מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
RIZATRIPTAN AS BENZOATE
ORGANON PHARMA ISRAEL LTD., ISRAEL
N02CC04
TABLETS
RIZATRIPTAN AS BENZOATE 10 MG
PER OS
Required
ORGANON LLC, USA
RIZATRIPTAN
RIZATRIPTAN
Rizalt is indicated for the acute treatment of migraine attacks with or without aura in adults.
2023-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is marketed upon physician's prescription only RIZALT ® 10 MG TABLETS RIZALT ® RPD ® 10 MG WAFERS EACH TABLET CONTAINS: Rizatriptan 10 mg (as benzoate) EACH WAFER CONTAINS: Rizatriptan 10 mg (as benzoate) For a list of inactive ingredients refer to section 6. See also section 2.7 “Important information about some of the ingredients of RIZALT 10 MG TABLETS and RIZALT RPD 10 MG WAFERS”. Unless otherwise stated, the information in this Patient Information Leaflet applies to both RIZALT 10 MG TABLETS and RIZALT RPD 10 MG WAFERS. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. • This leaflet contains concise information about RIZALT 10 MG TABLETS and RIZALT RPD 10 MG WAFERS. If you have any further questions, ask your doctor 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 ailment is similar. • This medicine is intended for adults above 18 years of age. 1. WHAT RIZALT IS AND WHAT IT IS INTENDED FOR? RIZALT is used for the acute treatment of migraine attacks in adults, with or without aura. RIZALT is not to be used to prevent migraine attacks. RIZALT is not for the treatment of hemiplegic or basilar migraines. It is not known if RIZALT is safe and effective for the treatment of cluster headaches. THERAPEUTIC GROUP: RIZALT belongs to a class of medicines called selective 5-HT 1B/1D receptor agonists or Triptans. 2. BEFORE USING RIZALT 2.1 DO NOT USE RIZALT IF: − you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of RIZALT (for the list of inactive ingredients see section 6). − you have or have had heart problems. − you have or have had a stroke or a transient ischemic attack (TIA). − you have or have had blood vessel problems including ischemic bowel disease. − you have uncontrolled high blood pressure. − you are concurrently taking antidepressa קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT RIZALT ® 10 mg Tablets RIZALT RPD ® 10 mg Wafers 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RIZALT 10 MG TABLETS Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan). Excipient(s) with known effect Lactose monohydrate 60.5 mg in the 10 mg tablet. RIZALT RPD 10 MG WAFERS Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan). For the full list of excipients, see section 2 1 . 3. PHARMACEUTICAL FORM RIZALT 10 MG TABLETS Tablet 10 mg tablets are pale pink, capsule-shaped, convex tablets, coded 267 on one side and plain on the other. RIZALT RPD 10 MG WAFERS Wafer 10 mg wafers are white to off-white, round with a flat or slightly irregular surface and a modified square on one side and plain on the other side, with a peppermint flavour. 4. THERAPEUTIC INDICATIONS RIZALT ® Tablets and RIZALT RPD ® 10 mg Wafers (orally disintegrating tablets) are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • RIZALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RIZALT, the diagnosis of migraine should be reconsidered before RIZALT is administered to treat any subsequent attacks. • RIZALT is not indicated for use in the management of hemiplegic or basilar migraine [_see_ _Contraindications_ (6)]. • RIZALT is not indicated for the prevention of migraine attacks. • Safety and effectiveness of RIZALT have not been established for cluster headache. 5 DOSAGE AND ADMINISTRATION 5.1 DOSING INFORMATION IN ADULTS The recommended starting dose of RIZALT is 10 mg for the acute treatment of migraines in adults. _Redosing _ Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should קרא את המסמך השלם