Metformin Hydrochloride B.P.
This medicine has been given to you on prescription and should not be given to anyone else even if their symptoms are similar to yours.
WHAT IS IN BIOPHAGE TABLETS?
Each tablet of Biophage contains as the active ingredient:
Metformin Hydrochloride 500mg
WHAT IS BIOPHAGE FOR?
Biophage is used for the treatment of Type 2 (non-insulin dependent) diabetes, a condition associated with high sugar level in the blood because of insufficient insulin or inability of insulin to enable body tissues use up the sugar in the blood. Biophage is used to support treatment by diet modifications when such modifications have not proved effective on its own. It is the drug of first choice in overweight patients because it is not associated with weight gain.
It is often added or given instead to patients who are not responding to other oral antidiabetic drugs.
HOW DOES BIOPHAGE WORK?
Biophage works by enhancing the body’s sensitivity to insulin and increasing glucose uptake into body tissues thereby lowering blood sugar levels.
WHAT YOU NEED TO KNOW BEFORE USING BIOPHAGE
Do not use Biophage if:
• You are allergic to the active ingredient in the product (An allergic reaction may include, rash, itching, swelling of face, lips or hands/feet or breathing difficulties).
• You have diabetic coma or ketoacidosis (symptoms include thirst, frequent urination, dehydration, weight loss, nausea, vomiting and abdominal pains) or other serious complications with your diabetes.
• You have severe infection, trauma or injury.
• You have kidney or liver problems.
• You take excessive alcohol.
• You have had heart failure, recent heart attack, circulatory, or breathing problems.
• You are to do an X-ray examination involving the use of contrast media. Biophage should be stopped 48 hours before examinations and withheld for at least 48 hours after examination.
• You are breast feeding.
Check with your doctor before using Biophage if:
• You are using other medications
• You are pregnant or wish to get pregnant
• You want to stop taking Biophage
HOW SHOULD BIOPHAGE BE TAKEN?
Your doctor or pharmacist can help you to know how much to take and how often you need to take Biophage based on laboratory result of your blood glucose measurement.
Initial dose is 1 tablet two or three times daily gradually increasing if necessary to 4 to 6 tablets daily.
Maximum daily dose is 3g taken as divided doses.
Children above 10 years:
Initial dose is 1 tablet daily gradually increasing if necessary to l tablet 2 or 3 times daily.
Maximum daily dose is 2g taken as divided doses.
To be taken with or after meals to minimize incident of gastrointestinal disturbances.
If you have forgotten to takes dose, take the next dose at the usual time, do not double the dose.
WARNING: DO NOT EXCEED THE MAXIMUM DAILY DOSE.
Contact your doctor immediately if too much is taken.
POSSIBLE SIDE EFFECTS
These include gastrointestinal disturbances including loss of appetite, abdominal pains, nausea, vomiting and diarrhoea. These usually occur at the beginning of treatment and do not last long. Others include a metallic taste and there may be weight loss.
Absorption of various substances including Vitamin B12 may be impaired. Annual monitoring of vitamin B12 concentration is advisable during long-term treatment with metformin to reduce the risk of megaloblastic anaemia.
Lactic acidosis or diabetic ketoacidosis characterized by rapid uncontrolled breathing, severe fatigue, nausea, vomiting and abdominal pains is a serious complication which must be reported immediately to your doctor for treatment.
Isolated cases of hepatitis (inflammation of the liver) resulting in jaundice (yellowing of eyes or skin) have been reported with metformin therapy. See your doctor immediately if you notice this.
If you experience other unusual symptoms or concerns, stop using the product immediately and see your doctor as soon as possible.
• Periodic blood glucose measurement and kidney function tests should be done before starting treatment with Biophage and at regular intervals during treatment.
• Special care should be taken in the elderly who are more prone to liver problems and in children for effect of the drug on growth and puberty.
• Inform your doctor of any infectious illness such as flu, respiratory or urinary tract infection or of any drug you are taking.
• If you are to undergo surgery, treatment with Biophage should be omitted on the day of operation. Insulin may be given if necessary.
PREGNANCY AND BREAST-FEEDING
Insulin is the preferred treatment of diabetes during pregnancy even in women with type 2 diabetes. Treatment should therefore be switched to insulin.
Metformin may be distributed into breast milk, the possible effects on the infant should therefore be considered if breast feeding is to be done while receiving treatment with Biophage.
HOW SHOULD BIOPHAGE BE STORED?
Store in a cool, dry place. Protect from light.
Do not use this medication after the expiry date on the pack.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pack of 100 tablets.
Manufactured in Nigeria by
SKG – Pharma Limited
7/9 Sapara Street,