Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pizotifen hydrogen malate
Alliance Healthcare (Distribution) Ltd
N02CX01
Pizotifen hydrogen malate
1.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070402
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pizotifen 1.5mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.175 mg Pizotifen Malate, equivalent to 1.5mg of pizotifen base. 3 PHARMACEUTICAL FORM Film coated tablet. The tablets, which are white, are marked PZ on one side, plain on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia). The International Classification of Headache Disorders 2nd edition (ICHD-II) are standard classifications of headache used by health professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache. It is not effective in relieving migraine attacks once in progress 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults:_ Usually 1.5mg daily, at night or in 3 divided doses. Dosage should be _ _ adjusted according to need, up to a maximum of 4.5mg daily. Up to 3mg can be given as a single dose. _ _ _Children (aged 2 years and over only):_ Use of 1.5mg tablet is not recommended for children. The appropriate paediatric doses may be given using the 0.5mg tablets. _ _ _Elderly:_ As for adults. Clinical work with this product has not shown elderly patients to require different dosages form younger patients Special populations _Renal and hepatic impairment _ Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2). Method of administration: oral 4.3 CONTRAINDICATIONS Hypersensitivity to the drug or to any of the other tablet ingredients (see section 6.1. List of excipients). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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 Read the complete document