Metformin 500mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin Hydrochloride 500 mg film coated tablets Metformin Hydrochloride 850 mg film coated tablets
Metformin hydrochloride
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 further questions, please 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 get serious or if you notice any side effects not listed on this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metformin is and what is it used for 4. Possible side effects
2. Before you take Metformin 5. How to store Metformin
3. How to take Metformin 6. Further information
1. WHAT IS METFORMIN AND WHAT IS IT USED FOR
Metformin belongs to a group of drugs called biguanides which are used in the treatment of diabetes. Metformin film coated tablets contain the active ingredient metformin hydrochloride. Each tablet contains either 500 mg or 850 mg of metformin hydrochloride.
Metformin is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus particularly in overweight patients, where diet and exercise changes alone have not been sufficient to control it. In type 2 diabetes, there is too much sugar (glucose) is in your blood because your pancreas does not produce enough insulin or because it produces insulin that does not work properly.
Adults
Your doctor can prescribe metformin for you to take on its own, or in combination with other oral antidiabetic medicines, or insulin.
Children aged 10 years or above and adolescents
Your doctor can prescribe metformin for you to take on its own, or in combination with insulin.
2. BEFORE YOU TAKE METFORMIN Do not take Metformin
• if you are you allergic (hypersensitive) to metformin or to any of the ingredients in this medicine.
• if you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration and you had fainted or suffered a coma due to your diabetes.
• if you have any problems with your liver or kidneys.
• if you are suffering from severe infection or have recently suffered a severe injury.
• if you have been treated for heart problems or have recently had a heart attack or have problems with your circulation (e.g. frequent cramp in your calves or leg ulcers that do not heal) or breathing difficulties.
• if you are pregnant.
• if you drink alcohol.
Take special care with Metformin
If you have diabetes you should have your blood or urine tested for sugar regularly. You should return to your doctor at least once a year to check the function of your kidneys (more often if you are elderly or if you have kidney problems).
Metformin may cause a very 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 in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Glucophage immediately and contact a doctor or the nearest hospital straight away.
If you need to have an X-ray examination tell your doctor that you take metformin as you may need to stop taking it for few days afterwards.
Tell your doctor if surgery is planned. Treatment with metformin should be stopped 2 days before surgery until at least 2 days following surgery.
You should continue your diet during treatment with metformin with an even intake of carbohydrate over the day. If you are overweight continue your energy-restricted diet under medical supervision.
No effect of metformin on growth and puberty has been detected although few children between the age of 10 and 12 years have been studied. Growth and puberty should be carefully monitored in children and adolescents.
Normal kidneys are essential for the treatment with metformin because of the risk of developing lactic acidosis. Tests will be done to check your kidney function at least once a year or more frequently if you are elderly, or when starting treatment for high blood pressure.
Taking metformin alone does not normally cause low blood sugar levels (hypoglycaemia). Taking metformin in combination with medicines called sulphonylureas, megalitinides, insulin or other treatments for diabetes may cause low blood sugar levels with symptoms such as sweating, fainting, dizziness or weakness, so in this case you should take extra care when driving or operating machinery.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
The effects of Metformin may be altered by;
• Other medicines used to lower blood sugar e.g. insulin.
• Angiotensin converting enzyme (ACE) inhibitors e.g. captopril or enalapril.
• Beta blockers e.g. propranolol.
• Diuretics (water tablets) e.g. furosemide or NSAID (non-steroidal anti-inflammatory drugs e.g. ibuprofen) you may be at increased risk of kidney problems.
• Glucocorticoids e.g.cortisone, budesonide, beclomethasone or prednisolone.
• Alcohol containing medicines.
• Sympathomimetics such as epinephrine used to treat heart attack or low blood pressure.
• Metformin must not be used at the same time as iodinated contrast media which may be used for medical imaging e.g. X-rays or scans because there is a risk of kidney failure. If you are going to undergo these procedures, you must tell your doctor you are taking Metformin. It is advised to stop taking Metformin for 48 hours before and after the procedure.
Taking Metformin with food and drink
The tablets should be swallowed whole with a glass of water during or after meals. This can reduce some side effects. Avoid alcohol while taking metformin.
Pregnancy and breast-feeding
Do not take Metformin if you are pregnant or breast feeding. Tell your doctor immediately if think you are pregnant or are breast feeding.
Driving and using machines:
Metformin does not affect your ability to drive vehicles or handle machinery, but if you are also taking other anti-diabetic medicines it is possible that you may feel faint, dizzy or weak. If this happens you should not drive or operate any machinery until you have recovered
3. HOW TO TAKE METFORMIN
Always take Metformin tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose in:
Adults: The usual starting dose is one or two 500 mg or 850 mg tablets two or three times a day.. Your doctor may increase the dose to a maximum of 3000 mg per day taken as divided doses.
Elderly: The starting dose will be determined after tests have been carried out on your kidney function.
Children aged 10 years and older and adolescents: Normally the starting dose is one 500 mg tablet daily. If the dose needs to be increased, 850 mg tablets may be used. Your doctor may increase the dose to a maximum of 2000 mg per day taken as divided doses.
Your doctor will test your blood glucose and your kidney function at intervals while you are taking metformin to make sure you are taking the right dose. This is especially important when you start taking other new medicines at the same time as metformin
If you take more Metformin than you should
Tell your doctor or contact the nearest hospital, taking the medicine or this leaflet with you.
If you forget to take Metformin
Take the missed dose as soon as you remember, but if your next regular dose is less than 2 hours away, skip the regular one.
Never take two doses at the same time.
If you stop taking Metformin
If you stop taking Metformin, tell your doctor as soon as possible, as your diabetes will not be controlled.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines metformin can cause side effects, although not everybody gets them.
If you start to lose weight unexpectedly, feel sick with stomach pains, have rapid uncontrolled breathing, or start to lose consciousness, you should stop taking the drug and, contact your doctor immediately or go to the nearest hospital accident and emergency department. These can be signs of very rare condition called “lactic acidosis” which can be dangerous and needs urgent hospital attention.
It is very common (affecting more than one person in 10) to have stomach pains or stomach upsets such as nausea, vomiting, diarrhoea, loss of appetite or a taste disturbance. Very rarely (affecting fewer than one in 10,000) a rash occurs (redness and itching of the skin, hives). These effects usually get better spontaneously and you should continue to take the tablets. If these do not get better after a few days, tell your doctor.
Very rarely:
Liver problems (hepatitis), possibly with jaundice (such yellowing of skin and eyes) which goes away on stopping metformin.
A decrease in vitamin B12 absorption, which can result in anaemia, sore tongue, tingling and numbness.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METFORMIN
Keep of the reach and sight of children. Do not take metformin tablets after the expiry date printed on the blister pack and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Metformin contains
The active substance is Metformin hydrochloride. Each film coated tablet contains 500 mg or 850 mg metformin hydrochloride. The other ingredients in the tablets are sodium starch glycolate (Type A), maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.
What Metformin looks like and contents of the pack
Metformin 500 mg film coated tablets are white, circular, bi-convex with diameter of 11 mm.
Metformin 850 mg film coated tablets are white, circular, bi-convex with diameter of 13.5 mm.
Metformin tablets are available in blister packs of 20, 28, 30, 50, 56, 60, 84, 90, 100 or 120 tablets (500 mg) and 20, 28, 30, 50, 56, 60, 84, 90, 100 or 120 tablets (850 mg).
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Morningside Healthcare Ltd 115 Narborough Road Leicester, UK.
Manufacturer:
Morningside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough, Leicestershire, UK