Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
pizotifen malate, Quantity: 0.725 mg
AFT Pharmaceuticals Pty Ltd
Tablet, sugar coated
Excipient Ingredients: colloidal anhydrous silica; povidone; Acacia; purified talc; sucrose; lactose monohydrate; cetyl palmitate; magnesium stearate; maize starch; titanium dioxide
Oral
100, 30, 2
(S4) Prescription Only Medicine
INDICATIONS AS AT 14 JUNE 2004: Prophylactic (interval) treatment of vascular headaches: Typical and atypical migraine, vasomotor headache, cluster headache (Horton's syndrome). Sandomigran is without effect in the migraine attack. For this purpose preparations containing ergotamine are recommended.
Visual Identification: Off-white, circular biconvex tablet approx 6mm in diameter.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
1999-06-24
SANDOMIGRAN ® _Pizotifen malate_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sandomigran. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE . Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sandomigran against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE . You may need to read it again. WHAT SANDOMIGRAN IS USED FOR Sandomigran is used to prevent "vascular" headaches, including migraine, cluster headaches and vasomotor headaches. Vascular headaches are thought to be caused by temporary changes in the size of small blood vessels in the brain. These changes cause the pain and problems with vision that often happen during a severe headache. Sandomigran prevents an attack by stopping the blood vessels from changing in size. Sandomigran is only used to prevent severe headaches from happening. It will not stop an attack once it has started. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Sandomigran is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend this medicine for children. BEFORE YOU TAKE SANDOMIGRAN _WHEN YOU MUST NOT TAKE IT_ _ _ DO NOT TAKE SANDOMIGRAN IF YOU HAVE AN ALLERGY TO PIZOTIFEN (THE ACTIVE INGREDIENT) OR TO ANY OF THE OTHER INGREDIENTS OF SANDOMIGRAN LISTED AT THE END OF THIS LEAFLET. Som Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION – SANDOMIGRAN (PIZOTIFEN MALATE) TABLET 1 NAME OF THE MEDICINE Pizotifen malate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 500 micrograms of pizotifen present as 725 micrograms of pizotifen malate. Excipients with known effects: lactose, sucrose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Off-white, circular biconvex sugar coated tablet, approx 6mm in diameter 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prophylactic (interval) treatment of vascular headaches. Typical and atypical migraine Vasomotor headache Cluster headache (Horton's syndrome) Sandomigran is without effect in the migraine attack. For this purpose preparations containing ergotamine are recommended. 4.2 D OSE AND METHOD OF ADMINISTRATION The dosage should be progressively increased, starting with 0.5 mg daily. The average maintenance dosage is 1.5 mg daily in single or divided doses. Recent studies have shown a single daily dose of 3 tablets (1.5 mg) taken at night to be effective. In refractory cases the dosage may be gradually raised to 3 - 4.5 mg daily in two or three divided doses. 4.3 C ONTRAINDICATIONS Hypersensitivity to pizotifen or any of the excipients in the formulation. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE _USE IN RENAL IMPAIRMENT _ Caution is required in patients with renal impairment. Dosage adjustment may be necessary. 2 _HEPATIC IMPAIRMENT _ Hepatic injury has been reported, ranging from transaminase elevations to severe hepatitis. Pizotifen treatment should be discontinued if there is any clinical evidence of hepatic dysfunction during treatment and until the cause of the liver abnormality is determined. Caution is required in patients with hepatic impairment. Dosage adjustment may be necessary. _ANTICHOLINERGIC EFFECTS _ In view of the very slight anticholinergic effect of pizotifen, caution is required in patients with narrow angle glaucoma (except those successfully treated by surgery) or urinary rete Soma hati kamili