NORFLEX orphenadrine citrate 100 mg slow release tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

orphenadrine citrate, Quantity: 100 mg

זמין מ:

iNova Pharmaceuticals (Australia) Pty Ltd

טופס פרצבטיות:

Tablet, modified release

הרכב:

Excipient Ingredients: ethylcellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

10 tablets - starter pack, 100 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Relief of painful muscle spasm associated with fibrositis, whiplash injuries, torticollis, prolapsed intervertebral disc, strains, sprains and similar conditions. Has also been shown to be of value in tension headache and persistent hiccup.

leaflet_short:

Visual Identification: White, round biconvex tablet. Markings N/X on one side and no markings on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2021-09-29

עלון מידע

NORFLEX
®
N
O
R
F
L
E
X
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NORFLEX?
NORFLEX contains the active ingredient orphenadrine citrate. 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. It is also useful for tension headache and
persistent hiccups.
For more information, see Section 1. Why am I using NORFLEX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORFLEX?
Do not use if you have ever had an allergic reaction to NORFLEX or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NORFLEX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NORFLEX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NORFLEX?
•
The usual dose is one tablet twice daily. Follow the instructions
provided on the pack.
More instructions can be found in Section 4. How do I use NORFLEX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NORFLEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NORFLEX.
•
Contact your doctor if you become pregnant whilst using NORFLEX.
THINGS YOU
SHOULD NOT DO
•
Do not give NORFLEX to anyone else even if they have the same
condition as you.
•
Do not take NORFLEX to treat any other complaints unless your doctor
tells you to.
DRIVING
OR USING
MACHINES
•
NORFLEX may cause drowsiness or blurred vision. Be careful driving or
operating machinery until you
know how NORFLEX affects you.
DRINKING
ALCOHOL
•
Avoid drinking alcohol while using NORFLEX.
•

מאפייני מוצר

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