PHEBRA NAPROXEN SUSPENSION naproxen 125mg/5mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

naproxen, Quantity: 25 mg/mL

Available from:

Phebra Pty Ltd

INN (International Name):

Naproxen

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: sorbitol solution (70 per cent) (crystallising); aluminium magnesium silicate; purified water; sucrose; sodium chloride; fumaric acid; methyl hydroxybenzoate; sunset yellow FCF; sodium hydroxide; Flavour

Administration route:

Oral

Units in package:

474 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, for the symptomatic treatment of primary dysmenorrhoea, for the relief of acute and/or chronic pain states in which there is an inflammatory component and as an analgesic in acute migraine attack.

Product summary:

Visual Identification: Light orange suspension with uniformly distributed particles which readily resuspend on shaking; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-06-01

Patient Information leaflet

Naproxen Suspension
V05
1
NAPROXEN SUSPENSION
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 NAPROXEN SUSPENSION?
Naproxen Suspension contains the active ingredient naproxen. Naproxen
Suspension is used to relieve pain and reduce
inflammation (swelling, redness and soreness) in different types of
arthritis, muscle and bone injuries, period pain, headaches,
after surgery and dental pain. Children (over the age of 5) can use
Naproxen Suspension to treat juvenile rheumatoid arthritis.
For more information, see Section 1. Why am I using Naproxen
Suspension?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NAPROXEN SUSPENSION?
Do not use if you have ever had an allergic reaction to naproxen or
any of the ingredients listed at the end of the CMI.
Do not use at all during the last three months of pregnancy. 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
Naproxen Suspension?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Naproxen Suspension 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 NAPROXEN SUSPENSION?
•
Take Naproxen Suspension exactly as your doctor has told you.
•
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use Naproxen
Suspension?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NAPROXEN SUSPENSION?
THINGS YOU SHOULD
DO
•
If you become pregnant while taking Naproxen Suspension, tell your
doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using Naproxen Suspension.
THINGS YOU SHOULD
NOT DO
•
Do not give Naproxen Suspension to a

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information - Naproxen Suspension
Page 1 of 15
Version 06
NAPROXEN SUSPENSION
(NAPROXEN)
1
NAME OF THE MEDICINE
Naproxen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Naproxen is a propionic acid derivative related to the arylacetic acid
class of drugs. It is unrelated to salicylates
and the corticosteroid hormones. It is an odourless, white to off
white crystalline substance. It is lipid soluble,
practically insoluble in water at low pH and freely soluble in water
at high pH.
Naproxen Suspension is a suspension containing 25 mg/mL of naproxen.
Excipients with known effect: sugars (as sucrose), sorbitol, sodium
and hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Naproxen Suspension is available as an orange aqueous suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Naproxen Suspension is indicated for the treatment of rheumatoid
arthritis, osteoarthritis, ankylosing spondylitis;
for the symptomatic treatment of primary dysmenorrhoea; for the relief
of acute and/or chronic pain states in which
there is an inflammatory component and as an analgesic in acute
migraine attack.
4.2
D
OSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest possible
duration should be used.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk factors and ongoing
need for treatment.
CHRONIC CONDITIONS
_Osteoarthritis/ rheumatoid arthritis/ ankylosing spondylitis/ chronic
pain states in which there is an inflammatory _
_component _
The starting dose of Naproxen Suspension should not be less than 500
mg daily and may be varied stepwise within
the range 375 to 1000 mg daily maintaining twice-daily administration
for long term maintenance, depending on
the needs of the patient.
ACUTE CONDITIONS
_Acute pain states in which there is an inflammatory component _
PRODUCT INFORMATION
NAPROXEN SUSPENSION
Australian Pr