Common: may affect up to 1 in 10 people:

•    Taste disturbance

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

•    Decreased vitamin B₁₂ levels

•    Skin rashes including redness, itching and hives

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

5. HOW TO STORE MEIJUMET 500 MG PROLONGED RELEASE TABLETS

Keep Meijumet 500 mg prolonged release tablets out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice description of the visible signs of deterioration. 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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Meijumet 500 mg prolonged release tablets contain:

Each prolonged release tablet contains 500 milligrams of the active ingredient metformin hydrochloride equivalent to 390 mg metformin. The other ingredients are microcrystalline cellulose, hypromellose, Povidone and magnesium stearate.

What Meijumet 500 mg prolonged release tablets looks like and contents of the pack

Meijumet 500 mg prolonged release tablets are white to off-white, capsule shaped, biconvex tablets, approximately 18 mm x 8.5 mm, debossed with ‘M2’ on one side and plain on other side.

Meijumet 500 mg prolonged release tablets are available in Alu -PVC/PVdC blister packs of 28’s and 56’s.

Meijumet 500 mg prolonged release tablets:

PL 21880/0159

This leaflet was last revised in January 2015

|POM|

Marketing Authorisation Holder and Manufacturer: MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Meijumet 500 mg

prolonged release 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 any further questions, ask your doctor or pharmacist or nurse

•    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

1.    What Meijumet 500 mg prolonged release tablets are and what they are used for

2.    What you need to know before you take Meijumet 500 mg prolonged release tablets

3.    How to take Meijumet 500 mg prolonged release tablets

4.    Possible Side effects

5.    How to store Meijumet 500 mg prolonged release tablets

6.    Contents of the pack and other information

1. WHAT MEIJUMET 500 MG PROLONGED RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR

Meijumet 500 mg prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes. Meijumet 500 mg prolonged release tablets is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar).

Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Meijumet 500 mg prolonged release tablets make the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Meijumet 500 mg prolonged release tablets are associated with either a stable body weight or modest weight loss.

Meijumet 500 mg prolonged release tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEIJUMET 500 MG PROLONGED RELEASE TABLETS:

Do not take Meijumet 500 mg prolonged release tablets if :

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

•    you have ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone bodies’ accumulate in the blood-you may notice that your breath has an unusual, fruity odour)

•    you have long-term kidney or liver problems

•    you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration

•    you have a severe infection or have recently suffered a severe injury

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•    you have been treated for heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties

•    you are a heavy drinker of alcohol

•    you are under 18 years of age

Warning and precautions

Take special care with Meijumet 500 mg prolonged release tablets after you have started taking your medicine:

If you have diabetes you should have your blood or urine tested for sugar regularly. You should return to your doctor at least once a year to check the function of your kidneys (more often if you are elderly or if you have kidney problems).

If you start to lose weight unexpectedly or suffer from weakness, confusion, severe nausea or vomiting, uncontrolled rapid breathing, abdominal pains or if you are feeling cold, stop taking the medicine and tell your doctor straight away. This can be a sign of a rare, but serious, complication with your diabetes called ‘lactic acidosis’ which means there is too much acid in the blood (see also under ‘4. Possible side effects’).

You may see some remains of the tablets in your stools. Do not worry - this is normal for this type of tablet.

If you need to have an X-ray examination involving the injection of a dye, tell the doctor that you take Meijumet 500 mg prolonged release tablets as you may need to stop taking it for a few days afterwards.

Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to stop taking Meijumet 500 mg prolonged release tablets for a couple of days before and after the procedure.

You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.

Do not stop taking this medicine without speaking to your doctor. Children and adolescents:

This medicine is not recommended for children and adolescents.

Taking Meijumet 500 mg prolonged release tablets with other medicines:

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

If you are taking any of the following medicines, your blood sugar levels may need to be checked more often and your dose adjusted:

•    Steroids such as prednisolone, mometasone, beclometasone.

•    Diuretics (water tablets) such as furosemide.

•    Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.

You should avoid drinking alcohol and using alcohol-containing medicines as this will increase the risk of lactic acidosis (see under ‘4. Possible side effects’).

Taking Meijumet 500 mg prolonged release tablets with food and drink:

You should take Meijumet 500 mg prolonged release tablets with or immediately after food.

Pregnancy and breast-feeding

Do not take Meijumet 500 mg prolonged release tablets if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Meijumet 500 mg prolonged release tablets taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.

You should be aware; however, that Meijumet 500 mg prolonged release tablets taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.

3. HOW TO TAKE MEIJUMET 500 MG PROLONGED RELEASE TABLETS

Your doctor may prescribe Meijumet 500 mg prolonged release tablets for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

Always take Meijumet 500 mg prolonged release tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a glass of water, do not chew. Usually you will start treatment with 500 milligrams Meijumet 500 mg prolonged release tablets daily. After you have been taking Meijumet 500 mg prolonged release tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Meijumet 500 mg prolonged release tablets. Normally, you should take the tablets once a day, with your evening meal.

In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.

Use in children and adolescents

This medicine is not recommended for children and adolescents.

If you take more Meijumet 500 mg prolonged release tablets than you should

If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. These symptoms may include weakness, confusion, fast breathing and new onset of nausea, vomiting, stomach pain or feeling cold. If the overdose is large, a rare side effect “lactic acidosis” (too much acid in the blood) is more likely and this is a medical emergency requiring treatment in hospital (see also under ‘4. Possible side effects’).

If you forget to take Meijumet 500 mg prolonged release tablets

Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.

If you stop taking Meijumet 500 mg prolonged release tablets

If you stop treatment with Meijumet 500 mg prolonged release tablets without medical advice, your blood sugar levels may increase. Late symptoms of diabetes, such as damage to the eyes, kidneys and vessels, may occur.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Meijumet 500 mg prolonged release tablets can cause side effects, although not everybody gets them. If you notice any of the following, stop taking Meijumet 500 mg prolonged release tablets and see your doctor immediately:

•    unexpected weight loss

•    weakness

•    confusion

•    very severe nausea or vomiting

•    very fast breathing which you cannot stop

•    stomach pains or feeling cold

These can be signs of serious problems with your diabetes and may mean you have a very rare side effect called “lactic acidosis” (too much acid in the blood). If this happens, see a doctor as you will need treatment straight away.

•    Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice. If you develop yellowing of the eyes and/or skin contact your doctor immediately:

Other possible side effects are listed by frequency as follows:

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

•    Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks. It helps if you take the tablets with or immediately after a meal.

© 121XXX ® This section is continued overleaf