SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pulmocap® Hedera, syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dry extract of ivy leaf (Hedera helix L., folium). 1 ml syrup (corresponding with 1,1 g) contains 5,4 mg extract (as dry extract) from Hedera helix L., folium (ivy leaf) (5-7,5:1). Extraction solvent: Ethanol 30% (m/m) For the full list of excipients, see section 6.1.
Excipients with known effect: Pulmocap Hedera contains 292,6 mg/ml sorbitol (E420) and 2,3 mg/ml Lactose monohydrate.
3. PHARMACEUTICAL FORM
Syrup
Green syrup with a characteristic odour
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Pulmocap Hedera is a herbal medicinal product used as an expectorant in case of productive cough.
Pulmocap Hedera is indicated in adults, adolescents and children older than 2 years.
4.2 Posology and method of administration
Posology Unless otherwise prescribed, the recommended dose is: - Adults, adolescents and elderly: 5 ml, 2 to 3 times a day (corresponding with 54-81 mg of ivy leaf dry extract) - Children aged 6 to 11 years old: 5 ml, 2 times a day (corresponding with 54 mg of ivy leaf dry extract) - Children aged 2 to 5 years old: 2,5 ml, 2 times a day (corresponding with 27 mg of ivy leaf dry extract).
Paediatric population Pulmocap Hedera is contraindicated in children under 2 years (see section 4.3).
Renal/hepatic impairment There are insufficient data for specific dose recommendations in renal/hepatic dysfunction.
Method of administration Pulmocap Hedera is a liquid for oral use. Use the included dosage cup to ensure the correct dosing.
Duration of treatment The duration of treatment with Pulmocap Hedera needs to be as short as possible with the lowest possible dose. If the symptoms persist longer than 5 days or worsen during the use of the medicinal product, medical advice should be sought.
4.3 Contraindications
- Hypersensitivity to the active substance; other members of the Araliaceae family or to any of the excipients listed in section 6.1. - Children under 2 years of age, because in general, in this patient group respiratory symptoms can aggravate.
4.4 Special warnings and precautions for use
- When dyspnoea, fever or purulent sputum occurs, or if symptoms persist after five days of use of Pulmocap Hedera, medical advice should be sought - Concomittant use with opiate antitussives such as codeine or dextromethorphan is not recommended without medical advice. - Caution is recommended in patients with gastritis or gastric ulcer. - This medicinal product contains 292,6 mg/ml sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. - This medicinal product contains 2,31 mg/ml lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Paediatric population Persistent or recurrent cough in children between 2-4 years of age requires medical diagnosis before treatment.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions with other medicinal products and other forms of interaction are reported. No systematic interaction studies have been performed. For this reason, it cannot be excluded that the effect of other medicinal products may be increased or decreased.
4.6 Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of dry extract of Hedera helix L, folium in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure, it is not recommended to use Pulmocap Hedera during pregnancy.
Breastfeeding There is insufficient information on the excretion of dry extract of Hedera helix L, folium/metabolites in human milk. A risk to the newborns/infants cannot be excluded. Pulmocap Hedera should not be used during breastfeeding.
Fertility No data regarding fertility are available
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Frequency not known (cannot be estimated from the available data): - Gastrointestinal disorders: Nausea, vomiting or diarrhoea has been reported.
- Immune system disorders: Allergic reactions (urticaria, skin rash, dyspnoea) have been reported.
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.
4.9 Overdose
Symptoms Overdose with ivy leaf extracts can provoke nausea, vomiting, diarrhoea and agitation. So far, one case has been reported of a 4-year old child who developed aggression and diarrhoea after accidental intake of an ivy leaf extract corresponding to 1,8 g herbal substance.
Management In case of symptoms of poisoning or overdose, symptomatic treatment is necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Expectorants, ATC code: R05CA12
Mechanism of action The mechanism of action is not known.
5.2 Pharmacokinetic properties
No pharmacokinetical data are available.
5.3 Preclinical safety data
Preclinical data are incomplete and therefore of limited informative value. Based on the long standing clinical use, there is a sufficiently established safety of usage in the given posology in humans. An Ames test on mutagenicity does not give any reason for concern for the herbal preparation. Furthermore, α-Hederin, ß-hederin and δ-hederin isolated from ivy leaf showed no mutagenic potential in the Ames test using Salmonella typhimurium strain TA 98, with or without S9 activation. Data on carcinogenicity and reproductive toxicity testing for ivy leaf preparations are not available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Benzoic acid (E210) Xanthan gum Ammonium glycyrrhizate Essential oil of Eucalyptus radiata (Sieber ex DC) Sorbitol (E420) Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years After first opening, the syrup should be used within 28 days.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Amber coloured glass bottle of 200ml with plastic child-resistant closure and dosing cup. The fluid is clear and green. The dosing cup has marks for 2,5 ml, 5 ml, 10 ml, 15 ml and 20 ml.
6.6 Special precautions for disposal
Any unused product or waste material should be disposed in accordance with local requirements
7. MARKETING AUTHORISATION HOLDER
[to be completed nationally]
8. MARKETING AUTHORISATION NUMBER
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed nationally]
10. DATE OF REVISION OF THE TEXT
03/2016