MUCOSOLVAN NEBUL 40ML 7,5MG/ML

MUCOSOLVAN 7,5 MG/ML SOLVED BY NEBULZATION

active ingredients

100 ml of solution contain: active ingredient: ambroxol hydrochloride 750 mg. For the full list of excipients, see paragraph 6.1.

Excellent

citric acid, bisodium phosphate, chloride sodium, benzalconio chloride, distilled water.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Severe liver and kidney alterations. Intake of the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see paragraph 4.4).

Population

We recommend the following dosages unless otherwise prescribed: Children up to 5 years: 1-2 ml solution 1-2 times a day. Adults and children over 5 years: 2-3 ml solution 1-2 times a day. Mucosolvan solution to nebulize can be used in various inhalation devices. It is mescible with saline physiological solutions and it is recommended to dilute in equal parts (Report 1:1) to obtain an optimal humidification of the air emitted by the inhaler. Mucosolvan solution to nebulize should not be mixed with chromoglycolic acid. Mucosolvan solution to nebulize should not be mixed with other solutions whose resulting mixture has a pH greater than 6.3, such as alkaline solutions for nebulization (emser salts). Due to the increase in pH the precipitation of the free base of the hydrochloride ambroxol or the softening of the solution may occur. Since inhalation itself can result in coughing, it is recommended to breathe normally during inhalation. It is recommended to heat the solution up to the body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. In acute respiratory distress, contact your doctor if symptoms do not improve or worsen during treatment with Mucosolvan.

Conservation

This medicine does not require any special condition of conservation. For the validity period after first opening, see paragraph 6.3.

Warnings

Ambroxol Hydrochloride should be administered with caution in patients carrying peptic ulcer. Cases of severe 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 hydrochloride should be stopped immediately and a doctor should be consulted. Most of these reactions could be explained by the severity of underlying diseases or other concomitant drugs. 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. In case of compromised kidney function, Mucosolvan can only be used after consulting the doctor. Important information about some excipients: Mucosolvan solution to nebulize contains benzalconio chloride as preservative. As a result of inhalation, this preservative can cause bronchospasm in sensitive patients with airway hyperreactivity. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “without sodium”.

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

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Municipality ≥ 1/100, Immune disorders. Rare: hypersensitivity reactions; Notable: anaphylactic reactions including anaphylactic shock, angioedema and itching. Pathologies of skin and subcutaneous tissue. Rare: rash, hives; Notable: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Nervous system pathologies. Municipality: disgeusia. Gastrointestinal disease. Common: nausea, oral hypoesthesia; Not common: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth; Rare: dry throat. Pirosis has been reported. Respiratory, thoracic and mediastinic pathologies. Common: pharyngeal hypoesthesia. 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 via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

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 Mucosolvan's undesirable expected effects at recommended doses and may require symptomatic treatment.

Pregnancy

Ambroxol Hydrochloride crosses the placental barrier. Preclinical 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, no harmful effects after 28^a week of gestation, it is recommended to take normal precautions on taking medications in pregnancy. Especially during the first quarter, Mucosolvan is not recommended.

Food

Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects in breast-feededed children, the use of Mucosolvan is not recommended during feeding.

Fertility

Preclinical studies have not evidenced directly or indirectly harmful effects for fertility.

Source: Farmadati