Patient leaflet - Gliclazide 80 mg tablets
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 anti-diabetic medicine used to treat Type 2 (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. What you need to know before you take Gliclazide Tablets
Do not take Gliclazide Tablets if:
you are allergic to gliclazide or any of the other ingredients of
Gliclazide Tablets (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides),
- you have a problem with your liver or kidneys,
you have diabetic ketoacidosis (complication of diabetes with rapid
weight loss, nausea or vomiting), or have suffered a diabetic coma,
- you are pregnant or breast-feeding,
- you have Type 1 Diabetes,
- you take miconazole (for fungal infections),
you have porphyria (a hereditary disease affecting the liver or
bone marrow).
Children and adolescents
Gliclazide Tablets are not recommended for use in children.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. glucose, lactose, galactose), contact your doctor before taking this medicinal product.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Gliclazide Tablets. 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.
Do not take Gliclazide Tablets if you have 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.
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.
Low blood sugar (Hypoglycaemia) may occur if:
- you take meals irregularly or skip meals altogether,
- you are fasting,
- you are malnourished,
- you change your diet,
you increase your physical activity and carbohydrate intake does
not match this increase,
- you drink alcohol, especially in combination with skipped meals,
- you take other medicines or natural remedies at the same time,
- you take too high doses of gliclazide,
you suffer from particular hormone-induced disorders (functional
disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
- 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
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Gliclazide Tablets, especially in elderly patients.
Gliclazide Tablets may increase the effects of medicines which reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product.
If you go into hospital tell the medical staff you are taking Gliclazide Tablets.
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.
Patients should not consume alcohol in combination with Gliclazide Tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will advise you to discontinue these tablets. You should not use Gliclazide Tablets if you are breast-feeding or are planning to breast-feed your baby.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on Gliclazide Tablets, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks.
Ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypocalcaemia),
- have few or no warning signals of low blood sugar (hypoglycaemia).
Gliclazide Tablets contain Lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.
3. How to take Gliclazide Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood sugar control may require change in gliclazide doses.
The recommended daily dose is 40-80 mg (1/2-1 tablet). Your doctor may then increase the 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 needed varies between different people. The total daily dose may vary from 40 to 320 mg.
The maximum single dose should be 160 mg (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 a combination therapy of Gliclazide Tablets with another oral anti-diabetic medicine is initiated, your doctor will determine the proper dose of each medicine individually for you. If you notice your blood sugar levels are high although you are taking the medicines as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide Tablets than you should
If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately.
The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2.
The symptoms can be helped by taking sugar (4 to 6 lumps) 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.
If 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. 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 medicine ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
POM
Low blood sugar (Hypoglycaemia)
The most commonly observed side effect is 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.
Other side effects
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Gliclazide Tablets are taken with a meal as recommended.
Skin disorders
Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may progress to widespread blistering or peeling of the skin. Exceptionally, 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.
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 sulfonylureas, 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 sulfonylurea, but may lead to life threatening liver failure in isolated cases.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gliclazide Tablets
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not keep the tablets above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Gliclazide Tablets contain
The active substance is gliclazide.
Each tablet contains 80 mg gliclazide.
The other ingredients are Lactose monohydrate, silicon dioxide, pregelatinised maize starch, talc, magnesium stearate.
What Gliclazide Tablets look like and contents of the pack
Gliclazide Tablets are white, round, scored on one side and embossed "G03" on the reverse side.
The tablets are packaged in blister foil packs, in boxes of 28 and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited,
Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP, UK.
PL 20395/0046
This leaflet was last revised in May 2026.
190 mm
190 mm