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PACKAGE LEAFLET Package Leaflet: Information for the Patient PACKAGE LEAFLET Package leaflet: Information for the patient Pulmocap Hedera, stroop Dry extract of ivy leaf Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 5 days. What is in this leaflet 1. What Pulmocap Hedera is and what it is used for 2. What you need to know before you take Pulmocap Hedera 3. How to take Pulmocap Hedera 4. Possible side effects 5. How to store Pulmocap Hedera 6. Contents of the pack and other information 1. What Pulmocap Hedera is and what it is used for Pulmocap Hedera is a herbal medicinal product used as an expectorant in case of productive cough. It contains the dry extract of ivy leaf (Hedera helix L., folium). Pulmocap Hedera is indicated in adults, adolescents and children older than 2 years. You must talk to a doctor if you do not feel better or if you feel worse after 5 days. 2. What you need to know before you take Pulmocap Hedera Do not use this medicine: - if you are allergic to ivy, other members of the Araliaceae family or any other ingredients of this medicine (listed in section 6). - in children under 2 years of age, because in general, in this patient group respiratory symptoms can aggravate. Warnings and precautions Talk to your doctor before taking this medicine: - if you suffer from shortness of breath, fever or purulent slime - if symptoms persist longer than 5 daysif you use opiate antitussives such as codeine or dextromethorphan - if you suffer from gastritis or gastric ulcer Children - Do not use in children younger than 2 years. See section “Do not take this medicine”. - If children between 2-4 years of age suffer from persistent or recurrent cough, medical diagnosis before treatment is required. Other medicines and Pulmocap Hedera Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 2 Pulmocap Hedera with food, drink and alcohol No interactions with food, drinks or alcohol are reported. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Pulmocap Hedera is not recommended during pregnancy. Breast-feeding Pulmocap Hedera should not be used during breastfeeding. Fertility No data regarding fertility are available. Driving and using machines No studies on the effect on the ability to drive and use machines have been performed. Pulmocap Hedera contains: - 292,6 mg/ml sorbitol (E420). Sorbitol may have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. - 2,3 mg/ml Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Pulmocap Hedera Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Age Dose Adults, adolescents and elderly 5 ml, 2 to 3 times a day Children between 6-11 years of 5 ml, 2 times a day age Children between 2-5 years of age 2,5 ml, 2 times a day Pulmocap Hedera is taken orally. The packaging contains a dosing cup to measure the correct dose. There are insufficient data for specific dose recommendations in renal/hepatic dysfunction. Medical advice should be sought if the symptoms persist after 5 days of use of the medicinal product. If you take more Pulmocap Hedera than you should Contact immediately your doctor or pharmacist when you take more of this medicine than you should. Overdose with ivy leaf extracts can provoke nausea, vomiting, diarrhoea and agitation. In case of symptoms of poisoning or overdose, symptomatic treatment is necessary. If you forget to take Pulmocap Hedera Do not take a double dose to make up for a forgotten dose. If you stop taking Pulmocap Hedera Not applicable If you have further questions on the use of this medicine, ask your doctor or pharmacist. 3 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.The following side effects were reported (frequency not known): - Gastrointestinal disorders such as nausea, vomiting or diarrhoea - Hypersensitivity reactions such as urticaria, skin rash or shortness of breath have been reported If you notice symptoms of hypersensitivity stop taking Pulmocap Hedera and see your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pulmocap Hedera Keep this medicine out of the sight and reach of children. Store below 25°C. After first opening, the syrup should be used within 28 days. Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Pulmocap Hedera contains: The active substance is: 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). The other ingredients are: Lactose monohydrate, sorbitol (E420), benzoic acid (E210), xanthan gum, ammonium glycyrrhizate, essential oil of Eucalyptus radiata (Sieber ex DC) and purified water. What Pulmocap Hedera looks like and contents of the pack Clear, green liquid with a characteristic odour in an amber glass bottle 200ml with plastic child-resistant closure and dosing cup. Marketing Authorisation Holder and Manufacturer Conforma NV Zenderstraat 10 9070 Destelbergen Belgium This medicinal product is authorised in the Member States of the EEA under the following names: BE: Pulmocap® Hedera, siroop NL: Pulmocap® Hedera, stroop LU: Pulmocap® Hedera, sirop FR: Hedetus, sirop DE: Pulmocap® Hedera, Sirup PL: Mituret IT: Edera Conforma ES: Hedetus, jarabe 4 PT: Pulmocap® Hedera, scarope AT: Pulmocap® Hedera, Sirup This leaflet was last revised in 12/2017. 5 .
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