MUCOSOLVAN 20CPS 75MG RP

MUCOSOLVAN 75 MG CAPSUES REPLACED

active ingredients

A rigid capsule contains: active ingredient: ambroxol hydrochloride 75 mg. For the full list of excipients, see paragraph 6.1.

Excellent

stearilic alcohol, carnauba wax, chrospovidone, magnesium stearate; operculum: gelatin, titanium dioxide, iron oxide yellow, iron oxide red.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to ambroxol or any of the excipients listed in the paragraph 6.1. Severe liver and kidney alterations. Children.

Population

The recommended dose is: 1 capsule per day (75 mg) to be taken in the morning after breakfast. Do not exceed the recommended doses. The capsules should not be open or chewed, but must be swallowed whole with plenty of water or other liquids. The possible presence in the feces of the shells of the granules that convey the active ingredient has no meaning since they have already released the drug during the passage through the digestive system. MUCOSOLVAN 75 mg long-release rigid capsules is contraindicated in children (see paragraph 4.3).

Conservation

Do not store over 30°C.

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.

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); Common (≥ 1/100, Immune system disorders: Rare: hypersensitivity reactions Not known: 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). Gastrointestinal diseases: Common: nausea. Not common: diarrhea, abdominal pain, vomiting, dyspepsia. Pirosis has been reported. 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 have not shown any harmful effects for the fetus 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