PACKAGE LEAFLET: INFORMATION FOR THE USER

Diagemet XL 500mg 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 any further questions, 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 in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Diagemet XL 500mg Prolonged-release Tablets are and what they are used for

2.    Before you take Diagemet XL 500mg Prolonged-release Tablets

3.    How to take Diagemet XL 500mg Prolonged-release Tablets

4.    Possible side-effects

5.    How to store Diagemet XL 500mg Prolonged-release Tablets

6.    Further information

1.    WHAT DIAGEMET XL 500mg PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR

Diagemet XL 500mg Prolonged-release Tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes.

Diagemet XL 500mg Prolonged-release Tablets are used for the treatment of type 2 (non-insulin dependant) 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. Diagemet XL 500mg Prolonged-release Tablets make the body more sensitive to insulin and help to lower your blood glucose levels. Diagemet XL 500mg Prolonged-release Tablets are specially made to release the drug slowly in your body and therefore are different to the immediate release type of tablets containing metformin hydrochloride which release the drug immediately.

2.    BEFORE YOU TAKE DIAGEMET XL 500mg PROLONGED-RELEASE TABLETS

Do not take Diagemet XL 500mg Prolonged-release Tablets if you:

•    are allergic to metformin hydrochloride or any of the other ingredients listed (see section 6 Further Information). An allergic reaction may cause a rash, itching or shortness of breath

•    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)

•    have long term kidney or liver problems

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

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

•    need to have an X-ray examination involving the injection of a dye into the bloodstream

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

•    are a heavy drinker

•    are under 18 years of age.

Take special care with Diagemet XL 500mg Prolonged-release Tablets After you have started taking your medicine:

If you have diabetes you should have your blood or your 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 severe nausea or vomiting, uncontrolled rapid breathing or abdominal pains, 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 section 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 your doctor that you take Diagemet XL 500mg Prolonged-release Tablets, as you may need to stop taking them 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 Diagemet XL 500mg 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.

Taking Diagemet XL 500mg Prolonged-release Tablets with other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicine 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

•    beta-2-agonists such as salbutamol used for asthma

•    diuretics (water tablets) such as bendromethazide

•    ACE inhibitors such as lisinopril, enalapril

•    you should avoid drinking alcohol and using alcohol-containing medicines as this will increase your risk of lactic acidosis (see section 4 Possible side-effects).

Taking Diagemet XL 500mg Prolonged-release Tablets with food and drink:

You should take Diagemet XL 500mg Prolonged-release Tablets with or immediately after food.

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

Pregnancy and Breast-feeding

Do not take Diagemet XL 500mg 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

Diagemet XL 500mg Prolonged-release Tablets taken on their own do not cause ‘hypos’ (symptoms of low blood sugar or hypoglycaemia, such as feeling faint, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery. You should be aware however, that Diagemet XL 500mg 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.

Please read the back of this leaflet.

GENUS PHARMACEUTICALS

24998802

’Trademark

GEN/DIA/PIL/330_02

3.    HOW TO TAKE DIAGEMET XL 500mg PROLONGED RELEASE TABLETS

Your doctor may prescribe Diagemet XL 500mg Prolonged-release Tablets for you to take on their own, or in combination with other oral antidiabetic medicine or insulin.

Always take Diagemet XL 500mg Prolonged-release Tablets exactly as your doctor has told you to. 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 Diagemet XL 500mg Prolonged-release Tablets daily. After you have been taking Diagemet XL 500mg Prolonged-release Tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 3000mg of Diagemet XL 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. In this case, take your tablet with your morning and evening meal.

If you take more Diagemet XL 500mg 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 or stomach pain.

If the overdose is large, lactic acidosis is more likely and this is a medical emergency requiring treatment in hospital (see also section 4 Possible side-effects).

If you forget to take Diagemet XL 500mg 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 Diagemet XL 500mg Prolonged-release tablets

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

4.    POSSIBLE SIDE-EFFECTS

Like all medicines, Diagemet XL 500mg Prolonged-release Tablets can cause side-effects, although not everybody gets them.

If you notice any of the following stop taking Diagemet XL 500mg Tablets and see your doctor immediately:

•    unexpected weight loss

•    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 (affects more than 1 person in 10):

•    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.

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

•    taste disturbance.

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

•    decreased vitamin B 12 levels.

•    skin rashes including redness, itching and hives.

Reporting of side effects

If you get any side effects, talk to your doctor, 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.

5.    HOW TO STORE DIAGEMET XL 500mg PROLONGED RELEASE TABLETS

Keep Diagemet XL 500mg Prolonged-release Tablets out of the sight and reach and of children.

Do not use them after the expiry date that is printed on the pack after "EXP". The expiry date 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

What Diagemet XL 500mg Prolonged-release Tablets contain

The active substance in Diagemet XL 500mg Prolonged-release Tablets is metformin hydrochloride. Each tablet contains 500mg of metformin hydrochloride. The other ingredients are stearic acid, shellac, povidone, colloidal silicon anhydrous, magnesium stearate, isopropyl alcohol, hypromellose, hydroxypropyl cellulose, titanium dioxide, propylene glycol, macrogol and talc.

What Diagemet XL 500mg Prolonged-release Tablets look like and contents of the pack

These tablets are off-white coloured, oval, biconvex, film coated tablets plain on both sides.

20, 28, 30, 50, 56, 60, 84, 90, 100, 112,120, 180, 600 tablets in blister strips composed of PVC/PVDC 40g. 20, 28, 30, 50, 56, 60, 84, 90, 100, 112,120, 180, 600 tablets in HDPE (High Density Polyethylene) bottles. HDPE bottles are composed of a two-piece plastic continuous thread closure with aluminium-foil induction seal (innerseal).

Not all pack sizes may be marketed.

Useful tips

•    if you smoke, try to stop

•    take regular exercise

•    drink as little alcohol as possible

•    look after your feet. Ask about this at the surgery or hospital

•    carry a card, bracelet or disk saying you are diabetic

•    visit your diabetic clinic regularly.

Tom

Marketing Authorisation Holder and Manufacturer:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. This leaflet was last revised in March 2015

trademark    24998802    GENUS PHARMACEUTICALS

GEN/DIA/PIL/330_02