BREXIN TABLET

Country: Малезија

Језик: Енглески

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

Активни састојак:

PIROXICAM-B-CYCLODEXTRIN

Доступно од:

GERMAX SDN. BHD.

INN (Међународно име):

PIROXICAM-B-CYCLODEXTRIN

Јединице у пакету:

20Tablet Tablets

Произведен од:

CHIESI FARMACEUTICI SPA

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BREXIN
®
TABLET
Piroxicam (20mg)
___________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Brexin Tablet is used for
2. How Brexin Tablet works
3. Before you use Brexin Tablet
4. How to use Brexin Tablet
5. While you are using it
6. Side effects
7. Storage and Disposal of Brexin Tablet
8. Product Description
9. Manufacturer & Product Registration
Holder
10. Date of revision
WHAT BREXIN TABLET IS USED FOR
Brexin
Tablet
is
an
anti-
inflammatory
and
anti-pain
drug,
used
to
relieve
some
symptoms
caused
by
rheumatic
disease
like
rheumatoid
arthritis,
osteoarthritis
(degenerative
joint
disease)
and
ankylosing spondylitis. However it
should
not
be
the
first
choice
treatment in these conditions.
HOW BREXIN TABLET WORKS
Piroxicam
is
a
nonsteroidal
anti-
inflammatory
drug
(NSAID).
This
medicine
works
by
reducing
substances
in
the
body
that
cause
pain and inflammation.
BEFORE YOU USE BREXIN TABLET
-
_When you must not use it _
Do not take Brexin Tablet:
-
If you are allergic (hypersensitive)
to
piroxicam
or
to
any
of
the
excipients of Brexin Tablet.
-
If you currently or previously had
a
stomach
or
intestinal
ulcer,
bleeding or perforation.
-
If
you
previously
had
a
serious
allergic
drug
reaction
to
piroxicam,
other
NSAIDs
and
other
medications,
especially
serious skin reactions (regardless
of
severity)
such
as
multiform
erythema,
exfoliative
dermatitis
(intense reddening of skin, with
skin
peeling
off
in
scales
or
layers),
vesiculo-bullous
reactions:
Stevens-Johnson
syndrome,
a
condition
with
red
blistered,
eroded,
bloody
or
crusted skin, and toxic epidermal
necrolysis,
a
disease
with
blistering and peeling of the top
layer of skin.
-
If you are or suspect to be pregnant.
-
If you are breast-feeding.
-
If you are aged less than 18 years.
-
If you have a severe liver disease.
-
If you have a severe kidney disease.
-
If you have severe blood alterations.
-
If you have haemorrhagic diathesis
(predisp

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
BREXIN 20MG TABLET
NAME OF THE MEDICINAL PRODUCT
BREXIN 20mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains Piroxicam β-cyclodextrin 191.2 mg (equivalent to
piroxicam 20 mg). Excipients
with known effect: Lactose (102.8 mg/tablet).
PRODUCT DESCRIPTION
Tablets for oral use.
Pale yellow, hexagonal tablets with deep median scoring line.
INDICATIONS
For the symptomatic relief of pain and inflammation in patients with
osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis.
However, it should not be the first choice of non-steroidal
anti-inflammatory drug (NSAID)
treatment in these conditions.
RECOMMENDED DOSAGE
1 tablet (equivalent to 20 mg of piroxicam) per day.
In elderly patients, the dosage must be carefully decided by the
physician and it may be
necessary to reduce the dosage (half a tablet) and limit the duration
of treatment.
A prolonged administration of doses higher than 30mg/day increases the
risk of gastro-intestinal
side effects.
After assessing the risk/benefit ration in each individual patient,
the lowest effective dose for the
shortest possible duration should be used.
METHOD OF ADMINISTRATION
Oral administration. 1 tablet per day. The tablet must be swallowed
whole during a meal with a
big glass of water.
CONTRAINDICATIONS
Piroxicam should not be prescribed to patients who are more likely to
develop side effects, such
as those with history of gastrointestinal disorders associated with
bleeding or those who have had
skin reactions to other medicines.
Piroxicam should not be prescribed in association with any other NSAID
or an anticoagulant.
This medicine is contraindicated in the following situations:
•
Pregnancy, from the 6
th
month onwards (beyond 24 weeks of amenorrhea) (see FERTILITY,
PREGNANCY AND LACTATION)
•
Hypersensitivity to the active substance or to any of the excipients
in BREXIN tablet, past
history of skin reaction (however serious it was) to Piroxicam, to
other NSAIDs and other
medication
•
Past history of asthma tr