Gliclazide 80mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Glimil 80mg Tablets
(gliclazide)
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.
This medicine has been prescribed for you. Do not pass it 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 Glimil Tablets are and what they are used for
2. Before you take Glimil Tablets
3. How to take Glimil Tablets
4. Possible side effects
5. How to store Glimil Tablets
6. Further information
1. WHAT GLIMIL TABLETS ARE AND WHAT THEY ARE USED FOR
Gliclazide is a hypoglycaemic sulphonylurea used to treat diabetes mellitus in adults. Sulphonylureas act by stimulating the release of insulin from beta cells in the pancreas and so lower the amount of sugar in your blood.
2. BEFORE YOU TAKE GLIMIL TABLETS Do not take Glimil Tablets
If you are allergic (hypersensitive) to sulphonylureas or related drugs or are allergic to any of the ingredients in the tablets (see Section 6 and end of Section 2).
If you have insulin-dependent diabetes (Type I)
If you have severe liver or kidney problems
If you are having an operation, or have a severe infection, or are suffering from extreme stress or trauma.
If you have ketoacidosis (a complication of diabetes with ketones in the urine).
If you are pregnant, thinking of becoming pregnant or breast-feeding (see Section “Pregnancy and breastfeeding”).
If you are taking miconazole, a medicine used to treat fungal infections (See section Taking other medicines)
Take special care with Glimil Tablets
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels.
This means, apart from regular tablet intake, you 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 is required.
Low blood sugar (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 and carbohydrate intake does not match this increase, if you drink alcohol, especially in combination with skipped meals,
•if you take other medicines or natural remedies at the same time,
•if you take too 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 kidney function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea.
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes).
Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptom of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (those acting on the central nervous system and beta blockers).
Symptoms of high blood sugar (Hypeglycaemia) may occur when Glyclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
If these symptoms occurred you must contact your doctor or pharmacist.
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, as they may interact with your tablet.
Do not take Glimil 80mg Tablets with Miconazole, a medicine used to treat fungal infections.
Tell your doctor BEFORE starting your medicine if you are taking any of the following: •other medicines used to treat high blood sugar (oral antidiabetics or insulin),
•antibiotics (e.g. sulphonamides, chloramphenicol)
•medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),
•medicines to treat fungal infections (Fluconazole), •medicines to treat ulcers in the stomach or duodenum (cimetidine)
•medicines to treat depression (monoamine oxidase inhibitors),
•painkiller or antirheumatics (phenylbutazone, ibuprofen),
•medicine for treating irregular heart beats (Disopyramide) blood thinning medicines such as warfarin
•medicines to treat disorders of the central nervous system (chlorpromazine),
•medicines reducing inflammation (corticosteroids),
•medicines containing alcohol
danzol (used to treat breast disorders and heavy menstrual bleeding and endometrosis) •intravenous ritodrine and terbutaline (used during labour)
•intravenous salbutamol (used to treat asthma)
Taking Glimil Tablets with food and drink
Glimil Tablets can be taken with breakfast and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, think you may be pregnant, are breast-feeding or planning to breast-feed.
Effects on the ability to drive and use machines
Low blood sugar may occur at the beginning of the treatment while your doctor is trying to find the dose that best suits you. If you experience the symptoms of low blood sugar (hypoglycaemia) - sweating, trembling, weakness, double vision, palpitations, confusion,
you should not drive or operate machinery.
When your blood sugar is stabilized you may drive or operate machinery.
Important information about some of the ingredients of Glimil Tablets
Lactose: - if you have an intolerance to some sugars, contact your doctor before taking this
medicine.
3. HOW TO TAKE GLIMIL TABLETS
Always take Glimil Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Glimil Tablets should be taken orally with food, either with breakfast or the first main meal of the day.
The usual dosage is as follows:
Adults and Elderly: The usual starting dose is 40 to 80mg ('A or 1 tablet) daily, adjusted according to your response, up to a maximum of 320mg (four tablets) daily. Up to 160mg (two tablets) can be taken at one time.
Your starting dose will be reduce if you are elderly or have liver or kidney problems.
Children: Gliclazide is not recommended for use in children.
You should continue to take these tablets for as long as your doctor tells you to.
Do not stop taking the tablets or alter the dosage without consulting your doctor.
If you take more Glimil Tablets than you should
If you or someone else accidentally takes too many Glimil Tablets seek immediate medical help by contacting your doctor or nearest hospital casualty department. Take the carton and any remaining tablets you have with you.
If you forget to take Glimil Tablets
If you forget to take a dose, do not worry, just wait until it is time for your next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Glimil Tablets
You should take your medicine for as long as your doctor tells you to. Do not stop taking this medicine without consulting your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Glimil Tablets can cause side effects, although not everybody gets them. You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. If this happens to you, stop taking the tablets immediately and seek medical help.
Low blood sugar (Hypoglycaemia)
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs include: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor 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, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
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.
Other side effects
• Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation.
These effects are reduced when Glimil 80mg Tablets are taken with a meal as recommended.
• Skin disorders: Skin reactions such as rash, redness, itching and hives have been reported.
• Blood disorders: 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. These symptoms usually stop when the treatment is discontinued.
• Liver disorders: There have been isolated reports of abnormal liver function which can cause yellow skin and eyes. If you get this see your doctor immediately. The symptoms generally disappear if the drug is stopped. Your doctor will decide whether to stop your treatment.
• Eye disorders: 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.
As for other sulphonylureas, the following adverse events have been observed: cases of 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 (e.g. jaundice) which in most cases disappeared after withdrawal of the sulphonylurea, but may lead 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 GLIMIL TABLETS
Keep out of the reach and sight of children
Do not use your medicine after the expiry date stated on the label.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Glimil Tablets contain The active substance is gliclazide.
Each tablet contains 80mg of gliclazide.
The other ingredients are: lactose monohydrate, silicon dioxide, pregelatinised maize starch, talc and magnesium stearate.
What Glimil Tablets look like and the contents of the pack
Glicmil tab80mg Tablets are white, round tablets scored on one side with G80 on the other side.
The registered pack sizes are 28 and 60 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD United Kingdom
Manufacturers:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD United Kingdom
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate,
Hal Far,Birzebbugia BBG 3000