GLICLAZIDE 60 MG MR TABLETS

Package Leaflet: Information for the user
GLICLAZIDE 60 mg MR Tablets, modified release tablets
Gliclazide
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 of the side effects gets serious talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

What is in this leaflet
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What Gliclazide 60 mg MR is and what it is used for
What you need to know before you take Gliclazide 60 mg MR
How to take Gliclazide 60 mg MR
Possible side effects
How to store Gliclazide 60 mg MR
Contents of the pack and other information

1. What Gliclazide 60 mg MR is and what it is used for
Gliclazide 60 mg MR is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to
the sulphonylurea group).
Gliclazide 60 mg MR is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet,
exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

2. What you need to know before you take Gliclazide 60 mg MR
Do not take Gliclazide 60 mg MR:
- if you are allergic to gliclazide or any of the other ingredients of Gliclazide 60 mg MR (listed in
section 6), or to other medicines of the same group (sulphonylurea), or 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 diabetic keto-acidosis), a
diabetic pre-coma or coma;
- if you have severe kidney or liver disease;
- if you are taking medicines to treat fungal infections (miconazole, see Section “Taking other
medicines”);
- if you are breastfeeding (see Section “Pregnancy and breastfeeding”).

Warnings and precautions
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 and also your
glycated haemoglobin (HbA1c) is necessary.
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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,
- 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.
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.
Symptoms 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 (e.g. those acting on the central nervous system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily
switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide 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 occur, you must contact your doctor or pharmacist.
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), lowering of the haemoglobin level and
breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.
Gliclazide 60 mg MR is not recommended for use in children due to a lack of data.

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Other medicines and Gliclazide 60mg MR
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:
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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 (H 2 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 60 mg MR 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 60 mg MR.
Taking Gliclazide 60 mg MR with food, drink and alcohol
Gliclazide 60 mg MR can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Gliclazide 60 mg MR is 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 while taking this medicine, inform your doctor so
that he may prescribe a more suitable treatment for you.
You must not take Gliclazide 60 mg MR while you are breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too
high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that
you could endanger yourself or others (e.g. when driving a car or using machines). Please 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 60 mg MR
contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

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3. How to take Gliclazide 60 mg MR
Dose
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood
sugar control may require changed gliclazide doses.
The recommended dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. This
depends on the response to treatment.
If a combination therapy of Gliclazide 60 mg MR with metformin, an alpha glucosidase inhibitor,a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 agonist receptor 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 half tablet or whole tablet(s) in one piece. Do not chew or crush. The tablet can be divided into
equal doses.
Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).
You must always eat a meal after taking your tablet(s).
If you take more Gliclazide 60 mg MR 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. The same should be done if somebody, e.g. a child, has taken the product unintentionally.
Unconscious patients must not be given food or drink.
It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide 60 mg MR
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of Gliclazide 60 mg MR, 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 60 mg MR
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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.

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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 medicine is stopped. Your
doctor will decide whether to stop your treatment.
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 have been reported. These
symptoms usually vanish when the treatment is discontinued.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are
reduced when Gliclazide 60 mg MR is taken with a meal as recommended.
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) have been observed 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.

5. How to store Gliclazide 60 mg MR
Keep out 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 strip. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 60 mg MR contains:
The active substance is gliclazide. Each modified release tablet contains 60 mg of gliclazide,
The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, silica
colloidal anhydrous.
What Gliclazide 60 mg MR looks like and contents of the pack:

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Gliclazide 60 mg MR is a white oblong modified release tablet, scored and engraved ‘DIA 60’ on both faces.
The tablets are available in blister packed in cartons of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 112,
120, 180 or 500 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex – France
Manufacturers:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
or
Servier (Ireland) Industries Ltd.,
Gorey Road,
Arklow - Co. Wicklow - Ireland.

This leaflet was last revised in 07/2012.

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