Pizotifen 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pizotifen hydrogen malate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N02CX01

INN (International Name):

Pizotifen hydrogen malate

Dosage:

1.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070402; GTIN: 5037563003525

Patient Information leaflet

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Summary of Product characteristics

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