Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Alpha pinene; Borneol; Menthol; Beta pinene; Menthone; Camphene; Cineole
Rowa Pharmaceuticals Limited
Alpha pinene; Borneol; Menthol; Beta pinene; Menthone; Camphene; Cineole
percent volume/volume
Oral drops, solution
Product not subject to medical prescription
Not marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ROWACHOL® ORAL DROPS, SOLUTION 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 take any other me Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rowachol Oral Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 g of oral drop solution contains: -Pinene 13.6 g, ß-Pinene 3.4 g Menthol 32.0 g, Menthone 6.0 g, Borneol 5.0 g, Camphene 5.0 g, Cineole 2.0g. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Drops, Solution Pale yellow to greenish-yellow oral drop 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: 3 to 5 oral drops three times daily before meals. _Paediatric Population:_ Children 0-6 years: No data are available Children aged 6 to 14 years: 1 to 2 oral drops three times daily before meals. Adolescents aged 14-18 years: 3 to 5 oral drops 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ Aqra d-dokument sħiħ