Norflex

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Orphenadrine citrate 100mg

Доступно од:

iNova Pharmaceuticals (New Zealand) Limited

INN (Међународно име):

Orphenadrine citrate 100 mg

Дозирање:

100 mg

Фармацеутски облик:

Tablet

Састав:

Active: Orphenadrine citrate 100mg Excipient: Colloidal silicon dioxide Ethylcellulose Lactose monohydrate Magnesium stearate

Јединице у пакету:

Bottle, plastic, 100 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Procos SpA

Терапеутске индикације:

Norflex (orphenadrine citrate) is indicated for the relief of stiffness and pain resulting from skeletal muscle spasm in sprains and strains, local muscle injury, prolapsed intervertebral disc, lumbago, fibrositis, non-articular rheumatism, acute torticollis, surgery, fractures, anxiety and tension. Orphenadrine citrate has also been shown to be effective for treatment of tension headache and persistent hiccoughs.

Резиме производа:

Package - Contents - Shelf Life: Blister pack, Alu-PVC/PVDC within a cardboard carton - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Датум одобрења:

1969-12-31

Информативни летак

NORFLEX™
1
NORFLEX™
_Orphenadrine citrate 100 mg 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 you 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.
The active ingredient in NORFLEX
is orphenadrine citrate, which 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.
NORFLEX is also used to treat
tension headache and persistent
hiccoughs.
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 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 condition in which the muscles
become weak and tire easily)
•
THE EXPIRY DATE ON THE BOTTLE HAS
PASSED
•
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 12 years have not

Карактеристике производа

NEW ZEALAND DATA SHEET
NORFLEX
TM
NORFLEX
Page 1 of 5
1
1 PRODUCT NAME
NORFLEX 100 mg slow release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each slow release tablet contains orphenadrine citrate 100 mg.
Excipient with known effect:
Lactose monohydrate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Slow release tablet
White, round, biconvex tablets marked N/X on one face and no markings
on the other face.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
For the relief of stiffness and pain resulting from skeletal muscle
spasm in sprains and strains, local
muscle injury, prolapsed intervertebral disc, lumbago, fibrositis,
non-articular rheumatism, acute
torticollis, surgery, fractures, anxiety and tension.
Orphenadrine citrate has also been shown to be effective for treatment
of tension headache and
persistent hiccoughs.
4.2
Dose and method of administration
Adults
Two tablets per day; one in the morning and one in the evening.
Children
Safety and effectiveness in children have not been established.
NORFLEX is not recommended for
children under 12 years.
Special Populations
_Elderly _
The elderly may be more susceptible to anticholinergic side effects
and should be given a reduced
dosage.
4.3
Contraindications
x
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
x
Glaucoma
x
Paralytic ileus
x
Pyloric or duodenal obstruction
NEW ZEALAND DATA SHEET
NORFLEX
TM
NORFLEX
Page 2 of 5
x
Stenosing peptic ulcers
x
Prostatic hypertrophy or obstruction of the prostate or bladder neck
x
Oesophageal spasm (megaesophagus)
x
Myasthenia gravis.
44.4
Special warnings and precautions for use
Orphenadrine citrate should be used with caution in patients with
impaired kidney or liver function,
tachycardia, cardiac decompensation, coronary insufficiency or cardiac
arrhythmias.
Safety of continuous long-term therapy with orphenadrine has not been
established. Therefore,
periodic monitoring of blood, urine and liver function values is
recommended if orphenadrine is
pre