Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROPINIROLE HYDROCHLORIDE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ROPINIROLE HYDROCHLORIDE
84 Tablets; 28 Tablets
GLAXO WELLCOME S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 REQUIP PD 24 HOUR PROLONGED RELEASE TABLET Ropinirole hydrochloride (2mg, 4mg) WHAT IS IN THIS LEAFLET 1. What REQUIP PD is used for 2. How REQUIP PD works 3. Before you use REQUIP PD 4. How to use REQUIP PD 5. While you are using it 6. Side Effects 7. Storage and Disposal of REQUIP PD 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT REQUIP PD IS USED FOR REQUIP PD is used to treat Parkinson’s disease. HOW REQUIP PD WORKS The active ingredient in REQUIP PD 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 brain. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. BEFORE YOU USE REQUIP PD - _When you must not use it _ Don’t take REQUIP PD if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of REQUIP PD. If you think this applies to you, don’t take REQUIP PD until you have checked with your doctor. - _Before you start to use it _ Before you take REQUIP PD 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 serious mental health problem • If you have experienced any unusual urges or behaviours (such as excessive gambling or excessive sexual behaviour) • If you have an intolerance to some sugars (such as lactose) Check with your doctor if you think any of these may apply to you. Your doctor will decide whether REQUIP PD is suitable for you. REQUIP PD is not usually recommended for use during pregnancy. If you are pregnant or think you could be, or if you are planning to become pregnant don’t take REQUIP PD without checking with your doctor. Your doctor will weigh up the benefit to Read the complete document
CONFIDENTIAL 1 [GSK LOGO] REQUIP PD 24 HOUR ROPINIROLE PROLONGED RELEASE TABLETS PARKINSON’S DISEASE QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains ropinirole hydrochloride equivalent to 2mg or 4mg ropinirole free base. CLINICAL INFORMATION INDICATIONS • _REQUIP PD 24 HOUR_ is indicated for the treatment of idiopathic Parkinson's disease. • _REQUIP PD 24 HOUR may be used alone (without levodopa [L-dopa]) in the _ _treatment of idiopathic Parkinson’s disease. _ • _Addition of REQUIP PD 24 HOUR to levodopa may be used to control ‘on-off’ _ _fluctuations and permit a reduction in the total daily dose of L-Dopa._ DOSAGE AND ADMINISTRATION _PHARMACEUTICAL FORM _ Film-coated, capsule-shaped tablets for oral administration. The tablet strengths are distinguished by colour and debossing; 2mg: pink, capsule-shaped, film-coated tablets marked "GS” on one side and "3V2" on the other. 4mg: light brown, capsule-shaped, film-coated tablets marked "GS" on one side and "WXG" on the other. Oral use. Individual dose titration against efficacy and tolerability is recommended. _REQUIP PD _ _24 HOUR_ prolonged-release tablets should be taken once a day and at a similar time each day. The tablets must be swallowed whole and must not be chewed, crushed or divided. The tablets may be taken with or without food (see Pharmacokinetics). _ADULTS _ _ _ _INITIAL TITRATION _ CONFIDENTIAL 2 The starting dose of _REQUIP PD 24 HOUR_ 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 _REQUIP _ _PD 24 HOUR_ 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 _REQUIP IR_ (immediate release) tablets at a lower daily dose, divided into three equal doses. _THERAPEUTIC REGIMEN Read the complete document