PACKAGE LEAFLET INFORMATION FOR THE USER

Glucient® SR 500 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.

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

In this leaflet:

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

2.    Before you take Glucient SR

3.    How to take Glucient SR

4.    Possible side effects

5.    How to store Glucient SR

6.    Further information

The name of this medicine is Glucient SR 500 mg prolonged-release tablets, which is referred to as Glucient SR throughout this leaflet.

Glucient SR contains the active substance metformin hydrochloride that belongs to a group of active substances called biguanides, which are used to treat diabetes by regulating the level of sugar in the blood.

Glucient SR is used in 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.

Glucient SR is a prolonged-release medicine. This means that the release of the medication is spread over a longer period of time than an immediate-release medicine.

Ask your doctor or pharmacist if you need additional information.

Do NOT take Glucient SR:

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

•    if you have diabetic ketoacidoisis (a complication of diabetes which may be associated with frequent urination, feeling and being sick, abdominal 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, have circulatory problems or breathing difficulties

•    if you are a heavy drinker

•    if you are breast-feeding.

Take special care with Glucient SR

Treatment with Glucient SR may rarely cause a serious condition called lactic acidosis (where there is too much acid in the blood) 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 Glucient SR. It is advisable to stop taking Glucient 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 Glucient SR with insulin or other antidiabetic medicines, as the combination may increase the risk of hypoglycaemia (excessively low sugar in your blood).

Children and adolescents should not take Glucient SR.

Taking other medicines

Glucient 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 Glucient SR. It is advisable to stop taking Glucient SR for 48 hours before and after the procedure.

Glucocorticoids (e.g. budesonide, beclometasone or hydrocortisone, which are sometimes used to suppress inflammation caused by allergic reactions and in asthma), beta-2-agonists (e.g. salbutamol, which are 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 Glucient SR with any of these medicines.

ACE (Angiotensin Converting Enzyme) inhibitors (e.g. quinapril or captopril, which are used to treat heart problems) can reduce blood sugar levels.

The use of diuretics, other treatments for high blood pressure or NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) may increase the risk of kidney problems.

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

Taking Glucient SR with food and drink

Taking your tablet with food can reduce unwanted side effects. Glucient SR must be taken during or after your evening meal.

You must avoid consuming alcohol and using alcohol-containing medicines whilst on Glucient 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 (please see ‘Do NOT take Glucient SR').

Pregnancy and breast-feeding

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 Glucient SR, consult your doctor so that they may change your treatment.

Do not take Glucient 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 Glucient SR does not affect your ability to drive or use machines. However, there is an increased risk of low blood sugar levels if Glucient SR is taken with other medicines for diabetes (sulphonylureas, insulin or repaglinide). This may cause dizziness and fainting. Do not drive or operate machines if you are affected.

Important information about some of the ingredients of Glucient

This medicinal product contains up to 1.9 mmol (or 43.2 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Always take Glucient SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablet whole with a drink of water during or after your evening meal. Do not chew or crush the tablet.

The usual doses are explained below.

Adults:

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

The usual starting dose is one tablet of 500 mg 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 Glucient SR tablets in one day).

For patients already taking Metformin and switching to Glucient SR:

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

For patients taking Glucient SR combined with insulin:

When taking Glucient SR with insulin, the usual starting dose is one tablet of 500 mg 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:

This medicine is not recommended for children and adolescents.

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

If you take more Glucient SR than you should

If you or someone else takes too much Glucient SR, 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 Glucient 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 Glucient SR

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

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

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

Like all medicines, Glucient SR 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; this could indicate you have lactic acidosis, a serious but very rare side effect of metformin.

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

Very common (affecting more than 1 person in 10):

•    Nausea (feeling sick)

•    Vomiting

•    Diarrhoea

•    Abdominal pain (stomach pain)

•    Loss of appetite.

Common (affecting less than 1 person in 10 but more than 1 person in 100):

•    Taste disturbances.

Very rare (affecting less than 1 person in 10,000):

•    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).

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

Keep out of the reach and sight of children.

Do not store above 30°C. Do not use Glucient SR after the expiry date that is stated on the blister and the carton. The expiry date refers to the last day of the month.

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.

What Glucient SR contains

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

•    The other ingredients are microcrystalline cellulose 102, carmellose sodium 2000, hypromellose 100M, colloidal anhydrous silica and magnesium stearate.

What Glucient SR looks like and contents of the pack:

•    Glucient SR 500 mg prolonged-release tablets are white, convex, capsule-shaped tablets marked “XR” on one side.

•    The tablets are available in pack sizes of 28,30,56, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Consilient Health Ltd., 5th floor, Beaux Lane House,

Mercer Street Lower, Dublin 2, Ireland

Manufacturer

McGregor Cory Limited, Middleton Close, Banbury,

Oxon, OX16 4RS

This leaflet was last revised in November 2010.

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