SINECOD TOSSE SED 200ML3MG/10G

SINECOD TOSSE SEDATIVO

active ingredients

SINECOD TOSSE SEDATIVO 2 mg/ml oral drops, solution 1 g solution (equal to 20 drops) contains: Active ingredient: butamirate citrate mg 2 (equal to butamirate mg 1,3 about). Excipients with known effects: ethanol 96 percent, methyl parahydroxybenzoate, sucrose. SINECOD TOSSE SEDATIVO 3 mg/10 g syrup 100 g syrup contains: Active ingredient: butamirate citrate g 0.0345 (equal to butamirate mg 21,3 ca). Excipients with known effects: ethanol, methyl parahydroxybenzoate, sorbitol. SINECOD TOSSE SEDATIVO 5 mg pills A pastel contains: Active ingredient: butamirate citrate mg 5 (equal to butamirate mg 3.1 ca). For the full list of excipients, see paragraph 6.1.

Excellent

SINECOD TOSSE SEDATIVO 2 mg/ml oral drops, solution: Glicerolo; sucrose; anetolo; vanillin; ethanol 96 percent; methyl parahydroxybenzoate; purified water. SINECOD TOSSE SEDATIVO 3 mg/10 g syrup: Citric acid; glycerol; sorbitol; anetolo; vanillin; methyl parahydroxybenzoate; ethanol; purified water. SINECOD TOSSE SEDATIVO 5 mg pills: Isomalto; mint essence; levomentol; potassic acesulphame; neoesperidine dihydrocalcone; blend of vegetable oils and fats and corn starch.

Therapeutic indications

Cough sedative.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; Sinecod Tosse Sedative pills: children under the age of 12; Sinecod Tosse Sedative syrup and drops: children under the age of 6.

Population

SINECOD TOSSE SEDATIVO sugar-free tablets: Adults: 1 batter every 6 hours (as a maximum dose, 1 batter every 4 hours; you can use two tablets consecutively at the time of bedtime, in order to have a more prolonged effect during night hours). Kids (over 12 years): 1 pill every 12 hours. The pills must be sucked or chewed in the mouth. SINECOD TOSSE SEDATIVO drops: Children aged (6-12 years): 20 drops every 8-6 hours. Adults: 40 drops every 6-5 hours. Drops should be given in some water or milk. SINECOD TOSSE SEDATIVO syrup: Children aged (6-12 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. The treatment will 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. Pediatric population: Sinecod Tosse Sedativo pastiglie is contraindicated in children under the age of 12 (see paragraph 4.3 Contraindications). Sinecod Tosse Sedative syrup and Sinecod Tosse Sedative drops is contraindicated in children under the age of 6 (see paragraph 4.3 Contraindications).

Conservation

Sinecod Tosse Sedative oral drops, solution and syrup: this medicine does not require any particular condition of conservation. Sinecod Tosse Sedativo pads: do not store at temperature above 30°C.

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 Sinecod Sedative cough 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 lasting than in subjects with hepatic and/or normal kidney function. SINECOD TOSSE SEDATIVO 2 mg/ml oral drops, solution contains: - ETANOLO: This medicine contains 5.1 mg of alcohol (ethanol) in 1 ml which is equivalent to 4.46 mg/g. The quantity in 1 ml of this medicine is equivalent to less than 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. - PARAIDROSSIBENZOATI AND LORO ESTERI: it is known that they can cause hives. In general it can cause delayed reactions as contact dermatitis; rarely immediate reactions with hives and bronchospasm. - SACCAROSIO: this medicine contains about 19,5 g/100 ml of sugar (saccharosine). If taken following the recommended dosage each dose (15 drops) provides about 0.13 g of sugar (saccharosine). Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or isomaltase sucrasis failure, should not take this medicine. SINECOD TOSSE SEDATIVO 3 mg/10 g syrup contains: - ETANOLO: This medicine contains 4.35 mg of alcohol (ethanol) in 1 ml which is equivalent to 3.71 mg/g. The amount in 1 ml of this medicine is equivalent to less than 0.11 ml of beer or 0.05 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. - PARAIDROSSIBENZOATI AND LORO ESTERI: it is known that they can cause hives. In general they can cause delayed reactions as contact dermatitis; rarely immediate reactions with hives and bronchospasm. - SORBITLE: This medicine contains 2876 mg of sorbitol for 10 ml (children's dose) and 4314 mg for 15 ml (adult doses), equivalent respectively to 287.6 mg/ml. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. It can cause gastric disorders and diarrhea.

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, according to the classification for systems, organs and frequency. The frequencies are defined as: very common (≥ 1/10); common (≥1/100, not common (≥1/1.000, rare (≥ 1/10.000; very rare (not known (frequency cannot be defined on the basis of available data). Within each frequency class, adverse reactions are reported in decreasing order of gravity. Diseases of the nervous system Rare: drowsiness, dizziness. Gastrointestinal diseases Rare: nausea, diarrhea. Pathologies of skin and subcutaneous tissue Rare: hives. Immune system pathologies Not known: hypersensitivity reactions. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

An overdose of Sinecod Sedative cough can 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. There is no known specific antidote.

Safety of use during pregnancy and nursing has not been evaluated in specific studies. The use of Sinecod Tosse Sedativo must be avoided during the first three months of pregnancy. During the rest of the pregnancy Sinecod Sedative cough should be used only if it is strictly necessary. It is not known whether the active ingredient and/or one of its metabolites are excreted in breast milk. For safety reasons, as a general rule, before taking Sinecod Sedative cough during breastfeeding, you must carefully assess the risks and benefits.

Source: Farmadati