Competact 15 mg/850 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Competact 15 mg/850 mg film-coated tablets

pioglitazone/metformin hydrochloride

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 must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Competact is and what it is used for
2. What you need to know before taking Competact
3. How to take Competact
4. Possible adverse effects
5. How to store Competact
6. Contents of the pack and other information

1. What Competact is and what it is used for

Competact contains pioglitazone and metformin. It is an antidiabetic medicine used in adult patients to treat type 2 diabetes mellitus (non-insulin-dependent) when treatment with metformin alone is not sufficient. This type of type 2 diabetes usually occurs in adults, primarily as a result of overweight and when the body either does not produce enough insulin (a hormone that controls blood sugar levels) or is unable to use the produced insulin effectively. Your doctor will monitor the effect of Competact between 3 and 6 months after starting treatment.

Competact helps control blood sugar levels in type 2 diabetes by enabling your body to use the insulin it produces more effectively.

2. What you need to know before taking Competact

Do not take Competact:

• if you are allergic to pioglitazone, metformin, or any of the other components 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 serious circulation problems such as shock, or have breathing difficulties.

• if you have any liver disease.

• if you drink excessive alcohol (daily or even occasionally).

• if you have uncontrolled diabetes, 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or fruity-smelling breath.

• if you have or have had bladder cancer.

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

• if you have severely reduced kidney function.

• if you have a severe infection or are dehydrated.

• if you are scheduled to undergo contrast radiography (a specific type of diagnostic X-ray procedure using an injectable contrast agent), consult your doctor, as you will need to stop taking Competact for a certain period before and after the procedure.

• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting Competact (also see section 4):

• if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or previous stroke who received pioglitazone together with insulin 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, especially if you are over 75 years old. Also consult 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 changes in your vision.
• if you have ovarian cysts (polycystic ovary syndrome). Your chance of becoming pregnant may increase, as ovulation may resume while taking Competact. If this applies to you, use appropriate contraceptive methods to avoid unintended pregnancy.
• if you have liver problems. Before starting treatment with Competact, a blood test will be performed to check your liver function. These tests should be repeated periodically. Inform your doctor immediately if you develop symptoms suggesting liver problems (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite, and/or dark urine), as liver function must be checked.

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

Risk of lactic acidosis

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

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

Contact your doctor immediately for advice if:

• You are known to have a genetic (inherited) disorder affecting mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting metformin treatment: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking Competact temporarily if you develop an illness that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital. 35

During treatment with Competact, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is declining.

If you need to undergo major surgery, you must stop taking Competact during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with Competact.

Hypoglycemia

If you take Competact together with other diabetes medicines, your blood sugar level is more likely to drop below normal (hypoglycemia). If you experience symptoms of hypoglycemia such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, take a source of sugar to raise your blood glucose level. Consult your doctor or pharmacist if you are unsure how to recognize these symptoms. It is advisable to carry sugar lumps, sweets, biscuits, or a sugary fruit juice 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

Not recommended for children and adolescents under 18 years of age.

Other medicines and Competact

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Competact before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Competact.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You may require 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 acid)
• 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 (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists)

Taking Competact with alcohol

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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor. Competact is not recommended during pregnancy. If you plan to become pregnant, your doctor will advise you to stop taking this medicine.
• do not take Competact if you are breastfeeding or plan to breastfeed (see section “Do not take Competact”).

Driving and using machines

This medicine does not affect the ability to drive or operate machinery, but you should exercise caution if you experience visual disturbances.

3. How to take Competact

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Take the tablets with a glass of water. You should take the tablets with food or immediately after meals to reduce the risk of gastrointestinal discomfort.

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

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

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

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, inform your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but this can be corrected by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or a sugared fruit juice.

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. However, if you miss a dose, skip the missed dose and continue with your regular treatment schedule. Do not take a double dose to make up for missed doses.

If you stop taking Competact

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Competact may cause a very rare (affecting up to 1 in 10,000 users), but very serious, adverse effect called lactic acidosis (see section “Risk of lactic acidosis”). If this occurs, you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. Bladder cancer has occurred infrequently (may affect up to 1 in 100 people) in patients taking Competact. Signs and symptoms include blood in the urine, pain when urinating, or a strong 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). If you experience this adverse effect, consult your doctor as soon as possible.

Cases of blurred vision due to swelling (or fluid) in the back of the eye (macular edema) have been reported (frequency cannot be estimated from the available data). If you experience these symptoms for the first time, inform your doctor as soon as possible. If you have previously experienced blurred vision and your symptoms worsen, consult 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 Competact. 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 adverse effects while 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 disturbances

Uncommon (may affect up to 1 in 100 people)

• inflammation of the sinuses (sinusitis)
• gas (flatulence)
• difficulty sleeping (insomnia)

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

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

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

• inflammation of the liver (hepatitis)
• impaired liver function (changes in liver enzymes)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton and on the 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 Competact

• The active substances 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).

Nature of the product and pack contents

Film-coated tablets (tablets) are white to off-white, rectangular, biconvex, and are marked with ‘15 / 850’ on one side and ‘4833M’ on the other.

Supplied in aluminium/aluminium blisters in pack sizes of 56 and 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

CHEPLAPHARM 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

Date of the most recent revision of this leaflet: April 2025

Other sources of information

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