticals Croatia d.o.o 
Tel: +385 1 377 88 96 
 
Ireland 
Takeda Products Ireland Limited 
Tel: +353 (0) 1 6420021 
 

România 
Takeda Pharmaceuticals SRL 
Tel: +40 21 335 03 91 
 
Slovenija 
Takeda GmbH Podružnica Slovenija 
Tel:+ 386 (0) 59 082 480 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
vistor@vistor.is  
 

Slovenská republika 
Takeda Pharmaceuticals Slovakia s.r.o. 
Tel: +421 (2) 20 602 600 
 
 

Italia 
Takeda Italia S.p.A. 
Tel: +39 06 502601 
 

Suomi/Finland 
Takeda Oy 
Puh/Tel: +358 20 746 5000 
 

Κύπρος 
Takeda Pharma A/S 
Τηλ: +45 46 77 11 11 
 

Sverige 
Takeda Pharma AB 
Tel: +46 8 731 28 00 
infosweden@takeda.com 
 

Latvija 
Takeda Latvia SIA 
Tel: +371 67840082 
 

United Kingdom 
Takeda UK Ltd 
Tel: +44 (0)1628 537 900 
 

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


	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what tandemact is and what it is used for', 'Section_Content': 'tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level. it is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus. this type 2 diabetes usually develops in adulthood where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it. your doctor will check whether tandemact is working 3 to 6 months after you start taking it.', 'Entity_Recognition': [{'Text': 'tandemact', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'tandemact', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 9}, {'Id': 0, 'BeginOffset': 19, 'EndOffset': 31, 'Score': 0.9974494576454163, 'Text': 'pioglitazone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 36, 'EndOffset': 47, 'Score': 0.9990850687026978, 'Text': 'glimepiride', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 12, 'BeginOffset': 58, 'EndOffset': 81, 'Score': 0.44674402475357056, 'Text': 'anti-diabetic medicines', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'blood sugar level', 'Type': 'TEST', 'BeginOffset': 99, 'EndOffset': 116}, {'Id': 3, 'BeginOffset': 144, 'EndOffset': 153, 'Score': 0.997309684753418, 'Text': 'metformin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'type 2 (non-insulin dependent) diabetes mellitus', 'Type': 'PROBLEM', 'BeginOffset': 179, 'EndOffset': 227}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 184, 'EndOffset': 185}, {'Text': 'this type 2 diabetes', 'Type': 'PROBLEM', 'BeginOffset': 229, 'EndOffset': 249}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 239, 'EndOffset': 240}, {'Id': 4, 'BeginOffset': 326, 'EndOffset': 333, 'Score': 0.9390326738357544, 'Text': 'insulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 13, 'BeginOffset': 337, 'EndOffset': 377, 'Score': 0.23669004440307617, 'Text': 'hormone that controls blood sugar levels', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'the insulin', 'Type': 'TREATMENT', 'BeginOffset': 406, 'EndOffset': 417}, {'Id': 11, 'BeginOffset': 502, 'EndOffset': 517, 'Score': 0.4207749366760254, 'Text': 'type 2 diabetes', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9514369368553162}]}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 507, 'EndOffset': 508}, {'Id': 6, 'BeginOffset': 546, 'EndOffset': 553, 'Score': 0.9853437542915344, 'Text': 'insulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': '3', 'Type': 'NUMBER', 'BeginOffset': 661, 'EndOffset': 662}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 666, 'EndOffset': 667}]}
{'Title': '2. what you need to know before you take tandemact', 'Section_Content': 'do not take tandemact: - if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, or any of the other ingredients of this medicine (listed in section 6) - if you have heart failure or have had heart failure in the past - if you have liver disease - if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting) - if you have severe problems with your kidneys - if you have or have ever had bladder cancer - if you have blood in your urine that your doctor has not checked - if you have insulin dependent diabetes (type 1) - if you are in a diabetic coma - if you are pregnant - if you are breast-feeding 35 warnings and precautions talk to your doctor or pharmacist before taking tandemact (see also section 4) - if you have a problem with your heart. some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure. inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. if you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor. - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision. - if you have a problem with your liver. before you start taking tandemact you will have a blood sample taken to check your liver function. this check should be repeated at intervals. inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked. - if you have cysts on your ovaries (polycystic ovary syndrome). there may be an increased possibility of becoming pregnant because you may ovulate again when you take tandemact. if this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy. - if you are already taking other medicines for the treatment of diabetes. - if you have problems with your enzyme called glucose-6-phosphodehydrogenase since it can decrease your red cells. you may also experience a reduction in blood count (anaemia). your doctor may take blood tests to monitor your blood cell levels and liver function. hypoglycaemia when you take tandemact, your blood sugar could fall below the normal level (hypoglycaemia). if you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again. ask your doctor or pharmacist for more information if you are not sure how to recognise this. it is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice. broken bones a higher number of bone fractures was seen in patients, particularly women taking pioglitazone. your doctor will take this into account when treating your diabetes. children and adolescents use in children and adolescents under 18 years is not recommended. other medicines and tandemact tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. this is because some medicines can weaken or strengthen the effect of tandemact on the level of sugar in your blood. the following medicines can increase the blood sugar lowering effect of tandemact. this can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil and fibrates (to lower high cholesterol level) - insulin, metformin or other medicines to treat diabetes mellitus - phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and inflammation) - long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (to treat bacterial or fungal infections) 36 - anabolic steroids (supporting muscle build up) or male sex hormone replacement therapy - fluoxetine, mao-inhibitors (to treat depression) - angiotensin-converting enzyme (ace) inhibitors, sympatholytics, disopyramide, pentoxifylline, coumarin derivatives such as warfarin (to treat heart or blood problems) - allopurinol, probenecid, sulfinpyrazone (to treat gout) - cyclophosphamide, ifosfamide, trofosfamide (to treat cancer) - fenfluramine (to reduce weight) - tritoqualine (to treat allergies) the following medicines may decrease the blood sugar lowering effect of tandemact. this can lead to a risk of hyperglycaemia (high blood sugar level): - oestrogens, progestogens (female sex hormones) - thiazide diuretics and saluretics also called water tablets (to treat high blood pressure) - levothyroxine (to stimulate the thyroid gland) - glucocorticoids (to treat allergies and inflammation) - chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders) - adrenaline and sympathicomimetics (to increase heart beat, to treat asthma or nasal congestion, coughs and colds or used in life-threatening emergencies) - nicotinic acid (to treat high cholesterol level) - long-term use of laxatives (to treat constipation) - phenytoin (to treat fits) - barbiturates (to treat nervousness and sleep problems) - azetazolamide (to treat increased pressure in the eye also called glaucoma) - diazoxide (to treat high blood pressure or low blood sugar) - rifampicin (to treat infections, tuberculosis) - glucagon (to treat severe low blood sugar levels) the following medicines can increase or decrease the blood sugar lowering effect of tandemact: - h2 antagonists (to treat stomach ulcers) - beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure). these can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines tandemact may either increase or weaken the effects of the following medicines: - coumarin derivatives such as warfarin (to slow down or stop blood clotting) tell your doctor or pharmacist if you are taking any of these. your blood sugar will be checked, and your dose of tandemact may need to be changed. tandemact with alcohol avoid alcohol while taking tandemact since alcohol may increase or decrease the blood sugar lowering action of tandemact in an unpredictable way. pregnancy and breast-feeding do not use tandemact if you are pregnant. you must tell your doctor if you are, you think you may be pregnant or are planning to have a baby. your doctor will advise you to discontinue this medicine. do not use tandemact if you are 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{'Title': '3. how to take tandemact', '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 once daily shortly before or with the first main meal. your doctor will tell you the dose to take or if necessary to change to a different dose. you should swallow the tablets with a glass of water. if you have the impression that the effect of tandemact is too weak, talk to your doctor. if you are following a special diet for diabetes, you should continue with this while you are taking tandemact. your weight should be checked at regular intervals; if your weight increases, inform your doctor. your doctor will ask you to have blood tests periodically during treatment with tandemact. if you take more tandemact than you should if you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. your blood sugar could fall below the normal level. the symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness, nausea, coma or convulsion. your blood sugar level can be increased by taking sugar. it is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice. if you forget to take tandemact take tandemact daily as prescribed. however if you miss a dose, skip the missed dose and just carry on with the next dose as normal. do not take a double dose to make up for a forgotten tablet. if you stop taking tandemact tandemact should be used every day to work properly. if you stop using tandemact, your blood sugar may go up. talk to your doctor before stopping this treatment. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'tandemact', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. in particular, patients have experienced the following serious side effects: bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking tandemact. signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. if you experience any of these, talk to your doctor as soon as possible. hypoglycaemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) in patients taking tandemact. the symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea. it is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs. ask your doctor or pharmacist for more information if you are not sure how to recognise this and what you should do if you experience the symptoms. decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes infections more likely) have been reported in patients taking tandemact rarely (may affect up to 1 in 1,000 people). if you experience this side effect, talk to your doctor as soon as possible. these problems generally get better after you stop taking tandemact. localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking tandemact in combination with insulin. if you experience this side effect, talk to your doctor as soon as possible. broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking tandemact. if you experience this side effect, talk to your doctor as soon as possible. blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported in patients taking tandemact (frequency cannot be estimated from the available data). if you experience this symptom for the first time, talk to your doctor as soon as possible. also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible. allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking tandemact. if you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor immediately. some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride: common (may affect up to 1 in 10 people) - weight gain - dizziness - gas - respiratory infection - numbness uncommon (may affect up to 1 in 100 people) - headache - inflammation of the sinuses (sinusitis) - vertigo - abnormal vision - sweating - tiredness - difficulty sleeping (insomnia) - decreased blood sugar - sugar in urine - proteins in urine - increased appetite - increase of an enzyme called lactic dehydrogenase (ldh) rare (may affect up to 1 in 1,000 people) - noticeable changes in blood very rare (may affect up to 1 in 10,000 people) - liver disease 39 - allergic reactions including allergic shock - feeling sick (nausea), vomiting and diarrhoea - stomach ache - abdominal pressure - feeling of fullness in the stomach - sensitivity to light - decrease in salt (sodium) concentrations in the blood not known (frequency can not be estimated from the available data) - increase in liver enzymes - itchy skin - raised and itchy rash (hives) 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 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{'Title': '5. how to store tandemact', '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 the 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 waste water or household waste. ask you 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 tandemact contains - the active substances are pioglitazone and glimepiride. each tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride. each tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride. each tandemact 45 mg/4 mg tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride. - the other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 'tandemact contains lactose monohydrate'), magnesium stearate and polysorbate 80. what tandemact looks like and contents of the pack - tandemact 30 mg/2 mg tablets are white to off-white, round, convex and debossed '4833 g' on one face and '30/2' on the other. - tandemact 30 mg/4 mg tablets are white to off-white, round, convex and debossed '4833 g' on one face and '30/4' on the other. - tandemact 45 mg/4 mg tablets are white to off-white, round, flat and debossed '4833 g' on one face and '45/4' on the other. the tablets are supplied in aluminium/aluminium blister packs containing either 14, 28, 30, 50, 90 or 98 tablets. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'tandemact', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 52, 'EndOffset': 64, 'Score': 0.9791117906570435, 'Text': 'pioglitazone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 69, 'EndOffset': 80, 'Score': 0.9975700974464417, 'Text': 'glimepiride', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9875146150588989, 'RelationshipScore': 0.9562342762947083, 'RelationshipType': 'FORM', 'Id': 8, 'BeginOffset': 108, 'EndOffset': 114, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'each tandemact', 'Type': 'TREATMENT', 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