Gliclazide 80 Mg Tablets
Pantone Reflex Blue C Keyline
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Gliclazide Tablets are and what they are used for
2. What you need to know before you take Gliclazide Tablets
3. How to take Gliclazide Tablets
4. Possible side effects
5. How to store Gliclazide Tablets
6. Contents of the pack and other information
1. What Gliclazide Tablets are and what they are used for
The full name of your medicine is Gliclazide 80mg Tablets but within the leaflet it will be referred to as Gliclazide Tablets. It contains the active substance gliclazide, one of a group of medicines called sulphonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug).
Gliclazide Tablets is used to keep blood sugar at the correct level in adults with non-insulin dependent diabetes when it is not controlled by diet, physical exercise and weight loss 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 this medicine (listed in section 6), to other medicines of the same group (sulphonylureas), to other related medicines (hypoglycaemic sulphonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma and coma;
• if you have severe kidney or liver disease;
• if you are taking miconazole (a treatment for fungal infections) (see Other medicines and Gliclazide Tablets);
• if you are breastfeeding (see Pregnancy and breastfeeding). Gliclazide Tablets are not recommended for use in children. Warnings and precautions
Follow your doctor's advice about diet and treatment. This is to reduce the chances of very low blood sugar (hypoglycaemia).
Make sure your doctor knows
• if you have an operation, a serious injury, fever or infection, difficulty in eating,
• if you plan a pregnancy or become pregnant,
• if you are taking any of the medicines listed in Other medicines and Gliclazide Tablets.
Tell your dentist about your treatment.
Dietary advice
This medicine may cause episodes of low blood sugar (hypoglycaemia).
This is more likely if:
• you are on a strict diet,
• your diet is poorly balanced,
• you are taking prolonged or strenuous exercise,
• you drink alcohol,
• if you are taking several medicines for high blood sugar (See Other medicines and Gliclazide Tablets).
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.
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 blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.
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.
While taking Gliclazide Tablets you should:
• follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal;
• take your medicine regularly (see How to take Gliclazide Tablets);
• check your blood glucose regularly as recommended by your doctor.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), contact your doctor before taking this medicinal product.
Other medicines and Gliclazide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:
• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (e.g. sulphonamides, clarithromycin),
• medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors),
• painkiller or antirheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:
• medicines to treat disorders of the central nervous system (chlorpromazine),
• medicines reducing inflammation (corticosteroids),
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
• medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
Gliclazide Tablets may increase the effects of medicines which reduce blood clotting (e.g. 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.
Gliclazide Tablets with food, drink and alcohol
Gliclazide Tablets can be taken with food and non-alcoholic drinks.
Pantone Reflex Blue C Keyline
Drinking alcohol is not recommended as it can alter the control of your diabetes.
Pregnancy and breast-feeding
Gliclazide Tablets are NOT recommended for use during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. He may prescribe a more suitable treatment for you.
You must not take Gliclazide Tablets while you are breast-feeding. 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 (hypoglycaemia),
• 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 (e.g. glucose, lactose, galactose), contact 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.
The recommended dose is from one half to four tablets. This depends on the response to treatment. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken morning and evening.
If a combination therapy of Gliclazide Tablets with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
Routes and method of administration
Oral use.
Swallow your tablets whole. DO NOT chew them.
Take your tablet(s) with a glass of water before a meal.
The tablet can be divided into equal doses.
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 you forget to take Gliclazide Tablets
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of Gliclazide Tablets, take the next dose at the usual time. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide Tablets
As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
• 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.
• Eve 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 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 and the blister pack after EXP The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Store in the original package.
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 80mg of gliclazide.
• The other ingredients are: lactose monohydrate, maize starch, povidone, silica colloidal anhydrous, magnesium stearate.
What Gliclazide Tablets look like and contents of the pack
Gliclazide 80mg are white, round (» 7.5mm diameter), flat faced beveled edge tablets with break line on one side and plain on other side.
Gliclazide Tablets are available in PVC/PVDC-Aluminium blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED United Kingdom