Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
rizatriptan benzoate, Quantity: 14.53 mg (Equivalent: rizatriptan, Qty 10 mg)
Arrotex Pharmaceuticals Pty Ltd
rizatriptan benzoate
Tablet, orally disintegrating
Excipient Ingredients: aspartame; crospovidone; calcium silicate; colloidal anhydrous silica; magnesium stearate; mannitol; microcrystalline cellulose; Flavour
Oral
2
(S4) Prescription Only Medicine
RIZATRIPTAN ODT is indicated for the acute treatment of migraine attacks with or without aura.
Visual Identification: White, round, flat, bevel-edged tablet embossed with "IZ 10" on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-02-19
RIZATRIPTAN ODT APOTEX ORODISPERSIBLE TABLETS 1 RIZATRIPTAN ODT APOTEX ORODISPERSIBLE TABLETS _Rizatriptan benzoate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about rizatriptan. 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 using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Rizatriptan is used to relieve the headache pain and other symptoms of migraine attacks. Rizatriptan does not work for other types of headaches. Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, and sensitivity to light or 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 anywhere from two hours to two days and they can return frequently. The severity and frequency of migraines may vary. Migraine occurs in about one out 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. They tend to run in families. Certain things trigger migraine attacks in some people, including: • certain foods or drinks e.g. cheese, dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine) • stress, anger, worry • changes in routine e.g. under or over sleeping, missing meals, change in diet • bright light or loud noises • hormonal changes in women e.g. during menstrual periods. If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. K Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – RIZATRIPTAN ODT APOTEX (RIZATRIPTAN BENZOATE) 1 NAME OF THE MEDICINE Rizatriptan benzoate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orally disintergrating tablet contains 10 mg rizatriptan (as benzoate). EXCIPIENTS WITH KNOWN EFFECTS: aspartame. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM White, round, flat, bevel-edged tablet embossed with “IZ 10” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rizatriptan is indicated for the acute treatment of migraine attacks with or without aura. 4.2 DOSE AND METHOD OF ADMINISTRATION This medicine is a rapidly dissolving tablet. Administration with liquid is not necessary. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The tablet should be removed with dry hands and the tablet placed on the tongue, where it will dissolve and be swallowed with the saliva. DOSAGE 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: d_oses 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: i_f 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 dose is ineffective, has not been examined in controlled trials. – Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks. _Patients receiving propranolol:_ plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol (see Section 4.5 Interactions with Other Medicines and Other For Read the complete document