Mucosolvan 60mg Granules For Oral Solution 20 Sachets

NAME
MUCOSOLVAN 60 MG GRANULATE FOR ORAL SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with cough suppressants; mucolytics.

ACTIVE PRINCIPLES
Ambroxol hydrochloride.

EXCIPIENTS
Sodium saccharinate, sorbitol, raspberry flavor powder.

INDICATIONS
Ambroxol is indicated in the treatment of secretion disorders in acute and chronic bronchopulmonary affections.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; severe liver and kidney changes. The intake of the drug is contraindicated in case of rare hereditary pathologies which may be incompatible with one of the excipients.

DOSAGE
Adults: 1 sachet 2 times a day. Dissolve the contents of the granules sachet in about half a glass of water, tea or fruit juice. The granules must be taken dissolved, regardless of meals. Administrable to patients with diabetes. In acute respiratory conditions, seek medical attention if symptoms do not improve or worsen during treatment with the drug.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
Ambroxol hydrochloride should be administered with caution in patients with peptic ulcer. There have been reports of severe cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol hydrochloride. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol hydrochloride should be discontinued immediately and a physician consulted. Most of these reactions could be explained by the severity of the underlying disease or by other concomitant medications. 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. In case of impaired renal function, the drug can be used only after consulting your doctor. The granulated drug contains sorbitol.

INTERACTIONS
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
Adverse reactions are listed below by system organ class and by frequency, according to the following categories: 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; not known. Disorders of the immune system. Rare: hypersensitivity reactions'; not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders. Rare: rash, hives; not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous exanthematous). Nervous system disorders. Common: dysgeusia. Gastrointestinal disorders. Common: nausea, oral hypoesthesia; uncommon: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth; rare: dry throat. Heartburn has also been reported. Respiratory, thoracic and mediastinal disorders. Common: pharyngeal hypoesthesia. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Ambroxol hydrochloride crosses the placental barrier. Preclinical studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / 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 recommended that normal precautions be taken when taking medications during pregnancy. Especially during the first trimester it is not recommended to take the medicine. Ambroxol hydrochloride is excreted in breast milk. Although undesirable effects are not expected in breastfed infants, the use of the drug is not recommended during breastfeeding. Preclinical studies have not shown any effects directly or indirectly harmful to fertility.