100 ml of the syrup contain 825 mg of ivy leaf dry extract (Hedera helix L., folium) ( 4-8:1). Extraction solvent: ethanol 30% (m/m).

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hedussin syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml of the syrup contain 825 mg of ivy leaf dry extract (Hedera helix L., folium) ( 4-8:1). Extraction solvent: ethanol 30% (m/m). Excipient with known effect: Sorbitol, liquid (non-crystallising); a single dose contains up to mg of sorbitol (E420). For the full list of excipients, see section PHARMACEUTICAL FORM Syrup. The syrup is a brown, opalescent liquid with a sweet taste and possible slight sediment. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Hedussin syrup is a herbal medicinal product used as an expectorant in case of productive cough Posology and method of administration Posology Adults and adolescents over 12 years of age: 6 ml of syrup twice daily (corresponding to 99 mg of ivy leaf dry extract daily). Children between 6-12 years of age: 4 ml of syrup twice daily (corresponding to 66 mg of ivy leaf dry extract daily). Children between 2-5 years of age 2 ml of syrup twice daily (corresponding to 33 mg of ivy leaf dry extract daily). It is recommended that the dose of 6ml is administered 2x3ml. The use in children under 2 years of age is contraindicated (see section 4.3 Contraindications ). Method of administration

2 Oral use. Medicinal product should be shaken before use. If the symptoms persist longer than one week during the use of the medicinal product, a doctor or a pharmacist should be consulted Contraindications - Hypersensitivity to the active substance, to other plants of the Araliaceae (ivy) family or to any of the excipients listed in section Children under 2 years of age because of the risk of aggravation of respiratory symptoms Special warnings and precautions for use Persistent or recurrent cough in children between 2-4 years of age requires medical diagnosis before treatment. When dyspnoea, fever or purulent sputum occurs, a doctor or a pharmacist should be consulted. Concomitant use with antitussives such as codeine or dextromethorphane is not recommended without medical advice. Caution is recommended in patients with gastritis or gastric ulcer. Hedussin syrup contains sorbitol (E420), therefore should not be taken by patients with rare hereditary problems of fructose intolerance Interaction with other medicinal products and other forms of interaction Hedussin syrup has not been reported to influence the effects of other drugs. No interactions studies have been performed Fertility, pregnancy and lactation There are no data on the effect of the medicinal product on fertility. Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed Undesirable effects Undesirable effects that may occur during treatment with Hedussin syrup are classified into the following groups in order of frequency: - very common ( 1/10), - common ( 1/100 to < 1/10),

3 - uncommon ( 1/1,000 to < 1/100), - rare ( 1/10,000 to < 1/1000), - very rare (< 1/10,000), - not known (cannot be estimated from the available data). Frequency of undesirable effects listed by individual organ systems: Immune system disorders Gastrointestinal disorders Common nausea vomiting diarrhoea Uncommon allergic reactions (urticaria, skin rash, couperoses, dyspnoea) If severe undesirable effects occur, treatment should be discontinued. If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V Overdose Intake of doses larger than those recommended can provoke nausea, vomiting, diarrhoea and agitation. Treatment is symptomatic. A case of an overdose has been reported in a 4 year old child. Following an accidental ingestion of a large amount of ivy extract (corresponding to 1.8 g of ivy leaf, which approximately amounts to 36 ml of Hedussin syrup), aggressiveness and diarrhoea occurred. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic group: Expectorants. ATC code: R05CA12. The mechanism of action is not known Pharmacokinetic properties There are no data available on the pharmacokinetic properties of ivy leaf extract Preclinical safety data

4 Preclinical data are incomplete and therefore of limited informative value. Based on the long standing clinical use there is a sufficiently established safety of the usage in the given posology in humans. An Ames-Test on mutagenicity does not give any reason for concern for the herbal preparation. Tests on reproductive toxicity and carcinogenicity do not exist. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients Sorbitol liquid (non-crystallising) (E420) Potassium sorbate (E202) Xanthan gum (E415) Citric acid anhydrous (E330) Purified water 6.2. Incompatibilities Not applicable Shelf life Originally sealed package: 36 months After first opening: 3 months 6.4. Special precautions for storage Keep out of the sight and reach of children. Do not store above 25 C after first opening Nature and contents of container Brown glass bottle of hydrolytic class III, with polyethylene screw cap and polypropylene measuring spoon (5 ml) with additional graduations of 1, 2, 3, and 4 ml in a box. Bottles of 100 ml volume are available Special precautions for disposal No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Phytopharm Klęka S.A. Klęka 1, Nowe Miasto nad Wartą Poland Tel.:

5 Fax: welcome@europlant-group.pl 8. MARKETING AUTHORISATION NUMBER 9. DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT