Relogen 40mg / 5ml

Syrup

Composition :

RELOGEN 40 mg / 5 ml single-dose syrup One single-dose container contains: Active ingredient: Sobrerol 40 mg Excipients: Maltisorb (Maltylol 75%) 2.750 mg Sodium 28.3 mg RELOGEN 40 mg / 5 ml syrup 5 ml syrup contain: Active ingredient: Sobrerol 40 mg Excipients: Maltisorb (Maltylol 75%) 2,750 mg Sodium 28.3 mg methyl p-hydroxybenzoate 45.0 mg propyl p-hydroxybenzoate 1.5 mg For a full list of excipients, see section 6.1

Excipients

Single-dose syrup: Maltisorb (Maltitol 75%), Glycerol 98%, Sodium phosphate monobasic, Sodium hydroxide, water for injections Multidose syrup 200 ml: Maltisorb (Maltitol 75%), Glycerol 98%, Sodium monobasic phosphate, Sodium hydroxide, Methyl p –Hydroxybenzoate, Propyl p – hydroxybenzoate, water for injections.

Therapeutic indications

RELOGEN is used for the treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Contraindications

The drug is contraindicated in children under 2 years of age. Hypersensitivity to the active substance or to any of the excipients.

Dosage

Syrup: use the notches on the measuring cup as a reference. Children over 2 years: 10 ml twice a day Adults: 10-20 ml twice a day

Warnings and Precautions

Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (see section 4.3). Warnings related to some of the ingredients of RELOGEN Due to the presence of maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains 0.29 mmol sodium in 5 ml, i.e. more than 1 mmol sodium per 20 ml. To be taken into consideration in people on a low sodium diet. The multidose syrup also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (including delayed type).

Interactions

There are no known interactions of sobrerol with other drugs.

Side effects

Gastric upset and nausea may occur. Bronchial obstruction may occur with unknown frequency.

Pregnancy and breastfeeding

The safety of sobrerol is not sufficiently demonstrated in pregnancy and lactation; therefore RELOGEN should only be administered when, in the judgment of the physician, the potential benefits outweigh the possible risks.