Product Details

Gliclazide MR 60mg Tablets Product Information

What you need to know before you take Gliclazide
Do not take Gliclazide if you:
• are allergic to gliclazide or any of the other ingredients in this medicine (listed in section 6), or to other medicines in the same group (sulfonylureas), or to other related medicines (hypoglycaemic sulfonamides)
• have insulin-dependent diabetes (type 1)
• have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
• have severe kidney or liver disease
• are taking medicines to treat fungal infections (miconazole, see section ‘Other medicines and Gliclazide’)
• are breast-feeding (see section ‘Pregnancy and breast-feeding’).
Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide.
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.
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 a dose 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 heartbeat, 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, if
you take St. John’s Wort (Hypericum perforatum)
preparations (see section ‘Other medicines
and Gliclazide), 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.
Blood glucose disturbance (low blood sugar
and high blood sugar) can occur when
gliclazide is prescribed at the same time than
medicines belonging to a class of antibiotics
called fluoroquinolones, especially in elderly
patients. In this case, your doctor will remind
you the importance of monitoring your blood
glucose.
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.
Cases of acute porphyria have been described
with some other sulfonylurea drugs, in patients
who have porphyria (inherited genetic
disorders with accumulation in the body of
porphyrins or porphyrin precursors).
Children and adolescents
Gliclazide is not recommended for use in
children and adolescents due to a lack of data.
Other medicines and Gliclazide
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 anti-diabetics, GLP-1 receptor
inhibitors or insulin)
• Antibiotics (e.g. sulfonamides or
clarithromycin)
• Medicines to treat high blood pressure or
heart failure (beta blockers, ACE-inhibitors
such as captopril or enalpril)
• Medicines to treat fungal infections (e.g.
miconazole, fluconazole)
• Medicines to treat ulcers in the stomach or
duodenum (H2
receptor antagonists)
• Medicines to treat depression (monamine
oxidase inhibitors)
• Painkillers 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 or tetracosactrin)
• Medicines to treat asthma or used during
labour (intravenous salbutamol, ritodrine and
terbutaline)
• Medicines to treat breast disorders, heavy
menstrual bleeding and endometriosis
(danazol)
• St. John’s Wort (Hypericum perforatum)
preparations.
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, especially in elderly patients.
Gliclazide 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.

Gliclazide with food, drink and alcohol
Gliclazide can be taken with food and nonalcoholic drinks.
Drinking alcohol is not recommended as it
can alter the control of your diabetes in an
unpredictable manner.
Pregnancy and breast-feeding
Pregnancy
Gliclazide is not recommended for use during
pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking this
medicine.
Breast-feeding
You must not take Gliclazide while you are
breast-feeding.
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 contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.