Metformin 850mg Tablets

Document: leaflet MAH GENERIC_PL 17907-0081 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMIN 500MG TABLETS BP _METFORMIN 850MG TABLETS BP_

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, please ask your doctor or pharmacist.

• This medicine has been prescribed for you only and you should not pass it on to others. It may harm them, even if their 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. 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 are and what they are used for What Metformin Tablets are?

Metformin is 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 Tablets helps to lower your blood glucose to as normal level as possible.

If you are an overweight adult when diet and exercise alone have not been sufficient in adequate glycaemic control, taking Metformin Tablets over a long period of time also helps to lower the risk of complications associated with diabetes. What Metformin Tablets are used for?

Metformin Tablets are used to treat patients with type 2 diabetes (also called 'noninsulin 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 or together with insulin.

2. What you need to know before you take Metformin Tablets Do not take these Tablets if you:

• are allergic to Metformin or any of the other ingredients of this medicine (listed in section 6)

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

• have uncontrolled diabetes, such as severe hyperglycaemia or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood. Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath

• 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')

• have a severe infection, such as 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')

• are treated for heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties. This may lead to lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Warnings and Precautions')

• 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 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 follow your doctor's instructions precisely.

Warnings and Precautions

Please note the following particular risk of lactic acidosis.

Metformin may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing 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 with a lack of oxygen supply (such as acute severe heart diseases).

It is important to you to comply with your medication intake, dietary instructions and regular exercise program 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. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away.

Metformin Tablets on their 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, glinides), 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 if you eat or drink something containing sugar. You may see some remains of the tablets in your stools. Do not worry - this is normal for this type of tablet.

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 contrast medicines that contain iodine into your bloodstream, for example, for the examinations such as X-ray or scan,

you must stop taking Metformin Tablets for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice').

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

• 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 inflammation of the skin or in asthma)

• ACE inhibitors used to treat high blood pressure such as lisinopril, enalapril etc

• other medicines used to treat diabetes 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 planning to become pregnant, so that he or she may change your treatment.

• Do not take this medicine if you are breast-feeding or if you are planning

to breast-feed your baby. _s

Metformin Insert

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Driving and using machines

• Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low)

Metformin Tablets on their own does not affect your ability to drive or use machines. However take special care if you take these tablets together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides). 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 and adolescents usually start with 500mg or 850mg 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 2 or 3 times a day. The maximum daily dose is 3000mg taken as 3 divided doses.

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

• Your doctor 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 the tablets with or after a meal. This will avoid you 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 vomiting, bellyache

(abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness and difficulty in breathing. Talk to your doctor or pharmacist 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 product, ask your doctor or pharmacist.

If you stop taking these Tablets

Do not stop taking these tablets without consulting your doctor. Treatment should continue for as long as your doctor feels it is needed. If you have any further questions on the use of this product, ask you doctor or pharmacist.

Overweight patients should continue their energy restricted diet.

| 4. Possible side effects |

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

Very common: 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 the tablets with or straight after a meal. If symptoms continue, stop taking Metformin Tablets and talk to your doctor.

Common: may affect up to 1 in 10 people

• changes in taste.

Very rare: 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. If you get this complication, you will need immediate treatment. 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. If this happens to you, stop taking Metformin Tablets immediately and tell your doctor straight away.

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

• low vitamin B₁₂ levels in the blood.

• 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 this medicine.

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 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 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 this medicine out of the sight and reach of children.

• Blisters: Do not store above 25°C. Store in the original package. Keep the blister in the outer carton

Containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.

• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

| 6. Contents of the pack and other information |

What Metformin Tablets contain

• The active substance is Metformin hydrochloride

• The other ingredients are: Sodium starch glycolate, Colloidal anhydrous silica, Maize starch, Povidone and Magnesium stearate in the tablet core; the film coat contains Hypromellose, Titanium dioxide (E171), Propylene glycol, Purified talc and Macrogol 6000.

What Metformin Tablets look like and contents of the pack

• Tablets are white coloured, film coated, round, biconvex tablets embossed with '500' or '850' on one face and plain on the other.

• Metformin tablets are available in packs of 14, 28, 56 or 84 tablets or containers containing 100, 250, 300 or 500 tablets.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

E-mail: info@bristol-labs.co.uk

Metformin 500mg tablets; PL 17907/0080 Metformin 850mg tablets; PL 17907/0081 This leaflet was revised in August 2015

V2 20-08-15 DO >

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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