ROWATINEX 30 CAPS Healthy Kidneys and urinary tract Treatment Pinene, Camphene, Cineol, Menlhone, Menlhol, Borneol Read all of this leaflet carefully before you start taklng this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Rowatinex* is and what it is used for 2. Before you take Rowatinexe 3. How to take Rowatinex* 4. Possible side effects 5. How to stor? Rowatinexe 6. Further information LWhat Rowatinex is and what it is used for Rowatinex contains essential oils that help to dissolve or break down and remove (disintegrating and eliminating) kidney and urinary tract Stones. Rowatinex* relieves muscle spasm thus reducing the pain of kidney and urinary colics. Rowatinex* is also used to relieve the effects associated with mild urinary tract infections. 2. Before you take Rowatinex DO NOT take Rowatinex* if you are allergic (hypersensitive) to any of the active substances or any of the other ingredients of Rowatinex* (see sec-tion 6 "Further information" for details). Take special care with Rowatinex Rowatinex* is not suitable in patients with severe pain (colic), decrease in urine production or severe infection of the urinary tract. Children and adolescents under 18 Children and adolescents under 18 years of age should not take Rowatinex*. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These medicines include: - medicines to thin your blood (ora? anti-coagulants e.g. Warfarin) - medicines that are broken down in the liver (ask your doctor for advise on this) Taking Rowatinex* with food or drink Rowatinex* should be taken on an empty stomach half an hour before meals. Pregnancy and breast feeding Ask your doctor or pharmacist for advice before taking any medicine. You should not take Rowatinex* in early pregnancy (the first trimester) or if you are breast feeding. No harmful effects on babies have been reported, but the risk is still unknown. Driving and using machines Rowatinex* is unlikely to have any effect on your driving or ability to use machines. Important information about some of the ingredients of Rowatinex Rowatinex* contains glycerine (glycerol) which is harmful in high doses. It may cause headache, stomach upset and diarrhoea. This medicine may cause allergic reactions (possibly delayed) as it contains sodium ethyl hydroxybenzoate (E215) and sodium propyl hydroxybenzoate (E217). 3. How to take Rowatinex Always take Rowatinex* exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sur?. Rowatinex* must only be taken by swallowing the whole capsule. Do not bite or chew the capsules. The usual dose for adults: Take one capsule 3-4 times daily, half an hour before meals. If you take mor? Rowatinex than you should Taking too much Rowatinex might cause: - stomach upset (gastric irritation) - If you have taken more capsules than you should, talk to your doctor or pharmacist immediately 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 stop taking Rowatinex Do not stop taking Rowatinex without discussing this with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.PossibleSideEffects Like all medicines, Rowatinex can cause side effects, although not every-bodygetsthem. A small number of patients have noted side effects such as: • slight and temporary stomach upset (gastric disturbance). • being sick (has been rarely reported). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5.How to store Rowatinex Keep the capsules out of the reach and sight of children. Do not store above 25?C. Store in a dry place. Do not use Rowatinex after the expiry date which is stated on the label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6.Further information What Rowatinex Capsules contain - The active substances are: pinene, camphene, cineol, fenchone, borneol and anethol Each capsule contains: - pinene [a+p] 31.0 mg - camphene 15.0 mg - cineol 3.0 mg - fenchone 4.0 mg - borneol 10.0 mg - anethol 4.0 mg. The other ingredients are olive oil (33 mg per capsule) The capsule shell contains: - gelatin ne - sodium ethylhydroxybenzoate E215 - sodium propylhydroxybenzoate E127 - sunset yellow FD+C, Yellow No. 6 EEC No. 110 85% - quinoline yellow, EEC No. 104 70% What Rowatinex Capsules look like and contents of the pack Rowatinex Capsules are yellow, ball shaped (spherical), soft gelatine capsules. The capsules are gastro-resistant. This means they only release the medicine in the intestine, not the stomach. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork, Ireland.