MUCICLAR SCIR 200ML 15MG/5ML

MUCICLAR

active ingredients

MUCICLAR 15mg/2ml solution to nebulize A single-dose container contains: Active ingredient: ambroxol hydrochloride 15 mg. MUCICLAR 15mg/5ml syrup 100ml of syrup contains: Active ingredient: ambroxol hydrochloride 300 mg. MUCICLAR 75mg prolonged release capsules One capsule contains: Active ingredient: ambroxol hydrochloride 75 mg. MUCICLAR 30mg granulated oral solution A bag contains: Active ingredient: ambroxol hydrochloride 30 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Nebulizing solution: sodium chloride, water for injectable preparations. Syrup: sorbitol solution, glycerin, methyl p–hydroxybenzoate, propile p–hydroxybeanzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry essence, purified water. Capsules: sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone. Granulated: sucrose, orange aroma, pineapple aroma.

Therapeutic indications

Turbs of secretion in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to ambroxol hydrochloride or any of the excipients. Severe liver and/or kidney alterations. Intake of the medicinal product is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see par. 4.4.). The medicinal product is contraindicated in children under 2 years of age (for oral forms).

Population

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, the content of a single-dose container of Muciclar can be mixed in the dispenser unit with distilled water in the ratio 1:1, thus obtaining optimum humidity of air to breathe. Oral use: Muciclar 15mg/5ml syrup: adults: 5–10 ml syrup 3 times a day, children over two years of age: 5 ml syrup 2 or 3 times a day. Muciclar 75mg extended release capsules: adults: 2 capsules are recommended in one administration after morning breakfast for 8 days (attack therapy). Subsequently, posology may be reduced to one capsule until the end of treatment. Muciclar 30mg granulated oral solution: adults: a bag 2–3 times a day.

Conservation

Syrup, capsules, granulated oral solution Store at a temperature not exceeding 25° C. Nebulizing solution No special precaution for conservation. After the opening of the aluminum envelope containing the solution monodose containers to be sprayed, the medicine must be used within three months; after that period, the unused medicinal product must be eliminated. When using half a dose of the single-dose container, the closed container must be kept at 2 – 8° C (in the refrigerator) at most for 12 hours; after this period the remaining medicine must be eliminated.

Warnings

Ambroxol must be administered with caution in patients carrying peptic ulcer. Serious skin reactions such as multiform erythema, Stevens–Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. In addition, in the initial phase of Stevens–Johnson's syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific symptoms similar to flu symptoms, such as fever, chills, rhinitis, cough and throat pain. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy is possible. If new lesions of the skin or mucosa occur, consult your doctor immediately and precautionally stop the treatment with ambroxol. During the administration of the solution to be nebulized, since in the too deep intake of aerosols it may arise coughs from irritation, it should be sought during inhalation to inhale and exhale normally. Particularly sensitive patients can recommend a preheating of inhalation at body temperature. For patients with bronchial asthma it is appropriate to resort to a bronchial spasmolytic before inhalation. In case of mild or moderate kidney failure, Muciclar can only be used after consulting the doctor. As with all medicines subject to hepatic metabolism and subsequent kidney elimination, the accumulation of ambroxol metabolites in the liver is predictable in the presence of severe kidney failure. Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They should not therefore be used in children under 2 years of age (for oral forms) (see par. 4.3.). I do syrup contains: – para–hydroxybenzoates: can cause allergic reactions (also delayed). – sorbitol: unsuitable in hereditary intolerance to fructose. It can cause gastric disorders and diarrhea. – glycerol: dangerous at high doses. It can cause migraine, gastric disorders and diarrhea. I do syrup it also contains 3 vol % of 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. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. The capsules and the granulated oral solution contain sucrose, therefore, patients with rare hereditary problems of fructose intolerance, glucose–galactose mal absorption, or sucrasis–isomaltasis failure, should not take this medicine.

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No interactions with other medicines have been reported.

Effects

The desired 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, itching and other hypersensitivity reactions Diseases of the nervous system City: Disgeusia (e.g. alterations of the sense of taste) Rare: Cephalea Respiratory, chest and mediastinic pathologies City: Hypoesthesia of oral cavity and Rare pharynx: Rinorrea Notable: Bronchial obstruction Gastrointestinal diseases City: Nausea Not common: Vomito, diarrhea, dyspepsia and abdominal pain, dryness of the Rare bundles: Pirosis, stips Not known: Dry gorge Pathologies of skin and subcutaneous tissue Rare: rash, hives, contact dermatitis Not known: severe skin adverse reactions (including multiform erythema, Stevens–Johnson syndrome/toxic epidermal necrolysis and generalized acute urstolosis) Kidney and urinary pathologies Rare: Disuria Systemic pathologies and conditions for administration Rare: Tiredness 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 through www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

So far no specific symptoms of overdose have been reported in man. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of medicinal products are consistent with the expected effects of Muciclar at recommended doses and may require symptomatic treatment.

Ambroxol crosses the placental barrier. Animal studies have not evidenced directly or indirectly harmful effects for pregnancy, embryo/fetal development, birth or post-natal development. Despite preclinical studies and extensive clinical experience have not shown any harmful effects for the fetus after 28^aweek of gestation, it is recommended to take the normal precautions on taking medications during pregnancy. Especially during the first trimester, ambroxol is not recommended. The medicine is excreted in breast milk, therefore the use of ambroxol is not recommended during breastfeeding. However, no negative effect on the infant is hypothesized. In pregnancy and during breastfeeding, the medicine will be administered only in case of actual need and under the direct control of the doctor.

Source: Farmadati