Muciclar 15 mg/2 ml 30×2 ml nebulising solution

Muciclar 15 mg/2 ml nebulizing solution is a mucolytic drug based on ambroxol hydrochloride , specifically formulated for the treatment of acute and chronic bronchopulmonary conditions characterized by excessive mucus production and difficulty in expectoration. Each pack contains 30 single-dose containers of 2 ml , ideal for use via aerosol or nebulization devices, ensuring precise and practical dosing for both adults and children.

Thanks to its targeted action, Muciclar nebulizing solution promotes the fluidification and elimination of phlegm and mucus from the respiratory tract , helping to clear the airways and reduce productive coughs . The active ingredient, ambroxol , acts directly on bronchial secretion, making the mucus less viscous and facilitating its expulsion. This makes the product particularly suitable for those suffering from bronchitis, tracheitis, and other respiratory diseases that involve an accumulation of secretions.

The nebulized solution formulation allows for rapid and localized action, ideal for the treatment of respiratory diseases in both the acute and chronic phases. Muciclar is an effective ally for the treatment of coughs and for improving the quality of breathing, offering rapid and long-lasting relief. The practicality of single-dose vials ensures hygiene and ease of use, making the product also suitable for use outside the home.

Trust Muciclar 15 mg/2 ml nebulizer solution for effective support in the management of bronchial secretions and to promote the well-being of the respiratory tract , both in adults and children. Available in the best online pharmacies .

ACTIVE INGREDIENTS

Active ingredients contained in Muciclar 15 mg/2 ml 30×2 ml nebulising solution - What is the active ingredient of Muciclar 15 mg/2 ml 30×2 ml nebulising solution?

MUCICLAR 15mg/2ml solution for nebulisation One single-dose container contains: Active ingredient: ambroxol hydrochloride 15 mg. MUCICLAR 15mg/5ml syrup 100ml of syrup contain: Active ingredient: ambroxol hydrochloride 300 mg. MUCICLAR 75mg prolonged-release capsules One capsule contains: Active ingredient: ambroxol hydrochloride 75 mg. MUCICLAR 30mg granules for oral solution One sachet contains: Active ingredient: ambroxol hydrochloride 30 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Muciclar 15 mg/2 ml 30×2 ml nebuliser solution - What does Muciclar 15 mg/2 ml 30×2 ml nebuliser solution contain?

Nebulizer solution : sodium chloride, water for injections. Syrup : sorbitol solution, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry essence, purified water. Capsules : sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone. Granules : sucrose, orange flavouring, pineapple flavouring.

DIRECTIONS

Therapeutic indications Muciclar 15 mg/2 ml 30×2 ml nebulising solution - Why is Muciclar 15 mg/2 ml 30×2 ml nebulising solution used? What is it used for?

Secretion disorders in acute and chronic bronchopulmonary diseases.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Muciclar 15 mg/2 ml 30×2 ml nebuliser solution - When should Muciclar 15 mg/2 ml 30×2 ml nebuliser solution not be used?

Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Severe hepatic and/or renal alterations. Taking the medicine is contraindicated in case of rare hereditary pathologies 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).

DOSAGE

Quantity and method of taking Muciclar 15 mg/2 ml 30×2 ml nebulising solution - How is Muciclar 15 mg/2 ml 30×2 ml nebulising solution taken?

Inhalation use : Muciclar 15 mg/2 ml nebulising 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 mixed in the dispenser with distilled water in a 1:1 ratio, thus obtaining optimal humidification of the air to be breathed. Oral use : Muciclar 15 mg/5 ml 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 75 mg prolonged-release capsules : adults: 2 capsules are recommended in a single administration after breakfast in the morning for 8 days (attack 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.

CONSERVATION

Storage Muciclar 15 mg/2 ml 30×2 ml nebuliser solution - How is Muciclar 15 mg/2 ml 30×2 ml nebuliser solution stored?

Syrup, capsules, granules for oral solution Store at a temperature not exceeding 25° C. Solution for nebulization No special precautions for storage. After opening the aluminum pouch containing the single-dose containers of solution for nebulization, the medicine must be used within three months; after this period, the unused medicine must 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 medicine must be discarded.

WARNINGS

Warnings Muciclar 15 mg/2 ml 30×2 ml nebulising solution - It is important to know that Muciclar 15 mg/2 ml 30×2 ml nebulising solution:

Ambroxol should be administered with caution to patients with peptic ulcer. 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 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 stopped immediately and a doctor should be consulted. Furthermore, in the early phase of Stevens–Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience non-specific flu-like symptoms such as fever, chills, rhinitis, cough and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy may be initiated. If new lesions of the skin or mucous membranes occur, consult your doctor immediately and discontinue treatment with ambroxol as a precaution. During administration of the nebulized solution, since excessively deep inhalation of aerosols may cause irritation coughing, you should try to inhale and exhale normally during inhalation. In particularly sensitive patients, pre-warming of the inhaled product to body temperature may be recommended. For patients with bronchial asthma, it is advisable to use 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 ambroxol metabolites in the liver is to be expected in the presence of severe renal insufficiency. Mucolytics may induce bronchial obstruction in children under 2 years of age. In fact, 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: – para-hydroxybenzoates : may cause allergic reactions (even delayed). – sorbitol : unsuitable in hereditary fructose intolerance. May cause gastric disorders and diarrhoea. – glycerol : dangerous in high doses. May cause migraine, gastric disorders 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 account in pregnant or breastfeeding women, in children and in 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.

INTERACTIONS

Interactions Muciclar 15 mg/2 ml 30×2 ml solution for nebulisation - Which medicines or foods can modify the effect of Muciclar 15 mg/2 ml 30×2 ml solution for nebulisation?

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.

SIDE EFFECTS

Like all medicines, Muciclar 15 mg/2 ml 30×2 ml solution for nebulisation can cause side effects - What are the side effects of Muciclar 15 mg/2 ml 30×2 ml solution for nebulisation?

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. altered sense of taste) Rare: Headache Respiratory, thoracic and mediastinal disorders Common: Hypoaesthesia of the mouth and pharynx Rare: Rhinorrhoea 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 Systemic disorders and conditions related to the administration site Rare: Tiredness Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. 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

Overdose Muciclar 15 mg/2 ml 30×2 ml solution for nebulization - What are the risks of Muciclar 15 mg/2 ml 30×2 ml solution for nebulization in case of overdose?

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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Muciclar 15 mg/2 ml 30×2 ml nebulising solution.

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 adopt the usual precautions when taking medicines during pregnancy. Especially during the first trimester, taking ambroxol is not recommended. The medicine is excreted in breast milk, therefore the use of ambroxol is not recommended during breastfeeding. However, no negative effects on the infant are foreseeable. During pregnancy and breastfeeding, the medicine should be administered only in case of real need and under the direct supervision of a doctor.

DRIVING AND USE OF MACHINERY

Taking Muciclar 15 mg/2 ml 30×2 ml nebuliser solution before driving or using machines - Does Muciclar 15 mg/2 ml 30×2 ml nebuliser solution affect driving or using machines?

There is no evidence of an effect on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.