LAMZARIN Prolonged-release tablet Ref.[49890] Active ingredients: Gliclazide

Posology

The daily dose may vary from 1 to 4 tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.

It is recommended that the tablet(s) be swallowed whole.

If a dose is forgotten, there must be no increase in the dose taken the next day.

As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient’s metabolic response (blood glucose, HbAlc).

Initial dose

The recommended starting dose is 30 mg daily.

If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.

The maximum recommended daily dose is 120 mg.

Switching from gliclazide 80 mg tablets to Lamzarin 30 mg Prolonged-release Tablets

1 tablet of gliclazide 80 mg is comparable to 1 tablet of Lamzarin 30 mg Prolonged-release. Consequently, the switch can be performed provided careful blood monitoring is undertaken.

Switching from another oral anti-diabetic agent to Lamzarin 30 mg Prolonged-release Tablets

Lamzarin 30mg Prolonged-release Tablets can be used to replace other oral anti-diabetic agents. The dosage and the half-life of the previous anti-diabetic agent should be taken into account when switching to Lamzarin 30mg Prolonged-release Tablets

A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient’s blood glucose response, as described above. When switching from a hypoglycaemic sulphonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.

The procedure described for initiating treatment should also be used when switching to treatment with Gliclazide Prolonged-release Tablets, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.

Combination treatment with other anti-diabetic agents

Lamzarin 30 mg Prolonged-release Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients not adequately controlled with Gliclazide, concomitant insulin therapy can be initiated under close medical supervision.

Special Populations

Older people (over 65 years of age)

Lamzarin 30mg Prolonged-release Tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.

Patients with mild to moderate renal insufficiency

The same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.

Patients at risk of hypoglycaemia

There is an increased risk of hypoglycaemia in the following circumstances:

• Undernourished or malnourished patients
• Patients with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency)
• Following withdrawal of prolonged and/or high dose corticosteroid therapy
• Patients with severe vascular disease (severe coronary heart disease, severe carotid impairment or diffuse vascular disease)

It is recommended that the minimum daily starting dose of 30 mg is used.

Paediatric population

The safety and efficacy of Lamzarin 30mg Prolonged-release Tablets in children and adolescents has not been established. No data and clinical studies are available in children.

Excipients

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

Method of administration

Oral use.

It is recommended that the tablet(s) be swallowed whole without chewing or crushing.

An overdose of sulphonylureas may cause hypoglycaemia. Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.

If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 ml of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/l. Patients should be monitored closely and, depending on the patient’s condition after this time, the doctor will decide if further monitoring is necessary.

Dialysis is of no benefit to patient’s due to the strong binding of gliclazide to proteins.

3 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC/Alu blisters.

PVC/Alu blister.

Pack sizes:

Blisters: 14, 28, 56 Prolonged-release Tablets.

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.