Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Menthol; Menthone; Alpha pinene; Borneol; Cineole; Camphene; Beta pinene
Rowa Pharmaceuticals Limited
Menthol; Menthone; Alpha pinene; Borneol; Cineole; Camphene; Beta pinene
percent volume/volume
Gastro-resistant capsule, soft
Product not subject to medical prescription
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ROWACHOL ® GASTRO-RESISTANT CAPSULES, SOFT Α-PINENE, Β -PINENE, MENTHOL, MENTHONE, CAMPHENE, BORNEOL, CINEOLE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What Rowachol® is and what it is used for 2. What you need to know before you take Rowachol® 3. How to take Rowachol® 4. Possible side effects 5. How to store Rowachol® 6. Contents of the pack and other information 1. WHAT ROWACHOL® IS AND WHAT IT IS USED FOR Rowachol® is intended for use in the breaking up (dissolving or disintegrating) or passage (expulsion) of gallstones. Rowachol® increases bile production and relaxes the bile ducts. This helps reduce painful spasms of bile ducts. It also makes it easier for any gallstones present to be passed out (expelled) with the bile. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWACHOL® DO NOT TAKE ROWACHOL®: - if you are allergic to α-pinene, β-pinene, borneol, menthol, menthone, camphene, cineole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR FIRST BEFORE YOU TAKE ROWACHOL® DO NOT TAKE ROWACHOL UNLESS YOUR DOCTOR HAS CONFIRMED A DIAGNOSIS OF GALLSTONES ESPECIALLY IN THE CASE OF CHILDREN. Talk to your doctor or pharmacist before taking Rowachol® if you are taking medicines to thin your blood or medicines that are broken down by the liver. OTHER MEDICINES AND ROWACHOL® Tell your doctor or pharmacist if you are taking, have recently taken or might tak Lugege kogu dokumenti
Health Products Regulatory Authority 17 February 2020 CRN009LV8 Page 1 of 4 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 32.0 mg, Menthone 6.0 mg, Borneol 5.0 mg, Camphene 5.0 mg, Cineole 2.0 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 Capsules, soft Spherical, green, soft gelatine, 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 Posology Method of administration: Oral. Adults: 1 to 2 capsules three times daily before meals. _Paediatric Population:_ Children aged 0 to 6 years: No data are available. 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. Health Products Regulatory Authority 17 February 2020 CRN009LV8 Page 2 of 4 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 s Lugege kogu dokumenti