Gliclazide MR Modified-Release Tablets

Gliclazide MR Ascend is a modified release tablet which contains the active substance called gliclazide. Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). Gliclazide MR Ascend, 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.

Do not take Gliclazide MR Ascend:

• if you are allergic to gliclazide or any of the other ingredients of Gliclazide MR Ascend (listed in section 6) or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides);
• 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 "Other medicines and Gliclazide MR Ascend, modified release tablet");
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding");
• If you are a child.

Warnings and special precautions: Talk to your doctor before taking Gliclazide MR Ascend. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to 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.

Do not share medicines prescribed for you with any other person. Always take Gliclazide MR Ascend exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist, or nurse 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 (weight reduction, change in lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses. Gliclazide MR 30 Ascend: The daily dose may vary from 1 to 4 tablets a day i.e. 30 mg to 120 mg taken as a single daily dose taken with breakfast. Gliclazide MR 60 Ascend: The daily dose may vary from half to 2 tablets a day i.e. 30 mg to 120 mg taken as a single daily dose taken with breakfast. Gliclazide MR Ascend, modified release tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). swallow your tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s). If a combination therapy of Gliclazide MR Ascend, modified release tablet with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated, your doctor will regularly check your blood sugar levels to keep check on signs of developing hypoglycaemia (low blood sugar) and 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. If you take more Gliclazide MR Ascend than you should: In the event of overdosage, consult doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Your doctor will control the dosage. However, in the event of overdosage, your doctor will manage the overdosage. If you forget to take Gliclazide MR Ascend: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR Ascend, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Ask your doctor for advice. If you stop taking Gliclazide MR Ascend: As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicine. 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.

Gliclazide MR Ascend can have side effects. Not all side effects reported for Gliclazide MR Ascend are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Gliclazide MR Ascend please consult your doctor or pharmacist for advice. If any of the following happens, stop taking Gliclazide MR Ascend and tell your doctor or pharmacist immediately or go to the casualty department at your nearest hospital:

• rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty). Rash may progress to widespread blistering or peeling of the skin. These are all very serious side effects. If you have them, you may have had a serious reaction to Gliclazide MR Ascend. You may need urgent medical attention.

The following are serious side-effects. You might need medical attention. Tell your doctor if you notice any of the following:

• Frequent side effects: Skin rash and itchiness, Metallic taste in mouth, increased appetite and weight gain, Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide MR Ascend is taken with a meal as recommended.

Less frequent side effects: Anorexia (eating disorder, obsession overweight), Hives (urticaria), abnormal redness of the skin (erythema), flat or raised skin lesions and fluid-filled blisters (maculopapular rashes and bullous reactions), signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature. 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. 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, 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 (for instance jaundice, which causes yellow skin and eyes) which in most cases disappeared after withdrawal of the sulfonylurea but may lead to life-threatening liver failure in isolated cases. If you get this, see your doctor immediately. Your doctor will decide whether to stop your treatment. Frequency unknown: If you develop 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.

Store at or below 25 °C. Keep the blister in the outer carton until required for use. Keep the bottle tightly closed. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle label. Do not throw away any medicines in drains or sewage systems. Return all unused medicine to the pharmacist.