البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ropinirole hydrochloride
Accord-UK Ltd
N04BC04
Ropinirole hydrochloride
8mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 5012617022820
_Continued top of next column _ BBBA6256 RAPONER XL 2MG, 4MG AND 8MG PROLONGED-RELEASE TABLETS Ropinirole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, 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 possible side effects not listed in this leaflet. See section 4 . • The full name of this medicine is Raponer XL 2mg, 4mg and 8mg Prolonged-release Tablets but within the leaflet it will be referred to as Raponer XL tablets. WHAT IS IN THIS LEAFLET: 1 WHAT RAPONER XL TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAPONER XL TABLETS 3 HOW TO TAKE RAPONER XL TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE RAPONER XL TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT RAPONER XL TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Raponer XL 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. Raponer XL prolonged-release tablets are 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 RAPONER XL TABLETS DO NOT TAKE RAPONER XL TABLETS IF YOU • are ALLERGIC to ropinirole or any of the other ingredients of this medicine (listed in section 6) • have a SERIOUS KIDNEY disease • 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 T اقرأ الوثيقة كاملة
OBJECT 1 RAPONER XL 8MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 05-Feb-2018 | Accord-UK Ltd 1. Name of the medicinal product Raponer XL 8mg Prolonged-release Tablets 2. Qualitative and quantitative composition Each prolonged-release tablet contains 8 mg ropinirole (as hydrochloride). Excipient with known effect: Each 8 mg prolonged-release tablet contains 55.88 mg lactose monohydrate. Raponer XL 8mg Prolonged-release Tablets contain hydrogenated castor oil For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet. Raponer XL 8mg prolonged-release tablets: Dark pink, mottled, oval tablet, 16.0 x 8.20 mm, with 8x debossed on one 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. Raponer XL prolonged-release tablets should be taken once a day, at a similar time each day. The prolonged-release tablets may be taken with or without food (see section 5.2). _Initial titration _ The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets. Patients who initiate treatment with a dose of 2 mg/day of ropinirole prolonged-release tablets and who experience side effects that they cannot tolerate, may benefit from switching to treatment with ropinirole film-coated (immediate release) tablets at a lower daily dose, divided into three equal do اقرأ الوثيقة كاملة