TANDEMACT 30 mg/4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Tandemact 30 mg/2 mg tablets

Tandemact 30 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.

Contents of the pack

1. What is Tandemact and what is it used for
2. What you need to know before you take Tandemact

1. How to take Tandemact
2. Possible side effects
3. Storage of Tandemact

1. Contents of the pack and further information

1. What is Tandemact and what is it used for

Tandemact contains pioglitazone and glimepiride, which are anti-diabetic 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). This type 2 diabetes usually develops in adulthood when the body does not produce enough insulin (a hormone that controls blood sugar levels) or cannot use it effectively.

Tandemact helps control blood sugar levels in people with type 2 diabetes by increasing the amount of insulin available and helping the body use it better. Your doctor will check the effect that Tandemact is having on you between 3 and 6 months after you start treatment.

2. What you need to know before you take 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 checked by your doctor
• if you have insulin-dependent diabetes (type 1)

• if you are in a diabetic coma
• if you are pregnant

• if you are breast-feeding

Warnings and precautions

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

• if you have any heart problems. Some patients with type 2 diabetes who have had a heart attack or stroke in the past and were treated with pioglitazone and insulin at the same time developed heart failure. Tell your doctor as soon as possible if you notice signs of heart failure such as unusual difficulty breathing or 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. If you are taking anti-inflammatory medicines that can also cause fluid retention and swelling, you should also consult your doctor.

• if you have a special type of diabetic eye disease called macular edema (swelling of the back of the eye), consult your doctor if you experience any changes in your vision.
• if you have any liver problems. Before you start taking Tandemact, you will have a blood test to check your liver function. This test should be repeated periodically. Tell your doctor as soon as possible if you show symptoms that suggest a liver problem (such as unexplained dizziness, vomiting, stomach pain, tiredness, loss of appetite and/or darkening of the urine) as your liver function will need to be checked.

• if you have cysts on the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant as Tandemact may cause you to ovulate again. In this case, use adequate contraceptive measures to avoid the possibility of an unplanned pregnancy.

• if you are already using other medicines for diabetes treatment.
• if you have problems with an enzyme called glucose-6-phosphate dehydrogenase as it may decrease the number of red blood cells.

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

Hypoglycemia

While taking Tandemact, your blood sugar levels may drop to below normal levels (hypoglycemia). If you experience symptoms of hypoglycemia, such as cold sweats, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, take some sugar to raise your blood sugar levels. Ask your doctor or pharmacist if you are not sure how to recognize these symptoms. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice with you.

Bone fractures

A higher number of bone fractures has been seen in patients, particularly in women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Tandemact is not recommended for use in children and adolescents under 18 years of age.

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 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 hypoglycemia (low blood sugar):

• gemfibrozil and fibrates (to reduce high cholesterol)

• insulin, metformin or other medicines to treat diabetes mellitus
• phenylbutazone, azapropazone, oxyphenbutazone, medicines similar to aspirin (to treat pain and inflammation)
• long-acting sulfonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (to treat bacterial or fungal infections)
• anabolic steroids (to promote muscle development) or male sex hormone replacement therapy
• fluoxetine, MAO inhibitors (to treat depression)

• ACE inhibitors, beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure). Also, they may mask the signs of hypoglycemia, so special care is needed when taking these medicines.

• allopurinol, probenecid, sulfinpyrazone (to treat gout)

• cyclophosphamide, ifosfamide, trofosfamide (to treat cancer)
• fenfluramine (to lose weight)
• tritoqualine (to treat allergy)

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

• estrogens, progestogens (female sex hormones)
• thiazide diuretics and saluretics (to treat high blood pressure)

• levothyroxine (to stimulate the thyroid gland)
• glucocorticoids (to treat allergies or inflammation)

• chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders)
• adrenaline and sympathomimetics (to increase heart rate, to treat asthma or nasal congestion, cough and colds or used in emergencies in life-threatening situations)
• nicotinic acid (to treat high cholesterol)

• prolonged use of laxatives (to treat constipation)
• phenytoin (to treat convulsions)
• barbiturates (to treat nervousness or sleep problems)

• acetazolamide (to treat glaucoma)
• diazoxide (to treat high blood pressure or reduce blood sugar)

• rifampicin (to treat infections, tuberculosis)
• glucagon (to treat very low blood sugar levels)

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

• H2 antagonists (to treat stomach ulcers)
• beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure). Also, they may mask the signs of hypoglycemia, so special care is needed when taking these medicines.

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

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

Tell your doctor or pharmacist if you are taking any of these medicines. Your blood sugar levels will be checked and you may need to adjust your dose of Tandemact.

Tandemact with alcohol

Avoid drinking alcohol while being treated with Tandemact as alcohol may increase or decrease blood sugar levels, reducing the effect of Tandemact in an unpredictable way.

Pregnancy and breast-feeding

Do not take Tandemact if you are pregnant. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Your doctor will advise you to stop treatment with this medicine.

Do not take Tandemact if you are breast-feeding or thinking of breast-feeding your baby (see section “Do not take Tandemact”).

Driving and using machines

Vigilance and reaction time may be impaired due to the increase or decrease in blood sugar levels caused by glimepiride, especially when starting or changing treatment, or if Tandemact is not taken regularly. This may affect your ability to drive or use machines.

Be careful if you experience vision changes.

Tandemact contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult them before taking Tandemact.

Tandemact contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Tandemact

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet once a day, shortly before the main meal or with it. Your doctor will tell you the dose you should take or if necessary, 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, consult your doctor.

If you are following a diet for diabetics, keep to it while taking Tandemact.

You should check your weight regularly. If you gain weight, tell your doctor.

Your doctor will ask you to have regular 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. Your blood sugar levels may drop below normal. The symptoms can include cold sweats, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea. You can increase your blood sugar levels by taking sugar. It is recommended that you always carry sugar lumps, sweets, biscuits or sugary fruit juice with you.

If you forget to take Tandemact

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

If you stop taking Tandemact

To get the correct effect, Tandemact should be taken every day. If you stop taking Tandemact, your blood sugar levels may increase. Consult your doctor before stopping treatment with Tandemact.

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

4. Possible side effects

Like all medicines, Tandemact can cause side effects, although not everybody gets them.

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

Uncommonly (may affect up to 1 in 100 people), bladder cancer has been developed in patients taking Tandemact. The signs and symptoms include blood in the urine, pain when urinating or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Uncommonly (may affect up to 1 in 100 people), hypoglycemia (low blood sugar) has been reported in patients taking Tandemact. The symptoms can include cold sweats, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea. It is important that you know the symptoms to expect when hypoglycemia is going to occur (low blood sugar). Ask your doctor or pharmacist if you are not sure how to recognize them or what you should do if you experience these symptoms.

Rarely (may affect up to 1 in 1,000 people), decreases in blood platelets (which increases the risk of bleeding or bruising), red blood cells (which causes paleness of the skin and causes weakness and breathing difficulties) and white blood cells (which increases the chances of infection) have been reported with Tandemact. If you experience this side effect, tell your doctor immediately. These disorders usually improve when treatment with Tandemact is stopped.

Commonly (may affect up to 1 in 10 people), localized swelling (edema) has been developed in patients taking Tandemact with insulin. If you experience this side effect, tell your doctor as soon as possible.

Bone fractures: commonly (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 side effect.

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

Allergic reactions have been reported with an 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 that 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 sulfonylureas, including glimepiride:

Common (may affect up to 1 in 10 people)

• weight gain

• dizziness
• gas

• respiratory infections
• numbness

Uncommon (may affect up to 1 in 100 people)

• headache
• sinusitis
• vertigo
• vision disturbances
• sweating
• tiredness
• difficulty sleeping (insomnia)
• low blood sugar
• sugar in the urine
• protein in the urine
• increased appetite
• increased levels of an enzyme called lactate dehydrogenase (LDH)

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

• blood changes

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

• liver disease

• allergic reactions, including anaphylactic shock
• nausea, vomiting and diarrhea
• stomach pain

• abdominal pressure
• feeling of stomach fullness

• sensitivity to light
• decreased sodium levels in the blood

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

• increased liver enzymes

• skin itching
• lumpy rash with itching

Reporting of side effects

If you experience 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. Storage of 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 on the blister after “EXP”. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Tandemact Composition

• The active ingredients 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, hydroxypropylmethylcellulose, lactose monohydrate (see section 2 "Tandemact contains lactose monohydrate"), magnesium stearate, and polysorbate 80.

Appearance of Tandemact and Packaging Contents

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

They are presented in aluminum/aluminum blister strips containing 28 tablets.

Marketing Authorization 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 Last Revision of this Leaflet: 08/2023

Other Sources of Information

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