Package Insert: Information for the Patient

Tandemact 30 mg/2 mg Tablets

Tandemact 30 mg/4 mg Tablets

pioglitazona/glimepirida

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• Consult your doctor or pharmacist if you have any questions.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. How to Take Tandemact
2. Possible Adverse Effects
3. Storage of Tandemact

1. Contents of the Package and Additional Information

Tandemact contains pioglitazone and glimepiride, which are antidiabetic medications, used to control blood sugar levels.

It is used in adults, when metformin is not suitable, to treat type 2 diabetes (non-insulin dependent). This type 2 diabetes typically develops in adulthood, when the body either 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 available insulin and helping the body to use it more effectively. Your doctor will monitor the effect of Tandemact on you between 3 and 6 months after starting treatment.

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 uncontrolled blood in your urine
• if you have type 1 diabetes (insulin-dependent)

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

• if you are breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tandemact (also see section 4)

• if you have any heart problems. Some patients with long-term type 2 diabetes and heart disease or who have had a previous stroke when treated with pioglitazone and insulin together developed heart failure. Inform your doctor as soon as possible if you notice signs of heart failure such as unusual difficulty breathing or a rapid increase in weight or localized swelling (edema).

• if you retain water (fluid retention) or have heart failure mainly if you are over 75 years old. If you take anti-inflammatory medicines which also can 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 change in vision.
• if you have any liver disease. Before starting to take Tandemact a blood sample will be taken to analyze liver function. This analysis should be repeated periodically. Inform your doctor as soon as possible if you show symptoms that suggest liver problems (such as inexplicable dizziness, vomiting, stomach pain, fatigue, loss of appetite and/or dark urine) as your liver function should be controlled.

• if you have ovarian cysts (polycystic ovary syndrome). They may increase the chances of you becoming pregnant, as taking Tandemact may cause you to ovulate again. In this case, use appropriate contraceptive measures to avoid the risk of unplanned pregnancy.

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

You may experience a reduction in the number of red blood cells (anemia). Your doctor may perform tests to control blood cell counts and liver function.

Hypoglycemia

While taking Tandemact the amount of sugar in the blood may decrease to below normal levels (hypoglycemia). If you experience symptoms of hypoglycemia, such as cold sweats, fatigue, headache, rapid heartbeat, hunger attacks, irritability, nervousness or nausea, take something sweet to increase blood sugar levels. Ask your doctor or pharmacist if you are unsure how to recognize these symptoms. It is recommended that you carry some sugar cubes, sweets, biscuits or fruit juice.

Fractures of bones

There has been a higher number of bone fractures 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.

Other medicines and Tandemact

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine. This is because some medicines can weaken or enhance the effect of Tandemact on blood sugar concentration.

The following medicines can increase the amount of sugar in the blood by 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 for the treatment of diabetes mellitus
• phenylbutazone, azapropazone, oxifenbutazone, similar medicines to aspirin (to treat pain and inflammation)
• sulfonamides with prolonged action, 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, sympatholytics, disopyramide, pentoxifylline, derivatives of coumarin such as warfarin (to treat blood or heart disorders)

• allopurinol, probenecid, sulfinpyrazone (to treat gout)

• cyclophosphamide, ifosfamide, trophosphamide (to treat cancer)
• fenfluramine (to lose weight)
• tritoqualine (to treat allergies)

The following medicines can reduce the amount of sugar in the blood by reducing the effect of Tandemact. This may lead to a risk of hyperglycemia (high blood sugar):

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

• levotiroxine (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, coughs 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 disorders)

• 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)

The following medicines can increase or reduce the amount of sugar in the blood by reducing the effect of Tandemact:

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

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

• derivatives of coumarin 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 controlled and you may need to adjust the dose of Tandemact.

Tandemact with alcohol

Avoid taking alcohol while you are being treated with Tandemact as alcohol may increase or decrease the amount of sugar in the blood, reducing the action of Tandemact unpredictably.

Pregnancy and lactation

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

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

Driving and operating machines

Your 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 operate machines.

Be careful if you experience visual disturbances.

Tandemact contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking Tandemact.

Tandemact contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

If you are following a diabetic diet, keep it while taking Tandemact.

You will need to control your weight regularly. If you gain weight, tell 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, by accident, you take too many tablets, or if someone else or a child takes your medication, tell your doctor or pharmacist immediately. The blood sugar level may drop below the normal level. Symptoms may include cold sweat, fatigue, headache, rapid heartbeat, hunger pangs, irritability, nervousness, nausea, coma, or convulsions. You can increase the blood sugar level by taking sugar. It is recommended that you always carry sugar cubes, candies, cookies, or fruit juices with sugar.

If you forget to take Tandemact

Take Tandemact every day as prescribed. 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 the missed doses.

If you interrupt treatment with Tandemact

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

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

Like all medicines, Tandemact can cause side effects, although not everyone will experience them.

Specifically, patients have developed the following serious side effects:

Infrequently (may affect up to 1 in 100 people), bladder cancer has developed in patients taking Tandemact. Symptoms include blood in the urine, pain while urinating, or a sudden need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Infrequently (may affect up to 1 in 100 people), hypoglycemia (low blood sugar) has been reported in patients taking Tandemact. Symptoms may include cold sweats, fatigue, headache, rapid heartbeat, hunger pangs, irritability, nervousness, or nausea. It is essential to know the symptoms you should expect when hypoglycemia occurs. Ask your doctor or pharmacist if you are unsure of how to recognize them or what to do if you experience these symptoms.

Rarely (may affect up to 1 in 1,000 people), Tandemact has been associated with decreases in blood platelets (increasing the risk of bleeding or bruising), red blood cells (causing pale skin and leading to weakness and breathing difficulties), and white blood cells (increasing the likelihood of infection). If you experience this side effect, report it to your doctor immediately. These disorders usually improve when treatment with Tandemact is discontinued.

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

Bone fractures: Frequent (may affect up to 1 in 10 people) reports have been made in both men and women taking Tandemact (frequency cannot be estimated from 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 been reported (frequency cannot be estimated from available data). If you experience these symptoms for the first time, speak with your doctor as soon as possible. Also, if you have previously experienced blurred vision but these symptoms worsen, you should speak with your doctor as soon as possible.

Unknown frequency (cannot be estimated from available data) allergic reactions have been reported in patients treated with Tandemact. If you experience a severe allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause breathing or swallowing difficulties, stop taking this medication and consult your doctor as soon as possible.

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

Infrequently (may affect up to 1 in 100 people)

• headache
• sinusitis
• dizziness
• vision abnormalities
• sweating
• fatigue
• difficulty sleeping (insomnia)
• low 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)

• observable 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 fullness in the stomach

• light sensitivity
• decreased sodium concentrations in the blood

Unknown frequency (cannot be estimated from available data)

• increases in liver enzymes

• itching of the skin
• raised, itchy eruptions

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD/EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Tandemact

• The active principles 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 contents of the container

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

They are presented in aluminum/aluminum blisters containing 28 tablets.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

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

Last revision date of this leaflet: 08/2023

Other sources of information

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