PACKAGE LEAFLET: INFORMATION FOR THE USER

Metabet SR 1000 mg Prolonged Release Tablets

Metformin hydrochloride

Read all of this leaflet carefully before you start taking

this medicine

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

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

•    This medicine has been prescribed for you. 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 get serious or if you notice any side effects not listed on this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Metabet SR is and what is it used for

2.    Before you take Metabet SR

3.    How to take Metabet SR

4.    Possible side effects

5.    How to store Metabet SR

6.    Further information

1. WHAT IS METABET SR AND WHAT IS IT USED FOR

Metabet SR 10OOmg prolonged release tablets contains the active ingredient metformin hydrochloride. Each tablet contains 1000 mg of metformin hydrochloride. Metformin belongs to a group of drugs called biguanides which are used in the treatment of diabetes.

Metabet SR is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus particularly in overweight patients, where diet and exercise changes alone have not been sufficient to control it. In type 2 diabetes, there is too much sugar (glucose) in your blood because your pancreas does not produce enough insulin or because it produces insulin that does not work properly.

Insulin is a hormone that enables body tissues to take glucose from the blood and use it for energy or fat 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. Metabet SR makes the body more sensitive to insulin and helps return to the normal way your body uses glucose.

Metabet SR 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.

Adults

Your doctor can prescribe Metabet SR for you to take on its own, or in combination with other oral antidiabetic medicines, orinsulin.

2. BEFORE YOU TAKE METABET SR

Do not take Metabet SR

•    if you are you allergic (hypersensitive) to metformin or to any of the ingredients in this medicine.

•    if 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).

•    if you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration and you have fainted or suffered a coma due to your diabetes.

•    if you have any long-term problems with your liver or kidneys.

•    if you are suffering from severe infection or have recently suffered a severe injury.

•    if you have been treated for heart problems or have recently had a heart attack or have problems with your circulation (e.g. frequent cramp in your calves or leg ulcers that do not heal) or breathing difficulties.

•    if you drink alcohol.

•    if you are under the age of 18 years.

Take special care with Metabet SR

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).

Metabet SR 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. 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. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metabet SR immediately and contact a doctor or the nearest hospital straight away.

If you need to have an X-ray examination tell your doctor that you take Metabet SR as you may need to stop taking it for few days afterwards.

Tell your doctor if surgery is planned. Treatment with Metabet SR should be stopped 2 days before surgery until at least 2 days following surgery.

You should continue your diet during treatment with Metabet SR with an even intake of carbohydrate over the day. If you are overweight continue your energy-restricted diet under medical supervision.

Normal kidneys are essential for the treatment with Metabet SR because of the risk of developing lactic acidosis. Tests will be done to check your kidney function at least once a year or more frequently if you are elderly, or when starting treatment for high blood pressure.

Taking Metabet SR alone does not normally cause low blood sugar levels (hypoglycaemia). Taking Metabet SR in combination with medicines called sulphonylureas, meglitinides, insulin or other treatments for diabetes may cause low blood sugar levels with symptoms such as sweating, fainting, dizziness or weakness, so in this case you should take extra care when driving or operating machinery.

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

Do not stop taking this medicine without speaking to your doctor.

Taking other medicines

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

•    Sympathomimetics such as epinephrine used to treat heart attack or low blood pressure.

•    Diuretics (water tablets) such as bendroflumethiazide

•    ACE inhibitors such as lisinopril, enalapril, captopril.

Taking Metabet SR with food and drink

The tablets should be swallowed whole with a glass of water during or immediately after meals. Avoid drinking alcohol while taking Metabet SR, as this will increase the risk of lactic acidosis (see under “4. Possible side effects”).

Pregnancy and breast-feeding

Do not take Metabet SR if you are pregnant or breast feeding. Tell your doctor immediately if think you are pregnant or are breastfeeding.

Driving and using machines:

Metabet SR 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 yourability to drive or use machinery.

You should be aware, however, that Metabet SR 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 METABET SR

Always take Metabet SR 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. The usual dose in:

Adults: The usual starting dose is one 500 mg tablet daily with your evening meals. After two weeks your doctor may increase the dose to a maximum of 2000 mg per day. In some cases, your doctor may recommend that you take the tablet twice a day. Always take the tablets with food.

Combination with insulin: When taking Metabet SR with insulin, the usual dose is one 500mg tablet once a day, while insulin dosage is adjusted on the basis of blood sugar measurements.

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

Children and adolescents below 18 years: The use of the medication is not recommended.

Your doctor will test your blood glucose and your kidney function at intervals while you are taking Metabet SR to make sure you are taking the right dose. This is especially important when you start taking other new medicines at the same time as Metabet SR.

If you take more Metabet SR than you should

Tell your doctor or contact the nearest hospital, taking the medicine or this leaflet with you. If the overdose is large, lactic acidosis 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 Metabet SR

Take the missed dose as soon as you remember, unless it's nearly time for the next one. Do not take a double dose to make up a forgotten dose.

If you stop taking Metabet SR

If you stop taking Metabet SR, tell your doctor as soon as possible, asyourdiabeteswill not be controlled.

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

your doctor immediately or go to the nearest hospital accident and emergency department. These can be signs of very rare condition called “lactic acidosis” which can be dangerous and needs urgent hospital attention.

The following side effects have also been reported:

Very common (affecting more than one person in 10):

•    Stomach pains or stomach upsets such as nausea, vomiting, diarrhoea, loss of appetite. These effects usually get better spontaneously and you should continue to take the tablets. If these do not get better after a few days, tell your doctor. It helps if you take your tablets with or immediately after a meal.

Common (affecting less then one person in 10 but more than one person in 100):

•    Taste disturbance.

Very rare (affecting less than one in 10,000):

•    Skin rash (redness and itching of the skin, hives).

•    Liver problems (hepatitis), possibly with jaundice (yellowing of skin and eyes) which goes away on stopping Metabet SR.

•    Adecrease in vitamin B12 absorption, which can result in anaemia, sore tongue, tingling and numbness.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOWTO STORE METABET SR

Keep out of the reach and sight of children. Do not take Metabet SR after the expiry date printed on the blister pack and carton. The expiry date (EXP) refers to the last day of that month

This medicinal product does not require any special storage conditions.

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.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines Metabet SR can cause side effects, although not everybody gets them.

If you start to lose weight unexpectedly, feel sick with stomach pains, have rapid uncontrolled breathing, or start to lose consciousness, you should stop taking the drug and, contact

What Metabet SR contains

The active substance is metformin hydrochloride. Each prolonged release tablet contains 1000 mg of metformin hydrochloride. The other ingredients in the tablets are Stearic Acid, Shellac (Refined bleached), Povidone K-30, Silica, colloidal anhydrous, Magnesium Stearate, Hypromellose, Hydroxy Propyl cellulose, Titanium dioxide, Propylene Glycol, Macrogol 6000, and Talc.

What Metabet SR looks like and contents of the pack

Metabet SR 1000 mg tablets are off-white coloured, oval, biconvex, film coated tablets plain on one side and a breakline on the other.

Metabet SR is available in blister packs of 7, 10, 14, 20, 28, 30,56,60,84,90,100 and 112 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder:

Morningside Healthcare Ltd

115 Narborough Road, Leicester, United Kingdom

Manufacturer:

Morningside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough, LE11 5GW, United Kingdom

This leaflet was last revised in January 2014