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PACKAGE LEAFLET: INFORMATION FOR THE USER

Edicil MR 30 mg modified-release tablets ratiopharm

Gliclazide

In this leaflet:

1.    What Edicil MR is and what it is used for

2.    Before you take Edicil MR

3.    How to take Edicil MR

4.    Possible side effects

5.    How to store Edicil MR

6.    Further information

1.    What Edicil MR is and what it is used for

Edicil MR is a medicine to reduce blood sugar levels (antidiabetic medicine taken orally).

This medicine 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.

2.    Before you take Edicil MR

Do not take this medicine:

•    if you are allergic (hypersensitive) to gliclazide, to other sulphonylureas, to sulphonamides or to any of the other ingredients of Edicil MR,

•if you have insulin-dependent (type 1) diabetes,

•    if you have ketone bodies and sugar in the 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 medicines to treat fungal infections (miconazole)

•    if you are breast feeding.

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

Take special care with this medicine

This medicine should be used only if you are likely to have regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of low blood sugar level (hypoglycaemia) if a meal is delayed or skipped, if an inadequate amount of food is consumed or if the food is low in carbohydrate.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level is necessary. Your doctor may also take blood tests to monitor your glycated haemoglobin (HbA_1c).

You should observe the treatment plan prescribed by your doctor in order to achieve the recommended blood sugar levels. This means regular tablet intake in addition to a dietary regimen and physical exercise.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. Therefore it is vital that you are carefully monitored by your doctor.

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 without an appropriate increase in carbohydrate intake,

•    if you consume alcohol, especially in combination with skipped meals,

•    if you take other medicines or natural remedies at the same time,

•    if you take 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 renal function or liver function is severely decreased.

If you suffer from low blood sugar you may have the following symptoms: headache, hunger, paleness, weakness, exhaustion, nausea, vomiting, weariness, sleepiness, sleep disorders, restlessness, aggressiveness, impaired 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, and sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris).

If your blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop cerebral convulsions, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness possibly resulting in coma. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke.

In most cases the symptoms of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take some form of sugar with you (sugar cubes). Remember that sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

It is possible that symptoms of reduced blood sugar may be absent, that they develop slowly or that you do not realise 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). It may also happen when you suffer from certain disorders of the endocrine system (e.g. certain disorders of thyroid function and anterior pituitary or adrenocortical insufficiency).

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

Symptoms of raised blood sugar (hyperglycaemia) may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and diminished performance. This may be due to inadequate control of blood sugar due to poor compliance with the treatment or stress situations such as infections. You must contact your doctor if in such a situation.

This medicine is not to be used for the treatment of diabetes in children and adolescents under 18 years of age.

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.

The effectiveness and safety of Edicil MR may be affected if this medicine is taken at the same time as certain other medicines. Conversely, other medicines may be affected if they are taken at the same time as Edicil. 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,

•    antibacterial medicines (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 indigestion and ulcers in the stomach or duodenum (H2 receptor antagonists such as ranitidine),

•    medicines to treat depression (monoamine oxidase inhibitors),

•    painkillers or antirheumatics (ibuprofen, phenylbutazone),

•    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:

•    medicine to treat disorders of the central nervous system (chlorpromazine),

•    medicines inhibiting inflammation (glucocorticoids),

•    medicine to treat asthma (salbutamol when given by injection),

•    medicines used during labour (ritodrine and terbutaline given by injection),

•    medicine to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol),

Gliclazide may potentiate anticoagulation during concurrent treatment with warfarin (a medicine that inhibits blood clotting).

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

Taking this medicine with food and drink

This medicine can be taken with food and non-alcoholic drinks.

Avoid alcohol as it can alter the control of your diabetes in an unpredictable manner and can even lead to coma.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice

before taking any medicine.

This medicine is not recommended for use during pregnancy. If you are planning a pregnancy, or become pregnant, inform your doctor.

You must not take this medicine while you are breast-feeding.

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

•    have frequent episodes of hypoglycaemia,

•    have fewer or no warning symptoms of hypoglycaemia.

Important information about some of the ingredients of this medicine

This medicine contains lactose.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take Edicil MR

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose of this medicine 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 starting dose is one tablet once daily. The usual dose can vary from one to a maximum of four tablets once daily. This depends on the response to treatment.

If blood glucose is not adequately controlled, your doctor may increase it in successive steps usually not less than 1 month apart. Edicil MR modified-release tablets can be used to replace other oral antidiabetic medicine, exactly like your doctor has told you. If a combination therapy of Edicil 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 speak with your doctor or pharmacist if you have the impression that this medicine is acting too strongly or not strongly enough.

Swallow your tablets whole with a glass of water whilst having your breakfast, preferably at the same time each day. It is important not to skip a mealwhen you are on this medicine.

If you take more Edicil MR than you should If you happen to have taken too much gliclazide or an additional dose there is a danger of low blood sugar levels, (signs of hypoglycaemia see section 2) and therefore you should instantly consume enough sugar (e.g. a small bar of grape cubes, sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately. The same should be done if somebody, e.g. a child, has taken the product unintentionally. Persons in a state of unconsciousness must not be given food or drink.

Since the state of hypoglycaemia may last for some time it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Severe cases of hypoglycaemia accompanied by loss of consciousness and severe neurological failure are cases of medical emergency requiring immediate medical treatment and admission into a hospital. 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 Edicil 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.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Edicil MR If you interrupt or stop the treatment you should be aware that your blood sugar control will deteriorate. If any change is necessary it is absolutely important to contact your doctor first.

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 assessment of side effects is based on their frequency.

Common (occur in less than 1 in 10 but more than 1 in 100 patients treated):

•    Hypoglycaemia (low blood sugar). The symptoms include sweating, pallor, hunger, irregular or fast heart beat and loss of consciousness and other (see point 2 Before you take Edicil MR). The symptoms can be helped by taking glucose or sugary drinks, followed by a substantial snack or meal. If the patient does not respond to the sugar or is not alert call nearest emergency department immediately. Never put anything into the mouth of an unconscious person!

Uncommon (occur in less than 1 in 100 but more than 1 in 1000 patients treated):

•    Abdominal pain

•    Nausea

•    Vomiting

•    Indigestion

•    Diarrhoea

•    Constipation.

These effects are reduced when Edicil MR is taken with a meal as recommended.

Rare (occur in less than 1 in 1,000 but more than 1 in 10,000 patients treated):

•    Decrease in the number of cells in the blood including (anaemia).

•    Changes in blood values (which may cause paleness, prolonged bleeding, bruising, sore throat and fever) normally vanish when the treatment is discontinued.

•    Skin reactions such as redness, itching and hives (rash). Severe skin reactions may also appear.

•    Abnormal liver function tests, changes in your liver (which can cause yellow skin and eyes).

•    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.

These generally disappear if the medicine is stopped.

Severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels have been described very rarely for other sulphonylureas. With other sulphonylureas signs and symptoms of liver impairment (e.g. jaundice) have been observed rarely which in most cases disappeared after withdrawal of the sulphonylureas, but may led to life-threatening liver failure in isolated cases.

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.

5.    How to store Edicil MR

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Expiry date

Do not use Edicil MR after the expiry date which is stated on the blister, the tablet container and the carton. The expiry date refers to the last day of that 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.

6.    Further information

What Edicil MR contains •The active substance is gliclazide. Each modified-release tablet contains 30 mg gliclazide.

•    The other ingredients are lactose monohydrate, hypromellose, calcium carbonate, colloidal anhydrous silica, magnesium stearate.

What Edicil MR looks like and contents of the pack

The modified-release tablets are white, oval, biconvex tablets.

Edicil MR is available in blisters in boxes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets and in tablet containers of 90, 120 or180 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.

Manufacturer

Krka, d.d., Novo mesto, Slovenia.

This medicinal product is authorised in the Member States of the EEA under the

following names:

Germany:    Gliclazid-ratiopharm

30 mg retardtabletten United Kingdom: EDICIL MR 30 mg

modified release tablets Gliclazide ratiopharm 30 mg comprime a liberation modifiee Gliclazid ratiopharm 30 mg tabletter med modificeret udlpsning Gliclazida ratiopharm 30 mg ccomprimidos delibertagaoprolongada Gliclazi de-ratio pharm 30 mg tabletten met gereguleerde afgifte Gliclazid-ratiopharm retard 30 mg Gliclazid-ratiopharm retard 30 mg Gliclazid-ratiopharm 30 mg retard tabletta Gliclazid-ratiopharm retard 30 mg tabletten

This leaflet was last approved in December 2007.

ratiopharm