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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 30C.

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