Muciclar 75mg Ambroxol Hydrochloride 20 Capsules Extended Release

NAME
MUCICLAR

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Ambroxol hydrochloride.

EXCIPIENTS
Solution to be sprayed: sodium chloride, water for injections. Syrup: sorbitol solution, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybeanzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry essence, purified water. Capsules: sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone. Granules: sucrose, orange flavor, pineapple flavor.

INDICATIONS
Disturbances of secretion in acute and chronic bronchopulmonary affections.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to ambroxol hydrochloride or to any of the excipients; severe liver and / or kidney changes; the use of the medicine is contraindicated in case of rare hereditary pathologies which may be incompatible with one of the excipients; the medicine is contraindicated in children younger than 2 years (for oral forms).

DOSAGE
>> Inhalation use. Nebuliser solution 15 mg / 2 ml. 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 medicine can be mixed in the dispensing device with distilled water in the ratio 1: 1, thus obtaining an optimal humidification of the air to be breathed. >> Oral use. Syrup 15 mg / 5 ml. Adults: 5-10ml of syrup 3 times a day, children over two years of age: 5 billion syrup 2 or 3 times a day. Prolonged-release capsules 75 mg Adults: 2 capsules in single administration are recommended after breakfast in the morning for 8 days (attack therapy). Subsequently, the dosage can be reduced to a single capsule until the end of the treatment. Granules for oral solution 30 mg. Adults: one sachet 2-3 times a day.

STORAGE
Syrup, capsules, granules for oral solution: keep at a temperature not exceeding 25 degrees C. Solution to be sprayed: no particular precautions for storage. After opening the foil pouch that contains the single-dose containers of solution to be nebulized, the medicine must be used within three months; after this period, any unused medicinal product should be discarded. When using half a dose of the single-dose container, the re-closed container should be stored at 2 - 8 degrees C (in the refrigerator) for up to 12 hours; after this period the residual medicinal product must be discarded.

WARNINGS
Ambroxol should be administered with caution to patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthemic pustulosis (AGEP) associated 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. 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. Because of these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. If new lesions of the skin or mucous membranes occur, consult your doctor immediately and discontinue treatment with ambroxol as a precaution. During the administration of the solution to be nebulized, since irritation cough may arise in the too deep inhalation of the aerosols, it is necessary to try to inhale and exhale normally during inhalation. In particularly sensitive patients, a pre-heating of the inhaled to body temperature can be recommended. For patients suffering from bronchial asthma it is advisable to resort to a bronchial spasmolytic before inhalation. In case of mild or moderate renal insufficiency, the medicine can 'be used only after consulting your doctor.As with all medicines subject to hepatic metabolism and subsequent renal elimination, accumulation of the metabolites of ambroxol in the liver is expected in the presence of severe renal insufficiency. Mucolytics can induce bronchial obstruction in children younger 'less than 2 years. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children younger than 2 years (for oral forms). The syrup contains: para-hydroxybenzoates; sorbitol and glycerol. 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. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. The capsules and granules for oral solution contain sucrose.

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
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); moltoraro (<1 / 10,000), frequency not known. Disorders of the immune system. Not known: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions. Nervous system disorders. Common: dysgeusia (eg changes in the sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders: Common: hypoesthesia of the oral cavity and pharynx; rare: rhinorrhea; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhea, 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: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Eurinary renal disorders. Rare: dysuria. General disorders and administration site conditions. Rare: fatigue. 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 crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryo / 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 medicines during pregnancy. Especially during the first trimester it is not recommended to take ambroxol. The drug is excreted in breast milk, therefore the use of diambroxol is not recommended during breastfeeding. However, no negative effects on the suckling child are foreseeable. During pregnancy and lactation, the medicine will be administered only in case of real need.