Medicinal Products

DIAMICRON 60 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Gliclazide
laboratory: Mediwin Limited

Modified release scored tablet
Box of 30
All forms

Indication

Non-insulin-dependent (type 2) diabetes in adults, when diet, exercise and weight reduction alone are not sufficient to achieve glycemic control.

Dosage DIAMICRON 60 mg Modified release scored tablet Box of 30

The daily dose of DIAMICRON 60 mg can range from ½ to 2 tablets per day, or 30 to 120 mg in a single oral intake at breakfast time.

It is recommended to swallow the tablet (s) without crushing or chewing.

If you miss a dose, the next day dose should not be increased.

As with any hypoglycemic agent, the dose should be adjusted according to the individual metabolic response of each patient (glycemia, HbA1c).

Initial dose

The recommended starting dose is 30 mg daily (½ tablet DIAMICRON 60 mg).

· If the glycemic control is satisfactory, this dose can be adopted as a maintenance treatment,

· If the glycemic control is not satisfactory, the dose may be increased to 60, 90 or 120 mg per day, in successive increments, with an interval of at least 1 month between each level, except in patients for whom blood glucose does not decrease after two weeks of treatment. In this case, it is possible to propose an increase in the dose at the end of the second week of treatment.

The maximum recommended dose is 120 mg daily.

A modified-release tablet of DIAMICRON 60 mg is equivalent to two modified-release tablets of DIAMICRON 30 mg. The breakability of DIAMICRON 60 mg modified release tablet ensures flexibility of the dose.

DIAMICRON 80 mg Relay, tablets by DIAMICRON 60 mg, scored tablets with modified release

One tablet of DIAMICRON 80 mg is comparable to 30 mg of the modified release formulation (ie ½ tablet of DIAMICRON 60 mg). Therefore, the relay can be done provided you follow carefully the evolution of blood glucose.

Relay of another oral anti-diabetic by DIAMICRON 60 mg

DIAMICRON 60 mg can take over from another oral antidiabetic treatment.

In this case, the dose and half-life of the previous antidiabetic agent should be taken into account.

The relay will generally be without a transition period, preferably starting with a dose of 30 mg. The dose will then be adjusted as indicated above, depending on the glycemic response of each patient.

In the case of relays of a sulphonylurea with a prolonged half-life, a therapeutic window of a few days may be necessary in order to avoid an additive effect of the two products which may lead to hypoglycaemia.

During this relay, it is recommended to follow the same procedure as when starting a treatment with DIAMICRON 60 mg, ie to start at the dose of 30 mg per day, then to increase the dose in successive stages, depending on the metabolic results.

Association with other oral antidiabetic agents

DIAMICRON 60 mg may be associated with biguanides, alpha-glucosidase inhibitors or insulin.

In patients inadequately balanced with DIAMICRON 60 mg, insulin-associated therapy may be initiated under strict medical supervision.

Special populations

Elderly

DIAMICRON 60 mg will be prescribed according to the same regimen as in subjects under 65 years of age.

Patients with renal insufficiency

In patients with mild to moderate renal impairment, the dosing regimen will be the same as in subjects with normal renal function, but with careful monitoring.

These data have been confirmed in clinical trials.

Patients at risk of hypoglycemia:

· States of undernutrition or malnutrition,

· Severe or poorly compensated endocrine pathologies (ante-pituitary insufficiency, hypothyroidism, adrenal insufficiency),

· Withdrawal from prolonged and / or high dose corticosteroid therapy,

· Severe vascular disease (severe coronary artery disease, severe carotid artery disease, diffuse vascular disease);

It is recommended that treatment be started at the minimum dose of 30 mg / day.

Pediatric population

The safety and effectiveness of DIAMICRON 60 mg have not been established in children and adolescents.

There are no data in children.

Against indications

Hypersensitivity to gliclazide or to any of the excipients listed under Composition, other sulfonylureas, sulfonamides;

· Type 1 diabetes;

· Diabetic pre-coma and coma, diabetic ketoacidosis;

· Severe renal or hepatic impairment: in these situations, insulin is recommended;

· Treatment with miconazole (see section Interactions with other medicinal products and other forms of interaction );

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Adverse effects Diamicron

Based on clinical experience with gliclazide, the following side effects have been reported:

hypoglycaemia

As with other hypoglycaemic sulfonamides, treatment with Diamicron may result in hypoglycaemia, particularly if meals are taken at irregular intervals and if a meal is skipped.

Possible symptoms are: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, decreased concentration, alertness and reactions, depression, confusion, visual disturbances and speech disorders, aphasia, tremors, paresis, sensory disturbances, dizziness, feeling of helplessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness, loss of consciousness or even coma and which can lead to a fatal outcome.

On the other hand, signs of adrenergic counter-regulation can be observed: hypersudation, moist skin, anxiety, tachycardia, hypertension, palpitations, angina and cardiac arrhythmia.

Symptoms usually disappear after taking carbohydrates (carbohydrates). On the other hand, artificial sweeteners have no effect. Experience with other sulphonylureas shows that despite initially effective measures, hypoglycaemia may re-offend.

In case of severe or prolonged hypoglycemia, even temporarily controlled by sugar absorption, immediate medical treatment or hospitalization may be required.

Other adverse effects

Gastrointestinal disorders such as abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation have been reported; they can be avoided or decreased if treatment is taken during breakfast.

The following side effects have been reported more rarely:

· Mucocutaneous rash: rash, pruritus, urticaria, angioedema, erythema, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

· Hematologic disorders : they are rare and include anemia, leukopenia, thrombocytopenia, granulocytopenia. These abnormalities are usually reversible when the treatment is stopped.

· Hepatobiliary disorders : elevated liver enzymes (ASAT, ALT, alkaline phosphatase), hepatitis (isolated cases). Discontinue treatment if cholestatic jaundice develops. In general, these symptoms regress when treatment is stopped.

· Visual disturbances: Transient visual disturbances due to changes in blood glucose may occur especially during the initiation of treatment.

Class effects

· As with other sulfonylureas, the following adverse effects were observed: erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia, increased liver enzymes, liver failure (cholestasis and jaundice), and even hepatitis, which decreased discontinuation of treatment; only a few cases have led to life-threatening liver failure.

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