Package Insert: Information for the Patient

Competact 15 mg/850 mg Film-Coated Tablets

Pioglitazone/Hydrochloride of Metformin

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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they 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.

Competact contains pioglitazona and metformina. It is an antidiabetic medication used in adult patients to treat type 2 diabetes mellitus (non-insulin dependent) when treatment with metformina alone is not sufficient. This type of type 2 diabetes typically presents in adults, primarily as a result of overweight and if the body either does not produce enough insulin (a hormone that controls blood sugar levels) or is unable to effectively use the insulin produced. Your doctor will monitor the effect that Competact is having on you between 3 and 6 months since treatment began.

Competact serves to control blood sugar levels if you have type 2 diabetes, allowing your body to use insulin more effectively that it produces.

Do not take Competact:

• if you are allergic to pioglitazone, metformin, or any of the other components of this medication (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 difficulty breathing.
• if you have any liver disease.
• if you drink too much alcohol (daily or 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 diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath.

• if you have or have had bladder cancer.
• if you have uncontrolled bleeding in your urine that has not been controlled by your doctor.
• if you have severe kidney function reduction.
• if you have a severe infection or dehydration.
• if you are undergoing a contrast radiology (a specific type of diagnostic test with 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 breastfeeding.

Warnings and precautions:

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

• if you have heart problems. Some patients with type 2 diabetes 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 take 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 polycystic ovary syndrome (PCOS). You may be more likely to become pregnant, as taking Competact can cause you to ovulate again. If this is your case, use suitable contraceptive methods to avoid the possibility of 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 liver problems (such as inexplicable nausea, vomiting, stomach pain, fatigue, loss of appetite, and/or dark urine) as your liver function should be checked.

You may also show a reduction in the count of blood cells (anemia).

Risk of lactic acidosis:

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

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

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 intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. 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 produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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

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

If you need to undergo major surgery, you should stop taking Competact while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Competact and when to restart it.

Hypoglycemia:

If you take Competact with other diabetes medications, you are more likely to have your blood sugar level drop below the normal limit (hypoglycemia). If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, take something sweet to raise your blood sugar levels. Consult your doctor or pharmacist if you are unsure how to recognize these symptoms. It is recommended that you carry sugar cubes, candies, cookies, or fruit juice with you.

Fractures:

There has been an increased 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:

Not recommended for children and adolescents under 18 years old.

Other medications and Competact:

If you need to receive an injection of a contrast medium containing iodine, such as in the context of a radiography or examination, you should stop taking Competact before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Competact and when to restart it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. 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 reduce 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)
• diuretics (used to treat high blood pressure)
• NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib (used to treat pain and inflammation)
• blood pressure medications (ACE inhibitors and angiotensin II receptor antagonists)

Competact and 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 breastfeeding:

• If you are pregnant or breastfeeding, or if you think you may be 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 medication.
• Do not take Competact if you are breastfeeding or plan to do so (see section “Do not take Competact”).

Driving and using machines:

This medication does not affect your ability to drive or use machines, but you should be cautious if you experience visual disturbances.

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 twice a day. If necessary, your doctor may prescribe a different dose. If you have reduced renal function, your doctor may prescribe a lower dose that may need to be administered in separate tablets of pioglitazone and metformin.

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

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

You will need to control your weight regularly. If you gain weight, inform your doctor.

Your doctor will ask you to have regular blood tests during treatment with Competact to check the proper functioning of your liver. At least once a year (more often if you are advanced in age or have kidney problems), your doctor will check the proper functioning of your kidneys.

If you take more Competact than you should

If you accidentally take too many tablets, or if a child or another person takes your medication, inform 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 some sugar cubes, candies, cookies, or some 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 forget to take a dose, omit the missed dose and continue your treatment as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Competact

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

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

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

Competact can cause a very rare but serious side effect called lactic acidosis (see section “Risk of lactic acidosis”), If this happens to you,you should stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. With low frequency (can affect up to 1 in 100 people) bladder cancer has developed in patients taking Competact. Symptoms and signs include blood in the urine, pain while urinating or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

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

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

Frequent unknown frequency (cannot be estimated from available data) allergic reactions have been reported 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 frequent (can affect more than 1 in 10 people)

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

Frequent (can affect up to 1 in 10 people)

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

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

• decrease in blood vitamin B12 levels
• skin redness
• skin itching
• hives

Unknown frequency (cannot be estimated from available data)

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

Reporting of side effects

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

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 packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Competact

- The active principles are pioglitazone and hydrochloride of metformin. Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of hydrochloride of metformin.

- 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 contents of the packaging

The film-coated tablets (tablets) are white to off-white, rectangular, convex, and have '15 / 850' engraved on one face 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

CHEPLAPHARMArzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturers Responsible

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

Last review date of this leaflet: August 2023

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency (EMA)

http://www.ema.europa.eu/http://www.ema.europa.eu/