Gliclazide 80mg Tablets
Gliclazide 80mg tablets
gliclazide
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• Your doctor has prescribed these tablets for you. Do not pass them on to others.
It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Gliclazide Tablets are and what they are used for
2. Before you take Gliclazide Tablets
3. How to take Gliclazide Tablets
4. Possible side effects
5. How to store Gliclazide Tablets
6. Further information
1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Gliclazide is one of a group of medicines called oral hypoglycaemics which work by reducing the level of sugar in the blood.
What are Gliclazide Tablets for?
Gliclazide is an antidiabetic medicine used to treat Type2 (non-insulin dependent) diabetes. This is the type of diabetes that usually develops in adulthood. This type of diabetes is not severe enough to need insulin but does not respond to dietary measures alone.
2. BEFORE YOU TAKE GLICLAZIDE TABLETS Do not take Gliclazide Tablets
• if you have severe liver or kidney disease
• if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of Gliclazide Tablets or to sulphonylureas or related drugs with symptoms such as skin rash, hives, swelling of face, or throat or difficulty breathing.
• if you have diabetic ketoacidosis (complication of diabetes with rapid weigh loss, nausea or vomiting), or have suffered a diabetic coma
• if you are pregnant
• if you have juvenile onset diabetes
• if you have recently had or about to have surgery under general anaesthetic after severe trauma or infection. Your doctor will advise you when it is safe to start taking them again after the surgery
Take special care with Gliclazide Tablets
Tell your doctor before you start taking these tablets:
• if you are taking other antidiabetic drugs, e.g. insulin, guar gum or a sulphonylurea drug such as glibenclamide
• if you are on a special diet, if you are eating less than usual, if you have a diet which is low in carbohydrate or if you do not regularly eat breakfast
• if you sometimes take prolonged or strenuous exercise
• if you drink alcohol
• if you have a severe infection, a fever, or are unwell in anyway
• if you have a problem with your liver or kidney (your doctor may need to give you a reduced dose of Gliclazide Tablets at the start of your treatment)
• if you have a problem with your thyroid or pituitary gland
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you should observe the recommended diet, have regular physical exercise, and where necessary reduce weight. During gliclazide treatment regular checks of your blood sugar level will be required; your doctor may ask you to check your own blood sugar level but will show you how to do this.
Over time, the effect of your medicine may become reduced in which case your doctor may need to adjust your dose or change your medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking any of the following medicines:
• salicylates or pyrazolone antiinflammatory pain killers
• atenolol or mecloprolol, betablockers used for treating hypertension (high blood pressure) and irregular heart rhythm
• disopyramide (used for treating irregular heart rhythm)
• diuretics (water tablets) used to treat high blood pressure
• clofibrate used to lower blood cholesterol
• cimetidine used to reduce the secretion of stomach acid
• Contraception pill or HRT treatment
• Prednisolone, betamethasone or dexamethasone - Glucocorticoids (steroids) since they can also affect the levels of sugar in the blood
• thyroid hormones
• antibiotics - chloramphenicol
• phenylbutazone
• sulphonamides
• coumarin derivatives (medicines used to thin the blood, e.g. warfarin)
• MAOIs
• phenothiazine
• miconazole (a treatment for fungal infections) if taken by mouth
• tetracyclines (type of antibiotic)
• laxatives
Taking Gliclazide Tablets with food and drink
It is recommended to take tablets either with or just after food, to reduce the chance of an upset stomach.
Pregnancy and breast-feeding
Tell your doctor if you are, you think you might be, or are planning to become pregnant. Your doctor will advise you to discontinue these tablets. You should not use Gliclazide Tablets if you are breastfeeding or are planning to breastfeed your baby.
Driving and using machines
Gliclazide Tablets on their own should not affect your ability to drive, but if you are taking other medicines which lower the blood sugar it is possible that their combined effects could make you feel faint, dizzy, weak or jittery. If this happens you should not drive or operate any machinery until you are recovered.
Important information about some of the ingredients of Gliclazide Tablets
These tablets contain lactose. If you have been told by your doctor you have intolerance to lactose let your doctor know before taking these tablets.
3. HOW TO TAKE GLICLAZIDE TABLETS
Always take Gliclazide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is 40 - 80mg (1/2 - 1 tablet). Your doctor may then increase your dose in a stepwise manner until the right dose for you is found. After a while your doctor may then be able to reduce the dose. The dose reached varies between different people. The total daily dose may vary from 40 to 320mg.
The maximum single dose should be 160mg (2 tablets) but if a higher dose is required this is split and taken twice daily.
The tablets should be taken with a glass of water during or after meals.
Do not chew the tablets but swallow them whole.
If you take more Gliclazide tablets than you should
If you swallow too many tablets, or someone else take accidentally your medicine, seek help from your doctor or pharmacist immediately or contact the nearest hospital straight away.
If you forget to take Gliclazide tablets
Try to take Gliclazide Tablets daily as prescribed. However if you miss a dose take it as soon as you remember unless it is nearly time for the next dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Gliclazide tablets
Do not stop taking Gliclazide tablets without first discussing it with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gliclazide tablets can cause side effects, although not everyone gets them.
At start of the treatment mild symptoms of low blood sugar (hypoglycaemia) such as sweating, headache, pale skin (pallor), feeling sick (nausea), being sick (vomiting), sleep problems, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, anxiety, confusion, weakness, dizziness, loss of self control, hunger pangs, fast heart rate (tachycardia), slow heart rate (bradycardia), chest pain, irregular heart beat, breathing problems. tremor, high blood pressure, drowsiness, visual and speech problems, and sensation of feeling unwell may occur. An adjustment of the dose by your doctor may be required if these side effects occur.
If you experience some of the following symptoms: feeling cold and uncomfortable, severe nausea or vomiting, abdominal pain, muscle pain, confusion, drowsiness, unexplained weigh loss or rapid breathing, this may be due to a serious condition called lactic acidosis (excess of lactic acid in your blood). Then contact your doctor or hospital immediately.
Other side effects which may occur are:
Common (happening in more than 1 in 100 patients but in less than 1 in 10):
• nausea
• indigestion
• diarrhoea
• constipation
These may occur at the beginning of the treatment. These may be avoided if Gliclazide
tablets are taken during a meal. If these signs do not get better after a few days then contact the doctor.
Rare (happening in more than 1 in 10,000 patients but in less than 1 in 1000):
• liver failure, hepatitis, jaundice
• skin rash (erythema)
• itching (pruritus)
• blood disorders (the symptoms of blood disorders include prolonged bleeding, bruising, sore throat, fever)
• anaemia and changes in the blood cells that may be measured by a blood test carried out by your doctor.
If you think you have any other side-effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE GLICLAZIDE TABLETS
Keep out of the reach and sight of children.
Do not use Gliclazide Tablets after the expiry date which is stated on the carton.
Do not store above 25°C.
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 Gliclazide Tablets contain
The active substance is gliclazide.
The other ingredients are lactose, silicon dioxide, pregelatinized maize starch, talc, magnesium stearate.
What Gliclazide Tablets look like and contents of the pack
Gliclazide 80mg tablets are white round tablets, with score; "G03" is embossed on one side. The tablets are packaged in blister foil packs in boxes of 28 and 60 tablets. Not all pack sizes are marketed.
Marketing Authorisation Holder
PRO-Gen Pharma
Unit 5, Aragon Park, Dunstable, LU5 5TA Manufacturer
Edmond Pharma - 131 Via dei Giovi, 20037 Paderno Dugnano - Milan, Italy Distributor
Genesis Pharmaceuticals, 15 Runnelfield, Harrow , HA1 3NY
This leaflet was last revised in February 2011