PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER Cynarix - coated tablets Active substance: dried artichoke leaf 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. - Talk to a doctor if you do not feel better or even worse after 14 days. What is in this leaflet: 1. What Cynarix - coated tablets are and what they are used for 2. What you need to know before you take Cynarix - coated tablets 3. How to take Cynarix - coated tablets 4. Possible side effects 5. How to store Cynarix - coated tablets 6. Contents of the pack and further information 1. What Cynarix - coated tablets are and what they are used for Cynarix is a traditional herbal medicine made from the extract of artichoke leafs. Cynarix is used to alleviated digestive complaints such as sensations of fullness, nausea, bloating and flatulence. Cynarix - coated tablets are used in adults and adolescents age 12 and above. The use of this traditional herbal medicine for the aforementioned complaints is solely based on may years of custom. Talk to a doctor if you do not feel better or even worse after 14 days. 2. What you need to know before you take Cynarix - coated tablets Do not take Cynarix - coated tablets, - if you are allergic to artichoke leafs, other plants of the daisy family (e.g. arnica, chrysanthemum), or any of the other ingredients of this medicine (listed in section 6), - if you have a biliary tract disorder (e.g. bile duct obstruction, bile duct inflammation, gallstones), - if you suffer from an inflammation of the liver. Warnings and precautions Please talk to your pharmacist before taking Cynarix - coated tablets.

2 Children Page 2 of 5

3 Page 3 of 5 The use in children below the age of 12 years is not recommended as not enough data is available. Other medicines and Cynarix Tell your doctor or your pharmacist if you are taking other medicines, have recently taken or might take other medicines. To date, there are no known interactions with other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or the pharmacist before taking this medicine. As no sufficient data are available, taking this medicine during pregnancy and breast-feeding cannot be recommended. Driving and using machines Cynarix has no or negligible effects on the ability to drive or use machines. Cynarix - coated tablets contain sugar (lactose and sucrose). If you have been told that you have an intolerance to certain sugars, please talk to your doctor before this medicine. 3. How to take Cynarix - coated tablets 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 dose is Adults and adolescents age 12 and above: 1-2 coated tablets, 3 times daily Use in children The use in children below the age of 12 years is not recommended as not enough data is available. Take Cynarix with your meals with sufficient liquid (e.g. 1 glass of water). Do not chew. If your symptoms get worse or do not improve after 2 weeks, you must consult a doctor. If you take more Cynarix - coated tablets than you should There are no reported cases of overdoses. If you forget to take Cynarix - coated tablets Do not take a double dose to make up for a forgotten dose. 4. Possible side effects Like all medicines, Cathejell can cause side effects, although not everybody gets them. Side effects can occur at the following incidence rates:

4 Page 4 of 5 -Very common ( 1/10) -Common ( 1/100, <1/10) -Uncommon ( 1/1.000, < 1/100) -Rare ( 1/10.000, < 1/1.000) -Very rare (< 1/10.000) -Unknown (incidence rate cannot be determined based on available data) The following side effects can occur: Gastrointestinal and immune system disorders Incidence rate unknown: Mild diarrhoea with abdominal cramps may occur, as well as upper abdominal complaints, such as nausea and heartburn. Allergic reactions can also occur. 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: Federal Office for Safety in Health Care Traisengasse VIENNA AUSTRIA Fax: + 43 (0) Website: By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Cynarix - coated tablets Store below 30 C. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton after {EXP} and blister {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 Cynarix contains The active substance is: dried artichoke leaf extract The active substance is: artichoke leaf extract. 1 coated tablet contains 55 mg artichoke leaf extract (Cynarae folium, DEV=4-6:1, extracting agent: water). The other ingredients are: Maltodextrin, silica, Cellactose (cellulose, lactose monohydrate), copovidone, crospovidone, talc, magnesium stearate, gum arabic, methyl cellulose, calcium carbonate, povidone K30, glycerol 85%, titanium dioxide (E171), indigotin I (E132), quinoline yellow (E104), Eudragit E, montan glycol wax, sucrose. What Cynarix - coated tablets look like and contents of the pack Coated tablets, yellow-green and biconvex, in aluminium-pvc/pvdc blister of with 60 tablets.

5 Page 5 of 5 Marketing Authorisation Holder and Manufacturer Pharm. Fabrik Montavit Ges.m.b.H. A-6067 Absam Tel: Fax: pharma@montavit.com MA.No.: HERB This leaflet was last revised in 05/2014