Transcription of INDICATIONS DOSAGE AND ADMINISTRATION
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NEW ZEALAND DATA SHEET Page 1 of 7 1 SANDOMIGRAN pizotifen coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is 4-(1-methyl-4-piperidylidene)-9,10-dihyd ro-4H-benzo-[4,5]cyclohepta[1,2-b] thiophene hydrogen malate (= pizotifen hydrogen malate). One coated tablet contains mg pizotifen hydrogen malate (corresponding to mg pizotifen base). For a full list of excipients, see section 3 PHARMACEUTICAL FORM Tablets for oral ADMINISTRATION 4 CLINICAL PARTICULARS Therapeutic 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.
Pizotifen hydrogen malate was evaluated in multiple reproductive and developmental toxicity studies for its effects on fertility and its embryotoxic, fetotoxic, teratogenic and …
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