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Diamicron®
gliclazide
Presentation and composition
Boxes of 20 and 60 scored tablets dosed at 80 mg of gliclazide.
Properties
HYPOGLYCAEMIC SULPHONYLUREA
ORAL ANTI-DIABETIC.
Indications
This medication is recommended for type 2 diabetes, in cases where dietary
measures have failed.
Contraindications
This medication MUST NOT BE USED in the following cases:
• if you are allergic to
gliclazide, to other sulfonylureas or sulfonamides or to one of excipients
included,
• if you have diabetes requiring treatment with insulin,
• in case of diabetes complicated by keto-acidosis, diabetic precoma,
• if you suffer from severe liver or kidney disease,
• if you are presently taking a treatment with miconazole (cf. interactions
with other medications),
• if you are breast-feeding.
Unless your doctor advises you to the contrary, it is generally inadvisable
to combine this medication with phenylbutazone, danazol and alcohol.
Warnings
Hypoglycaemia: (decrease in blood sugar levels)
You may suffer from hypoglycaemia in the course of your treatment. If this
happens, it may be necessary to hospitalise you to restore your sugar
levels.
After a hypoglycaemic episode,
your doctor will monitor you closely for at least 24 hours.
The following information is necessary to avoid episodes of hypoglycaemia:
• it is important to eat regular meals, including breakfast, due to the
increased risk of hypoglycaemia if a meal is missed, or in the case of an
inadequate diet or a diet low in sugars,
• age, renal insufficiency, hepatic insufficiency and certain disorders of
the adrenal glands or the pituitary gland may increase the risk of
hypoglycaemia,
• the risk of hypoglycaemia is heightened by the following : a diet which is
too strict or poorly balanced, considerable or prolonged exertion,
consumption of alcohol or combination treatment with other hypoglycaemic
medications (cf. Interactions with other medications).
Glycaemic imbalance:
In the case of surgery, trauma, fever or infection, your doctor may
discontinue this treatment and prescribe insulin for you.
Biological analyses:
The levels of glucose in your blood and urine should be monitored regularly.
Due to the presence of lactose, this drug should not be used in the case of
congenital galactosemia, the syndrome of malabsorption of glucose and
galactose or a deficit in lactase (rare metabolic diseases).
Precautions
Your doctor will explain to you and your family how to avoid hypoglycaemia,
how to recognise the first symptoms and how to treat them. Your doctor will
also explain the conditions under which you may become resistant to the
treatment with gliclazide: other medications may then be prescribed as a
replacement.
Interactions with other
medications
Please inform your doctor or pharmacist if you are taking or have taken
any other medicines even if it is a medicine that can be obtained without a
prescription:
1. Medications which risk increasing the hypoglycaemia : miconazole,
phenylbutazone, beta-blockers, fluconazole, angiotensin converting enzyme
inhibitors, medications containing alcohol.
2. Medications which risk producing hyperglycaemia by reducing the efficacy
of the anti-diabetic agent: danazol, chlorpromazine, glucocorticoids,
salbutamol, terbutaline, ritodrine.
Pregnancy - Breast-Feeding
If you are pregnant, your diabetes should be treated with insulin.
If you discover that you are
pregnant while taking this medication, you should discontinue your
treatment.
Tell your doctor, who will adjust
your hypoglycaemic treatment.
This medication is contra-indicated when breastfeeding.
Ask your doctor or your pharmacist for advice before taking any medicine.
Driving vehicles and operating machines
Patients should be made aware of the symptoms of hypoglycaemia and should be
careful when driving and operating machines.
Dosage and route of administration
Oral route.
The standard dosage is 2 tablets per day, in 2 daily doses. As with all
hypoglycaemic agents, the dosage must be adapted to suit each individual
case.
If you feel that the effect of
DIAMICRON 80 mg is too strong or too weak, consult your doctor or your
pharmacist.
What to do if you have forgotten to take one or more doses
Take one tablet with the next meal.
Do not take a double dose to compensate the simple dose you have
forgotten to take.
Overdosage
In all cases, tell your doctor immediately.
If you experience mild signs of hypoglycaemia : weakness, sweating, intense
hunger, trembling, drowsiness, dizziness, headache, visual problems, eat or
drink something containing sugar. Consult your doctor or your pharmacist
immediately.
Undesirable and distressing effects
As with all active substances, this medication may produce distressing
effects of varying severity in some people:
• hypoglycaemia (cf. Warnings and overdosage),
• skin reactions: urticaria, itching, skin rash,
• gastrointestinal disorders : nausea, diarrhoea, stomach problems,
constipation, jaundice, hepatitis,
• abnormal laboratory results affecting the blood, liver and kidney
functions.
If you notice undesirable effects which have not been mentioned in this
package insert, please inform your doctor or your pharmacist.
Storage conditions
Keep out of the reach and sight of children.
Do not use after the expiry date clearly indicated on the box.
Do not use Diamicron 80 mg if you note signs of deterioration on the
packaging or on blisters.
Below 30°C. |
