Package Leaflet: Information for the user

DIAMICRON 60 mg MR Tablets, modified release tablets

Gliclazide

What is in this leaflet

1.    What Diamicron 60 mg MR is and what it is used for

2.    What you need to know before you take Diamicron 60 mg MR

3.    How to take Diamicron 60 mg MR

4.    Possible side effects

5.    How to store Diamicron 60 mg MR

6.    Contents of the pack and other information

1. What Diamicron 60 mg MR is and what it is used for

Diamicron 60 mg MR is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).

Diamicron 60 mg MR is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

2. What you need to know before you take Diamicron 60 mg MR Do not take Diamicron 60 mg MR:

-    if you are allergic to gliclazide or any of the other ingredients of Diamicron 60 mg MR (listed in section 6), or to other medicines of the same group (sulphonylurea), 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”).

Warnings and precautions

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

Other medicines and Diamicron 60mg MR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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, GLP-1 receptor inhibitors or insulin),

-    antibiotics (e.g. sulphonamides, clarithromycin),

-    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 60 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 60 mg MR.

Taking Diamicron 60 mg MR with food, drink and alcohol

Diamicron 60 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 60 mg MR is not recommended for use during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby while taking this medicine, inform your doctor so that he may prescribe a more suitable treatment for you.

You must not take Diamicron 60 mg MR while you are breastfeeding.

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).

Diamicron 60 mg MR

contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dose

Always take this medicine exactly as your doctor has told you. 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 recommended dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.

If a combination therapy of Diamicron 60 mg MR with metformin, an alpha glucosidase inhibitory thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 agonist receptor or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.

If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

Routes and method of administration

Oral use.

Swallow your half tablet or whole tablet(s) in one piece. Do not chew or crush. The tablet can be divided into equal doses.

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 60 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 60 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 60 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 60 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) which increases the risk of developing complications of diabetes.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see Section “Warnings and precautions”).

If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Liver disorders

There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders

Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may progress to widespread blistering or peeling of the skin.

Blood disorders

Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.

Digestive disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Diamicron 60 mg MR is taken with a meal as recommended.

Eye disorders

Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for other sulphonylureas, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g. jaundice) have been observed which in most cases disappeared after withdrawal of the sulphonylurea, but may lead to life-threatening liver failure in isolated cases.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Diamicron 60 mg MR

Keep out this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister strip. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Diamicron 60 mg MR contains:

The active substance is gliclazide. Each modified release tablet contains 60 mg of gliclazide,

The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, silica colloidal anhydrous.

What Diamicron 60 mg MR looks like and contents of the pack:

Diamicron 60 mg MR is a white oblong modified release tablet, scored and engraved ‘DIA 60’ on both faces. The tablets are available in blister packed in cartons of 7, 10, 14, 15, 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

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex - France Manufacturers:

Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - France

or

Servier (Ireland) Industries Ltd.,

Gorey Road,

Arklow - Co. Wicklow - Ireland.

This leaflet was last revised in 01/2012.