Muciclar syrup 200ml 15mg/5ml

MUCICLAR * SCIR 200ML 15MG / 5ML

Therapeutic indications

Disturbances of secretion in acute and chronic bronchopulmonary affections.

Dosage and method of use

Inhalation use:Muciclar 15 mg / 2 ml solution to be nebulised: 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 mixed in the dispensing device with distilled water in the ratio 1: 1, thus obtaining optimal humidification of the air to be breathed.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 in single administration are recommended after breakfast in the morning for 8 days (attack therapy). Subsequently, the dosage can be reduced to a single capsule until the end of the treatment.Muciclar 30mg granules for oral solution: adults: one sachet 2-3 times a day.

Contraindications

Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Severe hepatic and / or renal 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).

Side effects

Undesirable effects listed by frequency are reported, using the following convention: Very common (≥1 / 10); Common (≥1 / 100, Immune system disorders Not known: Anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactionsNervous system disordersCommon: Dysgeusia (e.g. changes in the sense of taste) Rare: HeadacheRespiratory, thoracic and mediastinal disordersCommon: Hypoesthesia of the oral cavity and pharynx Rare: Rhinorrhea Not known: Bronchial obstructionGastrointestinal disordersCommon: Nausea Uncommon: Vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth Rare: Heartburn, constipation Not known: Dry throatSkin and subcutaneous tissue disordersRare: rash, urticaria, contact dermatitis Not known: severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis)Renal and urinary disordersRare: DysuriaGeneral disorders and administration site conditionsRare: FatigueReporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Ambroxol 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 (TEN) and acute generalized exanthemic pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a physician consulted. 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, cough and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. If new lesions of the skin or mucous membranes occur, consult your doctor immediately and stop treatment with ambroxol as a precaution. During the administration of the solution to be nebulized, as coughing from irritation may arise in the too deep inhalation of the aerosols, it is necessary to try to inhale and exhale normally. In particularly sensitive patients, a pre-heating of the inhaled to body temperature may be recommended. For patients suffering from bronchial asthma it is advisable to resort to a bronchial spasmolytic before inhalation. In case of mild or moderate renal insufficiency, Muciclar can only be used after consulting your doctor. As with all medicinal products subject to hepatic metabolism and subsequent renal elimination, accumulation of the metabolites of ambroxol in the liver is expected in the presence of severe renal insufficiency. Mucolytics can induce bronchial obstruction in children under 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 under 2 years of age (for oral forms) (see par. 4.3.). Thesyrupcontains:- para – hydroxybenzoates: they can cause allergic reactions (even delayed).- sorbitol: unsuitable for hereditary fructose intolerance. It can cause stomach upset and diarrhea.- glycerol: dangerous in high doses. It can cause migraines, stomach upset and diarrhea. Thesyrupit also contains 3 vol% ofethanol (alcohol),eg. up to 300 mg per dose (maximum dose), equivalent to 6 ml of beer, 2.5 ml of wine per dose. 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. Thecapsulesand thegranules for oral solutioncontainsucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency, should not take this medicine.

Pregnancy and breastfeeding

Ambroxol crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryo / fetal development, parturition or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects on the fetus after 28^toweek of gestation, it is advisable to take the usual precautions when taking medicines during pregnancy. Especially during the first trimester it is not recommended to take ambroxol. The medicine is excreted in breast milk, therefore the use of ambroxol is not recommended during breastfeeding. However, no adverse effects on the infant are conceivable. During pregnancy and breastfeeding, the medicine should be administered only in case of real need and under the direct supervision of the doctor.

Expiry and retention

Syrup, capsules, granules for oral solutionStore at a temperature not exceeding 25 ° C.Solution to be sprayedNo particular precautions for storage. After opening the aluminum bag containing the single-dose containers of solution to be nebulized, the medicine must be used within three months; after this period, any unused medicinal product should be discarded. When using half a dose of the single-dose container, the closed container must be stored at 2 - 8 ° C (in the refrigerator) for a maximum of 12 hours; after this period the residual medicinal product must be discarded.

Interactions with other drugs

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.

Overdose

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

Active principles

MUCICLAR 15mg / 2ml solution to be sprayedA single-dose container contains: Active ingredient: ambroxol hydrochloride 15 mg.MUCICLAR 15mg / 5ml syrup100ml of syrup contain: Active ingredient: ambroxol hydrochloride 300 mg.MUCICLAR 75mg prolonged-release capsulesOne capsule contains: Active ingredient: ambroxol hydrochloride 75 mg.MUCICLAR 30mg granules for oral solutionOne sachet contains: Active ingredient: 30 mg ambroxol hydrochloride. For the full list of excipients, see section 6.1.

Excipients

Solution to be sprayed: sodium chloride, water for injections.Syrup: sorbitol solution, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybeanzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry essence, purified water.Capsules: sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone.Granulated: sucrose, orange flavor, pineapple flavor.