Medicinal Products

AMAREL 1 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Glimepiride
laboratory: Sanofi-Aventis France

Compressed
Box of 120
All forms

Indication

This medication is indicated in non-insulin-dependent (type 2) diabetes mellitus in adults when diet, exercise and weight reduction alone are not sufficient to restore glycemic control.

Dosage AMAREL 1 mg Tablet Box of 120

Oral way

The basis of an effective diabetes treatment is a proper diet, regular physical activity as well as regular blood and urine tests. Non-compliance with the diet can not be offset by taking tablets or insulin treatment.

Dosage

The dosage depends on the results of blood glucose and glycosuria.

For the different dosages, several dosages are available.

The initial dosage of glimepiride is 1 mg per day, or 1 tablet per day:

· If glycemic control is satisfactory, this dosage may be adopted as maintenance therapy.

· If the glycemic control is insufficient, the dosage should be increased according to the glycemic balance to 2, 3 or 4 mg per day, in successive stages, respecting an interval of approximately 1 to 2 weeks between each level.

A dosage higher than 4 mg / day of glimepiride gives better results than in exceptional cases. The maximum recommended dose is 6 mg glimepiride daily.

In patients inadequately balanced with daily or daily maximum doses of metformin, the combination of glimepiride may be initiated. While maintaining the dosage of metformin, glimepiride will be started at low doses and then gradually increased to maximum doses, depending on the metabolic balance sought. The association will be started under strict medical supervision.

In patients inadequately balanced with maximum dose AMAREL, insulin therapy may be combined if necessary. Insulin therapy will be started at a low dose while maintaining the dosage of glimepiride.

The insulin dose will be adjusted according to the level of glycemic control desired. The combination with insulin should be instituted under strict medical supervision.

As a general rule, a single daily dose of AMAREL is sufficient. It is recommended to take the medicine immediately before or during a substantial breakfast, or - if the patient does not have breakfast - immediately before or during the first main meal.

Forgetting a dose should never be offset by taking a higher dose.

If the patient has a hypoglycaemic reaction after taking a 1 mg AMAREL tablet, treatment with diet alone may be considered in this patient.

The need for AMAREL may decrease during the course of treatment, the improvement in glycemic control resulting in greater sensitivity to insulin. In order to reduce the risk of hypoglycemia, a decrease in dosage or interruption of treatment may then be considered.

A change in dosage may also be necessary in the following cases: changes in the patient's weight, changes in lifestyle, appearance of factors that may increase the risk of hypoglycaemia or hyperglycemia.

Relay of another oral antidiabetic by AMAREL

The relay of an oral antidiabetic by AMAREL can generally be considered.

For switching to AMAREL, the dosage and half-life of the previous antidiabetic agent should be taken into account.

In some cases, particularly with long-half antidiabetics (eg chlorpropamide), a therapeutic window of a few days may be necessary 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 initiating a treatment with AMAREL, that is to say to start at the dosage of 1 mg / day, then increase the dosage in steps successively according to the metabolic results.

Insulin Relay by AMAREL

In exceptional cases of insulin-balanced type 2 diabetic patients, an AMAREL relay may be indicated.

This relay must be performed under strict medical supervision.

Special populations

Patients with renal or hepatic insufficiency : see section Contraindications .

Pediatric population:

There are no data available on the use of glimepiride in patients under 8 years of age. In children aged 8 to 17 years, data on the use of glimepiride monotherapy are limited (see sections Pharmacodynamic properties and Pharmacokinetic properties ).

The use of glimepiride is not recommended in the pediatric population given the lack of sufficient data on tolerance and efficacy.

Administration mode

The tablets are swallowed without chewing with a little liquid.

Against indications

AMAREL should not be taken in the following cases:

· Hypersensitivity to glimepiride, other sulfonylureas, sulfonamides, or any of the excipients listed under Composition,

· insulin-dependent diabetes,

· Diabetic coma,

· Ketoacidosis,

Severe renal or hepatic impairment: In these situations, insulin is recommended.

Amarel side effects

The following adverse reactions, reported in clinical studies and based on available data with glimepiride and other sulfonylureas, are listed below by organ system class and in descending order of frequency (very common: ≥ 1 / 10, frequent: ≥ 1/100 to <1/10, uncommon: ≥ 1/1000 to <1/100, rare ≥ 1/10000 to <1/1000, very rare: <1/10000, indeterminate frequency (no can be estimated on the basis of available data).

Hematologic disorders

Rare: thrombocytopenia, leukopenia, neutropenia, agranulocytosis, erythrocytopenia, haemolytic anemia and pancytopenia, usually reversible upon discontinuation of treatment.

Not known: severe thrombocytopenia (number of platelets <10 000 / mm3 or 10 giga / l) and thrombocytopenic purpura.

Immune system disorders

Very rare: leucocytoclastic vasculitis, moderate hypersensitivity reactions that may progress to more severe reactions with dyspnea, blood pressure or shock.

Not known: Cross-allergic reaction with sulfonylureas, sulfonamides and their derivatives is possible.

Metabolic and nutritional disorders

Rare: hypoglycemia.

These hypoglycemias appear most often from the outset, which can be severe and sometimes difficult to correct. The occurrence of these hypoglycaemias depends, as with any hypoglycemic treatment, on individual factors such as eating habits and the dose of the hypoglycemic agent (see Warnings and Precautions for Use section ).

Visual disorders

Not known: glycemic changes may result, especially at the beginning of treatment, transient visual disturbances.

Gastrointestinal disorders

Very rare: nausea, vomiting, diarrhea, abdominal distension, abdominal discomfort and abdominal pain, which may exceptionally lead to discontinuation of treatment.

Hepatobiliary disorders

Not known: elevation of liver enzymes.

Very rare: impaired hepatic function (with eg cholestasis and jaundice) or hepatitis may progress to liver failure.

Skin disorders

Not known: hypersensitivity reactions (pruritus, urticaria, rash and photosensitivity) may occur.

Other adverse effects

Very rare: hyponatremia.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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