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). Frequency not known: bronchial obstruction. Disorders of the immune system. Rare: hypersensitivity reactions; Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders. Rare: rash, hives; Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Viscomucil should be administered with caution in patients with peptic ulcer. Mucolytics can induce bronchial obstruction in children under 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). There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a physician consulted.Viscomucil contains sorbitolThis medicine contains 3.5g sorbitol per 10ml syrup dose. Patients with hereditary fructose intolerance should not be given this medicine.Viscomucil contains p-hydroxybenzoatesThis medicinal product contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (including delayed).Viscomucil contains ethanol (from raspberry flavor)This medicine contains 15 mg of alcohol (ethanol) per 10 ml syrup dose. The amount in 10ml of this medicine is equivalent to less than 1ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not produce relevant effects.

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

Data on ambroxol overdose are limited. 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 with known effects: Sorbitol, Methyl-parahydroxybenzoate, Propyl-parahydroxybenzoate, raspberry flavor (which contains ethanol). For the full list of excipients see section 6.1

Excipients

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