Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Pizotifen malate 0.725mg equivalent to 0.5 mg Pizotifen; ;
AFT Pharmaceuticals Ltd
Pizotifen malate 0.725 mg (equivalent to 0.5 mg Pizotifen)
500 mcg
Tablet
Active: Pizotifen malate 0.725mg equivalent to 0.5 mg Pizotifen Excipient: Acacia Cetyl palmitate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Sucrose Titanium dioxide
Blister pack, 100 tablets
Prescription
Prescription
Olon SpA
Indications Prophylactic treatment of recurrent vascular headaches, such as · typical or atypical migraine · vasomotor headache · cluster headache (Horton's syndrome). Sandomigran is less effective in tension headache and in psychogenic and post-traumatic headaches. It is not effective in relieving migraine attacks once in progress.
Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
1970-02-11
SANDOMIGRAN 1 SANDOMIGRAN 500 MCG TABLET PIZOTIFEN MALATE 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. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ. 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 this medicine is expected to 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 SANDOMIGRAN IS USED FOR Sandomigran contains the active ingredient pizotifen. It is used to prevent attacks of migraine (severe periodic headache). Migraine attacks are thought to be caused by temporary changes in the size of small blood vessels in the brain. These changes to the blood vessels cause the pain and problems with vision that often happen during a migraine. Sandomigran prevents migraine attacks by stopping the blood vessels from changing in size. Sandomigran can only be used to prevent migraine. It does not work during a migraine attack. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SANDOMIGRAN 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. BEFORE YOU TAKE SANDOMIGRAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SANDOMIGRAN IF YOU HAVE AN ALLERGY TO: • pizotifen (the active ingredient in Sandomigran) • any of the other ingredients listed at the end of Baca dokumen lengkapnya
SANDOMIGRAN ® 1. NAME OF THE MEDICINE SANDOMIGRAN ® pizotifen 500 micrograms coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One coated tablet contains 725 micrograms pizotifen hydrogen malate (corresponding to 500 micrograms pizotifen base). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Biconvex sugar coated tablets and white colour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SANDOMIGRAN® is indicated in adults and children from 2 years of age for the prophylactic treatment of recurrent vascular headaches, such as: • typical or atypical migraine • vasomotor headache • cluster headache (Horton’s syndrome) Sandomigran is less effective in tension headache and in psychogenic and post-traumatic headaches. It is not effective in relieving migraine attacks once in progress. 4.2 DOSE AND METHOD OF ADMINISTRATION General target population Starting with 0.5 mg daily, the dosage should be progressively increased. The average maintenance dosage is 1.5 mg daily in divided doses or as a single dose at night. In refractory cases the physician may gradually raise the dosage to 3 to 4.5 mg daily taken in 3 divided doses. _SPECIAL POPULATIONS _ PAEDIATRICS (CHILDREN FROM 2 YEARS OF AGE AND ADOLESCENTS) Starting with 0.5 mg, the daily dose may be increased up to 1.5 mg in divided doses, or 1 mg may be given as a single dose at night. _ _ Children below two years of age should not be given Sandomigran. GERIATRIC PATIENTS (AGED 65 YEARS AND ABOVE) There is no evidence to suggest that the dosage needs to be adjusted in elderly patients. RENAL AND HEPATIC IMPAIRMENT Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see _Pharmacokinetic properties_ ). _METHOD OF ADMINISTRATION _ Tablets for oral administration. _ _ 4.3 CONTRAINDICATIONS Hypersensitivity to pizotifen or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hepatic injury has been reported, ranging from transaminase elevat Baca dokumen lengkapnya