Drug Study: Diamicron

Generic name: gliclazide

Brand name: Diamicron 80 mg tablet

Category: anti-diabetes

Formulation: each scored tablet contains 80 mg gliclazide.

Description: Gliclazide is 1-3azobyclo [3.3.0] oct-3-yl) 3-(p-tolysulphonyl) urea.

Oral antidiabetic

Indication: Diamicron 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
-if you have diabetes requiring treatment with insulin,
-in case of diabetes complicated by ketosis and acidosis, diabetic precoma
-if you suffer from severe liver or kidney disease.
-in case of porphyria: accumulation of pigments (porphyria) in the body
-if you are presently taking a treatment with miconazole (see 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: Hypoglycemia (decrease in blood sugar levels). You may suffer from hypoglycemia in the course of your treatment. If this happens, it may be necessary to hospitalize you to restore your sugar levels. After a hypoglycemic episode, your doctor will monitor you closely for at least 24 hours.

The following information is necessary to avoid episode of hypoglycemia:
-it is important to eat regular meals, including breakfast, due to the increased risk of hypoglycemia 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 hypoglycemia.
-the risk of hypoglycemia is heightened by the following: a diet which is to strict or poorly balanced, considerable or prolonged exertion, consumption of alcohol or combination treatment with other hypoglycemic medications (see interactions with other medications)

Glycemic 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.

Precautions: Your doctor will explain to you and your family how to avoid hypoglycemia, and how to recognize 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: In order to avoid possible interactions with other drugs, you must always inform your doctor or pharmacist of any other drugs you are taking, in particular:
-medications which risk increasing hypoglycemia: miconazole, phenylbutazone, beta-blockers, fluconazole, angiotension converting enzyme inhibitors, alcohol.
-medications which risk producing hyperglycemia by reducing the efficacy of the antidiabetic agent: danazol, chlorpromazine, glucocorticoids, salbutamol, terbutaline, ritodrine

Pregnancy and 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 hypoglycemic treatment. This medication is contraindicated when breast-feeding.

Ask your doctor or your pharmacist for advice before taking any medicine.

Dosage and rout of administration: oral route: the standard dosage is 2 tablets per day, in 2 daily doses.

As with all hypoglycemic agents, the dosage must be adapted to suit each individual cases. If you feel that the effect of Diamicron 80 mg is too strong or too weak, consult your doctor.

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 single dose you have forgotten to take.

Overdosage: in all cases, tell your doctor immediately. If you can experience mild signs of hypoglycemia: 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:
-hypoglycemia (see Warning and Overdosage)
-skin reactions: urticaria, itching, skin rash
-gastrointestina disorders: nausea, diarrhea, stomach problems, constipation, jaundice and 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 reach and sign of children. Do not use after the expiry date clearly indicated on the packaging. Do not use Diamicron 80 mg if you note signs of deterioration on the packaging or on blisters. Store at temperature not exceeding 30 degrees Celsius.

Cautions: foods, drugs, devices and cosmetics act prohibits dispensing without prescription

Manufacturer: Les laboratories Servier Industrie 45520 Gidy-France

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