Norflex tablet 100mg

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

ORPHENADRINE CITRATE

Saatavilla:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (Kansainvälinen yleisnimi):

ORPHENADRINE CITRATE

Kpl paketissa:

100tablet Tablets

Valmistaja:

Adcock Ingram Limited - A Medreich Group Company

Pakkausseloste

1
_Consumer Medication Information Leaflet (RiMUP) _
NORFLEX TABLET 100MG
Orphenadrine citrate 100mg
WHAT IS IN THIS LEAFLET
1.
What Norflex Tablet 100mg is
used for
2.
How Norflex Tablet 100mg works
3.
Before you use Norflex Tablet
100mg
4.
How to use Norflex Tablet 100mg
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Norflex
Tablet 100mg
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT NORFLEX TABLET 100MG IS USED
FOR
Norflex Tablet 100mg is used to help
relax certain muscles in your body and
to relieve the pain and discomfort
caused by sprains, strains or other
injury to your muscles.
HOW NORFLEX TABLET 100MG WORKS
Orphenadrine citrate is a skeletal
muscle relaxant. It acts in the central
nervous system to produce muscle
relaxant effects.
BEFORE YOU USE NORFLEX TABLET 100MG
_-When you must not use it _
Do not use this medicine if you have
an allergy to:

any medicine containing
Orphenadrine citrate

any of the ingredients listed at the
end of this leaflet.
Do not take this medicine if you have

glaucoma (high pressure in the
eye)

intestinal blockage or oesophageal
disease

enlarged prostate or bladder
obstruction

myasthenia gravis ( a disease of
the muscles causing drooping
eyelids, double vision, difficulty in
speaking and swallowing, and,
sometimes, muscle weakness in
the arms or legs).
Do not take this medicine after the
expiry date printed on the pack or if the
packaging is torn or shows signs of
tampering.
Do not give this medicine to a child
under the age of 12 years.
Safety and effectiveness in children
younger than 12 years have not been
established.
_-Before you start to use it _
Tell your pharmacist if you have:

Allergies to any other medicines,
foods, preservatives or dyes.

Any heart problems

Any liver or kidney problems
Norflex Tablet 100mg is not
recommended for use during
pregnancy or lactation. Tell your
doctor if you pregnant or breastfeeding
or intend to become pregnant or
breastfeed.
If you a

Valmisteyhteenveto

Product Description
A white tablet marked N/X on one side and
no marking on reverse.
Pharmacodynamics
Orphendarine is a skeletal muscle relaxant.
Pharmacokinetics
Orphenadrine is readily absorbed from the
gastrointestinal tract and is almost
completely metabolised to at least eight
metabolites. Orphenadrine and its metabo-
lites are excreted from the body in the
urine, with a half life of 14 hours.
Indication
Relief of painful muscle spasm associated
with fibrositis, whiplash injuries, tor ticollis,
prolapsed interver tebral disc, strains,
sprains and similar conditions. Has also
been shown to be of value in tension
headache and persistent hiccough.
Contraindication
Orphenadrine shows some anticholinergic
activity and should not be used in patients
with glaucoma, prostatic hyper trophy or
obstruction at the bladder neck, or
myasthenia gravis.
Precautions
Orphenadrine may impair the ability of the patient to engage in potentially hazardous
activities such as operating machinery or
driving a motor vehicle; ambulatory
patients should therefore be cautioned
accordingly.
Orphenadrine citrate should be used with
caution in patients with tachycardia,
cardiac decompensation, coronary
insufficiency, cardiac arrhythmias.
Safety of continuous long-term therapy
with orphenadrine has not been
established. Therefore if orphenadrine is
prescribed for prolonged use, periodic
monitoring of blood, urine and liver
function is recommended.
Drug Interactions
The effects of antimuscarinic agents such
as orphenadrine may be enhanced by other
drugs with antimuscarinic proper ties such
as amantadine, some antihistamines,
butyrophenones and phenothiazines, and
tricyclic antidepressants. The reduction in
gastric motility caused by antimuscarinic
agents may affect the absorption of other
drugs.
Use in pregnancy
Safe use in pregnancy has not been
established, therefore the drug should not
be used in pregnant women or those likely
to become pregnant unless the expected
1
benefits outweigh the potential risks.
Use in lactation
It is unknown wh