Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
rizatriptan benzoate, Quantity: 14.53 mg (Equivalent: rizatriptan, Qty 10 mg)
ORGANON PHARMA PTY LTD
Wafer
Excipient Ingredients: glycine; mannitol; Gelatin; aspartame; Flavour
Oral
2 wafers, 3 wafers, 6 wafers, 1 wafer (sample pack), 2 wafers (sample pack)
(S4) Prescription Only Medicine
Maxalt is indicated for the acute treatment of migraine attacks with or without aura.
Visual Identification: White to off-white, round wafer with flat or slightly irregular surface, debossed on one side with a modified square, on the other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1999-06-23
MAXALT ® _Rizatriptan benzoate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using MAXALT Wafers. This leaflet answers some common questions about MAXALT Wafers. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MAXALT Wafers against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MAXALT WAFERS ARE USED FOR MAXALT Wafers are used to relieve the headache pain and other symptoms of migraine attacks. MAXALT Wafers do not work for other types of headaches. Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines. Migraine attacks last anything from two hours to two days and they can return frequently. The severity and frequency of migraine attacks may vary. Migraine occurs in about one out of every 10 people. It is three times more common in women than men. Six out of ten migraine sufferers have their first attack before the age of 20. There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are: • certain foods or drinks, for example, cheese and other dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine) • stress, anger, worry • changes in routine, for example, under or over sleeping, missing a meal, change in diet • bright light or loud noises • hormonal changes in women, for example, during menstrual periods If you understand what triggers your attacks, you may be able to prevent m Olvassa el a teljes dokumentumot
MK0462-AUS-2017-014577 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION MAXALT ® (RIZATRIPTAN BENZOATE) 1 NAME OF THE MEDICINE Rizatriptan benzoate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rizatriptan benzoate is a white to off-white, crystalline solid. Rizatriptan benzoate is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Each lyophilised wafer contains either 7.265 mg or 14.53 mg of rizatriptan benzoate (corresponding to 5 mg or 10 mg of rizatriptan, respectively). List of excipients with known effect: mannitol, aspartame For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 5 mg wafer - White to off-white round wafer with a flat or slightly irregular surface. 10 mg wafer - White to off-white round wafer with a flat or slightly irregular surface. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MAXALT is indicated for the acute treatment of migraine attacks with or without aura. 4.2 DOSE AND METHOD OF ADMINISTRATION MAXALT wafers are rapidly dissolving wafers. Administration with liquid is not necessary. The wafer is packaged in a blister within an outer aluminium sachet (pouch). Patients should be instructed not to remove the blister from the outer sachet until just prior to dosing. The blister pack should then be peeled open with dry hands and the wafer placed on the tongue, where it will dissolve and be swallowed with the saliva. The recommended dose is 10 mg. Clinical experience has shown that this dose provides the optimal clinical benefit. Onset of relief (i.e., reduction of headache pain to mild or none) can occur within 30 minutes after dosing. _Re-dosing: _Doses should be separated by at least 2 hours; no more than 30 mg should be taken in any 24-hour period. • _for headache recurrence within 24 hours: _If headache returns after relief of the initial attack, further doses may be taken. The above dosing limits should be observed. • _after non-response: _The effectiveness of a second dose for treatment of the same attack, when an initial Olvassa el a teljes dokumentumot