What is Competact used for?

• Type 2 (non-insulin dependent) diabetes.

Competact is licensed for use in people with type 2 diabetes, particularly overweight people, whose blood sugar is not controlled by the maximum tolerated dose of metformin alone.

How does it work?

• Competact tablets contain two active ingredients, metformin hydrochloride and pioglitazone hydrochloride.
• Metformin hydrochloride is a type of antidiabetic medicine known as a biguanide. It works in a number of ways to decrease the amount of sugar in the blood. Firstly, it reduces the amount of sugar produced by cells in the liver. Secondly, it increases the sensitivity of muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Finally, it also delays absorption of sugar from the intestines into the bloodstream after eating.
• Pioglitazone is a type of antidiabetic medicine known as a thiazolidinedione or glitazone. It helps to control blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Pioglitazone also reduces the amount of glucose produced by the liver, and preserves the functioning of the cells in the pancreas (beta cells) that produce insulin.
• This combination of medicines helps control blood sugar levels both directly after meals and between meals.

How do I take Competact?

• One Competact tablet should be taken twice a day (morning and evening) regularly every day.
• The tablets can be taken either with or without food, but if you find they upset your stomach this can be minimised by taking the tablets with or just after food. Swallow them with a drink of water.
• If you forget to take a dose, just leave out the missed dose and take your next dose as usual. Do not take a double dose to make up for a missed dose.

Competact should be used with caution in

• Elderly people.
• Heart disease, for example people who suffer from angina or who have had a heart attack in the past.
• People with low haemoglobin levels in their blood.
• Hereditary blood disorders called acute porphyrias.
• People with swelling of the back of the eye (macular oedema).
• People who smoke or used to smoke.
• People who have ever had radiation treatment to the pelvic area.
• People with a history of exposure to cancer causing agents, such as aromatic compounds and chemicals used in industry, or chemotherapy medicines such as cyclophosphamide.
• Women with polycystic ovary syndrome (PCOS). Competact may cause women with PCOS who have stopped ovulating to start ovulating again. If you have PCOS you may therefore need to use contraception to prevent pregnancy. Ask your doctor for advice. If you get pregnant or want to try for a baby you should tell your doctor, as you will need to stop taking this medicine.

Who shouldn't take Competact​?

• People with diabetic ketoacidosis (due to severe and inadequately treated diabetes).
• People with decreased kidney function or kidney failure.
• People with liver problems.
• People with a history of  heart failure or who have recently had a heart attack.
• People with conditions that cause breathing to be ineffective, ie to not effectively oxygenate the blood or remove carbon dioxide from the lungs (respiratory failure).
• People with reduced blood flow to vital internal organs (shock).
• People with severe infections or sepsis.
• People who are dehydrated.
• People with active bladder cancer or a history of bladder cancer.
• People with blood in their urine, when the cause of this has not been investigated.
• People who drink large amounts of alcohol or who suffer from alcoholism.
• Women who are pregnant or breastfeeding.
• Children and adolescents under 18 years of age (the safety and effectiveness of pioglitazone have not been studied in children).
• Competact should not be used if you are allergic to any of its ingredients. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Can I take Competact while pregnant or breastfeeding?

• Competact should not be used during pregnancy as the safety of pioglitazone has not been established in pregnant women. You should therefore use contraception to avoid getting pregnant while you are taking Competact. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor. Control of diabetes mellitus in pregnancy is usually achieved using insulin, because this provides a more stable control of blood sugar.
• It is not known if pioglitazone passes into breast milk. Metformin does pass into breast milk. As it could have side effects on a nursing infant, mothers who need to take Competact should not breastfeed. It is important to seek medical advice from your doctor.

What are the possible side effects of Competact?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with Competact. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common 

• Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain.
• Loss of appetite.

Common 

• Weight gain (see what should I know above).
• Excessive fluid retention in the body tissues, resulting in swelling (oedema - see what should I know above).
• Upper airway infections.
• Anaemia.
• Decreased sense of touch, numbness.
• Headache.
• Metallic taste.
• Visual disturbances.
• Joint pain.
• Increased chance of breaking a bone (only in women).
• Blood in the urine (haematuria). Tell your doctor straight away if you notice nay blood in your urine so that this can be investigated.
• Impotence (erectile dysfunction).

Uncommon

• Inflammation of the sinuses (sinusitis).
• Difficulty sleeping (insomnia).
• Excess gas in the stomach and intestines (flatulence or wind).
• Bladder cancer (see what should I know above).

Very rare

• Skin reactions such as rash, itching or flushing.
• Decreased absorption of vitamin B12 during long-term use.
• Elevated levels of lactic acid in the blood.

Unknown frequency

• Swelling of the back of the eye (macular oedema). See what should I know above.
• Inflammation of the liver (hepatitis).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with Competact, please read the information provided with the medicine or consult your doctor or pharmacist.

Can I take other medicines with Competact?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with Competact. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There may be an increased risk of heart failure if pioglitazone is used in combination with insulin. If you are taking this medicine in combination with insulin it is important to let your doctor know if you experience any shortness of breath, weight gain or swelling, particularly of the ankles.

There may be an increased risk of fluid retention (oedema or swelling) and heart failure if you take non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, naproxen or ibuprofen, or COX-2 inhibitors such as celecoxib or etoricoxib while you are taking pioglitazone. You should not take these types of painkiller without first getting advice from your pharmacist or doctor.

Gemfibrozil may increase the amount of pioglitazone in the blood. As this could increase the chance of side effects, you should let your doctor know if you get any new or increased side effects if you start taking gemfibrozil with this medicine. Your doctor may want you to monitor your blood sugar more frequently and may need to decrease your dose of this medicine.

The antibiotic rifampicin may decrease the amount of pioglitazone in your blood and could make it less effective. Your doctor may want you to monitor your blood sugar more frequently if you are prescribed a course of rifampicin. Your dose of pioglitazone may need to be temporarily increased.

The following medicines may increase blood glucose levels. If you start treatment with any of these your dose of this medicine may therefore need increasing:

• beta-2-agonists, such as salbutamol
• corticosteroids, such as prednisolone
• diazoxide
• diuretics, especially thiazide diuretics, eg bendroflumethiazide
• lithium
• oestrogens and progestogens, such as those found in the contraceptive pill.
• Octreotide and lanreotide may also affect blood sugar levels. If you are being treated with one of these medicines your doctor may want to check your blood sugar levels and adjust your metformin dose if necessary.

Low blood sugar levels (hypoglycaemia) may occur, sometimes unpredictably, if ACE inhibitors such as captopril are taken with this medicine.

MAOI antidepressants, such as phenelzine, tranylcypromine or isocarboxazid, may enhance the blood sugar lowering effect of metformin. Your doctor may ask you to monitor your blood sugar more frequently if you are prescribed an MAOI antidepressant with this medicine.

Cimetidine may cause an increase in the blood level of metformin. Your doctor may reduce your metformin dose if you take both medicines.

Metformin should be stopped before X-ray examinations involving injections of iodinated contrast materials, as these may cause a temporary decrease in kidney function that could affect the blood level of metformin. Metformin should not be started again after the X-ray until kidney function has been tested and found to be normal.

A drop in the number of blood cells called platelets in the blood has been seen in some people taking the antihistamine ketotifen in combination with metformin. The manufacturer of ketotifen recommends that it should be avoided in people taking metformin.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.netdoctor.co.uk/medicines/diabetes/a6808/competact-metformin-and-pioglitazone/

http://www.theodora.com/drugs/eu/competact.html

https://www.medicines.org.uk/emc/medicine/18719

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000655/human_med_000720.jsp&mid=WC0b01ac058001d124

http://www.diagnosia.com/en/drug/competact-15-mg850-mg-film-coated-tablets