Gliclazide Tablets Bp 80mg
I
KEEP ALL MEDICATION OUT OF THE REACH OF CHILDREN
GLICLAZIDE TABLETS BP 80 mg
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY
This leaflet contains a summary of the information about your medicine, Gliclazide Tablets BP 80 mg.
YOUR MEDICINE
Your medicine is in the form of a white, round, scored tablet, marked 'GZ 80' on one side with a 'G' on the other. Each tablet contains 80 mg of the active ingredient Gliclazide. Each tablet also contains lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycollate, talc and magnesium stearate.
Gliclazide Tablets are available in blister packs of 7, 10, 28, 30, 56, 60, 100, 120 and 250 tablets.
*Your pharmacist will dispense the number of tablets prescribed by your doctor.
(1Only the marketed pack sizes will feature on the printed leaflet)
Product Licence Holder and Manufacturer:
Generics [UK] Limited, Potters Bar, Herts EN6 1TL Distributed by: Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex. SS14 3FR.
HOW DOES YOUR MEDICINE WORK?
GLICLAZIDE TABLETS are a medicine which your doctor may prescribe for you, together with diet, to help reduce your blood sugar if you suffer from NON INSULIN DEPENDENT DIABETES MELLITUS. This condition is also called maturity onset diabetes mellitus or Type II diabetes mellitus. This type of diabetes can occur if your pancreas does not produce enough insulin or if your body becomes resistant to insulin. Insulin is a natural chemical, which is released by the pancreas and which helps your body to use sugar in your food for energy. Gliclazide Tablets, which belong to the group of medicines called Sulphonylureas, act on the pancreas to help it release more insulin and so reduce your blood sugar. Your doctor will prescribe Gliclazide Tablets for you if your diabetes cannot be controlled by diet alone. If you take Gliclazide Tablets it is important that you should still continue with your diabetic diet.
WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?
YOU MUST TELL YOUR DOCTOR BEFORE TAKING YOUR MEDICINE IF:
• your diabetes is very poorly controlled
• you have been told that your diabetes is complicated by ketosis / acidosis
• you are pregnant, intend to become pregnant or you are breast feeding.
• you suffer from kidney or liver disease.
• you are suffering from stress or have an infection.
• you are to undergo surgery
• you are not eating properly
• You have been told that you suffer from a cond it ion called porphyria
• you are already taking any of the following medicines:
Non-steroidal anti inflammatory drugs such as Phenylbutazone, salicylates (e.g. aspirin) Antibiotics to treat infection (e.g. sulphonamides, tetracyclines, chloramphenicol, miconazole)
Anticoagulants to thin the blood (e.g. warfarin) Medicine to treat mental illness (e.g. mono-amine oxidase inhibitors, phenothiazines) Medicine to treat heart problems especially a beta-blocker or disopyramide An oral contraceptive Diuretics ('water tablets')
Medicine to treat an underactive thyroid gland (thyroxine)
Laxatives
Cimetidine to help treat indigestion (including hyperacidity, dyspepsia and heartburn), or stomach or gut ulcers Corticosteroids (e.g. prednisolone)
Clofibrate to lower the level of cholesterol in the blood
• Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.
Do not take these tablets if you think you are allergic to any of the ingredients especially lactose monohydrate and microcrystalline cellulose.
WHILE TAKING GLICLAZIDE TABLETS
Regular exercise and a good diet are important factors in helping to control your diabetes. Your doctor will also advise you how to check your blood and urine glucose (sugar) level. If you are unsure check with your doctor.
You may suffer from poor concentration, particularly at the start of your treatment.
DO NOT drive or operate machinery if after taking Gliclazide Tablets you feel dizzy, drowsy or if your ability to concentrate is affected.
Warning: As alcoholic drinks may increase the effect of Gliclazide Tablets, it is recommended that alcohol should be consumed only in small quantities or avoided altogether.
HOW SHOULD YOU TAKE YOUR TABLETS?
Your doctor will normally only start you on Gliclazide if treatment by diet alone has not resulted in a satisfactory response. Your doctor will usually start you on half or one tablet (40 or 80 mg of Gliclazide) a day, taking your age into account. In the first few days of treatment, your doctor will monitor your blood sugar levels. Depending on how your blood sugar level responds, your doctor will gradually increase your dose, if necessary to a maximum of 4 tablets (320 mg of Gliclazide) a day. If your diabetes does not respond adequately to treatment with Gliclazide Tablets, your doctor may prescribe additional medication for you.
You doctor will probably tell you to take your tablets with meals, as this can help to avoid side effects. If you are taking more than two tablets (160 mg of Gliclazide) a day, your doctor will split your dose so that you take the tablets with your main meals of the day (for example, your doctor might tell you to take half of your daily dose with your lunch and the remainder with your evening meal).
Elderly patients, patients with poor diets and patients with kidney or liver problems, are more sensitive to the effects of Gliclazide Tablets. Your doctor may therefore start you on a low dose of Gliclazide and increase the dose cautiously, with regular monitoring of your blood sugar level.
Gliclazide Tablets are not normally prescribed for children, as they are unsuitable for the treatment of juvenile onset diabetes (the type of diabetes that tends to occur in children and young people).
If you forget to take a dose take it as soon as you remember. If it is almost time for your next dose though, do not double the dose just carry on as before.
IF YOU TAKE TOO MUCH OF YOUR MEDICATION CONTACT YOUR DOCTOR IMMEDIATELY
Too much Gliclazide or a reduction in food intake will cause your blood sugar level to drop too low (hypoglycaemia) and you may suffer from the side effects listed below (under 'Can your medicine have any side effects?'). If left untreated, hypoglycaemia can lead to loss of consciousness. The symptoms of hypoglycaemia can be relieved by having a sugary snack or a sugary drink.
CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?
The most common side effects are feeling sick, diarrhoea or constipation, indigestion and wind. These side effects usually improve if you take Gliclazide Tablets with a meal. Other side effects include rashes and red, itchy skin,
temperature/fever, liver problems (possible symptoms are yellowing of the skin and whites of the eyes) and generally feeling unwell, possibly with a sore throat and/or unusual bruising or bleeding.
If your blood sugar level drops too low (hypoglycaemia), you may suffer from any of the following side-effects, including hunger, stomach pains, feeling anxious, chills and cold sweats, looking pale and feeling confused, a fast heart beat, shakiness, feeling unusually tired or weak, feeling and being sick. These symptoms can be relieved by having a sugary snack or a sugary drink. You must tell your doctor immediately if you experience the symptoms of hypoglycaemia. He will want to review your diet and meal times and he may decide to reduce your daily dose of Gliclazide.
Hypoglycaemia is likely to occur under the following circumstances:
• if up until now your diabetes has been controlled by diet alone
• if you are taking too much Gliclazide
• if you are not eating properly
• if you have liver or kidney problems.
You doctor will take all of these factors into account when adjusting your dosage of Gliclazide.
Loss of control of blood glucose (hyperglycaemia) can occur while taking Gliclazide if you are exposed to stress, such as fever, injury, infection or surgery. Your doctor may have to increase your dose in such circumstances, and if the response is not satisfactory he may decide to discontinue your treatment with Gliclazide and prescribe insulin for you instead.
If you should suffer from any of these undesired effects or any undesired effect please tell your pharmacist or doctor.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE LABEL
REMEMBER this medicine was prescribed by your doctor for you.
DO NOT give it to others. It may harm them.
Store at or below 25°C.
Date of Revision: January 2011 ITEM CODE
you have taken Gliclazide Tablets or a similar medicine before and suffered an unusual or allergic reaction.