Metformin 500 mg Film-Coated Tablets

METFORMIN BIOTECH contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. 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 BIOTECH helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking METFORMIN BIOTECH over a long period of time also helps to lower the risk of complications associated with diabetes. METFORMIN BIOTECH is associated with either a stable body weight or modest weight loss. METFORMIN BIOTECH 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 and children over 12 years of age can take METFORMIN BIOTECH on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Do not take METFORMIN BIOTECH:

• if you are hypersensitive (allergic) to metformin or any of the other ingredients of METFORMIN BIOTECH (listed in section 6).
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) 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 your breath developing an unusual fruity smell.
• if you have severely reduced kidney function.
• 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 Warnings and precautions).
• 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 Warnings and precautions).
• 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.
• if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) 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 Warnings and precautions).
• if you have liver problems.
• if you drink a lot of alcohol.
• if you are pregnant or breastfeeding your infant.

Warnings and precautions

Take special care with METFORMIN BIOTECH: Risk of lactic acidosis METFORMIN BIOTECH may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).

Do not share medicines prescribed for you with any other person. Always take METFORMIN BIOTECH exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take METFORMIN BIOTECH with or after a meal. This will avoid you having side effects affecting your digestion. The usual dose is METFORMIN 850 BIOTECH twice a day or METFORMIN 500 BIOTECH three times a day. If you are elderly your doctor will adjust the dose based on renal function. If you are older than 12 years your doctor will prescribe a dose according to your blood glucose measurements. Do not crush or chew the tablets. Swallow each tablet with a glass of water. If you take one dose a day, take it in the morning (breakfast). If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner). If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner). Your doctor will tell you how long your treatment with METFORMIN BIOTECH will last. Do not stop treatment early because you feel better. If you have the impression that the effect of METFORMIN BIOTECH is too strong or too weak, tell your doctor or pharmacist. If you take more METFORMIN BIOTECH than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take METFORMIN BIOTECH Do not take a double dose to make up for forgotten individual doses. If you stop taking METFORMIN BIOTECH Do not stop taking METFORMIN BIOTECH without talking to your doctor first. Your blood sugar levels will be uncontrolled if you stop taking METFORMIN BIOTECH.

METFORMIN BIOTECH can have side effects. Not all side effects reported for METFORMIN BIOTECH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking METFORMIN BIOTECH, please consult your healthcare provider for advice. If any of the following happens, stop taking METFORMIN BIOTECH and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to METFORMIN BIOTECH. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see Warning and precautions)

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• bellyache (abdominal pain)
• loss of appetite

These side effects most often happen at the beginning of the treatment with METFORMIN BIOTECH. It helps if you spread the doses over the day and if you take Glucophage with or straight after a meal.

Less frequent side effects:

• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes).
• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of METFORMIN BIOTECH.

Store all medicines out of reach of children. Store at or below 25˚ C in a well -closed container. Do not remove tablets from original packaging until required for use. Protect from light and moisture. Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).