Tandemact

Package leaflet: Information for the patient

Tandemact 30 mg/2 mg tablets, 30 mg/4 mg tablets

pioglitazone/glimepiride
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tandemact is and what it is used for
2. What you need to know before taking 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 antidiabetic medicines used to control blood sugar levels.
It is used in adults to treat type 2 diabetes mellitus (non-insulin-dependent diabetes) when metformin is not suitable. This type of diabetes usually occurs in adults when the body does not produce enough insulin (a hormone that regulates blood sugar levels) or cannot effectively use the insulin it produces.
Tandemact helps control blood sugar levels in patients with type 2 diabetes by increasing the amount of available insulin and helping the body use insulin more effectively. Your doctor will check whether Tandemact is working 3 to 6 months after starting treatment.

2. What you need to know before taking Tandemact

Do not take Tandemact

• if you are allergic to pioglitazone, glimepiride, other sulfonylureas or sulfonamides, or any of the other ingredients of this medicine (listed in section 6)
• if you have heart failure or have previously had heart failure
• if you have liver problems
• if you have diabetic ketoacidosis (a diabetes complication with rapid weight loss, nausea or vomiting)
• if you have severe kidney problems
• if you have or have ever had bladder cancer (bladder tumour)
• if you have blood in your urine and your doctor has not yet investigated the cause
• if you have insulin-dependent diabetes (type 1)
• if you are in a diabetic coma
• if you are pregnant
• if you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Tandemact (also see section 4)

• if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke, treated with pioglitazone and insulin together, have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure, such as unusually shortness of breath, rapid weight gain, or localized swelling (edema).
• if you retain water (fluid retention) or have heart failure problems, especially if you are over 75 years old. You should also inform your doctor if you are taking anti-inflammatory medicines, which may also cause fluid retention and swelling.
• if you have a specific type of diabetic eye disease called macular edema (swelling at the back of the eye), consult your doctor if you notice any changes in your vision.
• if you have liver problems. Before starting Tandemact, you will need a blood test to check your liver function. This test should be repeated periodically. Inform your doctor as soon as possible if you develop symptoms suggesting liver problems (such as unexplained malaise, vomiting, stomach pain, fatigue, loss of appetite, and/or dark urine), as your liver function needs to be monitored.
• if you have ovarian cysts (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, as ovulation may resume when taking Tandemact. If this applies to you, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
• if you are already taking other medicines for diabetes.
• if you have a problem with the enzyme called glucose-6-phosphate dehydrogenase, as this may reduce red blood cell count.

You may also experience a decrease in blood cell count (anaemia). Your doctor may take blood samples to monitor your blood cell levels and liver function.

Hypoglycaemia
When taking Tandemact, your blood sugar may drop below normal levels (hypoglycaemia). If you experience symptoms of hypoglycaemia such as cold sweat, fatigue, headache, rapid heartbeat, hunger pangs, irritability, nervousness, or nausea, you should take sugar to raise your blood sugar level. Ask your doctor or pharmacist for further information if you are unsure how to recognise these symptoms. It is advisable to carry sugar cubes, sweets, biscuits, or sugared fruit juices with you.

Bone fractures
An increased number of bone fractures has been observed in patients, particularly in women, taking pioglitazone. Your doctor will take this into account when managing your diabetes.

Children and adolescents
Use in children and adolescents under 18 years of age 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. Some medicines may weaken or strengthen the effect of Tandemact on blood sugar levels.

The following medicines may enhance the blood sugar-lowering effect of Tandemact. This may increase the risk of hypoglycaemia (low blood sugar):

• gemfibrozil and fibrates (used to lower high cholesterol levels in the blood)
• insulin, metformin, or other medicines for treating diabetes mellitus
• phenylbutazone, azapropazone, oxyphenbutazone, medicines such as aspirin (used to treat pain and inflammation)
• long-acting sulfonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (used to treat bacterial or fungal infections)
• anabolic steroids or male sex hormone replacement therapy
• fluoxetine, MAO inhibitors (used to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors, sympatholytics, disopyramide, pentoxifylline, coumarin derivatives such as warfarin (used to treat heart or blood problems)
• allopurinol, probenecid, sulfinpyrazone (used to treat gout)
• cyclophosphamide, ifosfamide, trofosfamide (used to treat cancer)
• fenfluramine (used to reduce weight)
• tritoqualine (used to treat allergies)

The following medicines may reduce the blood sugar-lowering effect of Tandemact. This may be associated with a risk of hyperglycaemia (high blood sugar):

• oestrogens, progestogens (female sex hormones)
• thiazide and saluretic diuretics, also known as water tablets (used to treat high blood pressure)
• levothyroxine (used to stimulate the thyroid gland)
• glucocorticoids (used to treat allergies and inflammation)
• chlorpromazine and other phenothiazine derivatives (used to treat severe mental disorders)
• adrenaline and sympathomimetics (used to increase heart rate, to treat asthma or nasal congestion, cough and cold, or used in life-threatening emergencies)
• nicotinic acid (used to treat high cholesterol levels)
• long-term use of laxatives (used to treat constipation)
• phenytoin (used to treat epileptic seizures)
• barbiturates (used to treat nervousness and sleep disorders)
• acetazolamide (used to treat increased eye pressure, also known as glaucoma)
• diazoxide (used to treat high blood pressure or low blood sugar)
• rifampicin (used to treat infections, tuberculosis)
• glucagon (used to treat very low blood sugar)

The following medicines may either increase or decrease the blood sugar-lowering effect of Tandemact:

• H-receptor antagonists (used to treat gastric ulcers)
• beta-blockers, clonidine, guanethidine, and reserpine (used to treat high blood pressure or heart failure). These may also mask the signs of hypoglycaemia, so extra caution is required when taking these medicines.

Tandemact may increase or decrease the effects of the following medicines:

• coumarin derivatives, such as warfarin (used to slow or stop blood clotting)

Talk to your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be monitored, and the dose of Tandemact may need to be adjusted.

Tandemact and alcohol
Avoid alcohol while taking Tandemact, as alcohol may unpredictably increase or decrease the blood sugar-lowering effect of Tandemact.

Pregnancy and breastfeeding
Do not take Tandemact if you are pregnant. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor. Your doctor will advise you to stop treatment with this medicine.

Do not use Tandemact if you are breastfeeding or intend to breastfeed (see section “Do not take Tandemact”).

Driving and using machines
Your attention and reaction time may be reduced due to low or high blood sugar levels caused by glimepiride, especially at the beginning of treatment, after changing treatment, or if Tandemact is not taken regularly. This medicine may affect your ability to drive or operate machinery.

Be cautious if you experience abnormal vision.

Tandemact contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Tandemact.

Tandemact contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Tandemact

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet taken once daily, just before or during the main meal. Your doctor will tell you what dose to take or whether you need to switch to a different dose. Swallow the tablets with a glass of water.
If you feel that the effect of Tandemact is too weak, consult your doctor.
If you are following a special diabetic diet, you must continue it while taking Tandemact.
Your weight should be monitored regularly; if you gain weight, inform your doctor.
Your doctor will ask you to have periodic blood tests 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 tablets, contact your doctor or pharmacist immediately. Your blood sugar level may drop below normal. Symptoms may include cold sweats, tiredness, headache, rapid heartbeat, stomach cramps, hunger, irritability, nervousness, nausea, coma, or seizures. Low blood sugar can be treated by taking sugar. It is advisable to carry some sugar lumps, sweets, biscuits, or a sugary fruit juice with you.

If you forget to take Tandemact
Take Tandemact every day as prescribed. However, if you forget a dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Tandemact
Tandemact must be taken every day for it to work properly. If you stop taking Tandemact, your blood sugar level may rise. Consult your doctor before stopping treatment.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
In particular, patients have experienced the following serious side effects:

Uncommon cases of bladder carcinoma (bladder tumour) (may affect up to 1 in 100 patients) have been observed in patients treated with Tandemact. Signs and symptoms include blood in the urine, pain during urination, or a sudden need to urinate. If you experience any of these symptoms, speak to your doctor as soon as possible.

Hypoglycaemia (low blood sugar level) has been reported uncommonly (may affect up to 1 in 100 people) in patients treated with Tandemact. Symptoms may include cold sweat, fatigue, headache, rapid heartbeat, stomach cramps due to hunger, irritability, nervousness, or nausea. It is important to know which symptoms to expect when hypoglycaemia (low blood sugar) occurs. Speak to your doctor or pharmacist for further information if you are unsure about how to recognise hypoglycaemia and what to do if you experience these symptoms.

In patients treated with Tandemact, rare cases (may affect up to 1 in 1,000 people) of reduced platelet counts (increasing the risk of bleeding or bruising), reduced red blood cells (causing pale skin, weakness, or shortness of breath), and reduced white blood cells (increasing the likelihood of infections) have been reported. If you experience any of these side effects, consult your doctor as soon as possible. These problems usually improve after discontinuation of Tandemact.

Localized swelling (oedema) has commonly occurred (may affect up to 1 in 10 people) in patients treated with Tandemact and insulin. If you experience this side effect, speak to your doctor as soon as possible.

Common cases (may affect up to 1 in 10 people) of bone fractures have been reported in female patients and also in male patients taking Tandemact (available data do not allow estimation of frequency). If you experience this side effect, inform your doctor as soon as possible.

Blurred vision due to swelling (oedema) at the back of the eye (macular oedema) has also been reported in patients treated with Tandemact (frequency cannot be determined from available data). Inform your doctor as soon as possible if you notice the onset of these symptoms for the first time. Also inform your doctor as soon as possible if you already suffer from blurred vision and these symptoms worsen.

Allergic reactions have been reported with unknown frequency (frequency cannot be determined from available data) in patients taking Tandemact. If you experience a severe allergic reaction, including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine immediately and speak to your doctor without delay.

The following side effects have been reported in some patients taking pioglitazone and sulphonylureas, including glimepiride:

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

• weight gain
• dizziness
• gas (flatulence)
• respiratory infections
• numbness (paraesthesia)

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

• headache
• inflammation of the sinuses (sinusitis)
• dizziness (vertigo)
• abnormal vision
• sweating
• fatigue
• difficulty sleeping (insomnia)
• decreased blood sugar
• sugar in the urine
• protein in the urine
• increased appetite
• increase in an enzyme called lactate dehydrogenase (LDH)

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

• noticeable changes in blood test values

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

• liver disease
• allergic reactions including anaphylactic shock
• feeling unwell (nausea), vomiting, and diarrhoea
• stomach ache
• abdominal pressure
• feeling of fullness in the stomach
• light sensitivity
• reduced concentration of salt (sodium) in the blood

Frequency not known (frequency cannot be determined from available data):

• increased liver enzymes
• skin itching (pruritus)
• increased skin irritation and itching (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the cardboard box and blister after "Exp./EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tandemact contains

• The active substances are pioglitazone and glimepiride. Each Tandemact 30 mg/2 mg tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride. Each Tandemact 30 mg/4 mg tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
• The other components are microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, lactose monohydrate (see section 2 “Tandemact contains lactose monohydrate”), magnesium stearate and polysorbate 80.

Description of the appearance of Tandemact and package contents

• Tandemact 30 mg/2 mg tablets are white to off-white, round, biconvex, with ‘4833 G’ imprinted on one side and “30/2” on the other.
• Tandemact 30 mg/4 mg tablets are white to off-white, round, biconvex, with ‘4833 G’ imprinted on one side and “30/4” on the other. The tablets are supplied in aluminum/aluminum blisters, in packs containing 28 tablets.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
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
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu