Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

• Keep this leaflet. You may need to read it again before, during or after use of this medicine. 
• If you have any further questions, ask your health care provider. 
• This medicine has been prescribed for you only. 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 become serious, or if you notice any side effects not listed in this leaflet, please inform your health care provider. 

In this leaflet: 

1. What Metformin Tablet is and what it is used for 
2. What you need to know before you take Metformin Tablet 
3. How to use Metformin Tablet 
4. Possible side effects 
5. How to store Metformin Tablet 
6. Contents of the pack and other information 

 

1. WHAT METFORMIN TABLET IS AND WHAT IT IS USED FOR 

Metformin Tablets contain metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. 

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use. 

If you have diabetes, your pancreas does not make enough insulin, or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin helps to lower your blood glucose to as normal a level as possible. 

If you are an overweight adult, taking Metformin Tablets over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Tablets is associated with either a stable body weight or modest weight loss. 

Metformin Tablets is used to treat patients with type 2 diabetes (also called ‘non-insulin dependent diabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients. 

Adults can take Metformin Tablet on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Children 10 years and over as well as adolescents can take Metformin Tablet on its own  or together with insulin. 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN TABLET Do not take METFORMIN TABLET: 

• If you are allergic (hypersensitive) to metformin. 
• If you have liver problems 
• If you lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘warnings and precautions’). 
• If you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘ warnings and precautions’). 
• If you have severely reduced kidney function. 
• If you have uncontrolled diabetes, with, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell. 
• If you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see ‘ warnings and precautions’) 
• If you drink a lot of alcohol 

If any of the above applies to you, talk to your doctor, before you start taking this  medicine.  

Make sure you ask your doctor for advice, if: 

• You need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream 
• You need to have major surgery 

You must stop taking Metformin tablets for a certain period before and after the  examination or the surgery. Your doctor will decide whether you need any other  treatment for this time. It is important that you follow your doctor’s instructions precisely. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Metformin Tablets.  

Risk of lactic acidosis 

Metformin Tablets may cause a very rare, but very serious side effect called lactic  acidosis, particularly if your kidneys are not working properly. The risk of developing  lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged  fasting or alcohol intake, dehydration (see further information below) liver problems and  any medical conditions in which a region of the body has a reduced supply of oxygen  (such as acute severe heart diseases).  

If any of the above applies to you, talk to your doctor for further instructions.  Lactic acidosis is a medical emergency and must be treated in a hospital.  

Metformin Tablet on its own does not cause hypoglycaemia (a blood glucose level which  is too low). However, if you take Metformin Tablets together with other medicines to treat  diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides),  there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as  weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty  in concentration, it usually helps to eat or drink something containing sugar.  

Stop taking Metformin Tablets for a short time if you have a condition that may be  associated with dehydration (significant loss of body fluids) such as severe vomiting,  diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your  doctor for further instructions.  

Stop taking Metformin Tablets and contact a doctor or the nearest hospital  immediately if you experience some of the symptoms of lactic acidosis, as this  condition may lead to coma.  

Symptoms of lactic acidosis include:  

• Vomiting 
• Stomachache (abdominal pain) 
• Muscle cramps 
• A general feeling of not being well, with severe tiredness 
• Difficulty in breathing 
• Reduced body temperature and heartbeat 

If you need to have major surgery, you must stop taking Metformin Tablets during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Tablets.  

During treatment with Metformin Tablets, your doctor will check your kidney function at  least once a year or more frequently if you are elderly and/or if you have worsening  kidney function.  

Other medicines and Metformin Tablets  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any  other medicines.  

If you need to have an injection of a contrast medium that contains iodine into your  bloodstream. For example, in the context of an X-ray or scan, you must stop taking  Metformin Tablets before or at the time of injection. Your doctor will decide when you  must stop and when to restart your treatment with Metformin Tablets.  

You may need more frequent blood glucose and kidney function tests, or your doctor  may need to adjust the dosage of Metformin Tablets. It is especially important to mention  the following:  

• Medicines which increase urine production (diuretics) beta-2 agonists such as salbutamol or terbutaline (used to treat asthma) 
• Corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma) 
• Medicines that may change the amount of metformin tablets in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib). • Other medicines used to treat diabetes 
• Medicines which increase urine production (diuretics) 
• Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) 
• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists) 

Metformin Tablets with food, drink and alcohol 

Avoid excessive alcohol intake while taking Metformin Tablets since this may increase  the risk of lactic acidosis (see section “Warnings and precautions”). 

Pregnancy and breastfeeding 

During pregnancy, you need insulin to treat your diabetes. If you are 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. 

This medicine is not recommended if you are breast-feeding or if you are planning to  breast-feed your baby.  

Driving and using machines  

Metformin Tablet on its own does not cause hypoglycaemia (a blood glucose level which  is too low). This means that it will not affect your ability to drive or use machines.  

However, take special care if you take Metformin Tablets together with other medicines  to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin,  meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased  sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or  use machines if you start to feel these symptoms.  

3. HOW TO TAKE METFORMIN TABLETS 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 

Metformin Tablets cannot replace the benefits of a healthy lifestyle. 

Continue to follow any advice about diet that your doctor has given you and get some regular exercise. 

Recommended dose 

Children 10 years and over as well as adolescents usually start with 500 mg or 850 mg Metformin Tablets once a day. 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. 

Adults usually start with 500 mg or 850 mg Metformin Tablets two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses. 

If you have reduced kidney function, your doctor may prescribe a lower dose. The maximum dose is 1000 mg daily, given as 2 divided doses. 

The renal function should be closely monitored (every 3 – 6 months). 

If you take insulin too, your doctor will tell you how to start Metformin Tablets. 

Monitoring 

• Your doctor will perform regular blood glucose tests and will adapt your dose of

Metformin Tablets to your blood glucose levels. Make sure that you talk to your doctor  regularly. This is particularly important for children and adolescents or if you are an older  person.  

• Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally. 

How to take Metformin Tablets 

Take Metformin Tablets with or after a meal. This will prevent you from having side effects affecting your digestion. 

Do not crush or chew the tablets. Swallow each tablet with a glass of water. • If you take one dose a day, take it in the morning (breakfast) 

• If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner). 
• If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner), 

If, after some time, you think that the effect of Metformin Tablets is too strong or too weak, talk to your doctor or pharmacist. 

If you take more Metformin Tablets than you should 

If you have taken more Metformin Tablets than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are nonspecific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heartbeat. If you experience some of these symptoms, you should seek immediate medical attention, as lactic acidosis may lead to coma. Stop taking Metformin Tablets immediately and contact a doctor or the nearest hospital straight away. 

If you forget to take Metformin Tablets 

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

4. POSSIBLE SIDE EFFECTS 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

The following side effects may occur:  

Metformin tablets may cause a very rare (may affect up to 1 user in 10,000), but very  serious side effect called lactic acidosis (see section ‘Warnings and precautions’). If this  happens you must stop taking Metformin tablets and contact a doctor or the  nearest hospital immediately, as lactic acidosis may lead to coma.  

Very common side effects:( may affect more than 1 in 10 people)  

• Digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin Tablets. It helps if you spread the doses over the day and if you take Metformin Tables with or straight after a meal. If symptoms continue, stop taking metformin and talk to your doctor. 

Common side effects: (may affect up to 1 in 10 people) 

• Changes in taste. 

Very rare side effects:( may affect up to 1 in 10,000 people) 

• Lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. 

Symptoms of lactic acidosis are non-specific (See section “Warning and precautions”). • Abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking metformin tablets and talk to your doctor. • Skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives). • Low vitamin B12 levels in the blood. 

Children and adolescents 

Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults 

5. HOW TO STORE METFORMIN TABLET 

• Keep all medicines out of the sight and reach of children 
• Do not take this medicine after the expiry date which is stated on the label after “EXP” The expiry date refers to the last day of that month. 
• Store below 30˚C. 
• Store in the original container.

6. FURTHER INFORMATION. 

Each Metformin 500 Tablet contains Metformin 500mg 

Each Metformin 1000 Tablet contains Metformin 1000mg 

What METFORMIN TABLET looks like and contents of the pack 

Metformin 500 Tablet: tablets packed in 10 X 10 blisters and placed in an inner carton with insert. 

Metformin 1000 Tablet: tablets packed in 10 X 10 blisters and placed in an inner carton with insert.