Gliclazide MR 30 mg Tablets

GLICLAZIDE MR ZYDUS is an oral antidiabetic medicine belonging to the sulphonylurea group that reduces blood sugar levels. GLICLAZIDE MR ZYDUS 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 ZYDUS

• If you are hypersensitive (allergic) to gliclazide, other sulphonylureas, sulphonamides, or to any of the other ingredients of GLICLAZIDE MR ZYDUS listed in section 6 of this leaflet.
• If you have insulin-dependent diabetes (type 1).
• If you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma.
• If you have a severe liver or kidney disease.
• If you are taking miconazole (a medicine used to treat fungal infections).
• If you are pregnant or breastfeeding your baby.
• Do not give GLICLAZIDE MR ZYDUS to children.

Warnings and precautions

Talk to your doctor before taking GLICLAZIDE MR ZYDUS. Follow the treatment plan prescribed by your doctor carefully to achieve proper blood sugar levels. This means, apart from regularly taking GLICLAZIDE MR ZYDUS, you should observe your dietary regimen, do physical exercise and, where necessary, reduce your weight. During GLICLAZIDE MR ZYDUS treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycosylated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased.

Do not share medicines prescribed for you with any other person. Always take GLICLAZIDE MR ZYDUS exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is 30 mg to 120 mg, taken once a day with breakfast.

Your doctor may adjust your dose depending on blood sugar levels. Changes in external factors (such as weight loss, change in lifestyle, stress) or improvements in blood sugar control, may also require your dose of GLICLAZIDE MR ZYDUS to change.

Method of administration

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).

Your doctor will tell you how long your treatment with GLICLAZIDE MR ZYDUS will last.

If you have the impression that the effect of GLICLAZIDE MR ZYDUS is too strong or too weak, or if you notice that your blood sugar levels are high even though you are taking GLICLAZIDE MR ZYDUS as prescribed, you should tell your doctor or pharmacist.

If you take more GLICLAZIDE MR ZYDUS than you should

In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre. You may require medical attention. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar 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 GLICLAZIDE MR ZYDUS 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 GLICLAZIDE MR ZYDUS

If you forget a dose, this dose should be skipped, and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.

If you stop taking GLICLAZIDE MR ZYDUS

As the treatment for diabetes is usually life long, you should discuss it with your doctor before stopping GLICLAZIDE MR ZYDUS. Stopping could cause high blood sugar (hyperglycaemia), which increases the risk of developing complications of diabetes.

GLICLAZIDE MR ZYDUS can have side effects. Not all side effects reported for GLICLAZIDE MR ZYDUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GLICLAZIDE MR ZYDUS, please consult your health care provider for advice.

If any of the following happens, stop taking GLICLAZIDE MR ZYDUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to GLICLAZIDE MR ZYDUS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• low blood sugar (hypoglycaemia). For signs and symptoms of hypoglycaemia, please refer to the section Take special care with GLICLAZIDE MR ZYDUS – Signs of low blood sugar (hypoglycaemia). If left untreated, these symptoms can progress to drowsiness, loss of consciousness or possible 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.
• blood disorders (including paleness of the skin, prolonged bleeding, bruising, sore throat and fever),
• yellowing of the skin and eyes, also called hepatitis or jaundice,
• painful, blistering or peeling skin rash, such as Stevens-Johnson syndrome or toxic epidermal necrolysis,
• DRESS syndrome (skin rash on your face that extends to your body, fever and flu-like symptoms).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• stomach pain, feeling sick (nausea), being sick (vomiting), heartburn, diarrhoea, constipation,
• rash, itching.
• Less frequent side effects:
• visual difficulties,
• abnormal liver function test results,
• skin reactions, such as hives, redness, blisters or swelling.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of GLICLAZIDE MR ZYDUS.

• Store at or below 25 °C, in a dry place.

• Keep the blister strips in the outer carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton or blister strip.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).