TEVA UK Ref: 86463-W LEA METFORMIN 500 MG SR TAB TUK Version: 1    05 December 2014

BOLAMYN SR 500 mg PROLONGED RELEASE TABLETS

metformin hydrochloride

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 or nurse. This includes any possible side effects not listed in this leaflet, See section 4.

What is in this leaflet:

Pharma code 3313

1.    What Bolamyn SR 500 mg Prolonged Release Tablets are and what they are used for

2.    What you need to know before you take Bolamyn SR 500 mg Prolonged Release Tablets

3.    How to take Bolamyn SR 500 mg Prolonged Release Tablets

4.    Possible side effects

5.    How to store Bolamyn SR 500 mg Prolonged Release Tablets

6.    Contents of the pack and other information

OWhat Bolamyn SR 500 mg

Prolonged Release Tablets are and what they are used for

Metformin, active substance of Bolamyn SR 500mg Prolonged Release Tablets, belongs to a group of active substances called biguanides, which are used to treat diabetes by regulating the level of sugar in the blood.

• Bolamyn SR is used for patients who have non-insulin-dependent (type 2) diabetes, particularly in overweight patients, where diet and exercise alone have failed to control it. Metformin can be given alone or in combination with other oral antidiabetic medicines or with insulin.

This is a prolonged release tablet which a type of tablet that spreads the release of the medication over a longer period of time than an immediate release tablet. Ask your doctor or pharmacist if you need additional information.

©What you need to know

before you take Bolamyn SR 500 mg Prolonged Release Tablets

Do not take Bolamyn SR Tablets:

• If you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6)

• If you have diabetic ketoacidosis (a complication of diabetes which may be associated with frequent urination, feeling and being sick, abdominal (stomach) pain, lethargy and sleepiness) or diabetic pre-coma (altered mental state due to an imbalance in blood sugar)

• If you have kidney or liver problems • If you are dehydrated • If you are suffering from a severe infection

• If you are going to have a certain type of X-ray with an injectable dye - see below under "Taking other medicines" • If you have recently suffered from heart failure

• If you have recently had a heart attack or have circulatory problems or breathing difficulties

• If you are a heavy drinker (either every day or only from time to time)

• If you are breast-feeding.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Bolamyn SR Tablets Bolamyn SR treatment may rarely cause a serious condition called lactic acidosis which requires urgent hospital treatment to prevent it leading to coma. Other

illnesses, prolonged fasting, poor blood sugar control, or alcohol intake can all increase the risk of lactic acidosis developing. You should be aware of the warning symptoms which include muscle cramps, abdominal pain, breathlessness and a feeling of being very weak and unwell. If you develop these symptoms you must tell your doctor immediately.

•    Your doctor should check that your kidneys are working properly at least once a year or more often if needed

•    If you are going to have an anaesthetic, X-ray or scan, tell your doctor that you are taking Bolamyn SR. It is advised to stop taking Bolamyn SR for 48 hours before and after the procedure

•    Continue to follow any dietary advice your doctor has given you and get some regular exercise while you are taking this medicine

•    Be careful if you are taking Bolamyn SR with insulin or other antidiabetic medicines, as the combination may increase the risk of hypoglycaemia ("hypos", excessively low sugar in your blood)

•    Children and adolescents should not take Bolamyn SR.

Other medicines and Bolamyn SR Tablets

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

•    Bolamyn SR must not be used at the same time as some injectable dyes used for certain kinds of X-rays or scans, because there is a risk of kidney failure. If you are going to undergo these procedures, you must tell your doctor you are taking Bolamyn SR. It is advised to stop taking Bolamyn SR for 48 hours before and after the procedure.

•    Glucocorticoids (e.g. budesonide, beclomethasone or hydrocortisone, which are sometimes used to suppress inflammation caused by allergic reactions and in asthma), beta-2-agonists (e.g. salbutamol, which are mostly used in the treatment of asthma) and diuretics (water tablets which increase urine production and may be used to treat high blood pressure) can all increase blood sugar levels. You should check your blood sugar more often if you are taking Bolamyn SR with any of these medicines.

•    ACE (Angiotensin Converting Enzyme) inhibitors (e.g. quinapril, captopril, which are used to treat heart problems) can reduce blood sugar levels. Tell your doctor if you start treatment with an ACE inhibitor.

•    Be careful and tell your doctor if you start treatment for high blood pressure or start to take a diuretic (water tablets which increase urine production) or NSAID (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) as you may be at increased risk for kidney problems.

Bolamyn SR Tablets with food and drink

•    Bolamyn SR must be taken during or after your evening meal. Taking your tablets with food can reduce unwanted side effects.

•    You must avoid consuming alcohol and using alcohol-containing medicines whilst on Bolamyn SR, as you could be at greater risk of developing lactic acidosis, a serious complication which can be recognised by muscle cramps, abdominal pain, breathlessness and a feeling of being very weak and unwell.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

•    Tell your doctor if you are, think you might be or are planning to become pregnant. During pregnancy, diabetes should be treated with insulin. If you find out that you are pregnant while taking Bolamyn SR, consult your doctor so that he/she may change your treatment.

Top of page cut-off to middle of registration mark: 44 mm.

•    You must not take Bolamyn SR if you are breast-feeding or if you are planning to breast feed your baby.

•    Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Taking Bolamyn SR does not affect your ability to drive or use machines.

However, there is an increased risk of low blood sugar Bolamyn SR is taken with other medicine for diabetes (sulphonylureas, insulin, repaglinide). This may cause dizziness and fainting. Do not drive or operate machines unless you are sure that you are not affected.

©How to take Bolamyn SR 500 mg Prolonged Release Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with a drink of water during or after your evening meal. You may see the shell of the tablet in your bowel motions. This is normal.

The recommended doses are explained below.

Adults

For patients taking Bolamyn SR by itself or combined with other oral antidiabetic medicines:

The usual starting dose is one tablet once a day. After 10 to 15 days, your doctor will adjust the dose on the basis of blood glucose measurements. Your doctor may increase the dose up to a maximum of 2,000 mg of metformin hydrochloride per day (four of these 500 mg Bolamyn SR in one day).

For patients already taking Metformin and switching to Bolamyn SR:

The usual starting dose of Bolamyn SR should be equal to your daily dose of metformin immediate-release tablets.

For patients taking Bolamyn SR combined with insulin:

When taking Bolamyn SR with insulin, the usual starting dose is one tablet once a day, while insulin dosage is adjusted on the basis of blood sugar measurements.

Older people:

The starting dose will be determined after tests have been carried out on your kidney function.

Use in children:

This medicine is not recommended for children.

You should continue to take these tablets for as long as your doctor tells you to.

If you take more Bolamyn SR than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

If you forget to take Bolamyn SR

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct time.

If you stop taking Bolamyn SR Tablets

If you stop treatment with Bolamyn SR without medical advice, you have to be aware of uncontrolled blood sugar increase. Late symptoms of diabetes, such as damage of the eyes, kidneys and vessels, may occur.

If you see another doctor or go into hospital, let him or the staff know what medicines you are taking.

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

Possible side effects

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

If you experience any of the following, contact your nearest hospital casualty

department or your doctor immediately:

•    If you have symptoms which include muscle cramps, stomach pain, breathlessness and a feeling of being very weak and unwell: these symptoms could indicate you have lactic acidosis, a serious but very rare (may affect up to 1 in 10,000 people) side effect of metformin.

The following side effects have been reported at the approximate frequencies shown:

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

•    Nausea (feeling sick)

•    Vomiting

•    Diarrhoea

•    Abdominal pain (stomach pain)

•    Loss of appetite.

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

•    Taste disturbances.

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

•    Decrease in vitamin B12. Over time this may lead to anaemia, a sore mouth or tongue or possibly numbness or tingling in the limbs.

•    Redness and itching of the skin, hives (nettle rash)

•    There have also been isolated reports of liver problems, including hepatitis (jaundice: yellowing of the skin or eyes).

Reporting of side effects

If you get any side effects, talk to your doctor or 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 at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Bolamyn SR 500 mg Prolonged Release Tablets

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the blister and 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.

©Contents of the pack and other information

What Bolamyn SR contain:

• The active substance is metformin hydrochloride. One prolonged-release tablet contains 500 mg metformin hydrochloride corresponding to 390 mg of metformin.

• The other ingredients are

hypromellose (E454), ethylcellulose, cellulose microcrystalline and magnesium stearate.

What Bolamyn SR look like and contents of the pack:

• Bolamyn SR 500 mg Prolonged release Tablets are white to off white, oval shaped tablets, with "93" on one side and "7267" on the other side • The tablets are available in pack sizes of 1, 20, 28, 30, 56, 60, 90 & 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Ltd, Eastbourne, East Sussex, BN229AG

This leaflet was last approved in July 2014

PL 00289/1013

TEVA UK LIMITED

86463-W