Metformin 500mg Tablets
Patient Information Leaflet
Metformin 500mg/850mg Tablets Metformin Hydrochloride
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 further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms 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.
• The name of your medicine is Metformin 500mg/850mg Tablets but will be referred to as 'Metformin Tablets' throughout the remainder of this leaflet.
What is in this leaflet
1. What Metformin 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 IS AND WHAT IT IS USED FOR
Metformin contains the active substance Metformin Hydrochloride and it belongs to a group of medicines called biguanides.
Metformin is used for the treatment of Type 2 diabetes (non-insulin dependent diabetes) in children above 10 years and in adults.
How Metformin works
• In type 2 diabetes, there is too much sugar (glucose) in your blood. This is because your body does not make enough insulin or because it makes insulin that does not work properly.
• Insulin is a hormone that allows your body tissue to take glucose from the blood and use it for energy or for storage for future use.
• Metformin works by improving the sensitivity of your body to insulin. It helps your body to use glucose in the normal way again.
Using this medicine
• This medicine is given when diet and exercise alone has not been able to control your blood sugar levels.
• Metformin can be given on its own. However, sometimes it is given with other medicines for diabetes or with insulin.
• In patients who are overweight, long-term use of metformin also helps to lower the risk of any problems related to diabetes.
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 other ingredients (see section 6: Further information). An allergic reaction can include a rash, itching or shortness of breath.
• you have recently had a heart attack or any other heart problems
• you have severe circulation problems or difficulty in breathing • you have liver or kidney problems
• you have had serious problems with your diabetes in the past called “diabetic ketoacidosis”. When you have this you lose weight quickly, feel sick (nausea) or are sick (vomiting). See also in Section 4: Possible side effects
• you have recently had a severe infection, injury or trauma (shock)
• you are dehydrated
• you are going to have an X-ray where you will be injected with a dye
• you are a heavy drinker of alcohol (more than 21 units a week for a man or 14 units a
week for a woman). A unit is equivalent to a small glass of wine, one shot or half a pint of beer.
• you are pregnant, planning to get pregnant or are breast-feeding (see Pregnancy and Breast-feeding).
Operations and tests while taking Metformin Tablets
• 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).
• 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.
• 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.
Other medicines and Metformin Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the following:
• Water tablets (Thiazides and loop diuretics), e.g. bendrofluazide or frusemide.
• Glucocorticoids, used for the treatment of allergies, inflammation, asthma and some immune system disorders.
• Iodinated contrast agents, use a dye for radiographic procedures e.g. X-ray for increasing the visibility of blood vessels and organs during such procedures.
• Medicines for the treatment of high blood pressure such as ACE inhibitors, e.g. captopril, enalapril, ramipril, perindopril, lisinopril.
• Medicines known as Beta-2-agonists, used for smooth muscle relaxation and Asthma (eg. Salbutamol, terbutaline)
Taking Metformin Tablets with food and drink
• You need to eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you need to continue to follow this.
• Do not drink alcohol or take medicines containing alcohol while taking metformin.
Pregnancy, breast-feeding and fertility
If your pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Metformin tablets should not be taken during pregnancy and breast-feeding and discuss with the doctor before breast-feeding.
Driving and using machines
Do not drive or use any tools or machines when your blood sugar level is low (sometimes called “hypo”). Signs include feeling faint, confused and sweaty. This can happen if metformin is taken with other diabetic medicines.
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.
Taking this medicine
• Swallow the Tablets whole with a glass of water.
• Take with or just after food. This lowers the chance of getting an upset stomach.
Adults
• The usual starting dose is one 500mg tablet two or three times a day or one 850mg tablet twice a day.
• The maximum daily dose is six 500mg tablets or three 850mg tablets.
• Your doctor may check your blood after two weeks. The dose may be changed, depending on the sugar level in your blood.
Children(10 years and above) : Treatment usually starts with a single dose of 500mg tablet or 850 mg tablets per day. Physician may change the dose as required. The maximum divided doses should not be more than 2 gm per day.
If you take more Metformin Tablets than you should Talk to a doctor or go to a hospital straight away.
If you forget to take Metformin Tablets
Take it as soon as you remember. However, if it is less than 2 hours away from the next dose, skip the missed dose. Then go on as before. Do not take a double dose to make up for the forgotten dose.
If you stop taking Metformin Tablets
Keep taking this medicine until your doctor tells you to stop.
If you have any further questions in the use if this medicine, ask you doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, metformin can cause side effects, although not everybody gets them. Following are the side effects which may occur during the treatment with Metformin Tablets. Very common:
• Nausea
• Vomiting
• Pain in stomach
• Diarrhoea
• Loss of appetite Common: Taste disturbances Very rare:
• Skin rashes, itching
• Prolonged treatment with Metformin Hydrochloride can deplete reserves of vitamin B12 and this may cause anaemia. Regular blood tests for kidney function and vitamin B12 should therefore be carried out.
• Other side effects like liver problems may also occur while taking treatment with Metformin Tablets.
Lactic Acidosis. In very rare cases, Metformin can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This buildup can cause serious damage.
Signs of lactic acidosis are:
• feeling very weak, tired, or uncomfortable
• unusual muscle pain
• trouble breathing
• unusual or unexpected stomach discomfort
• feeling cold
• feeling dizzy or lightheaded
• suddenly developing a slow or irregular heartbeat
If your medical condition suddenly changes, stop taking Metformin and call your doctor right away. This may be a sign of lactic acidosis or another serious side effect.
Metformin may cause hypoglycemia (low blood sugar) when used along with other medicines for treating Diabetes.
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.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE METFORMIN TABLETS
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Store in the original package in order to protect from light.
• Do not use after the expiry date which is stated on the label and carton EXP (month, year). The expiry date refers to the last day of that month.
• 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 What Metformin tablet contains
Each Metfromin 500mg Tablet contains 500mg of the active ingredient metformin hydrochloride Each Metfromin 850mg Tablet contains 850mg of the active ingredient 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 Tablet looks like and contents of the pack
Metformin Tablets are white coloured, film-coated, round, biconvex tablets. They are available in blister packs of 28 (500mg) tablets and 56 (850mg) tablets.
Marketing Authorization Holder & Manufacturer:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
The leaflet was last revised in December 2014.