GALVUS 50mg 28 TABLET / جالفس 50مغ 28 قرص

Galvus®

NAME OF THE MEDICINAL PRODUCT Galvus 50 mg tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 mg of vildagliptin.

 CLINICAL PARTICULARS

Therapeutic indications

Vildagliptin is indicated in the treatment of type 2 diabetes mellitus:

 As dual oral therapy in combination with

-        metformin, in patients with insufficient glycaernic control despite maximal  tolerated dose of monotherapy with metformin,

-         a sulphonylurea, in patients With insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin IS inappropriate due to contraindications  or intolerance,

-         A thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.

Posology and method of administration

 Adults

When used in dual combination with metformin or thiazolidinedione, the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.

When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.

Galvus can be administrated with or without a meal

Paediatric population (<18 years)

Galvus is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Galvus should not be used during pregnancy and lactation.

Special warnings and precautions for use

Galvus is not suitable for insulin in insulin-requiring patients. Galvus should not be used n patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Interaction with other medicinal products and other forms of interaction

 Vildagliptine has a low potential for interactions with co-administration medical products.