Norgesic blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

orphenadrine citrate, Quantity: 35 mg; paracetamol, Quantity: 450 mg

Prieinama:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (Tarptautinis Pavadinimas):

Orphenadrine citrate,Paracetamol

Vaisto forma:

Tablet, uncoated

Sudėtis:

Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; Gelatin

Vartojimo būdas:

Oral

Vienetai pakuotėje:

8 (sample pack), 100, 24

Klasė:

Medicine Registered

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.

Produkto santrauka:

Visual Identification: white scored biconvex tablet marked "N/C" on one side and no markings on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

2009-01-14

Pakuotės lapelis

NORGESIC
®
N
O
R
G
E
S
I
C
®
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 NORGESIC?
NORGESIC contains the active ingredients orphenadrine citrate and
paracetamol. NORGESIC is used to treat tension headache
and headaches caused by muscle spasms in the back of your head and
neck. It also helps relax certain muscles in your body and to
relieve the pain and discomfort caused by sprains, strains or other
injury to your muscles.
For more information, see Section 1. Why am I using NORGESIC? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORGESIC?
Do not use if you have ever had an allergic reaction to NORGESIC 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
NORGESIC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NORGESIC 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 NORGESIC?
The usual dose of NORGESIC in adults is two tablets three times a day.
Your doctor will prescribe the correct dose for you. Follow
instructions provided on the pack.
More instructions can be found in Section 4. How do I use NORGESIC? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NORGESIC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NORGESIC.
•
Contact your doctor if you become pregnant while using NORGESIC.
THINGS YOU
SHOULD NOT DO
•
Do not give NORGESIC to anyone else even if they have the same
condition as you.
•
Do not take NORGESIC to treat any other complaints unless your doctor
tells you to.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until yo

Prekės savybės

1
AUSTRALIAN PRODUCT INFORMATION – NORGESIC (ORPHENADRINE
AND PARACETAMOL) TABLETS
1
NAME OF THE MEDICINE
Orphenadrine and paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orphenadrine citrate 35 mg and paracetamol 450 mg tablets.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated
White, scored, immediate release tablets marked N/C on one side and no
markings on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tension headache, occipital headaches associated with spasm of
skeletal muscles in the region
of the head and neck. Acute and traumatic conditions of the limbs and
trunk: sprains, strains,
whiplash injuries, acute torticollis, prolapsed intervertebral disc.
4.2
D
OSE AND METHOD OF ADMINISTRATION
2 tablets three times daily.
4.3
C
ONTRAINDICATIONS
•
Glaucoma
•
Prostatic hypertrophy or obstruction at the bladder neck,
•
Myasthenia gravis
•
Oesophageal spasm and pyloric or duodenal obstruction.
•
Hypersensitivity to paracetamol or orphenadrine citrate.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Orphenadrine citrate should be used with caution in patients with
tachycardia, cardiac
decompensation, coronary insufficiency or cardiac arrhythmias.
Paracetamol should be used with caution in patients with hepatic or
renal dysfunction.
2
Concomitant treatment with other medicines that contain orphenadrine
or paracetamol is not
recommended.
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
The elderly should be advised to take a reduced dosage as they may be
more susceptible to anti-
cholinergic side effects at regular doses.
PAEDIATRIC USE
NORGESIC is not recommended for children under 12 years of age.
EFFECTS ON LABORATORY TESTS
4.5
I
NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
Interactions have been