MediHerb UriCo Phytosynergist

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Agathosma betulina,Echinacea angustifolia,Elymus repens,Glycyrrhiza glabra

Available from:

Integria Healthcare Australia Pty Ltd

INN (International Name):

Agathosma betulina,Echinacea angustifolia,Elymus repens,Glycyrrhiza glabra

Class:

Medicine Listed (Export Only)

Authorization status:

Listed (Export Only)

Patient Information leaflet

NORFLEX™
_Orphenadrine citrate 100mg tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NORFLEX tablets.
However it does not contain all the
available information. Your doctor
and pharmacist have more
information about this medicine.
IF YOU HAVE ANY QUESTIONS ABOUT
NORFLEX THAT ARE NOT ANSWERED
BY THIS LEAFLET, PLEASE ASK YOUR
DOCTOR OR PHARMACIST.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your taking NORFLEX
against the benefits before
prescribing it for you.
IF YOU ARE WORRIED ABOUT TAKING
THIS MEDICINE PLEASE TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE AS YOU MAY WANT TO READ
IT AGAIN.
WHAT NORFLEX IS
USED FOR
The name of your medicine is
NORFLEX. It contains orphenadrine
citrate. Orphenadrine citrate is a
skeletal muscle relaxant. It acts in the
central nervous system to produce its
muscle relaxant effects.
NORFLEX 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.
Your doctor may have prescribed
NORFLEX for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
NORFLEX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORFLEX IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO ORPHENADRINE CITRATE
OR OTHER SIMILAR MEDICINES, OR
TO ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
•
YOU HAVE ANY OF THE FOLLOWING:
-
GLAUCOMA
(high pressure in the eye);
-
INTESTINAL BLOCKAGE, STOMACH
ULCER 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).
•
AFTER THE EXPIRY DATE ON THE
BOTTLE
•
IF THE PACKAGING 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NORFLEX (ORPHENADRINE
CITRATE) SLOW RELEASE TABLETS
1
NAME OF THE MEDICINE
Orphenadrine citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NORFLEX slow release (modified release) tablets contain orphenadrine
citrate 100 mg.
Excipients with known effect:
•
Sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Slow release (modified release) tablet, 100 mg:
White, round, biconvex tablet. Markings N/X on one side and no
markings on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Relief of painful muscle spasm associated with fibrositis, whiplash
injuries, torticollis, prolapsed
intervertebral disc, strains, sprains and similar conditions. Norflex
has also been shown to be of
value in tension headache and persistent hiccup.
4.2
D
OSE AND METHOD OF ADMINISTRATION
100mg twice daily. In severe cases, dosage may be increased to 300mg
in any 24 hour period.
4.3
C
ONTRAINDICATIONS
Orphenadrine shows some anticholinergic activity and should not be
used in patients with
glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or
myasthenia gravis.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
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.
USE IN THE ELDERLY
No data available.
2
PAEDIATRIC USE
No data available.
EFFECTS ON LABORATORY TESTS
No data available.
4.5
I
NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
Interactions have been reported between orphenadrine and
phenothiazines and other drugs
with anti-muscarinic properties.
Concomitant use with alcohol or other CNS depressants should be
avoided.
4.6
F
ERTILITY
, PREGNANCY AND LACTATION
EFFECTS ON FERTILITY
No data availa