Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
a-pinene, b-pinene, menthol, menthone, borneol, camphene, cineole
Rowa Pharmaceuticals Ltd.
բուսական ծագման դեղ
a-pinene, b-pinene, menthol, menthone, borneol, camphene, cineole
13,6mg+ 3,4mg+ 32mg+ 6mg+ 5mg+ 5mg+ 2mg
capsules gastro-resistant, soft
(100/10x10/) blisters
Prescription
Registered
2018-08-31
-1- SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rowachol Gastro-resistant Capsules, Soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: α-Pinene 13.6 mg, ß-Pinene 3.4 mg, Menthol 32 mg, Menthone 6 mg, Borneol 5 mg, Cineole 2 mg and Camphene 5 mg. Excipient(s) with known effect: Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215) and Sodium Propyl Parahydroxybenzoate (E217). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant soft capsules. Spherical, green, soft gelatin, gastro-resistant capsules containing a greenish yellow oral solution with a strong aromatic odour. 4. CLINICAL PARTICULARS _4.1 THERAPEUTIC INDICATIONS _ In the management and dissolution of radiolucent gallstones in the functioning gall bladder where a definite diagnosis has been made by a doctor especially in the case of children. _4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ Method of administration: Oral. Posology _Adults_: 1 to 2 capsules three times daily before meals. _Paediatric Population _ Children aged 0 to 6 years: No data are available. -2- Children aged 6 to 14 years: 1 capsule twice daily before meals. Adolescents aged 14 to 18 years: 1 to 2 capsules three times 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 radiolucent gallstones 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 cholelithiasis should be initiated with the awareness that stones can give rise to serious clinical complications, especially if the stones obstruct the common bile duct such as obstructive jaundice, ascending cholangitis, sepsis, acute pancreatitis. The physician should be aware of the necessity of be Læs hele dokumentet