Metformin 500mg Tablets
Patient Information Leaflet METFORMIN 500 mg TABLETS and METFORMIN 850 mg TABLETS
Metformin Hydrochloride
Read all ot this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metformin Tablets are and what they are used for
2. Before you take Metformin Tablets
3. How to take Metformin Tablets
4. Possible side effects
5. How to store Metformin Tablets
6. Further information
1. What Metformin Tablets are and what they are used for
These tablets are available in two different strengths and your doctor will have decided which is the most suitable for you. Each tablet contains either 500 mg or 850 mg of the active ingredient, metformin hydrochloride.
Metformin is one of a group of medicines called oral hypoglycaemics, which work by reducing the level of sugar in the blood.
Metformin Tablets are used for the treatment of a type of diabetes which usually only occurs in adults, and is not severe enough to need insulin, butwhich does not respond to dietary measures alone. In some patients metformin may be used in combination with other antidiabetic medicines called sulphonylureas.
2. Before you take Metformin Tablets
Some people must not take these tablets. Do not
take these tablets if:
• You know you are allergic to metformin, or to any of the other ingredients (these are listed in section 6)
• You have failed to respond to treatment with other antidiabetic medicines called sulphonylureas
• You have ever fainted or even suffered a coma from having diabetes
• You have problems with your liver or kidneys
• You have an acute or chronic disease which could cause decreased oxygen supply (hypoxia), like heart failure, respiratory failure or a recent heart attack.
• You are pregnant or think you may be pregnant
• You suffer from alcoholism or acute alcohol intoxication
• You have any problems with your circulation, causing for example, frequent cramp in your calves or leg ulcers that do not heal
• You have an infection, a fever, are suffering from shock or trauma or are unwell in any other way.
• You suffer from an inflamed pancreas (pancreatitis)
• You are on a special low calorie diet (less than 1000 calories per day or 4200 KJ per day)
• You are dehydrated (feeling extremely thirsty)
• You have breathing problems.
You must check with your doctor before taking these tablets If you are breast-feeding.
Other special warnings
• If you are going to have an operation requiring an anaesthetic or you are to undergo a scan requiring injection of a dye, you must ensure the doctor in charge is aware you are taking Metformin Tablets (as they will need to be stopped up to 48 hours before the procedures)
• You should not drink alcohol while taking Metformin Tablets
• Patients who are already on insulin should only be started on a course of treatment with metformin in hospital
• Metformin Tablets should not be taken by children
• If you are taking these tablets continuously, your doctor will perform regular blood tests to check your Vitamin B12 levels and your kidney function.
• If you are an elderly patient (approximately over the age of 65 years) your doctor will perform blood and urine tests to check your kidney function before starting metformin.
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
Metformin Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:
•
• Monoamine-oxidase inhibitors (MAOIs) or other medicines to treat depression or psychoses such as chlorpromazine
• Aspirin or any other non-steroidal medicines for pain and inflammation
• ACE inhibitors and beta-blockers for high blood pressure
• Other medicines for high blood pressure eg. clonidine, reserpine, guanethidine or diazoxide
• Thiazides and loop diuretics (water tablets)
•
clofibrate or nicotinic acid derivatives
• Cyclophosphamide (to control inflammation)
• Cimetidine (to treat stomach ulcers)
• Hormone drugs such as the contraceptive pill or hormone replacement therapy (HRT)
• Steroids such as prednisolone or hydrocortisone
• Oxytetracycline (an antibiotic to treat infections)
• Phenprocoumone (an anticoagulant to thin the blood)
• Adrenaline and other sympathomimetics (used to treat allergic conditions and heart attacks)
• Glucagon (used to control low blood sugar levels)
• Thyroid hormones such as thyroxine.
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
Continued, please turn over
Driving and using machinery
Metformin Tablets taken on their own should not affect your ability to drive or operate machinery, but if you are also taking them with another medicine (sulphonylureas or insulin) to lower blood sugar levels, it is possible the combined effect of these medicines may make some patients feel faint or dizzy. If this happens do not drive or operate machinery until you feel better.
3. How to take Metformin Tablets
The tablets should be swallowed whole with a glass of water during or after meals.
The doctor will decide what dose you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist's label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual starting dose for adults is: One or two
500 mg tablets, or one 850 mg tablet each day. The dose will be gradually increased by your doctor until the right dose to control your symptoms is found. In most cases symptoms can be eventually controlled with three 500 mg tablets or two 850 mg tablets each day in divided doses. The maximum daily doses are six 500 mg tablets or three 850 mg tablets.
Ifyou take more tablets than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your tablets or the pack with you so that the doctor knows what you have taken.
Ifyou forget to take a dose of Metformin Tablets
If you miss a dose, take the missed dose as soon as you remember unless it is nearly time for your next dose. Never take a double dose to make up for the missed dose.
Rarely liver disorders such as inflammation of the liver may occur or blood tests to check your liver may have abnormal results.
Veryrarely skin reactions such as redness, itching or hives or allergic reactions may occur. If you notice a rash ask your doctor for advice about continuing to take the tablets.
Prolonged treatment with Metformin Tablets can result in a lack of Vitamin B12 and this may cause anaemia. Your doctor will carry out regular blood tests to check for this. If you notice any unwanted effects, even one not mentioned here, please go and see your doctor.
5. How to store Metformin Tablets
Keep out of the reach and sight of children - preferably in a locked cupboard or cabinet.
Do not store above 25°C. Store the tablets in the original blister pack.
Do not take the tablets after the expiry date shown on the carton.
If your doctor tells you to stop taking the tablets, please take any unused medicine back to your pharmacist to be destroyed.
6. Further Information
4. Possible side effects
Metformin Tablets are suitable for most people, but like all medicines they can sometimes cause side effects.
Ifyou suddenly experience any ofthe following effects:
»
breathing), tiredness, clouding of consciousness, severe abdominal pain or severe indigestion.
You must IMMEDIATELY go to the nearest hospital casualty department, as these may be symptoms of the very rare but serious condition of lactic acidosis.
The most common side effects (usually when you first start taking metformin) are:
»
appetite or a metallic taste.
If these side-effects occur they usually get better spontaneously so you should continue to take the tablets unless your stomach upset is severe or shows no signs of getting better after a few days - in this case contact your doctor.
Ingredients
Each tablet contains either 500 mg or 850 mg of the active ingredient, metformin hydrochloride.
The tablets also contain sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.
What the medicine looks like
Metformin Tablets are round, white, film-coated tablets. The 500 mg strength tablets are marked with ”500” on one side and the 850 mg strength tablets are marked with ”850” on one side.
They are available in blister packs containing 28, 56 or 84 tablets (500 mg) and 28,42, 56 or 84 tablets (850 mg). Not all pack sizes are marketed.
Product licence holder and manufacturer
The marketing authorisation holder is Auden Mckenzie (Pharma Division) Limited, McKenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL UK Manufactured by RX Farma Ltd, Unit 3 Colonial Way, Watford, WD24 4YR
Product licence numbers
Metformin 500 mg Tablets - PL 17507/0007 Metformin 850 mg Tablets - PL 17507/0008
Date leaflet was last revised: May 2011
If you would like this leaflet in a different format, please contact the licence holder at the above address.
Illlllll
Patient Information Leaflet
METFORMIN 500 mg TABLETS and METFORMIN 850 mg 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.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please askyour doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metformin Tablets are and whatthey are used for
2. Before you take Metformin Tablets
3. How to take Metformin Tablets
4. Possible side effects
5. How to store Metformin Tablets
6. Further information
These tablets are available in two different strengths and your doctor will have decided which is the most suitable for you. Each tablet contains either 500 mg or 850 mg of the active ingredient, metformin hydrochloride.
Metformin is one of a group of medicines called oral hypoglycaemics, which work by reducing the level of sugar in the blood.
Metformin Tablets are used for the treatment of a type of diabetes which usually only occurs in adults, and is not severe enough to need insulin, but which does not respond to dietary measures alone. In some patients metformin may be used in combination with other anti-diabetic medicines called sulphonylureas.
Some people must not take these tablets.
Do not take these tablets if:
• You know you are allergic to metformin, or to any of the other ingredients (these are listed in section 6)
• You have failed to respond to treatment with other antidiabetic medicines called sulphonylureas
• You have ever fainted or even suffered a coma from having diabetes
• You have problems with your liver or kidneys
• You have an acute or chronic disease which could cause decreased oxygen supply (hypoxia), like heart failure, respiratory failure or a recent heart attack.
• You are pregnant or think you may be pregnant
• You suffer from alcoholism or acute alcohol intoxication
• You have any problems with your circulation, causing for example, frequent cramp in your calves or leg ulcers that do not heal
• You have an infection, a fever, are sufferingfrom shock or trauma or are unwell in any other way.
• You suffer from an inflamed pancreas (pancreatitis)
• You are on a special low calorie diet (less than 1000 calories per day or 4200 KJ per day)
• You are dehydrated (feeling extremely thirsty)
• You have breathing problems.
You must check with your doctor before taking these tablets if you are breast-feeding.
Other special warnings
• If you are going to have an operation requiring an anaesthetic or you are to undergo a scan requiring injection of a dye, you must ensure the doctor in charge is aware you are taking Metformin Tablets (as they will need to be stopped up to 48 hours before the procedures)
• You should not drink alcohol while taking Metformin Tablets
• Patients who are already on insulin should only be started on a course of treatment with metformin in hospital
• Metformin Tablets should not be taken by children
• If you are taking these tablets continuously your doctor will perform regular blood tests to check your Vitamin B12 levels and your kidney function.
• If you are an elderly patient (approximately over the age
of 65 years) your doctor will perform blood and urine tests to checkyour kidney function before starting metformin.
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
Metformin Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:
• Insulin, other diabetic drugs and guar
• Monoamine-oxidase inhibitors (MAOIs) or other medicines to treat depression or psychoses such as chlorpromazine
• Aspirin or any other non-steroidal medicines for pain and inflammation
• ACE inhibitors and beta-blockers for high blood pressure
• Other medicines for high blood pressure eg. clonidine, reserpine, guanethidine or diazoxide
• Thiazides and loop diuretics (water tablets)
• Medicines for lowering cholesterol in the blood such as clofibrate or nicotinic acid derivatives
• Cyclophosphamide (to control inflammation)
• Cimetidine (to treat stomach ulcers)
• Hormone drugs such as the contraceptive pill or hormone replacement therapy (HRT)
• Steroids such as prednisolone or hydrocortisone
• Oxytetracycline (an antibiotic to treat infections)
• Phenprocoumone (an anticoagulant to thin the blood)
• Adrenaline and other sympathomimetics (used to treat allergic conditions and heart attacks)
• Glucagon (used to control low blood sugar levels)
• Thyroid hormones such as thyroxine.
Continued, please turn over
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
Driving and using machinery
Metformin Tablets taken on their own should not affect your ability to drive or operate machinery but if you are also taking them with another medicine (sulphonylureas or insulin) to lower blood sugar levels, it is possible the combined effect of these medicines may make some patients feel faint or dizzy. If this happens do not drive or operate machinery until you feel better.
If these side-effects occur they usually get better spontaneously so you should continue to take the tablets unless your stomach upset is severe or shows no signs of getting better after a few days - in this case contact your doctor.
Rarely liver disorders such as inflammation of the liver may occur or blood tests to check your liver may have abnormal results.
Very rarely skin reactions such as redness, itching or hives or allergic reactions may occur. If you notice a rash ask your doctorfor advice about continuingto take the tablets. Prolonged treatment with Metformin Tablets can result in a lack of Vitamin B12 and this may cause anaemia. Your doctor will carry out regular blood tests to check for this.
If you notice any unwanted effects, even one not mentioned here, please go and see your doctor.
The tablets should be swallowed whole with a glass of water during or after meals.
The doctor will decide what dose you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist's label. If you are notsure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual starting dose for adults is: One or two 500 mg
tablets, or one 850 mg tablet each day. The dose will be gradually increased by your doctor until the right dose to control your symptoms is found. In most cases symptoms can be eventually controlled with three 500 mg tablets or two 850 mg tablets each day in divided doses. The maximum daily doses are six 500 mgtablets or three 850 mgtablets.
If you take more tablets than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your tablets or the pack with you so that the doctor knows what you have taken.
If you forget to take a dose of Metformin Tablets
If you miss a dose, take the missed dose as soon as you remember unless it is nearly time for your next dose. Never take a double dose to make up for the missed dose.
Keep out of the reach and sight of children - preferably in a locked cupboard or cabinet.
Do not store above 25°C. Store the tablets in the original blister pack.
Do nottake the tablets afterthe expiry date shown on the carton.
If your doctor tells you to stop taking the tablets, please take any unused medicine back to your pharmacist to be destroyed.
Metformin Tablets are suitable for most people, but like all medicines they can sometimes cause side effects.
If you suddenly experience any of the following effects:
• Muscle pains or spasms, hyperventilation (over breathing), tiredness, clouding of consciousness, severe abdominal pain or severe indigestion.
You must IMMEDIATELY go to the nearest hospital casualty department, as these may be symptoms of the very rare but serious condition of lactic acidosis.
The most common side effects (usually when you first start taking metformin) are:
• Nausea, vomiting, abdominal pain, diarrhoea, loss of appetite or a metallic taste.
Ingredients
Each tablet contains either 500 mg or 850 mg of the active ingredient, metformin hydrochloride.
The tablets also contain sodium starch glycol late, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.
What the medicine looks like
Metformin Tablets are round, white, film-coated tablets. The 500 mg strength tablets are marked with “500" on one side and the 850 mg strength tablets are marked with “850" on one side
They are available in blister packs containing 28, 56 or 84 tablets (500 mg) and 28, 42, 56 or 84 tablets (850 mg). Not all pack sizes are marketed.
Product licence holder and manufacturer
The marketing authorisation holder is Auden Mckenzie (Pharma Division) Limited, 30 Stadium Business Centre, North End Road, Middlesex, HA9 OAT UK.
Manufactured by Co-pharma Ltd, Tolpits Lane, Watford, Herts, UK, WD1 8SS.
Product licence numbers
Metformin 500 mg Tablets - PL 17507/0007
Metformin 850 mg Tablets - PL 17507/0008
Date leaflet was last revised: May 2011.
If you would like this leaflet in a different format, please contact the licence holder at the above address.