국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ropinirole hydrochloride
Phoenix Healthcare Distribution Ltd
N04BC04
Ropinirole hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100
PACKAGE LEAFLET: INFORMATION FOR THE USER ROPINIROLE 5MG FILM-COATED TABLETS ROPINIROLE HYDROCHLORIDE (Referred to as Ropinirole Tablets in remainder of the leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAIN IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, please ask your doctor or pharmacist. − 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. − If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ropinirole Tablets are and what they are used for 2. What you need to know before you take Ropinirole Tablets 3. How to take Ropinirole Tablets 4. Possible side effects 5. How to store Ropinirole Tablets 6. Contents of the pack and other information 1. WHAT ROPINIROLE TABLETS ARE AND WHAT THEY ARE USED FOR Ropinirole Tablets are used to treat Parkinson’s disease. The active ingredient in Ropinirole Tablets 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. 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 ROPINIROLE TABLETS DO NOT TAKE ROPINIROLE TABLETS: • if you are allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6) • if you have a serious kidney disease • if you have a 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 taking Ropinirole Tablets: • if you are pregnant or think you may be pregnant • if you are breas 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ropinirole 5mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 5.7mg ropinirole hydrochloride, equivalent to 5mg ropinirole. Excipient(s) with known effect Lactose monohydrate – 113.2mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue, irregular hexagonal shape film-coated tablets, debossed with ‘W’ on one side and ‘177’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson's Disease under the following conditions: _ _ - Initial treatment as monotherapy, in order to delay the introduction of levodopa. - 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 Posology Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole 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 one week. Thereafter, the dose of ropinirole can be increased in 0.25mg three times daily increments, according to the following regimen:_ _ Week 3 Unit dose (mg) of ropinirole 0. 7 5 Total daily dose (mg)_ _of ropinirole 2. 2 5 _THERAPEUTIC REGIMEN_: After the initial titration, weekly increments of 0.5 to 1mg three times daily (1.5 to 3mg/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 24mg/day._ _ Doses of ropinirole_ _above 24 mg/day have not been studied. If treatment is interrupted for one day or more, re-initiation by dose titra 전체 문서 읽기