VISCOMUCIL SCIR 200ML 3MG/ML

VISCOMUCIL 3 MG/ML

active ingredients

Viscomucil 3 mg/ml syrup 100 ml contain: Active ingredients: Ambroxol Hydrochloride 300 mg. Excipients with known effects: Sorbitol, methyl-parahydroxybenzoate, Propile-parahydroxybenzoate, raspberry aroma (which contains ethanol). For the full list of excipients see paragraph 6.1

Excellent

Sorbitol, glycerine, methyl para-hydroxybenzoate; propile para-hydroxybenzoate; raspberry essence; purified water.

Therapeutic indications

Treatment of acute respiratory affections characterized by dense and viscous hypersecretion.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Severe liver and/or kidney alterations. The drug is contraindicated in children under 2 years of age.

Population

Adults: 10 ml (30 mg) 3 times a day. Children from 2 to 5 years: 2.5 ml (7,5 mg) 3 times a day. Children over 5 years: 5 ml (15 mg) 3 times a day. It is recommended to take syrup after meals. Do not use Viscomucil for protracted treatments.

Conservation

None.

Warnings

Viscomucil should be administered with caution in patients with peptic ulcer. Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Cases of severe skin reactions such as multiform erythema, Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. Viscomucil contains sorbitol This medicine contains 3.5 g sorbitol per dose of 10 ml syrup. Patients with hereditary fructose intolerance should not be given this medicine. Viscomucil contains p-hydroxybenzoate This medicine contains p-hydroxybenzoate methyl and p-hydroxybenzoate propile that can cause allergic reactions (also delayed). Viscomucil contains ethanol (from raspberry aroma) This medicine contains 15 mg of alcohol (ethanol) per dose of 10 ml syrup. The quantity in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

Viscomucil generally does not interfere with other drugs.

Effects

Rarely: fatigue, dry mouth, rhyrrhea, dysuria, headache, gastrointestinal disorders (pyrosis, dyspepsia, stipsi, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes). Frequency not known: bronchial obstruction. Immune disorders. Rare: hypersensitivity reactions; Notable: anaphylactic reactions, including anaphylactic shock, angioedema and itching. Pathologies of skin and subcutaneous tissue. Rare: rash, hives; Notable: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Ambroxol overdose data is limited. Syntomatology corresponds to the undesirable effects described. In case of need to implement suitable symptomatic and support therapy.

Clinical data relating to exposed pregnancy are not available for ambroxol. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see paragraph 5.3). It is necessary to be prudent in prescribing the medicine to pregnant women. In pregnancy drugs should only be prescribed if the expected benefit for the mother is considered greater than the risk of the fetus. All drugs 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 it is necessary to decide whether to stop breastfeeding or treatment with the medicinal product, taking into account the importance of the drug for the mother.

Source: Farmadati