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METFORMIN 500 mg TABLETS METFORMIN 850 mg TABLETS

Metformin hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects become troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What Metformin is and what it is used for

2.    Before you take Metformin

3.    How to take Metformin

4.    Possible side effects

5.    How to store Metformin

6.    Further information

OWHAT METFORMIN IS AND WHAT IT IS USED FOR

What Metformin is

Metformin contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin helps to lower your blood glucose to as normal a level as possible.

If you are an overweight adult, taking Metformin over a long period of time also helps to lower the risk of complications associated with diabetes.

In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss.

What Metformin is used for

Metformin is used to treat patients with type 2 diabetes (also called 'non-insulin-dependent diabetes'), when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

Adults can take Metformin on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Children 10 years and over and adolescents can take Metformin on its own or together with insulin.

BEFORE YOU TAKE METFORMIN

Do not take Metformin

•    If you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin contains' in section 6)

•    If you have kidney or liver problems

•    If you have uncontrolled diabetes, such as with e.g. severe hyperglycaemia (high blood glucose, nausea, vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath

•    If you lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin' below)

•    If you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin' below)

•    If you are treated for heart failure or have recently had a heart attack, have severe problems with your circulatory system or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Take special care with Metformin' below)

•    If you drink a lot of alcohol.

If any of the above applies to you, talk to your doctor before you start taking this medicine.

Make sure you ask your doctor for advice if

•    you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream

•    you need to have major surgery.

You must stop taking Metformin for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor's instructions precisely.

Take special care with Metformin

•    Metformin may cause a rare but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away

•    Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take it together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

Taking other medicines

If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above).

Tell your doctor if you take any of the following medicines and Metformin at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin:

•    Diuretics (used to remove water from the body by making more urine)

•    Beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)

•    Corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma)

•    Other medicines used to treat diabetes.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Metformin with food and drink

Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis, especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol.

Pregnancy and breast-feeding

•    During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, think you might be or are planning to become pregnant, so that he/she may change your treatment

•    Metformin is not recommended if you are breast-feeding or if you are planning to breast-feed your baby

•    Ask your doctor or pharmacist for advice before taking any medicine.

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