Diamicron 30 mg MR

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

In this leaflet:

1. What DIAMICRON 30 mg MR is and what it is used for
2. Before you take DIAMICRON 30 mg MR
3. How to take DIAMICRON 30 mg MR
4. Possible side effects
5. How to store DIAMICRON 30 mg MR
6. Further information

Do not take DIAMICRON 30 mg MR

• if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of DIAMICRON 30 mg MR, or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma;
• if you have severe kidney or liver disease;
• if you are taking medicines to treat fungal infections (miconazole, see Section “Taking other medicines”);
• if you are breastfeeding (see Section “Pregnancy and breastfeeding”).

Take special care with DIAMICRON 30 mg MR

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

• if you take meals irregularly or skip meals altogether,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity and carbohydrate intake does not match this increase,
• if you drink alcohol, especially in combination with skipped meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
• if your kidney function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea.

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta blockers).

If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

If these symptoms occur, you must contact your doctor or pharmacist.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

DIAMICRON 30 mg MR is not recommended for use in children due to a lack of data.

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, as they may interact with your DIAMICRON 30 mg MR.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:

• other medicines used to treat high blood sugar (oral antidiabetics or insulin),
• antibiotics (e.g. sulphonamides),
• medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors),
• painkiller or antirheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

• medicines to treat disorders of the central nervous system (chlorpromazine),
• medicines reducing inflammation (corticosteroids),
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
• medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).

DIAMICRON 30 mg MR may increase the effects of medicines which reduce blood clotting (e.g. warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking DIAMICRON 30 mg MR.

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 in an unpredictable manner.

Pregnancy and breastfeeding

DIAMICRON 30 mg MR is not recommended for use during pregnancy. If you are planning a pregnancy, or become pregnant, inform your doctor so that he may prescribe a more suitable treatment for you.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions.

Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines).

Please ask your doctor whether you can drive a car if you:

• have frequent episodes of low blood sugar (hypoglycaemia),
• have few or no warning signals of low blood sugar (hypoglycaemia).

Dosage

Always take DIAMICRON 30 mg MR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.

Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The usual dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.

If a combination therapy of DIAMICRON 30 mg MR with metformin, an alpha glucosidase inhibitor or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.

Please talk to your doctor or pharmacist if you have the impression that DIAMICRON 30 mg MR is acting too strongly or not strongly enough.

Methods and routes of administration

Oral use.

Swallow your tablets whole. Do not chew them.

Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).

You must always eat a meal after taking your tablet(s).

If you take more DIAMICRON 30 mg MR than you should

If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2. The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, e.g. a child, has taken the product unintentionally. Unconscious patients must not be given food or drink.

It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take DIAMICRON 30 mg MR

It is important to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of DIAMICRON 30 mg MR, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking DIAMICRON 30 mg MR

As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product.

Stopping could cause high blood sugar (hyperglycaemia).

What DIAMICRON 30 mg MR contains

The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in a modified release formulation.

The other ingredients are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

What DIAMICRON 30 mg MR looks like and contents of the pack

DIAMICRON 30 mg MR tablets are white oblong modified release tablets, engraved on both faces, ‘DIA 30’ on one face and the Servier logo on the other. The tablets are available in blister packed in cartons of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 or 500 tablets.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer