1.3.1 PACKAGE LEAFLET

Transcription

1 AT/H/0516/001/IB/ PACKAGE LEAFLET Package Leaflet of Mucoplant cough syrup ivy 1, please see attachment. 1 Mucoplant cough syrup ivy (During the DCP the dosage form following Mucoplant is mentioned as "cough syrup ivy" in the texts of Modul and The appropriate relevant national translations of the dosage form are presented in Annex 5.19 of Module 1.2 and will be considered in the national procedure of the DCP.) Page 1

2 PACKAGE LEAFLET Page 1

3 Package leaflet: Information for the patient Mucoplant cough syrup ivy Syrup Active substance: Ivy leaf dry extract 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 7 days. What is in this leaflet: 1. What Mucoplant cough syrup ivy is and what it is used for 2. What you need to know before you take Mucoplant cough syrup ivy 3. How you take Mucoplant cough syrup ivy 4. Possible side effects 5. How to store Mucoplant cough syrup ivy 6. Contents of the pack and other information 1. What Mucoplant cough syrup ivy is and what it is used for Mucoplant cough syrup ivy contains ivy leaf dry extract. Mucoplant cough syrup ivy is a herbal medicinal product used as an expectorant in case of productive cough for adults, adolescents and children from 2 years of age. You must talk to a doctor if you do not feel better or if you feel worse afer 7 days. 2. What you need to know before you take Mucoplant cough syrup ivy Do not take Mucoplant cough syrup ivy - If you are allergic to ivy leafs, to plants of the Araliaceae (ivy) family or to any of the other ingredients of this medicine (listed in section 6). - Mucoplant cough syrup ivy is not allowed to use in children under 2 years of age because of the risk of worsening of respiratory symptoms. Page 2

4 Warnings and precautions - If children between 2 4 years of age have persistent or recurrent cough they require medical diagnosis before treatment. - If difficulty in breathing, fever, or purulent (pus containing) sputum occurs, you should consult your doctor or a pharmacist. - If the symptoms do not improve within 7 days of the use of the medicine, you should see your doctor. - It is not recommended that you take this medicine with other medicines that suppress cough (antitussives such as codeine or dextromethorphan) without medical advice. - If you have stomach problems (gastritis, stomach ulcer), the medicine should be used with caution. - If you suffer from renal insufficiency or hepatic impairment, please talk to your doctor or pharmacist before taking Mucoplant cough syrup ivy. Data for dose recommendations in these patients have not been established. Other medicines and Mucoplant cough syrup ivy Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Mucoplant cough syrup ivy has not been reported to influence the effect of other medicines. Mucoplant cough syrup ivy with food and drink You may take Mucoplant cough syrup ivy regardless of meals. 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. Mucoplant cough syrup ivy is not recommended during pregnancy and breast-feeding due to insufficient data on the use of ivy leaf dry extract in pregnant women and breast-feeding mothers. Driving and using machines No studies on the effect on the ability to drive and use machines have been performed. Mucoplant cough syrup ivy has not been reported to affect the ability to drive and use machines. Mucoplant cough syrup ivy contains maltitol, liquid If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 10 ml contain 4 g maltitol, liquid corresponding to 0.3 bread units. This has to be considered if you suffer from diabetes mellitus. The calorific value is 2.3 kcal/g maltitol, liquid. Maltitol, liquid may have a mild laxative effect. Page 3

5 3. How to take Mucoplant cough syrup ivy Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended doses are for adults, adolescents over 12 years of age: 15 ml three times a day. for children from 6-11 years of age: 15 ml two times a day. for children from 2-5 years of age: 10 ml two times a day. Please use the enclosed measuring cup for correct dosage. The use in children under 2 years of age is contraindicated. Mucoplant cough syrup ivy is taken undiluted and regardless of meals. You should drink plenty of water or other warm caffeine-free beverages while taking Mucoplant cough syrup ivy. If the symptoms persist longer than one week during the use of this product, consult your doctor or pharmacist. If the effect of Mucoplant cough syrup ivy seems too strong or too weak, please talk to your doctor or pharmacist. If you take more Mucoplant cough syrup ivy than you should Do not take larger doses than recommended. Intake of doses larger than those recommended (more than three times the single dose) may cause nausea, vomiting, diarrhoea and agitation. Please consult your doctor who will decide on the necessary treatment. One case of a 4 year old child who developed aggressivity and diarrhoea after accidental intake of an ivy extract corresponding to 1.8 g herbal substance, (equivalent to 195 ml of Mucoplant cough syrup ivy) has been reported. If you forget to take Mucoplant cough syrup ivy Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are classified into the following groups in order of frequency: Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhoea. Uncommon (may affect up to 1 in 100 people): Allergic reaction of the skin manifested as hives (urticaria), rashes, broken capillaries, mostly on the cheeks and nose (couperoses) and severe allergic reactions as difficulty in breathing and swellings. Page 4

6 If an allergic reaction occurs, stop taking the medicine and talk to your doctor immediately. Reporting of side effects If you get any side effects talk to you 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 Mucoplant cough syrup ivy Keep this medicine out of the sight and reach of children. Do not use Mucoplant cough syrup ivy after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Do not store above 25 C. The medicinal product can be used 6 weeks after opening the bottle. Any unused medicinal product or waste material should be disposed of in accordance with the local requirements. 6. Contents of the pack and other information What Mucoplant cough syrup ivy contains The active substance is ivy leaf dry extract. 100 ml contain 154 mg of ivy leaf dry extract (Hedera helix L. folium) (4-8 : 1). Extraction solvent: Ethanol 30 % (m/m). The other ingredients are: Potassium sorbate; hydroxyethyl cellulose; flavour, black currant; maltitol, liquid (E 965); citric acid anhydrous; water purified. What Mucoplant cough syrup ivy looks like and contents of the pack Mucoplant cough syrup ivy is a brownish-yellow, slightly turbid syrup with characteristic odour (currant). Mucoplant cough syrup ivy is available in boxes with 100 ml, 200 ml, 250 ml of syrup in a brown glass bottle, a measuring cup is enclosed. Marketing authorisation holder and manufacturer Dr. Theiss Naturwaren GmbH Michelinstraße Homburg Germany Page 5

7 This medicinal product is authorised in the member states of the EEA under the following names: Austria Mucoplant Hustensaft Efeu Sirup Bulgaria Мукоплант експекторант с бръшлян 154 mg/100 ml, сироп Croatia Mucoplant sirup od bršljana Czech Republic Mucoplant břečťanový sirup proti kašli Germany Mucoplant Hustensaft Efeu Hungary Mucoplant Dr. Theiss Borostyán köhögés elleni szirup Slovakia Mucoplant sirup proti kašľu s brečtanom This leaflet was last revised in <[MM/YYYY}>. Page 6