VISCOMUCIL * SCIR 200ML 3MG / ML

VISCOMUCIL * SCIR 200ML 3MG / ML

Therapeutic indications

Treatment of acute respiratory diseases characterized by thick and viscous hypersecretion.

Dosage and method of use

Adults: 10 ml (30 mg) 3 times a day. Children 2 to 5 years: 2.5ml (7.5mg) 3 times a day. Children over 5 years: 5 ml (15 mg) 3 times a day. It is recommended to take the syrup after meals. Do not use Viscomucil for prolonged treatments

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Severe hepatic and / or renal disorders. The drug is contraindicated in children under 2 years of age.

Side effects

Rarely: tiredness, dry mouth, rhinorrhea, dysuria, headache, gastrointestinal disturbances (heartburn, dyspepsia, constipation, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes). Unknown frequency: bronchial obstruction.

Special warnings

Viscomucil should be administered with caution in patients with peptic ulcer. Due to the sorbitol present in the formulation, individuals with rare hereditary forms of fructose intolerance should not take this medicine. The amount of sorbitol contained in this medicinal product may cause a mild laxative effect. The caloric value of sorbitol is 2.6 kcal / g. The product contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate which can cause allergic reactions (including delayed type). 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 below 2 years of age (see section 4.3).

Pregnancy and breastfeeding

For ambroxol, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing the medicine to pregnant women. In pregnancy, drugs should only be prescribed if the expected benefit to the mother is considered to be greater than the risk to the fetus. All medications should be avoided, if possible, during the first trimester of pregnancy. The drug is excreted in breast milk. The use of ambroxol by the mother can cause undesirable effects in the infant; therefore, a decision must be made whether to discontinue breastfeeding or treatment with the drug, taking into account the importance of the drug to the mother.

Expiration and retention

None

Interactions with other drugs

Viscomucil generally does not interfere with other medications

Overdose

There are limited data on ambroxol overdose. Symptoms corresponding to the undesirable effects described are to be expected. If necessary, implement suitable symptomatic and supportive therapy.

Active principles

Viscomucil 3 mg / ml syrup 100 ml contain: Active ingredients: Ambroxol hydrochloride 300 mg Excipients: Sorbitol Methyl – parahydroxybenzoate Propyl – parahydroxybenzoate For the full list of excipients see section 6.1

Excipients

Sorbitol, glycerin, methyl para-hydroxybenzoate; propyl para-hydroxybenzoate; raspberry essence; purified water.