Tandemact 30 mg/2 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tandemact 30 mg/2 mg tablets

Tandemact 30 mg/4 mg tablets

pioglitazone/glimepiride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 when metformin is not suitable, to treat type 2 diabetes mellitus (non-insulin-dependent diabetes). Type 2 diabetes usually develops in adulthood, when 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 blood sugar levels in people with type 2 diabetes by increasing the amount of insulin available and helping the body to use it more effectively. Your doctor will monitor the effect of Tandemact between 3 and 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 had it in the past

• if you have any liver disease

• if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting)

• if you have severe kidney problems

• if you have or have had bladder cancer

• if you have blood in your urine that has not been evaluated and controlled by your doctor

• if you have insulin-dependent diabetes (type 1 diabetes)

• if you are experiencing diabetic coma

• if you are pregnant

• if you are breastfeeding

Warnings and precautions

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

• if you have any heart problems. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke developed heart failure when treated with pioglitazone and insulin together. Inform your doctor as soon as possible if you notice signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).

• if you retain fluid (fluid retention) or have heart failure, especially if you are over 75 years old. If you are taking anti-inflammatory medicines that may also cause fluid retention and swelling, discuss this with your doctor.

• 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 vision.

• if you have any liver problems. Before starting Tandemact, a blood sample will be taken to assess liver function. This test should be repeated periodically. Inform your doctor immediately if you develop symptoms suggesting liver problems (such as unexplained fatigue, nausea, stomach pain, tiredness, loss of appetite, and/or darkening of the urine), as your liver function should be monitored.

• if you have ovarian cysts (polycystic ovary syndrome). This may increase the chance of becoming pregnant, as ovulation may resume while taking Tandemact. In this case, use appropriate contraceptive measures to avoid unplanned pregnancy.

• if you are already using other medicines for the treatment of diabetes.

• if you have a problem with an enzyme called glucose-6-phosphate dehydrogenase, as this may reduce the number of red blood cells.

You may experience a decrease in red blood cell count (anemia). Your doctor may perform blood tests to monitor blood cell counts and liver function.

Hypoglycemia

While taking Tandemact, your blood sugar levels may drop below normal (hypoglycemia). If you experience symptoms of hypoglycemia such as cold sweats, fatigue, headache, rapid heartbeat, hunger, irritability, nervousness, or nausea, take a source of sugar to raise your blood sugar levels. Ask your doctor or pharmacist if you are unsure how to recognize these symptoms. It is advisable to carry sugar cubes, sweets, biscuits, or a sugary fruit juice.

Bone fractures

An increased number of bone fractures has been observed in patients, particularly in women taking pioglitazone. Your doctor will consider this when treating 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 need to take any other medicines. This is because some medicines may weaken or enhance the effect of Tandemact on blood sugar levels.

The following medicines may increase blood sugar levels, reducing the effect of Tandemact. This may lead to a risk of hyperglycemia (high blood sugar):

• gemfibrozil and fibrates (to lower high cholesterol)
• insulin, metformin, or other medicines for treating diabetes mellitus
• phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (for treating pain and inflammation)
• long-acting sulfonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (for treating bacterial or fungal infections)
• anabolic steroids (to promote muscle development) or male hormone replacement therapy
• fluoxetine, MAO inhibitors (for treating depression)
• ACE inhibitors, sympatholytics, disopyramide, pentoxifylline, coumarin derivatives such as warfarin (for treating blood or heart disorders)
• allopurinol, probenecid, sulfinpyrazone (for treating gout)
• cyclophosphamide, ifosfamide, trofosfamide (for treating cancer)
• fenfluramine (for weight loss)
• tritoqualine (for treating allergy)

The following medicines may reduce blood sugar levels, reducing the effect of Tandemact. This may lead to a risk of hypoglycemia (low blood sugar):

• estrogens, progestogens (female sex hormones)
• thiazide and loop diuretics (for treating high blood pressure)
• levothyroxine (to stimulate the thyroid gland)
• glucocorticoids (for treating allergies or inflammation)
• chlorpromazine and other phenothiazine derivatives (for treating serious mental disorders)
• adrenaline and sympathomimetics (to increase heart rate, for treating asthma or nasal congestion, cough and colds, or used in life-threatening emergencies)
• nicotinic acid (for treating high cholesterol)
• prolonged use of laxatives (for treating constipation)
• phenytoin (for treating seizures)
• barbiturates (for treating nervousness or sleep problems)
• acetazolamide (for treating ocular hypertension, also called glaucoma)
• diazoxide (for treating high blood pressure or reducing blood sugar)
• rifampicin (for treating infections, tuberculosis)
• glucagon (for treating very low blood sugar)

The following medicines may increase or decrease blood sugar levels, reducing the effect of Tandemact:

• H2 antagonists (for treating stomach ulcers)
• beta-blockers, clonidine, guanethidine, and reserpine (for treating high blood pressure or heart failure). In addition, these medicines may mask the signs of hypoglycemia, so extra caution is needed when taking them.

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

• coumarin derivatives such as warfarin (to reduce or prevent blood clotting)

Inform your doctor or pharmacist if you are taking any of these medicines. Your blood sugar levels will be monitored, and you may require an adjustment of your Tandemact dose.

Tandemact and alcohol

Avoid drinking alcohol while being treated with Tandemact, as alcohol may unpredictably increase or decrease blood sugar levels, thereby reducing the effectiveness of Tandemact.

Pregnancy and breastfeeding

Do not take Tandemact if you are pregnant. Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you to stop treatment with this medicine.

Do not take Tandemact if you are breastfeeding or planning to breastfeed your child (see section “Do not take Tandemact”).

Driving and using machines

Your alertness and reaction time may be impaired due to increased or decreased blood sugar levels caused by glimepiride, especially when treatment is started or changed, or if Tandemact is not taken regularly. This may affect your ability to drive or operate machinery.

Be cautious if you experience vision disturbances.

Tandemact contains lactose monohydrate

If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking Tandemact.

Tandemact contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Tandemact

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet once daily, taken shortly before or with the main meal. Your doctor will tell you which dose to take or whether you need to take a different dose. The tablets should be swallowed with a glass of water.

If you feel that the effect of Tandemact is too weak, talk to your doctor.

If you are following a diabetic diet, continue to follow it while taking Tandemact.

You should monitor your weight regularly. If you gain weight, inform your doctor.

Your doctor will ask you to have periodic blood tests while you are being treated 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, tell your doctor or pharmacist immediately. The amount of sugar in your blood may fall below normal levels. Symptoms may include cold sweating, tiredness, headache, rapid heartbeat, intense hunger pangs, irritability, nervousness, nausea, coma, or seizures. Blood sugar levels can be raised by taking sugar. It is recommended that you always carry sugar lumps, sweets, biscuits, or sugared fruit juices.

If you forget to take Tandemact

Take Tandemact every day as prescribed. However, if you forget to take a dose, skip the missed dose and continue your treatment as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Tandemact

To achieve the proper effect, Tandemact must be taken every day. If you stop taking Tandemact, your blood sugar level may increase. Consult your doctor before stopping treatment with Tandemact.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tandemact may cause adverse effects, although not everyone experiences them.

In particular, patients have developed the following serious adverse effects:

Bladder cancer has been reported infrequently (may affect up to 1 in 100 people) in patients taking Tandemact. Signs and symptoms include blood in the urine, pain when urinating, or a strong urge to urinate. If you experience any of these symptoms, consult your doctor immediately.

Hypoglycaemia (low blood sugar level) has been reported infrequently (may affect up to 1 in 100 people) in patients taking Tandemact. Symptoms may include cold sweat, tiredness, headache, rapid heartbeat, intense hunger, irritability, nervousness, or nausea. It is important that you are aware of the symptoms you may experience when hypoglycaemia occurs (low blood sugar). Ask your doctor or pharmacist if you are unsure how to recognize them or what you should do if you experience these symptoms.

Rarely (may affect up to 1 in 1,000 people), Tandemact has been associated with reduced levels in blood of platelets (which increases the risk of bleeding or bruising), red blood cells (causing paleness of the skin, weakness, and difficulty breathing), and white blood cells (increasing the likelihood of infection). If you experience this adverse effect, inform your doctor immediately. These disorders usually improve when treatment with Tandemact is discontinued.

Localized swelling (oedema) has occurred frequently (may affect up to 1 in 10 people) in patients taking Tandemact together with insulin. If you experience this adverse effect, inform your doctor as soon as possible.

Bone fractures: These have been reported frequently (may affect up to 1 in 10 people) in both women and men taking Tandemact (frequency cannot be estimated from the available data). Consult your doctor as soon as possible if you experience this adverse effect.

In patients taking Tandemact, blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported (frequency cannot be estimated from the available data). If you experience these symptoms for the first time, speak to your doctor as soon as possible. Also, if you have previously experienced blurred vision and these symptoms worsen, you should speak to your doctor as soon as possible.

Allergic reactions have been reported with unknown frequency (cannot be estimated from the available data) in patients treated with Tandemact. If you have 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 and consult your doctor immediately.

Some patients have experienced the following side effects when taking pioglitazone and sulphonylureas, including glimepiride:

Frequent (may affect up to 1 in 10 people)

• weight gain
• dizziness
• flatulence
• respiratory infections
• numbness

Uncommon (may affect up to 1 in 100 people)

• headache
• sinusitis
• vertigo
• visual disturbances
• sweating
• fatigue
• difficulty sleeping (insomnia)
• decreased blood sugar
• sugar in urine
• protein in urine
• increased appetite
• increase in an enzyme called lactate dehydrogenase (LDH)

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

• observable blood changes

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

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

Frequency not known (cannot be estimated from the available data)

• increases in liver enzymes
• skin itching
• raised, itchy rashes

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tandemact

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tandemact

• 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, hypromellose, monohydrate lactose (see section 2 “Tandemact contains monohydrate lactose”), magnesium stearate and polysorbate 80.

What Tandemact looks like and contents of the pack

• Tandemact 30 mg/2 mg tablets are white or almost white, round, convex, engraved with “4833 G” on one side and “30/2” on the other.
• Tandemact 30 mg/4 mg tablets are white or almost white, round, convex, engraved with “4833 G” on one side and “30/4” on the other.

They are presented in aluminum/aluminum blister strips 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

Date of the most recent revision of this leaflet: 08/2023

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu