Pizotifen 1.5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Pizotifen hydrogen malate

Verfügbar ab:

Tillomed Laboratories Ltd

ATC-Code:

N02CX01

INN (Internationale Bezeichnung):

Pizotifen hydrogen malate

Dosierung:

1.5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04070402; GTIN: 5024655003006

Gebrauchsinformation

WHAT PIZOTIFEN IS AND WHAT
IT IS USED FOR
1
Pizotifen is an anti-migraine medicine.
Pizotifen tablets are used to help prevent or
reduce the pain of headaches, cluster
headaches and migraines.
Pizotifen will not relieve a migraine once it has
started
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE PIZOTIFEN
2
DO NOT TAKE PIZOTIFEN IF:
ƒ you are allergic to pizotifen or any of the
other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING PIZOTIFEN IF:
ƒ you suffer from liver or kidney problems
(your dose may need to be adjusted)
ƒ you have difficulty passing urine (e.g. an
enlarged prostate gland)
ƒ you suffer from closed angle glaucoma
(increased pressure in the eye)
ƒ you have a history of epilepsy
OTHER MEDICINES AND PIZOTIFEN
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including those obtained without a
prescription. This includes herbal medicines.
Medicines which MAY INTERACT WITH OR BE
AFFECTED BY Pizotifen:
ƒ Medicines to help you sleep (hypnotics),
such as nitrazepam
ƒ Medicines which help to relieve anxiety
(sedatives), such as diazepam
ƒ Medicines used to relieve allergies
(antihistamines), including some common
cold medicines
ƒ Medicines used to lower blood pressure
(adrenergic neurone blockers), such as
guanethidine
TAKING PIZOTIFEN WITH ALCOHOL
You should NOT drink alcohol whilst taking
Pizotifen.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think
you might be pregnant or are planning to
have a baby, ask your doctor for advice
before taking this medicine.
PREGNANCY
You should not take Pizotifen unless the
expected benefits outweigh the potential risks.
BREAST-FEEDING
The use of pizotifen is not recommended
whilst breast-feeding.
DRIVING AND USING MACHINES
Pizotifen may cause drowsiness, tiredness or
dizziness. If this occurs, you should not drive
or operate machinery.
PIZOTIFEN CONTAINS LACTOSE
If you have been told by your doctor that you
have intolerance to so

Fachinformation

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).
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.
Pizotifen is not effective in relieving a migraine attack once in
progress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
_Adults including the elderly: _
Usually 1.5mg daily. This may be taken as a single dose at night or in
three divided
doses.
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.
_Children (aged 2 years and over): _
Up to 1.5mg daily, usually as a divided dose, although up to 1mg has
been given as
a single dose at night.
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
For oral use.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the active substance 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 elevations
to severe
hepatitis. Pizotifen