Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ropinirole hydrochloride
DE Pharmaceuticals
N04BC04
Ropinirole hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER REQUIP ® 5MG TABLETS (ropinirole hydrochloride) Your medicine is available using the name Requip 5mg Tablets, but will be referred to as Requip throughout this leaflet. This medicine is also available in strengths 0.25mg, 1mg and 2mg. 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. 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 REQUIP IS USED TO TREAT PARKINSON’S DISEASE. 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. 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 taking Requip: if you are PREGNANT or think you may be pregnant if you are BREAST-FE Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ropinirole 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ropinirole hydrochloride equivalent to 5.0 mg of ropinirole. Ropinirole 5 mg film-coated tablets: Each film-coated tablet contains ropinirole hydrochloride equivalent to 5 mg of ropinirole Excipient with known effect: 67.55 mg lactose (as lactose monohydrate and lactose anhydrous). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 5.0 mg Blue, circular, bevelled edged, biconvex film coated tablets with ‘259’ debossed on one side and ‘G’ 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 Oral use. Parkinson’s disease: Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole 0.25 mg film-coated tablets 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 titr Прочетете целия документ