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Metformin 500mg Tablets    Metformin 850mg Tablets

Metformin hydrochloride    Metformin hydrochloride

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this medicine because It contains Important Information foryou.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist ornurse.

•    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 are and what they are used for

2.    Whatyou 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 ARE AND WHAT THEY ARE USEDFOR

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 over a long period of time also helps to lower the risk of complications associated with diabetes.

Metformin is associated with either a stable body weight or modest weight loss.

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

Children 10 years and over and adolescents can take Metformin on its own ortogetherwith insulin.

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 majorsurgery

You must stop taking Metformin fora certain period of time 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 followyourdoctor's instructions precisely.

Warnings and Precautions

Please note the following particular risk of lactic acidosis.

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. Body fluid deficit (dehydration) due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived of oxygen supply (such as acute heart disease).

It is important for you to comply with your medicine intake, dietary instructions and regular exercise programme because this can reduce the risk of lactic acidosis.

The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Furthersymptoms are reduced body temperature and heart beat.

If you experience some of these symptoms, you should seek immediate medical attention, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straightaway.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN TABLETS

Do not take Metformin

•    if you are allergic (hypersensitive) to metformin orany of the other ingredients of this medicine (see 'What Metformin Tablet contains' in section 6)

•    if you have kidney or liver problems (glomerular filtration rate below 45ml/min)

•    if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss 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 unusual fruity odour of the breath

•    if you lost too much waterfrom 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' below).

•    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’ below).

•    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' below)

•    ifyoudrinkalotof alcohol

Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin 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.

Other medicines and Metformin Tablets

If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin for a certain period of time before and after (at least 48 hours) the examination (see 'Make sure you askyourdoctorfor advice' above).

Tell your doctor if you take any of the following medicines and Metformin at the same time. You may need more frequent blood glucose tests oryourdoctor may adjust the dosage of Metformin:

•    diuretics (used to remove water from the body by making more urine).

•    beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)

•    corticosteroids (used to treat a variety of conditions, such as severe infl ammation of the skin or in asthma)

•    other medicines used to treat diabetes

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Metformin with food and drink

Do not drink alcohol when you take this medicine. 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

During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment.

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 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 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 heartbeat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

3.    HOWTOTAKEMETFORMINTABLETS

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

Metformin cannot replace the benefits of a healthy lifestyle.

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

Recommended dose

Children 10 years and over and adolescents usually start with 500mg or850mg Metformin once a day. The maximum daily dose is 2000mg 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 500mg or 850mg Metformin two or three times a day. The maximum daily dose is 3000mg taken as 3 divided doses.

In patients with renal impairment with GFR between 45 and 60 ml/min, the starting dose is 500mg or850 mg metformin, once daily. The maximum dose is 1000mg daily, given as 2 divided doses. The renal function should be closely monitored (every 3 to 6 months).

If you take insulin too, yourdoctorwill tell you howto start Metformin.

Monitoring

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

Howto take Metformin

Take Metformin with or after a meal. This will avoid you having side effects affecting yourdigestion.

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 is too strong ortoo weak, talk to yourdoctor or pharmacist.

If you take more Metformin than you should

If you have taken more Metformin 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 heart beat.

If you experience some of these symptoms, you should seek immediate medical attention, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away.

If you forget to take Metformin

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 product, 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:

Very common side effects (in 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. It helps if you spread the doses over the day and ifyou take the Metformin with or straight after a meal.

If symptoms continue, stop taking Metformin and talk to your doctor.

Common side effects (in less than 1 in 10 people)

•    changes in taste.

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

•    abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or withoutyellowing of the skin or whites of the eyes).

If this happens to you, stop taking Metformin and talk to your doctor.

•    skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).

•    lowvitaminB12levelsintheblood.

Children and adolescents

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: 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 sight and reach of children. If a child is treated with Metformin tablets, parents and caregivers are advised to oversee howthis medicine is used.

Do not use Metformin Tablets after the expiry date which is stated on the carton. 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.

Do not store the tablets above 25°C.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Metformin Tablets contain

The active substance is 500mg or850mg of metformin hydrochloride. The other ingredients are sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate. The film coating is made up of hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.

What Metformin Tablets look like and contents of the pack

Metformin Tablets are white coloured, film coated round biconvex tablets.

The tablets are supplied in blister packs of 28 and 84 tablets for the 500mg dose and packs of 56 tablets forthe 850mg dose.

Metformin Tablets are also available in securitainers of 500 tablets for the 500mg dose and 300 tablets for the 850mg dose.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes, Cheshire WA80RP, UK

Date leaflet approved: February 2016 PL 20395/0027 and0028