FROBEN DRY COUGH SCIR 125ML

FROBEN SECTOR 1.7 MG/5ML

active ingredients

Syrup: 100 ml of syrup contain: active ingredient: 34,5 mg of butamirate citrate (equivalent to 21,3 mg of butamirate). Excipients with known effects: glycerol; 70% sorbitol; methyl p-hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Syrup: Citric acid; glycerol; 70% sorbitol; vanillin; p-hydroxybenzoate methyl; purified water.

Therapeutic indications

Cough sedative.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Children under the age of 6. The product contains sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Population

Syrup: Children between 6 and 12 years: 10 ml every 8-6 hours. Adults: 15 ml every 8-6 hours. Wash and dry the graduated scoop after each use and after use between different patients. Do not exceed the recommended doses. Prolonged use of cough sedatives is not justified. Treatment must be limited to the symptomatic period. If the cough persists for more than 7 days, in the presence of fever, dispnea or chest pain, the doctor must be consulted.

Conservation

No special precaution.

Warnings

Due to the inhibition of cough reflex by butamirate, concurrent use with expectorants should be avoided, because it can cause mucus stagnation in the respiratory tract with increased risk of bronchospasm and respiratory infection. In subjects with severe kidney and/or liver failure, FROBEN SECCA TOSSE should be administered only in case of actual need and under direct control of the doctor, taking into account that effective plasma rates of citrate butamirate may be higher and/or longer than in subjects with normal liver and/or kidney function. FROBEN SECCA TOSSE contains glycerol, sorbitol and parahydroxybenzoate. It can cause headaches, gastric disorders and diarrhea. Patients with rare hereditary problems of fructose intolerance should not take this medicine. It can cause allergic reactions (also delayed).

Interactions

Specific interaction studies have not been conducted. Concurrent use with expectors must be avoided (see paragraph 4.4).

Effects

Adverse reactions are listed below, depending on the classification for organ and frequency systems. The frequencies are defined as: very common (≥ 1/10); common (≥1/100, Nervous system pathologies. Rare: drowsiness, dizziness. Gastrointestinal diseases. Rare: nausea, diarrhea. Pathologies of skin and subcutaneous tissue. Rare: hives. Immune system pathologies. Not known: hypersensitivity reactions. Disorders of metabolism and nutrition. Rare: anorexia. 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

A overdose of FROBEN SECCA TOSSE may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness and hypotension. The usual emergency measures must be implemented: gastric lavender, active carbon administration, monitoring and maintenance of vital functions, if necessary. A specific antidote is not known.

Safety of use during pregnancy and lactation was not assessed in specific studies. Pregnancy: The use of FROBEN SECCA TOSSE must be avoided during the first three months of pregnancy. During the rest of pregnancy FROBEN SECCA TOSSE must be used only if it is strictly necessary. Nursing: It is not known whether the active ingredient and/or one of its metabolites are excreted in breast milk. For security reasons, as a general rule, before hiring FROBEN SECCA TOSSE during breastfeeding, the risks and benefits must be carefully assessed.

Source: Farmadati