CERATOR EXTENDED-RELEASE TABLET 400mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

PENTOXIFYLLINE

Tillgänglig från:

MEDISPEC (M) SDN.BHD

INN (International namn):

PENTOXIFYLLINE

Enheter i paketet:

100Tablet Tablets

Tillverkad av:

Unison Laboratories Co. Ltd.

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CERATOR EXTENDED-RELEASE TABLET 400MG
Pentoxifylline (400 mg)
Page no. 1
WHAT IS IN THIS LEAFLET
1. What CERATOR is used for
2. How CERATOR works
3. Before you use CERATOR
4. How to use CERATOR
5. While you are using it
6. Side effects
7. Storage and Disposal of CERATOR
8. Product Description
9. Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT CERATOR IS USED FOR
CERATOR contains a medicine called
Pentoxifylline. This belongs to a group of
medicines called peripheral vasodilators.
It works by increasing the blood flow.
CERATOR is indicated for:

Disorder of brain blood circulation as a
consequence of cerebral artriosclerosis
(thickening and hardening of the walls
of the blood vessels in the brain) e.g.
lack/
difficulty
in
concentration,
vertigo, forgetfulness/ impairment of
memory

Peripheral blood vessel disease (poor
circulation to the arms and legs).

Intermittent
claudication
(pain
on
walking
or
at
rest
caused
by
poor
circulation to the legs)

Trophic disturbances (e.g. leg ulcers
and
gangrene).
HOW CERATOR WORKS
Pentoxifylline works by
reducing blood
viscosity and improving peripheral blood
flow
thus
enhance
peripheral
tissue
oxygenation.
BEFORE YOU USE CERATOR
_- When you must not use it_

If you are allergic (hypersensitive) to
Pentoxyfylline, other methyl xanthines,
or
to
any
of
the
other
ingredients
of
CERATOR.
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling
of
your
lips,
face,
throat
or
tongue.

If you have heart problems or have
recently had heart attack

If you have severe palpitations (very
fast and uneven heartbeats)

If you have had a stroke with bleeding
in the brain (cerebral hemorrhage)

If you have had bleeding in the eye
(retinal hemorrhage)

If you are Pregnant and breast-feeding

You should not use CERATOR if
you are pregnant. CERATOR may
be used only if the doctor decides
that
the
anticipated
benefit
of
the
treatment
outweighs
the
potential
risks

Produktens egenskaper

CERATOR 400
EXTENDED-RELEASE TABLET
PERIPHERAL VASODILATOR
Each film coated tablet contains:
PENTOXIFYLLINE 400 MG

PRODUCT DESCRIPTION:
White, oval, biconvex, film coated tablet with engraved CR-400 on one
side and scored on the other

MECHANISM OF ACTION:
_PHARMACOLOGY _
Leukocyte properties of hemorrheologic importance have been modified
in animal and _in vitro_ human studies. Pentoxifylline has been shown
to increase leukocyte deformability and to
inhibit neutrophil adhesion and activation.
_PHARMACOKINETICS _
The half life of absorption of Pentoxifylline 400 is 4-6 hours.
Pentoxifylline is extensively metabolized, mainly in the liver. Sixty
percent of a single dose of Pentoxifylline 400 is
eliminated via the kidney over 24 hours.

INDICATION
@
:
Cerebral circulatory disorders (sequelae of cerebral arteriosclerosis,
e.g. lack/ difficulty in concentration, vertigo, forgetfulness/
impairment of memory), ischemic and postapoplectic
conditions.
Peripheral occlusive arterial disease and arteriovenous disorders of
an arteriosclerotic or diabetic nature (e.g. intermittent claudication
or rest pain) and trophic disturbances (e.g. leg ulcers
and gangrene).

DOSAGE AND ADMINISTRATION
@
:
In principle, dosage and mode of administration is based on the type
of severity of the circulatory disorder and on how the individual
patient tolerates the drug. Dosage is generally based
on the following guidelines and is determined by the physician in
accordance with individual requirements:
_USUAL DOSE _
1 tab 2 or 3 times daily. The tablets are to be swallowed whole during
or shortly after a meal with sufficient amounts of liquid
(approximately ½ glass).
In patients with marked impairment of renal function (creatinine
clearance < 10 mL/ min), it may be necessary to reduce the dose to 2
or 1 tablet daily. The precise reduction implemented
will vary depending on how the patient tolerates the drug.
A dose reduction, guided by individual tolerance is necessary in
patients with severely impaired liver function.
Treatment m