Coryfin Expectorant 3 mg/ml Ambroxol Syrup 200 ml

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary affections.

Dosage

Posology Adults In the first days of treatment 10 ml, 3 times a day; then 5 ml, 3 times a day. Pediatric population In children 2 to 5 years: 2.5 ml, 3 times a day; over 5 years: 3 ml, 4 times a day.

Overdose

No specific symptoms of overdose in humans have been reported to date. Symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the expected side effects of CORYFIN EXPECTORANT at recommended doses and may require symptomatic treatment.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Severe liver and kidney disorders. • In children under 2 years of age.

Side effects

Adverse reactions are listed below by system organ class and frequency according to the following categories: Very common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1 / 1,000 to <1/100 Rare ≥ 1 / 10,000 to <1 / 1,000 Very rare <1 / 10,000 Not known frequency cannot be estimated from the available data. Immune system disorders : Rare: hypersensitivity reactions. Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders : Rare: rash, urticaria. Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis. Nervous system disorders : Common: dysgeusia. Gastrointestinal disorders : Common: nausea, oral hypoesthesia. Uncommon: vomiting , diarrhea, dyspepsia, abdominal pain, dry mouth Not known: dry throat. Heartburn has also been reported. Respiratory, thoracic and mediastinal disorders : Common: pharyngeal hypoesthesia . Not known: bronchial obstruction. Suspected adverse reactions occurring after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic / fetal development, parturition or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects after the 28th week ^of gestation, it is recommended that normal precautions be taken when taking medications during pregnancy. Especially during the first trimester it is not recommended to take CORYFIN EXPECTORANT. Ambroxol hydrochloride is excreted in breast milk. Although no adverse effects are expected in breastfed infants, the use of CORYFIN EXPECTORANT is not recommended during breastfeeding.

Special warnings

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 less than 2 years of age (see section 4.3). Ambroxol hydrochloride should be administered with caution to patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens Johnson syndrome (SJS) / toxic epidermal necrolysis (NET) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. Most of these could be explained by the severity of underlying disease or other concomitant medications. Also in the early stage of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific flu-like symptoms, such as fever, chills, rhinitis, cold and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be stopped immediately and a physician consulted. In case of impaired renal function, CORYFIN EXPECTORANT can only be used after consulting your doctor. Avoid mixing CORYFIN EXPECTORANT with solutions having an alkaline reaction, as clouding and / or flocculation phenomena may occur due to the acidity of the CORYFIN EXPECTORANT solution (pH = 5.0). CORYFIN EXPECTORANT contains : - Sodium bisulfite : it can rarely cause severe hypersensitivity reactions and bronchospasm. - Sorbitol : patients with rare hereditary problems of fructose intolerance should not take this medicine. It may have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal / g. - Methyl parahydroxybenzoate : can cause allergic reactions (even delayed). - Ethanol : This medicine contains 3.8 vol% ethanol (alcohol), eg. up to 300 mg per serving (10 ml), equivalent to 7.6 ml of beer, 3.1 ml of wine per serving. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. The doses indicated for children from 2 to 5 years and for children over 5 years contain small quantities of ethyl alcohol (ethanol), less than 100 mg per dose.

Expiry and Retention

This medicine does not require any special storage conditions.

Active principles

100 ml of syrup contain: ambroxol hydrochloride 300 mg. Excipients with known effects : non-crystallizable liquid sorbitol (E420), methyl parahydroxybenzoate (E218), sodium bisulfite (E222), 96 percent ethanol. For the full list of excipients, see section 6.1.

Excipients

Non crystallizable liquid sorbitol (E420), glycerol, methyl paradroxybenzoate (E218), benzoic acid (E210), sodium bisulfite (E222), licorice extract, raspberry essence, 96 percent ethanol, purified water.