Broncohexal 200mg

Sachets

Composition :

BRONCOHEXAL 100 mg powder for oral solution One sachet contains: Active ingredient: Acetylcysteine 100 mg Excipients Sucrose 3.83 mg BRONCOHEXAL 200 mg powder for oral solution One sachet contains: Active ingredient: Acetylcysteine 200 mg Excipients Sucrose 2.7 mg For the list full of excipients, see section 6.1

Excipients

BRONCOHEXAL 100 mg powder for oral solution Each sachet contains: sucrose, ascorbic acid, saccharin, orange flavor BRONCOHEXAL 200 mg powder for oral solution Each sachet contains: sucrose, ascorbic acid, saccharin, orange flavor

Therapeutic indications

Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. The drug is contraindicated in children under 2 years of age.

Dosage

Adults: 1 sachet of BRONCOHEXAL 200 mg or 2 sachets of BRONCOHEXAL 100 mg, 2-3 times a day. Any dose adjustments may relate to the frequency of administration or dose splitting but must still be within the maximum daily dose of 600 mg. Children from 2 years of age: 1 sachet of BRONCOHEXAL 100 mg 2 to 4 times a day, according to age. The duration of therapy is from 5 to 10 days. INSTRUCTIONS FOR USE: Dissolve the contents of the sachet in a glass containing a little water, stirring as needed with a teaspoon. The powder can also be dissolved in fruit juice or iced tea. The mucolytic effect of acetylcysteine is favored by the intake of liquids.

Warnings and Precautions

Mucolytics can induce bronchial obstruction in children less than 2 years of age. 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 less than 2 years of age (see section 4.3). Patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, your treatment should be stopped immediately. In case of gastro-duodenal ulcer the product should be administered with caution. The administration of acetylcysteine, at the beginning of the treatment, can thin the bronchial secretions and at the same time increase the volume; if the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid secretion retention. The medicine contains sucrose: patients with rare hereditary forms of fructose intolerance, glucose / galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine. In the case of diabetic subjects or those who follow low-calorie diets, it should be borne in mind that the preparation in sachets contains sugar in an amount corresponding to about ½ teaspoonful of each sachet. The possible presence of a sulphurous odor does not indicate alteration of the preparation, but is typical of the active ingredient contained therein.

Interactions

Cases of drug interactions and particular incompatibilities for acetylcysteine taken orally are not described in the literature. It is recommended not to mix other drugs with the syrup.

Side effects

Intake of the product may occasionally be followed by nausea and vomiting, rarely by hypersensitivity reactions such as urticaria and bronchospasm and with an unknown frequency of bronchial obstruction.

Pregnancy and breastfeeding

Although teratological studies conducted with acetylcysteine in animals have not shown any teratogenic effects, controlled studies in humans are not available. Therefore, its administration during pregnancy can only be carried out in case of real need under the direct supervision of the doctor. In the absence of studies on the possible excretion in breast milk, the use of BRONCOHEXAL should be avoided during breastfeeding.