Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
ANETHOLE; BORNEOL; CAMPHENE; CINEOLE; FENCHONE; PINENE ALFA; PINENE BETA
MEGAPHARM LTD
G04BC
CAPSULES
CAMPHENE 15 MG; CINEOLE 3 MG; FENCHONE 4 MG; BORNEOL 10 MG; ANETHOLE 4 MG; PINENE BETA 6.2 MG; PINENE ALFA 24.8 MG
PER OS
Not required
ROWA PHARMACEUT. LTD.,IRELAND
URINARY CONCREMENT SOLVENTS
As an adjuvant in infections of kidenys and urinary tract.
2022-10-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS_ _(PREPARATIONS) - 1986 This medicine is dispensed without a physician's prescription Rowatinex Capsules Active ingredients: _Camphene_ 15 mg _Cineole_ 3 mg _Fenchone_ 4 mg_ _ _Borneol_ 10 mg _ _ _Anethole_ 4 mg_ _ _Pinene_ _beta_ 6.2 mg_ _ _Pinene_ _alfa_ 24.8 mg _ _ For a list of inactive and allergenic ingredients in the preparation, see chapter 2 Section “Important information about some of the medicine’s ingredients” and chapter 6 “Additional information”. _ _ Read this leaflet carefully in its entirety before using the medicine._ _This leaflet contains concise information about the medicine._ _If you have further questions, consult your physician or pharmacist. Take the medicine in accordance with the instructions in chapter 3 “How should you use the medicine?”._ _Consult with a pharmacist if you require more information._ _Consult with a physician if the symptoms of the illness get worse or do not improve after 14 days. The duration of treatment may vary depending on the size of the stones and the physician’s diagnosis. _ _ 1. What is this medicine intended for? _ _ Rowatinex is an adjuvant in infections of kidneys and urinary tract. Rowatinex helps to dissolve, break down and remove kidney and urinary tract stones._ _ Rowatinex relaxes muscles in the area, increases blood flow and reduces inflammation, thus reducing pain and helping to remove the stones._ _ Rowatinex reduces the formation of stones by increasing the solubility of calcium salts, which are the main component of kidney and urinary tract stones._ _ _ _ 2. Before using the medicine_ _ _ _ Do not use this medicine if: You are sensitive (allergic) to any of the active ingredients, Camphene, Cineole, Fenchone, Borneol, Anethole, Pinene beta, Pinene alfa, or to any of the additional ingredients contained in the medicine (please see chapter 6 “Additional information”). Special warnings regarding the use of the medicine: Before treatment with Rowatinex, te Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rowatinex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: − Pinene 24.8 mg, β − Pinene 6.2 mg, Camphene 15.0 mg, Borneol 10.0 mg, Anethol 4.0 mg, Fenchone 4.0 mg, Cineole 3.0 mg. Excipient(s) with known effect: Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215), Sodium Propyl Parahydroxybenzoate (E217) and Sunset Yellow FCF 85% (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant Capsules, Soft yellow, spherical, soft gelatine gastro-resistant capsules containing a pale yellow to greenish-yellow oral solution with a strong aromatic odor. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjuvant in infections of kidneys and urinary tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral. Recommended Dosage Schedule: Adults: The usual dosage is 1-2 capsule 3 times daily before meals Children aged 6 to 14 years: The usual dosage is 1 capsule twice daily before meals. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE DEFINITE DIAGNOSIS OF UROLITHIASIS AND NEPHROLITHIASIS MUST BE MADE BEFORE TAKING THIS PRODUCT TO RULE OUT OTHER POSSIBLE CONDITIONS. The product should only be used with caution in patients on anti-coagulants or drugs dependent on the liver for metabolism and excretion. Conservative medical management of uro- and nephrolithiasis should be initiated with the awareness that stones can give rise to serious clinical complications such as obstruction of the urinary system, sepsis. The physician should be aware of the necessity of being properly informed so that appropriate measures can be taken. Rowatinex capsules contain sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed). Rowatinex also contains sunset yellow FCF 85% (E110) which may c Leggi il documento completo