Oral solution for lung diseases.
Indications
Muciclar in case of secretion disorders in acute and chronic bronchopulmonary diseases.
Composition
Active ingredient: ambroxol hydrochloride 30 mg. Excipients: sucrose, orange flavoring, pineapple flavoring.
Directions for use and Dosage
Inhalation use: Muciclar 15 mg/2 ml nebulizing solution: adults: 2–3 single-dose containers per day, children: 1–2 single-dose containers per day. For inhalation use, the contents of a single-dose container of Muciclar can be used. It can be mixed in the dispenser with distilled water in a 1:1 ratio, thus obtaining optimal humidification of the air we breathe. Oral use: Muciclar 15mg/5ml syrup: adults: 5–10 ml of syrup 3 times a day, children over two years of age: 5 ml of syrup 2 or 3 times a day. Muciclar 75mg prolonged-release capsules: adults: 2 capsules are recommended in a single administration after breakfast for 8 days (initial therapy). Subsequently, the dosage may be reduced to a single capsule until the end of treatment. Muciclar 30mg granules for oral solution: adults: one sachet 2–3 times a day.
Warnings
Ambroxol should be administered with caution to patients with peptic ulcers. Cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and acute generalized exanthemal pustulosis (AGEP) have been reported with ambroxol administration. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a doctor should be consulted. Furthermore, in the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience nonspecific flu-like symptoms, such as fever, chills, rhinitis, cough, and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold medication may be initiated. If new skin or mucosal lesions occur, consult a doctor immediately and discontinue treatment with ambroxol as a precaution. When administering the nebulized solution, since excessively deep inhalation of aerosols may cause an irritating cough, try to inhale and exhale normally during inhalation. In particularly sensitive patients, prewarming the inhaled solution to body temperature may be recommended. Patients with bronchial asthma should take a bronchial antispasmodic before inhalation. In cases of mild or moderate renal insufficiency, Muciclar should be used only after consulting a doctor. As with all medicinal products subject to hepatic metabolism and subsequent renal elimination, accumulation of ambroxol metabolites in the liver is expected in the presence of severe renal insufficiency. Mucolytics may induce bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (for oral forms) (see section 4.3.). The syrup contains: – parahydroxybenzoates: may cause allergic reactions (possibly delayed). – sorbitol: unsuitable for hereditary fructose intolerance. May cause gastric disturbances and diarrhoea. – glycerol: dangerous in high doses. May cause migraine, gastric disturbances and diarrhoea. The syrup also contains 3 vol% ethanol (alcohol), e.g. up to 300 mg per dose (maximum dose), equivalent to 6 ml of beer, 2.5 ml of wine per dose. May be harmful for alcoholics. To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy. The capsules and granules for oral solution contain sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Contraindications
Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Severe liver and/or kidney disorders. Taking the medicine is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4). The medicine is contraindicated in children under 2 years of age (for oral forms).
Interactions
Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been reported.
Undesirable effects
The undesirable effects listed by frequency are reported using the following convention: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), frequency not known (frequency cannot be estimated from the available data). Immune system disorders Not known: Anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions Nervous system disorders Common: Dysgeusia (e.g., taste disturbances) Rare: Headache Respiratory, thoracic and mediastinal disorders Common: Hypoaesthesia of the mouth and pharynx Rare: Rhinorrhea Not known: Bronchial obstruction Gastrointestinal disorders Common: Nausea Uncommon: Vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth Rare: Heartburn, constipation Not known: Dry throat Skin and subcutaneous tissue disorders Rare: Rash, urticaria, contact dermatitis Not known: Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis) Renal and urinary disorders Rare: Dysuria General disorders and administration site conditions Rare: Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via www.agenziafarmaco.gov.it/it/responsabili.
Overdose
No specific symptoms of overdose have been reported in humans to date. The symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of medicinal products are consistent with the expected adverse effects of Muciclar at the recommended doses and may require symptomatic treatment.
Pregnancy and breastfeeding
Ambroxol 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 on the fetus after the 28th week of gestation, it is advisable to take the usual precautions when taking medications during pregnancy. Taking ambroxol is not recommended, especially during the first trimester. The medicine is excreted in breast milk, therefore, its use is not recommended during breastfeeding. However, no adverse effects on the infant are expected. During pregnancy and breastfeeding, the medicine should be administered only when strictly necessary and under the direct supervision of a doctor.
Format
30 sachets of 30 mg.
Product Code:FRCM109144
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