Metformin 500mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet.
1. What Metformin Tablets is and what it is used for
2. What you need to know before you take Metformin Tablets
3. How to take Metformin Tablets
4. Possible side effects
5. How to store Metformin Tablets
6. Contents of the pack and other information.
1. WHAT METFORMIN TABLETS IS AND WHAT IT IS USED FOR
Metformin belongs to 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 type 2 (non-insulin dependant) diabetes particularly in overweight patients, where diet and exercise changes alone have not been sufficient to control it. The tablet may either be used alone or in combination with other medicines called sulphonylureas or with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN TABLETS
Do not take Metformin Tablets
• If you are allergic ( hypersensitive) to metformin or any of the ingredients in the tablet.
• If you have had serious complication with your diabetes or other serious condition which resulted in rapid weight loss, nausea, vomiting or dehydration and you had fainted or suffered a coma due to your diabetes.
• If you are suffering from severe infection or have recently suffer a severe injury.
• If you have any problem with your liver or kidneys.
• If you have been treated for heart problems or have recently had a heart attack or have problem with your circulation including shock or breathing difficulty.
• If you are pregnant or breast feeding
• If you are likely to have a surgery, or as scan or an X-Ray
• If you drink alcohol excessively
Warnings and precautions
Talk to your doctor or pharmacist before
taking Metformin Tablets,
• If you have kidney failure, blood levels of metformin can increase, which can very rarely cause lactic acidosis. This results in breathing difficulty nausea or vomiting, abdominal pain or loss of consciousness and if not treated, this can be very dangerous and needs immediate hospital attention.
• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Metformin before the operation. Your doctor may stop you taking metformin for a couple of days before and after the operation.
• If you are going to have an X-ray, tell your doctor you are taking metformin. If this
involves having a dye injected, you must stop taking metformin.
The amount of sugar in your blood or urine should be checked regularly. Your doctor will also check your kidneys are working properly. This should be done at least once a year (more often if you are elderly or have kidney problems).
Other medicines and Metformin Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Patients who are already on insulin should only be started on a course of treatment in hospital.
Consult your doctor if you are on:
• Other medicines used to lower blood sugar i.e. insulin
• Medicines for asthma such as salbutamol
• Diuretics (water tablets) such as furosemide or bendrofluazide.
• ACE-inhibitors such as captopril, ramipril used for heart problems and high blood pressure
• Beta-blockers such as atenolol
• Steriods such as prednisolone, used to treat i nflammatory and allergic disorders.
Metformin Tablets 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 whilst taking Metformin Tablets. 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
Do not take Metformin tablets if you are pregnant, planning to become pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using medicines
Metformin does not affect your ability to drive or handle machinery but if you are also taking any other medicines which lower the blood glucose it is possible that their combined effects could make you feel faint, dizzy, weak or jittery. If this happens you should not drive or operate any machinery until you have recovered.
3. HOW TO TAKE METFORMIN TABLETS
Always take Metformin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For oral use only. Metformin Tablets should be swallowed, without chewing, with half a glassful of water during or after meals.
The usual dose in
Adults: the usual starting dose is 500mg or 850mg Metformin, two or three times a day during or after meals. The maximum daily dose is 3000mg taken as 3 divided doses. Elderly: the starting dose will be determined after tests have been carried on your kidney function.
Children: Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin once a day during meals or after meals. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.
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If you take more Metformin Tablets than you should
If you or someone else swallows several of these tablets all together, you may experience lactic acidosis (symptoms are vomiting, abdominal pain, a general feeling of not being well with severe tiredness, and difficulty in breathing), contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you, this leaflet and also the box, as this will allow easier identification of the tablets.
If you forget to take Metformin Tablets
If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Metformin Tablets
If you stop taking Metformin Tablets 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 medicine, ask your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin Tablets can cause side effects, although not everybody gets them. The following side effects may occur:
Very common side effects (in more than 1 in 10 people)
• Upset stomach, such as feeling sick (nausea), being sick (vomiting), diarrhoea, abdominal pain and loss of appetite.
These side effects most often happen at the beginning of the treatment with Metformin. It helps if you spread the doses over the day and if you take metformin with or straight after a meal. If symptoms continue, stop taking Metformin tablets and talk to your doctor.
Common side effects (in less than 1 in 10 people)
• Changes in taste.
Very rarely reported side effects (in less than 1 in 10,000 people)
• Skin rash (including redness, itching, hives).
• Low levels of Vitamin B12. Over the time this may lead to anaemia, a sore mouth or tounge or possibly numbness or tingling in the limbs.
• Liver problems abnormal liver function tests and hepatitis (inflammation of the liver) that may result in jaundice. If you notice yellowing of the eyes/skin contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
What Metformin Tablets contains The active substance is Metformin hydrochloride.
The other ingredients are sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.
What Metformin Tablets look like and the contents of the pack
Metformin Tablets are white round, biconvex film-coated tablets, embossed with either ‘M 500’ (500mg) or 'M850' (850 mg) on one side and plain on the other side.
Metformin 500mg Tablets are available in blister packs of 28, 84, and 504 tablets. They are also available in plastic securitaners of 500 tablets
Metformin 850mg tablets are available in blister packs of 28, 56, 60, 84, and 308 tablets. They are also available in plastic securitaners of 300 tablets
(Not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD United Kingdom.
This leaflet was last revised in 10/2015
5. HOW TO STORE METFORMIN TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package and keep containers tightly closed.
Do not use the tablets after the expiry date which is stated on the label.