SPC SUMMARY PRODUCT CHARACTERISTICS BRONCHOTUSSINE (BROMHEXINE HYDROCHLORIDE)

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TRADE NAME OF THE PHARMACEUTICAL PRODUCT BRONCHOTUSSINE QUALITATIVE AND QUANTITATIVE COMPOSITION Bromhexine Hydrochloride 4mg/5ml Syrup, colourless liquid PHARMACEUTICAL FORM Syrup CLINICAL CHARACTERISTICS

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4.1. Therapeutical indications As assistant agent for the liquefaction of the mucous secretions of the respiratory passageway in cases of acute and chronic bronchopulmonary diseases (bronchitis, emphysema, chronic asthmatic bronchitis) During acute exacerbations of bronchitis it must be administered in combination with the appropriate antibiotic. 4.2. Posology and Method of Administration To be taken orally. Adults and children over 10 years old: 8-16 mg 3 times daily Children 5-10 years old: 4 mg 3 times daily Children under 5 years old: 2 mg 3 times daily General dosage schedule for children: 0,5 mg/kg of body weight per day. The duration of the therapy should not exceed the 8-10 days without medical advice. 4.3. Contraindications None is known. 4.4. Special warnings and special precautions on use It must be administered with caution to patients with active duodenal ulcer, active tuberculosis or severe hepatic lesions. During the use of the drug an increase of the volume of the liquefied bronchial secretions may be induced and if they are not removed by the cough, special support may be needed in order to keep the respiratory passageways open. Attention in the administration: The drug must not be administered simultaneously to antitussive agents or to drugs with atropinic activity. BRONCHOTUSSINE contains Sorbitol E420. Therefore, patients with rare hereditary problems of fructose intolerance should not take this medicine without physicians advice. The probability of allergic reactions due to the presence of Methyl paraben E218 and Propyl paraben E216 should be considered while taking this medication.

BRONCHOTUSSINE contains Ethanol 2,4% vol (alcohol) i.e. up to 100mg per dose (5ml), equivalent to 2,5ml beer, 1ml wine per dose. It is harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease, or epilepsy. 4.5. Interactions with other drugs and other forms of interaction The administration of the bromhexine simultaneously to antibiotics (amoxicillin, cefuroxime, erythromycine, doxycycline) leads to an increase of the bronchopulmonar distribution (penetration) of the antibiotics. No relevant negative clinical side effect has been reported with other drugs. 4.6. Pregnancy and lactation By experiments realized in animals there is no evidence that the drug has any effect on fetal development. As the studies in humans are limited so as to have safe conclusions, its use must be avoided during pregnancy and lactation. 4.7. Effect on driving ability to drive and operating of moving machines None is known 4.8. Undesirable effects Gastrointestinal symptoms (epigastric discomfort, nausea, vomiting, diarrhea) may be present, which generally are mild and sometimes transient increase of the transaminases. Rarely allergic skin reactions have been reported. 4.9. Overdosage Treatment Until now the symptoms of the bromhexine poisoning are not known. If they appear, symptomatic therapy is recommended. 5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamics Bromhexine is an agent that regulates the mucus, which is useful in the decrease of the tenacity of the bronchial secretions. When it is administered orally, it is absorbed rapidly and its action appears 30 minutes to 1 hour later. When it is administered in inhalation form its action appears in 10-15 minutes. The immediate action of bromhexine appears with an increase in the quantity of the sputum, which appears 2-3 days after the initiation of the treatment. By the cleavage of the fibers of the acid mucopolysaccharides the bronchial secretion is diluted and the expectoration is facilitated. Bromhexine also ameliorates the efficiency of the bronchodilators. 5.2. Pharmacokinetics Bromhexine hydrochloride is rapidly absorbed by the gastrointestinal tract and about 8590% of the administered dose is excreted in the urine mainly in metabolite form. The maximum concentration in plasma appears after about an hour later. The half-life time is about 6.5 hours. Bromhexine is strongly bound to the plasma proteins in a percentage 95-98%. The bioavailiability is about 20-25% of the administered dose because of the phenomenon of the first passage in the liver.

5.3. Preclinical data for safety (toxicological data): 6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients: Sorbitol Glycerin Methyl Paraben Propyl Paraben Alcohol Cherry Essence Citric Acid Monohydrate Demineralised water 6.2. Incompatibilities None is known 6.3. Shelf life It is indicated in both the external and internal package of the drug. In the event the expiry date has elapsed, do not use the drug. 6.4. Special precautions for storage Store in room temperature <30C away from light 6.5. Nature and contents of container White Polyethylene Bottle containing 100ml of syrup 6.6. Instructions for use and handling None 7. MARKETING AUTHORIZATION HOLDER ADELCO CHROMATOURGIA ATHINON E. COLOKOTRONIS BROS S.A., 37 PIREOS STR., MOSCHATO, ATHENS, GREECE TEL. 210 4819 311- 4, FAX: 210 4816790 MARKETING AUTHORIZATION NUMBER MA072/00101 DATE OF INITIAL AUTHORIZATION

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10. DATE OF (PARTIAL) REVIEW OF THE TEXT

adelco

ADELCO CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS SA. 37, PIREOS STR., 183 46 MOSCHATO TEL: 210 4819311 4, FAX: 210 4816790