Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• This leaflet does not contain the full information on your medicine. If you have further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours.

What is in your medicine?

The name of your medicine is DIAMICRON® 30 mg MR Tablets, but will be referred to throughout as DIAMICRON® 30 mg MR. Each tablet contains 30 mg of the active ingredient gliclazide in a modified release formulation. In addition, the tablet contains a number of inactive ingredients.

These are necessary to add bulk and consistency to medicines. They improve the packaging, storage and handling characteristics of the tablets and make them easier to use. The inactive ingredients are calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, and anhydrous colloidal silica.

DIAMICRON® 30 mg MR tablets are white oblong tablets, engraved on both faces, ‘DIA 30’ on one face and

on the other, and come in cartons of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 or 500 tablets. Not all pack sizes are available.

What type of medicine is DIAMICRON® 30 mg MR?

The active ingredient in your tablets, gliclazide, is one of a group of medicines called sulphonylureas.

[pharmacotherapeutic group: hypoglycaemic sulphonylurea – oral antidiabetic agent]

What is my medicine for?

DIAMICRON® 30 mg MR is used to keep blood sugar at the correct level in people with diabetes when it is not controlled by diet, physical exercise and weight loss alone.

Do not take DIAMICRON® 30 mg MR:

• If you have insulin dependent (type 1) diabetes,
• if you have a known allergy to gliclazide, to any of the other ingredients or to other sulphonylureas and other related drugs,
• if you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), diabetic pre-coma or coma,
• if you have severe kidney or liver disease,
• if you are taking miconazole (a treatment for fungal infections),
• if you are breast feeding,
• for the treatment of diabetes in children.

If you think any of the above situations applies to you, you should tell your doctor, nurse or pharmacist.

Tell your doctor immediately:

• if you get symptoms of low blood sugar (hypoglycaemia) such as sweating, pallor, hunger, irregular or fast heart beat. This can be helped by taking glucose or sugary drinks. As with any treatment for diabetes, your blood sugar level may become too low if your food intake is reduced or your meals are delayed.

Make sure your doctor knows:

• if you have an infection, an operation, or suffer a serious injury,
• if you plan to become pregnant.

Taking DIAMICRON® 30 mg MR with food and drink

DIAMICRON® 30 mg MR can be taken with food and non-alcoholic drinks.

Drinking alcohol is not recommended as it can alter the control of your diabetes.

Pregnancy

DIAMICRON® 30 mg MR is not recommended for use during pregnancy. If you are planning a pregnancy, or become pregnant, inform your doctor.

Breastfeeding

You must not take DIAMICRON® 30 mg MR while you are breastfeeding.

Driving and using machines

Provided your blood glucose levels are satisfactorily controlled on DIAMICRON® 30 mg MR, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks.

Taking other medicines

The effect of DIAMICRON® 30 mg MR on your blood sugar levels may be changed by a number of other medicines. You must tell your doctor or your pharmacist of any other medicines that you are taking, including any you have bought without a doctor's prescription.

The effect of DIAMICRON® 30 mg MR may be altered by:

• NSAIDs (anti-inflammatory agents for pain relief e.g. ibuprofen),
• beta blockers (used to treat high blood pressure),
• angiotensin converting enzyme (ACE) inhibitors such as captopril, or enalapril (used to treat high blood pressure and heart failure),
• other medicines used to treat high blood sugar (e.g. insulin),
• H2 receptor antagonists for ulcers or indigestion (e.g. ranitidine),
• steroids (for treating a number of conditions including severe asthma and rheumatoid arthritis),
• sulphonamides (a type of antibiotic),
• fluconazole (an oral treatment for fungus infection),
• monoamine oxidase inhibitors (MAOIs) for depression,
• chlorpromazine (used to treat thought or mood disorders),
• anticoagulants to control blood clotting (e.g. warfarin),
• intravenous salbutamol (for asthma),
• ritodrine and terbutaline (used during labour),
• danazol (for breast disorders, heavy menstrual bleeding and endometriosis),
• phenylbutazone (used to treat arthritis).

If you go into hospital tell the medical staff you are taking DIAMICRON® 30 mg MR.

If you or someone else takes more DIAMICRON® 30 mg MR than you should:

Contact your doctor or nearest hospital Accident & Emergency department immediately.

The signs of overdose are those of hypoglycaemia (low blood sugar): sweating, pallor, hunger, irregular or fast heart beat, and tiredness. The symptoms can be helped by taking glucose or sugary drinks, followed by a substantial snack or meal.

If you forget to take DIAMICRON® 30 mg MR:

If you forget your tablet(s) on one day, continue taking your tablet(s) as usual on the following day. You must not increase the next dose you take.