Pizogran Tablet 0.5 mg

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

PIZOTIFEN MALATE

제공처:

EUCOGEN SDN BHD

INN (국제 이름):

PIZOTIFEN MALATE

패키지 단위:

100Tablet Tablets

Manufactured by:

REMEDICA LTD

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PIZOGRAN TABLET
_ _
Pizotifen (0.5 mg)
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WHAT IS IN THIS LEAFLET
1. What Pizogran is used for
2. How Pizogran works
3. Before you use Pizogran
4. How to use Pizogran
5. While you are using it
6. Side effects
7. Storage and Disposal of Pizogran
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PIZOGRAN IS USED FOR
Used for migraine type headache.
Pizogran can help to prevent
headaches or reduce the pain of
cluster headaches, common and
classical migraine. They will not stop
migraine attacks once they have
started.
HOW PIZOGRAN WORKS
Pizotifen tablet belong to a group of
medicines called antihistamines or
antiserotonin agents.
Pizotifen are a migraine treatment.
They may help to stop the effects of
certain naturally occurring substances
in your body called “serotonin”,
“histamine”, and “tryptamine” which
are involved in causing some kinds of
headache, including migraine.
BEFORE YOU USE PIZOGRAN
_- When you must not use it _
Do not use Pizogran if you are having
an allergy to:
(a)
pizotifen
(b)
Any of other ingredients listed at
the end of this leaflet
_- Before you start to use it _
Tell your doctor if you have or have
had any of the following medical
conditions:
(a)
rare heretitary problems of
galactose intolerance, the Lapp
lactase deficiency or glucose-
galactose malabsorption.
(b)
kidney problems
(c)
increased pressure in the eye due
to glaucoma.
(d)
Difficulty in passing urine
(water), due to prostate problems
or any other cause.
Tell your doctor if you are pregnant,
plan to become pregnant or
breastfeeding.
_- Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE PIZOGRAN
_- How much to use _
Starting with 0.5mg daily, the dosage
should be progressively increased.
The average maintenance dosage is
1.5mg daily in divided do

제품 특성 요약

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PACKAGE INSERT
1. PRODUCT NAME
Pizogran 0,5 Tablets
2. NAME AND STRENGTH OF ACTIVE INGREDIENT
Pizotifen 0,5 mg (as Malate)
3. PRODUCT DESCRIPTION
Film-Coated Tablets.
White, round, film-coated tablets with Remedica’s logo on one side.
4. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacodynamic studies demonstrate pizotifen to have powerful
anti-serotonin and
anti-tryptaminic properties, marked anti-histaminic effects and some
antagonistic activity
against kinins. It also possesses weak anti-cholinergic effects and
sedative properties.
Pizotifen also possesses appetite-stimulating properties.
The prophylactic effect of pizotifen in migraine is associated with
its ability to modify the
humoral mechanisms of headache.
It inhibits the permeability-increasing effect of serotonin and
histamine on the affected
cranial
vessels,
thereby
checking
the
transudation
of
plasmakinin
so
that
the
pain
threshold of the receptors is maintained at 'normal' levels. In the
sequence of events
leading to migraine attack, depletion of plasma serotonin contributes
to loss of tone in the
extracranial
vessels.
Pizotifen
inhibits
serotonin
re-uptake
by
the
platelets,
thus
maintaining plasma serotonin and preventing the loss of tone and
passive distension of
the extracranial arteries.
PHARMACOKINETICS
Absorption
Absorption of pizotifen is fast (absorption half life 0.5 to 0.8
hours) and nearly complete
(80%).
Biotransformation
Pizotifen is metabolised with a half life of about 1 hour. The main
metabolite (N-
glucuronide) is eliminated with a half life of approximately 23 hours.
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Distribution
Protein binding amounts to 91% and distribution volume to 485 litres.
Elimination
Less than 1% of the administered dose is excreted unchanged in the
urine, whereas 55%
is excreted as metabolites
5. CLINICAL PARTICULARS
INDICATIONS
Prophylactic (interval) treatment of vascular headaches, such as –
typical or atypical
migraine – vasomotor headaches - cluster head