País: Israel
Idioma: inglés
Fuente: Ministry of Health
ROPINIROLE AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
N04BC04
FILM COATED TABLETS - PROLONGED RELEASE
ROPINIROLE AS HYDROCHLORIDE 4 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
ROPINIROLE
ROPINIROLE
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)."
2014-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician's prescription only Requip Modutab 2 mg Requip Modutab 4 mg Requip Modutab 8 mg Film-coated prolonged-release tablets that contain ropinirole (as hydrochloride) 2 mg, 4 mg or 8 mg. For the list of the inactive and allergenic ingredients in the medicine, see section 2 - Important information about some of the ingredients in the medicine and section 6 - Additional information . Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Requip Modutab is indicated for the 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). The active ingredient in Requip Modutab is ropinirole. 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. You can take Requip Modutab either on its own or along with L-dopa (see section 4 of this leaflet for more details). Therapeutic group: dopamine agonist. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive (allergic) to the active ingredient ropinirole or to any of the additional ingredients contained in this medicine (listed in sectio Leer el documento completo
Page 1 of 11 REQUIP MODUTAB 2 MG REQUIP MODUTAB 4 MG REQUIP MODUTAB 8 MG 1. NAME OF THE MEDICINAL PRODUCT Requip Modutab 2 mg Requip Modutab 4 mg Requip Modutab 8 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2 / 4 / 8 mg ropinirole (as hydrochloride). Excipients with known effect: 44.0 mg/41.8 mg/37.5 mg (respectively) Lactose 1.24 mg Sunset yellow (E110) (Requip Modutab 4 mg only) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. 2 mg: Pink capsule-shaped, film-coated tablets marked "GS" on one side and "3V2" on the other. 4 mg: Light brown capsule-shaped, film-coated tablets marked "GS" on one side and "WXG" on the other. 8 mg: Red capsule-shaped, film-coated tablets marked "GS" on one side and "5CC" on the other. 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. Individual dose titration against efficacy and tolerability is recommended. Page 2 of 11 Ropinirole 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. A high fat meal may double the AUC and Cmax in some individuals (See 5.2 Pharmacokinetics). ADULTS 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. THERAPEUTIC REGIMEN Patients should be maintained on the lowest dose Leer el documento completo