Pizotifen 1.5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Pizotifen hydrogen malate

Dostępny od:

Phoenix Healthcare Distribution Ltd

Kod ATC:

N02CX01

INN (International Nazwa):

Pizotifen hydrogen malate

Dawkowanie:

1.5mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04070402

Ulotka dla pacjenta

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Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pizotifen 1.5mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Pizotifen Malate equivalent to Pizotifen 1.5mg.
Excipients with known effect: Each tablet contains 200.62 mg of
lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Pale cream to yellow circular biconvex film-coated tablets with an
approximate
diameter of 9.1 mm, marked “PZT 1.5” on one face
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of recurrent vascular headaches, including
classical migraine,
common migraine and cluster headache (periodic migrainous neuralgia).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults including the older people _
Usually 1.5mg daily. This may be taken as a single dose at night or in
three divided
doses, using 1.5mg tablets or 0.5mg tablets as appropriate. Dosage
should be adjusted
to individual patients’ requirements up to a maximum of 4.5mg daily.
Up to 3mg may
be given as a single daily dose.
_Paediatric population _
Up to 1.5mg daily, usually as a divided dose. Use of the 1.5mg tablets
is not
recommended but up to 1mg has been given as a single dose at night.
Method of administration:
For oral use.
4.3
CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although
the
anticholinergic
activity
of
pizotifen
is
relatively
weak,
caution
is
required
in
the
presence
of
closed
angle
glaucoma
and
in
patients
with
a
predisposition to urinary retention (eg prostate hypertrophy). Dosage
adjustment may
be necessary in patients with kidney insufficiency. Pizotifen should
be used with
caution in patients with a history of epilepsy as seizures as adverse
effects have been
observed more frequently in such patients.
This product contains lactose, patients with rare hereditary problems
of galactose
intolerance, the Lapp-lactase deficiency or