Competact

- Your doctor may want you to check your blood sugar level from time to time while you are taking this medicine. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.
- Pioglitazone can cause weight gain. You should stick to a calorie controlled diet and monitor your weight closely while taking this medicine. Consult your doctor if you put on weight.
- This medicine may cause women who have stopped ovulating due to polycystic ovary syndrome to start ovulating again. If you have PCOS you may therefore need to use contraception to prevent pregnancy. 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.
- Pioglitazone may on rare occasions cause fluid retention that may cause or worsen heart failure. For this reason you should consult your doctor immediately if you experience shortness of breath, swollen ankles, or rapid and excessive weight gain (which may be due to fluid retention) while taking this medicine.
- Metformin can cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood. It is more likely to occur in people with decreased kidney function. Drinking excessive amounts of alcohol, particularly on an empty stomach or if you have liver problems, can also increase the risk of lactic acidosis. Your doctor will monitor you for this side effect, but symptoms that might indicate it's development include rapid and/or deep breathing and non-specific symptoms such as feeling weak, sick or generally unwell, vomiting, abdominal pain, or unusual muscle pains or discomfort. You should stop taking this medicine and consult your doctor if you experience any of these.
- Your kidney function should be monitored regularly while you are taking this medicine. Your doctor will usually want to check your kidney function once or twice a year, or more frequently if you are elderly or have any existing kidney problems.
- Your liver function should also be monitored regularly while you are taking this medicine. Consult your doctor if you develop any of the following symptoms, as they may be signs of liver problems: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the skin or whites of the eyes (jaundice).
- If you notice any problems with your eyesight while taking this medicine, in particular any new or worsening problems with blurred vision or seeing fine detail, you should let your doctor know. He may want you to have an eye test.
- Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye (contrast agent). Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.
- Consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic. In these situations blood sugar is normally controlled by insulin, so your doctor may ask you to stop taking this medicine 48 hours before surgery.

Use with caution in

- Heart disease
- People with low haemoglobin levels in their blood
- Swelling of the back of the eye (macular oedema).

Not to be used in

- Diabetic keto-acidosis
- Diabetic pre-coma (due to ketoacidosis in severe and inadequately treated diabetes)
- People having insulin treatment
- Decreased kidney function
- Kidney failure
- Decreased liver function
- Heart failure or people with a history of this
- People who have recently had a heart attack
- People who have stopped breathing (respiratory failure)
- Reduced blood flow to vital internal organs (shock)
- Severe infections or trauma
- Dehydration
- Alcohol intoxication
- Alcoholism
- Pregnancy
- Breastfeeding
- Children and adolescents under 18 years of age (as pioglitazone has not been studied in children).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

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

Label warnings

- Take this medication with or after food.

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