each CONTROBETIC 60mg MR oral tablet contains: Gliclazide: 60mg q.s.f for one modified release tablet.
This medication is recommended in adults for non-insulin-dependent Diabetes (type 2). In association with dietary measures and with physical exercise, when these measures alone are not sufficient to obtain normal blood glucose levels (levels of sugar in the blood).
This medication SHOULD NEVER BE USED in the following cases:
- If you are allergic to gliclazide or to one of the excipients, to other medicines of the same group (sulphonylureas), to sulphonamides.
- If you have insulin-dependent diabetes (type 1).
- In the case of diabetes with keto-acidiosis or diabetic precoma.
- If you suffer from severe liver or kidney insufficiency.
- If you are currently taking a treatment with miconazole (refer to interactions with other drugs and other forms of interaction).
- If you are breast feeding
- Unless your doctor advices you to the contrary, it is generally inadvisable to combine this medication with Phenylbutazone and danazol (refer to interactions with other drugs and other forms of interaction)
Hypoglycemia: This medicine is susceptible to cause episodes of hypoglycemia (decrease of blood sugar levels): In the case of sweating, intense hunger, trembling, pallor, visual disturbances, feeling of malaise, abnormal behavior, immediately eat sugar or something containing sugar and inform your doctor.
Hypoglycemia is favored by a strict or poorly balanced diet, by prolonged or strenuous exercise, by the intake of alco hol or during use of other hypoglycemic drugs (refers to interactions with other drugs and other forms of interaction).
In consequence, treatment with a hypoglycemic sulphonylurea requires:
- A regular diet: it is important to eat regular meals, including breakfast, never to miss a meal due to an increase in the risk of the onset of hypoglycemia caused by an inadequate diet or a sugar imbalance.
- Precise regularity in the administration of treatment: it is important to take the treatment regularly, once a day, preferably at breakfast time refers to method and route of administration).
Administration of CONTROBETIC 60 MR must be followed by a meal.
Follow as closely as possible the diet prescribed to you by your doctor; regularly carry out the laboratory tests as prescribed or recommended by your doctor.
Inform your doctor in the following cases:
- In the case of surgery, trauma, fever or infection, difficulty eating.
- In the case of a planned pregnancy.
- In the case of administration of other drugs, in particular anti-inflammatory agent, beta-blocker, corticoid.
- Also inform your dentist of your treatment.
Administration of CONTROBETIC 60 MR, modified release tablet with drinks: Avoid alcohol and alcoholic drinks.
Pregnancy and lactation
Pregnancy: If you are pregnant, your diabetes should be treated with insulin.Tell your doctor if you wish to become pregnant. If you are pregnant inform your doctor so that he may prescribe a more suitable treatment for you.
If you discover that you are pregnant while taking this medication, you should discontinue your treatment. Consult your doctor or pharmacist for advice before taking a medicine.
Lactation: This drug is contra-indicated when breast feeding. Consult your doctor or pharmacist for advice before taking medicine.
Driving or operating machinery
Patients should be made aware of the symptoms of hypoglycemia and should be careful when driving or operating machinery.
Interactions with other drugs and other forms of interaction
Certain interactions with other drugs must be avoided as they can cause significant changes in your blood glucose levels.You must not take other drugs on your own initiative.
You must inform your doctor or pharmacist if you are taking. Or have recently taken any other drugs, especially danazol (hormonal drug), Corticoides, diuretics, miconazole (drug which treats infections caused by microscopic fungi),even if you can buy them without a prescription, or alcohol.
Dosage and method of administration
Dosage: The usual daily dosage is 1 to 2 tablets per day as a single dose. It is recommended that the drug be taken at breakfast time.
Method and route of administration: Oral route: The tablet must be taken whole with half a glass of water just before breakfast. It is
preferable to take this drug before breakfast in order to avoid or minimize the possible onset of digestive disorders.
Frequency of administration: The Once daily administration of CONTROBETIC 60 MR, modified release tablet must always be followed by a meal.
Duration of treatment: Follow your doctor’s prescription. In all cases, strictly comply with your doctor’s prescription.
As with all drugs CONTROBETIC 60 MR, modified release tablet. Is likely to have undesirable effects.
- Hypoglycemia manifestations (sweating, pallor, intense hunger, malaise), (refer to warning and overdose).
- Skin reactions: urticaria, itching, skin rash.
- Gastrointestinal disorders: nausea, diarrhea, stomach upsets, constipation, hepatitis.
- Abnormal laboratory results affecting blood and liver functions.
If you notice any undesirable effects, which have not been mentioned in this package insert. You should inform your doctor or pharmacist.
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