Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROPINIROLE HYDROCHLORIDE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ROPINIROLE HYDROCHLORIDE
21 Tablets
GLAXO WELLCOME S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 REQUIP TABLET Ropinirole hydrochloride (0.25mg, 1mg) WHAT IS IN THIS LEAFLET 1. What REQUIP is used for 2. How REQUIP works 3. Before you use REQUIP 4. How to use REQUIP 5. While you are using it 6. Side Effects 7. Storage and Disposal of REQUIP 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT REQUIP IS USED FOR REQUIP is used to treat Parkinson’s disease and restless legs syndrome (RLS). HOW REQUIP WORKS 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 part of their brain. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. Restless legs syndrome is also called Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their body. They can often have unpleasant sensations in their limbs — sometimes described as ‘crawling’ or ‘bubbling’ — which can begin as soon as they sit or lie down, and which are only relieved by movement. This can often cause problems with sitting still, and especially with sleeping. REQUIP relieves the unpleasant sensations, and so reduces the urge to move the legs and other limbs. This can help you sleep better at night. BEFORE YOU USE REQUIP - _When you must not use it _ Don’t take REQUIP if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of REQUIP. If you think this applies to you, don’t take REQUIP until you have checked with your doctor. - _Before you start to use it _ Before you take REQUIP your doctor needs to know: • If you’re under 18 • If you have heart disease • If you have liver disease • If you have kidney disease • If you have a s Lees het volledige document
CONFIDENTIAL [GSK logo] REQUIP ROPINIROLE IMMEDIATE RELEASE TABLETS_ _ QUALITATIVE AND QUANTITATIVE COMPOSITION Each immediate release tablet contains ropinirole hydrochloride equivalent to 0.25 mg or 1.0 mg ropinirole free base. CLINICAL INFORMATION INDICATIONS REQUIP is indicated for the treatment of idiopathic Parkinson's disease: • REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment of idiopathic Parkinson's disease. • Addition of REQUIP to levodopa may be used to control "on-off" fluctuations and permit a reduction in the total daily dose of L-Dopa. Treatment of Restless Legs Syndrome: • Ropinirole is indicated for the treatment of idiopathic/primary Restless Legs Syndrome. DOSAGE AND ADMINISTRATION PHARMACEUTICAL FORM: Film-coated, pentagonal-shaped tablets for oral administration. The tablet strengths are distinguished by colour and debossing; 0.25 mg: white, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4890" on the other. 1.0 mg: green, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4892" on the other. When switching treatment from another dopamine agonist to REQUIP, the manufacturer's guidance on discontinuation should be followed before initiating REQUIP. Individual dose titration against efficacy and tolerability is recommended. Patients should be down-titrated if they experience disabling somnolence at any dose level. For other adverse events, down-titration followed by more gradual up-titration has been shown to be beneficial. CONFIDENTIAL _Parkinson's Disease _ • ADULTS REQUIP should be taken three times a day and may be taken with or without food (see Pharmacokinetics). _TREATMENT INITIATION: _ The initial dose should be 0.25 mg t.i.d (three times a day). A guide for the titration regimen for the first four weeks of treatment is given in the table below: Week 1 2 3 4 Unit dose (mg) 0.25 0.5 0.75 1.0 Total daily dose (mg) 0.75 1.5 2.25 3.0 _THERAPEUTIC REGIMEN_ : After the initial titration, weekly increments of up to 3 mg/day may Lees het volledige document