ROWATINEX has anti-bacterial activity against a range of gram-positive and gram-negative organisms. 5.2 Pharmacokinetic properties

Rowachol capsules contain a mixture of terpene compounds produced by plants, in an olive oil base. The capsules help dissolve or break-up gallstones. Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. Although no teratogenic effects have been reported, ROWATINEX should not be given in the first trimester of pregnancy. Although no evidence is available,ROWATINEX should not be given to lactating females. 4.7 Effects on ability to drive and use machines Rowachol capsules increase the solubility of cholesterol in the bile, which helps to dissolve gallstones.After Chaussy et al. [ 3] introduced SWL for the treatment of urinary stones in 1980, SWL has become the primary treatment modality for urinary stones. SWL is a noninvasive treatment of urinary stones. However, stone expulsion does not occur immediately after SWL; rather, the debris is released slowly for about 1 month. The remnant stones may cause obstruction, recurrent infection, or calculus regrowth [ 7]. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Before a drug is prescribed, the patient will be examined for the current medical condition as well as taking the patient's history to be able to give a suitable dose for each different group of subjects: DO NOT take Rowatinex ® if you are allergic (hypersensitive) to any of the active substances or any of the other ingredients of Rowatinex® (see section 6 “Further information” for details).

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. It is not known if this medicine passes into breast milk. The manufacturer states it should not be used by women who are breastfeeding. function e(){var e=document.createElement('script');e.type='text/javascript',e.async=true,e.src='//staticw2.yotpo.com/MCN0waWlSaGnmquVBtpvetg2aznN9nNnQb9m8rPf/widget.js';var t=document.getElementsByTagName('script')[0];t.parentNode.insertBefore(e,t)})(); In caz de supradozaj pot sa apara iritatie gastrica cu greata, varsaturi si diaree. Daca medicamentul a fost inghitit de putin timp, se va efectua lavaj gastric. Pacientul trebuie supravegheat cu atentie si, daca este necesar, se va institui tratament simptomatic. Trebuie monitorizate functiile cardiaca, respiratorie, renala si hepatica. Studiile toxicologice la animale au evidentiat faptul ca dozele mari de uleiuri esentiale pot provoca deprimarea sistemului nervos central cu stare de stupoare si insuficienta respiratorie sau stimularea sistemului nervos central pana la stare de excitatie si convulsii.Doza uzuala este de 3-5 picaturi orale, solutie Rowatinex de 4-5 ori pe zi, cu 30 de minute inainte de mese sau conform recomandarii medicului. The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Medical treatment has been proven to be effective at inhibiting stone growth and recurrence of urinary stones [ 8, 9]. Previous studies have reported that Rowatinex can help with the removal of remnant stone after SWL [ 10]. Rowatinex is an essential oil of terpenic type that consists of pinene (3%), camphene (15%), borneol (10%), anethol (4%), and cineol (3%). Rowatinex is used for the treatment of ureteral stones, kidney stones, renal colic, and other urologic conditions [ 11- 13]. active substances or any of the other ingredients of Rowatinex® (see section 6 “Further information” for details). Trebuie avute in vedere precautii la pacientii tratati cu anticoagulante sau alte medicamente metabolizate la nivel hepatic care au un indice terapeutic mic. Should not be used in patients receiving oral anti-coagulants or other drugs metabolised by the liver where dose is critical. 4.6 Pregnancy and lactation

Prospect Rowatinex x 30 caps.

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® If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible Side Effects Urolithiasis, nephrolithiasis and mild urinary tract infections. ROWATINEX promotes the disintegration of stones, and by its spasmolytic action promotesthe spontaneous passage of stones in the renal and urinary tracts.ROWATINEX gives symptomatic relief of mild to moderate renal and urinarycolic associated with the presence of stones in the renal and urinary tracts.ROWATINEX is also indicated for the relief of frequency and urgencyassociated with mild urinary tract infections. 4.2 Posology and method of administration This medicine is not known to significantly affect other medicines. However, you should always tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this one. If medication has been recently ingested, the stomach should be emptied by gastric lavage. Observation should be carried out with symptomatic treatmentIf necessary. Monitoring of cardiac, respiratory, renal and hepatic functionsare advised.