Marco Viti Tusseval Mucolytic 4mg/5ml Syrup

NAME
BROMEXINE PHARMENTIS 4 MG / 5 ML SYRUP

PHARMACOTHERAPEUTIC CATEGORY
Mucolytics.

ACTIVE PRINCIPLES
100 ml of syrup contain: bromhexine hydrochloride 80 mg (equal to bromhexine 73 mg) (1 teaspoon, equal to 5 ml, contains: bromhexine hydrochloride 4 mg).

EXCIPIENTS
Tartaric acid, benzoic acid, carmellose sodium, glycerol, liquid sorbitol, ethanol (96%), all fruit flavor, sodium hydroxide, purified water.

INDICATIONS
Treatment of secretion disorders in acute and chronic respiratory diseases.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. In case of hereditary conditions which may be incompatible with one of the excipients. There are no absolute contraindications, but in patients with gastroduodenal ulcer, its use is recommended after consulting your doctor. Contraindicated during lactation. The drug is contraindicated in children younger than 2 years.

DOSAGE
The following dosages are recommended unless otherwise prescribed. Adults: 5-10 ml 3 times a day (= 24 mg per day). In adults, at the start of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided in three times. Pediatric population. Children older than 2 years: 2.5 - 5 ml 3 times a day (= 12 mg per day). Method of administration: it is recommended to take the drug after meals. The syrup can be administered to diabetics and children, it does not contain fructose or sucrose. Do not exceed the recommended dose.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
Treatment with the drug leads to an increase in bronchial secretion (this promotes expectoration). There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with administration of bromhexine hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with bromhexine hydrochloride should be discontinued immediately and a physician consulted. Pediatric population: 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 'less than 2 years. Do not use for prolonged treatments. After a short period of treatment without noticeable results, conduct further investigations. The medicine contains sorbitol.

INTERACTIONS
No clinically relevant interactions with other medicinal products have been reported.

SIDE EFFECTS
Cases of diarrhea, nausea, vomiting, and cases of other minor gastrointestinal disturbances have been reported. Disorders of the immune system. Rare: hypersensitivity reactions'; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Respiratory, thoracic and mediastinal disorders. Not known: bronchial obstruction. 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 pustulosis). Report any suspected adverse reactions via the reporting system.

PREGNANCY AND BREASTFEEDING
Use the product in cases of real need under the direct supervision of the doctor. The results of preclinical studies and clinical use of the drug did not show adverse effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of drugs during pregnancy, especially in the first trimester. As' the drug passes into breast milk avoid administration in case of breastfeeding.