COMPETACT 15 mg/850 mg FILM-COATED TABLETS

2. What you need to know before you take Competact

Do not take Competact:

• if you are allergic to pioglitazone, metformin 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 recently had a heart attack, have severe circulation problems such as shock, or breathing difficulties.
• if you have any liver disease.
• if you drink a lot of alcohol (every day or only occasionally).
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or if your breath develops an unusual fruity odor.

• if you have or have had bladder cancer.
• if you have blood in your urine that has not been controlled by your doctor.
• if you have severe kidney function impairment.
• if you have a severe infection or are dehydrated.
• if you are going to have a contrast X-ray (a specific type of diagnostic test using X-rays and an injectable contrast medium), consult your doctor as you will need to stop taking Competact for a certain period of time before and after the test.
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting Competact (see also section 4)

• if you have heart problems. Some patients with type 2 diabetes mellitus of long duration and heart disease or previous stroke who received pioglitazone and insulin together developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localized swelling (edema).
• if you have fluid retention or heart problems, particularly if you are over 75 years old. If you are taking anti-inflammatory medications 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 (inflammation of the back of the eye), consult your doctor if you notice changes in your vision.
• if you have cysts on the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant as Competact may cause you to ovulate again. If this applies to you, use appropriate contraceptive methods to avoid the possibility of an unplanned pregnancy.
• if you have liver problems. Before starting treatment with Competact, you will have a blood test to check your liver function. These tests should be done periodically. Inform your doctor as soon as possible if you develop symptoms that suggest a liver problem (such as unexplained nausea, vomiting, stomach pain, tiredness, loss of appetite and/or dark urine) as your liver function will need to be checked.

You may also experience a reduction in blood cell count (anemia).

Risk of lactic acidosis

Competact may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as severe and acute heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Consult your doctor immediately if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and deafness.

Stop taking Competact for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking Competact and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis can produce, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of being unwell, with intense tiredness
• difficulty breathing
• reduced body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital. During treatment with Competact, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if your kidney function is deteriorating.

If you need to undergo major surgery, you should stop taking Competact during the procedure and for a period of time after it. Your doctor will decide when you should stop taking Competact and when you can restart it.

Hypoglycemia

If you take Competact with other diabetes medications, it is more likely that your blood sugar level may drop below normal (hypoglycemia). If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision changes, or difficulty concentrating, take some sugar to raise your blood sugar levels. Consult your doctor or pharmacist if you are unsure how to recognize such symptoms. It is recommended that you carry glucose tablets, sweets, biscuits, or some sugary fruit juice with you.

Bone fractures

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

Children and adolescents

Competact is not recommended for children and adolescents under 18 years of age.

Other medicines and Competact

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Competact before the injection or at the time of the injection. Your doctor will decide when you should stop taking Competact and when you can restart it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact. It is especially important to mention the following:

• gemfibrozil (used to lower cholesterol)
• rifampicin (used to treat tuberculosis and other infections)
• cimetidine (used to reduce stomach acidity)
• glucocorticoids (used to treat inflammation)
• beta-2 agonists (used to treat asthma)
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)

Taking Competact with alcohol

Avoid excessive alcohol consumption while taking Competact, as this can increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice. Competact is not recommended during pregnancy. If you are planning to have a baby, your doctor will advise you to stop taking this medicine.
• do not take Competact if you are breast-feeding or if you plan to breast-feed (see section “Do not take Competact”).

Driving and using machines

This medicine does not affect your ability to drive or use machines, but you should be careful if you experience vision changes.

3. How to take Competact

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is one tablet twice a day. If necessary, your doctor may prescribe a different dose. If you have reduced kidney function, your doctor may prescribe a lower dose that may need to be given as separate tablets of pioglitazone and metformin.

Take the tablets with a glass of water. You should take the tablets with meals or just after meals to reduce the risk of digestive upset.

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

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

Your doctor will regularly ask you to have blood tests during treatment with Competact to check that your liver is working correctly. At least once a year (more often if you are elderly or have kidney problems), your doctor will check that your kidneys are working correctly.

If you take more Competact than you should

If you accidentally take too many tablets, or if a child or another person takes your medicine, tell your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but you can increase it by taking sugar. It is recommended that you carry glucose tablets, sweets, biscuits, or some sugary fruit juice with you.

If you have taken more Competact than you should, you may experience lactic acidosis (see section “Risk of lactic acidosis”

If you forget to take Competact

Take Competact 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 missed doses.

If you stop taking Competact

Take Competact every day as prescribed by your doctor. If you stop taking Competact, your blood sugar level may increase. Consult your doctor before stopping treatment.

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

4. Possible side effects

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

Competact may cause a very rare but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”), If this happens to you, stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

With a frequency that cannot be estimated from the available data, bladder cancer has been reported in patients taking Competact. The signs and symptoms include blood in the urine, pain when urinating, or an urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

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

Blurred vision due to swelling (or fluid) in the back of the eye (macular edema) has been reported with a frequency that cannot be estimated from the available data. If you experience these symptoms for the first time, tell your doctor as soon as possible. If you have already experienced blurred vision and the symptoms worsen, consult your doctor as soon as possible.

Allergic reactions have been reported with a frequency that cannot be estimated from the available data in patients treated with Competact. 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 Competact:

Very common (may affect more than 1 in 10 people)

• stomach pain
• nausea
• vomiting
• diarrhea
• loss of appetite

Common (may affect up to 1 in 10 people)

• localized swelling (edema)
• weight gain
• headache
• respiratory infection
• vision disorders
• joint pain
• impotence
• blood in the urine
• reduced red blood cell count (anemia)
• numbness
• taste disturbance

Uncommon (may affect up to 1 in 100 people)

• inflammation of the nasal passages (sinusitis)
• gas
• difficulty sleeping (insomnia)

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

• reduced vitamin B12 levels in the blood
• redness of the skin
• itching of the skin
• hives

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

• inflammation of the liver (hepatitis)
• liver dysfunction (changes in liver enzymes)

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 Competact

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 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 Content and Additional Information

Composition of Competact

• The active ingredients are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
• The other components are microcrystalline cellulose, povidone (K 30), sodium croscarmellose, magnesium stearate, hypromellose, macrogol 8000, talc, and titanium dioxide (E171).

Appearance of the Product and Packaging Content

The film-coated tablets (tablets) are white to off-white, rectangular, convex, and bear the inscription '15 / 850' on one side and '4833M' on the other.

They are supplied in aluminum/aluminum blisters in packs of 56 and 112 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

CHEPLAPHARMA Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturers

Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland

Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain 39

Date of the Last Revision of this Leaflet: April 2025

Other Sources of Information

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