AMARYL 3.0 TABLETS 3 mg

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET

**Posology and method of administration** For oral administration The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet. Posology Dose is determined by the results of blood and urinary glucose determinations. The starting dose is 1 mg glimepiride per day. If good control is achieved this dose should be used for maintenance therapy. For the different dose regimens appropriate strengths are available. If control is unsatisfactory the dose should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg glimepiride per day. A dose of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day. In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated. While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up depending on the desired level of metabolic control up to the maximum daily dose. The combination therapy should be initiated under close medical supervision. In patients not adequately controlled with the maximum daily dose of Amaryl, concomitant insulin therapy can be initiated if necessary. While maintaining the glimepiride dose, insulin treatment is started at low dose and titrated up depending on the desired level of metabolic control. The combination therapy should be initiated under close medical supervision. Normally a single daily dose of glimepiride is sufficient. It is recommended that this dose be taken shortly before or during a substantial breakfast or - if none is taken – shortly before or during the first main meal. If a dose is forgotten, this should not be corrected by increasing the next dose. If a patient has a hypoglycaemic reaction on 1 mg glimepiride daily, this indicates that they can be controlled by diet alone. In the course of treatment, as an improvement in control of diabetes is associated with higher insulin sensitivity, glimepiride requirements may fall. To avoid hypoglycaemia timely dose reduction or cessation of therapy must therefore be considered. Change in dose may also be necessary, if there are changes in weight or life style of the patient, or other factors that increase the risk of hypo- or hyperglycaemia. - _**Switch over from other oral hypoglycaemic agents to Amaryl**_ A switch over from other oral hypoglycaemic agents to Amaryl can generally be done. For the switch over to Amaryl the strength and the half-life of the previous medicinal product has to be taken into account. In some cases, especially in antidiabetics with a long half-life (e.g. chlorpropamide), a wash out period of a few days is advisable in order to minimise the risk of hypoglycaemic reactions due to the additive effect. The recommended starting dose is 1 mg glimepiride per day. Based on the response the glimepiride dose may be increased stepwise, as indicated earlier. - _**Switch over from Insulin to Amaryl**_ In exceptional cases, where type 2 diabetic patients are regulated on insulin, a changeover to Amaryl may be indicated. The changeover should be undertaken under close medical supervision. - _**Special Populations**_ Patients with renal or hepatic impairment: See section Contraindications. - _**Paediatric population:**_ There are no data available on the use of glimepiride in patients under 8 years of age. For children aged 8 to 17 years, there are limited data on glimepiride as monotherapy. The available data on safety and efficacy are insufficient in the paediatric population and therefore such use is not recommended. Method of administration Tablets should be swallowed without chewing with some liquid.