Special Information on Avandamet

Most Important Fact about Avandamet
Avandamet could cause a very rare, but potentially fatal, side effect known as lactic acidosis. It is caused by a buildup of lactic acid in the blood. The problem is most likely to occur in people whose liver or kidneys are not working well, and in those who have multiple medical problems, take several medications, or have congestive heart failure. The risk also is higher if you are an older adult or drink alcohol. Lactic acidosis is a medical emergency that must be treated in a hospital.

Avandamet precautions if you are pregnant or breastfeeding
Avandamet should not normally be used during pregnancy. Diabetes mellitus is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking Avandamet, or are planning a pregnancy, you should seek medical advice from your doctor.

There is no information available about the safety of Avandamet during breastfeeding. For this reason, the manufacturer states that Avandamet should not be used during breastfeeding. Seek medical advice from your doctor.

Special warnings about Avandamet
Avandamet is not recommended for children and adolescents under 18 years of age, as there is no information regarding its safety and efficacy in this age group.

People taking Avandamet should have regular blood tests to monitor their kidney function.

You should have a blood test to monitor your liver function before starting treatment with Avandamet. Your doctor may then want to monitor your liver function during treatment. Consult your doctor if you develop any of the following symptoms while taking Avandamet, as they may be signs of liver problems: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).

Avandamet can cause weight gain. You should stick to a calorie controlled diet and monitor your weight closely. Consult your doctor if your weight increases.

Avandamet may cause women who have stopped ovulating, for example due to polycystic ovary syndrome, to start ovulating again. These women will therefore need to use contraception to prevent pregnancy. If you get pregnant or wish to become pregnant you should tell your doctor, as you will need to stop taking Avandamet .

Avandamet may rarely cause fluid retention that may cause 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 Avandamet.

Consult your doctor if your experience the following symptoms while taking Avandamet, as they may be indicative of a serious condition called lactic acidosis: nausea, vomiting, abdominal pain, general feeling of illness, loss of appetite, weight loss, rapid and/or weak breathing, weakness.

You should avoid drinking alcohol while you are taking Avandamet, as it can increase the risk of low blood sugar (hypoglycaemia) and lactic acidosis.

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 Avandamet 48 hours before surgery.

Your doctor will ask you to stop taking Avandamet temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye. Tell your doctor that you are taking Avandamet if you are due to have this type of X-ray. You should not start taking Avandamet again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.

Why Avandamet should not be prescribed ?
Avandamet should not be used if you suffer from severe infections or severe breathing difficulties or inherited inability to absorb the sugars glucose and galactose (glucose-galactose malabsorption).

Avandamet should not be used by people receiving insulin treatment, people who have recently had a heart attack.

Avandamet 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 Avandamet and inform your doctor or pharmacist immediately.