Rowatinex Renal and urinary discoders urolithiasis stones 50 capsules 1. What Rowatinex is and what it is used for Rowatinex helps to dissolve/break down and remove (disintegrate and eliminate) kidney and urinary tract stones. Rowatinex relieves muscle spasm thus reducing the pain of renal and urinary colic. It increases blood flow and reduces inflammation, which could be associated with the presence of kidney stones. 2. What you need to know before you take Rowatinex Do not take Rowatinex: - if you are allergic to ?-pinene, ?-pinene, camphene, borneol, anethol, fenchone, cineole or any of the other ingredients of this medicine. Warnings and precautions Talk to your doctor first before you take Rowatinex Do not take Rowatinex for treatment of urinary stones unless your doctor has confirmed a diagnosis of urinary stones especially in the case of children. Talk to your doctor or pharmacist before taking Rowatinex if you are taking medicines to thin your blood or medicines that are broken down by the liver. 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 pharmacist for advice before taking this medicine. Driving and using machines Rowatinex is unlikely to have any effect on your driving or ability to use machines. Rowatinex contains sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) and sunset yellow FCF 85% (E110) Sodium ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217) may cause allergic reactions (possibly delayed). Sunset yellow FCF 85% (E110) may cause allergic reactions 3. How to take Rowatinex 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. Rowatinex must only be taken by swallowing the whole capsule. Do not bite or chew the capsules. The recommended dose for adults is: 1 capsule 4 to 5 times daily before meals. Use in children and adolescents: Children aged 0 to 6 years: No data are available. Children aged 6 to 14 years: 1 to 2 capsules twice daily before meals. Adolescents aged 14 to 18 years: 1 capsule 4 to 5 times daily before meals. If you take more Rowatinex than you should If you have taken more capsules than you should, talk to your doctor or pharmacist. If you forget to take Rowatinex Do not take a double dose to make up for a forgotten dose. Just take it as soon as you remember. Then go on taking your next dose at the usual time. If you have any further questions on the use of this product, ask your doctor or pharmacist 4. Possible side effects Like all medicines, this medicine can cause side effects although not everybody gets them. 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 HPRA Pharmacovigilance, Earlsfort Terrace, 5. Contents of the pack and other information What Rowatinex contains - The active substances in one gastro-resistant capsule, soft are 24.8 mg ?-pinene, 6.2 mg ?-pinene, 15.0 mg camphene, 10.0 mg borneol, 4.0 mg anethol, 4.0 mg fenchone, 3.0 mg cineole. - The other ingredient is Virgin Olive Oil. - The capsule shell contains gelatine, glycerol 85%, sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217), sunset yellow FCF 85% (E110), quinoline yellow 70% (E104). See section 2 “Rowatinex contains sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) and sunset yellow FCF 85% (E110)”. What Rowatinex looks like and contents of the pack Rowatinex Capsules are yellow, ball shaped (spherical), soft gelatine gastro-resistant capsules containing a pale yellow to greenish-yellow oral solution with a strong aromatic odour.