Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Ropinirole hydrochloride
GlaxoSmithKline (Ireland) Limited
N04BC; N04BC04
Ropinirole hydrochloride
1 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Dopamine agonists; ropinirole
Marketed
1996-12-03
Reason for Update: PRAC Recommendation PSUSA/00002661/202207 Market: IE Agency Approval Date: 05Jun23 (Type IAIN) Text Date: 18May2023 Issue and Draft No.: Issue 11 Draft 1 1 REQUIP PACKAGE LEAFLET: INFORMATION FOR THE USER REQUIP 0.25 MG FILM-COATED TABLETS REQUIP 1 MG FILM-COATED TABLETS REQUIP 2 MG FILM-COATED TABLETS REQUIP 5 MG FILM-COATED TABLETS ropinirole (as hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. Keep this leaflet. You may need to read it again. If you have any more questions, ask your doctor or pharmacist (chemist). 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. WHAT IS IN THIS LEAFLET 1. WHAT REQUIP IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REQUIP 3. HOW TO TAKE REQUIP 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE REQUIP 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT REQUIP IS AND WHAT IT IS USED FOR The active ingredient in Requip is ropinirole, which belongs to a group of medicines called DOPAMINE AGONISTS . Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. REQUIP IS USED TO TREAT PARKINSON’S DISEASE . People with Parkinson’s disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REQUIP DO NOT TAKE REQUIP: ▪ if you are ALLERGIC to ropinirole or any of the other ingredients of this medicine (listed in section 6) ▪ if you have SERIOUS KIDNEY DISEASE ▪ if you have LIVER DISEASE ➔ TELL YOUR DOCTOR if you think any of these may apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before ta Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 17 July 2023 CRN00DM78 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Requip 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg of ropinirole (as ropinirole hydrochloride). Excipient with known effect Each tablet contains 44.9 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Green, pentagonal-shaped bevelled edge tablets marked “SB” on one side and “4892” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson's disease under the following conditions: o Initial treatment as monotherapy, in order to delay the introduction of levodopa o In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (end of dose or on-off type fluctuations) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. Adults Individual dose titration against efficacy and tolerability is recommended. Requip should be taken three times a day, preferably with meals to improve gastrointestinal tolerance. _Treatment initiation_ The initial dose of ropinirole should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times daily increments, according to the following regimen: Week 1 2 3 4 Unit dose (mg) of ropinirole 0.25 0.5 0.75 1.0 Total daily dose (mg) of ropinirole 0.75 1.5 2.25 3.0 _Therapeutic regimen_ After the initial titration, weekly increments of 0.5 to 1 mg three times daily (1.5 to 3 mg/day) of ropinirole may be given. A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If sufficient symptomatic control is not achieved, or maintained after the initial titration as described above, the dose of ropinirole may be increased up to 24 mg/day. Doses of ropinirole above 24 mg/day have not been studied. Health Products Regulatory Authority 17 J Olvassa el a teljes dokumentumot