INZA 250 naproxen 250 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

naproxen, Quantity: 250 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; sodium starch glycollate; maize starch; purified talc; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

90, 20, 120, 60, 30, 100, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of rheumatoid arthritis, juvenile rheumatoid arthritis and osteoarthritis, ankylosing spondylitis; symptomatic treatment of primary dysmenorrhoea, 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: 11mm white flat bevelled edge tablet marked NP/250 on one side, G on the reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1992-08-10

Patient Information leaflet

INZA
I
N
Z
A
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 INZA?
INZA contains the active ingredient naproxen. INZA is used to relieve
pain and reduce inflammation that may occur with different
types of arthritis, muscle and bone injuries, after setting broken or
dislocated bones, period pain, headache, migraine, after surgery,
or dental pain. For more information, see Section 1. Why am I using
INZA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INZA?
Do not use if you have ever had an allergic reaction to naproxen,
aspirin or any other NSAID 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
INZA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INZA 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 INZA?
•
Your doctor will tell you how many INZA tablets to take each day. Take
the tablets during or immediately after food with a full
glass of water or milk.
More instructions can be found in Section 4. How do I use INZA? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INZA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
INZA.
•
Tell your doctor if you get an infection, or if you feel the tablets
are not helping your condition.
•
Call your doctor straight away if you become pregnant while taking
INZA.
THINGS YOU
SHOULD NOT DO
•
Do not give INZA to anyone else, even if they have the same condition
as you.
•
Do not use INZA to treat other complaints, unless your doctor tells
you to.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machine

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
INZA
_naproxen tablet _
1
NAME OF THE MEDICINE
Naproxen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INZA tablets contain 250 mg or 500 mg of naproxen as the active
ingredient.
Excipients of known effect: galactose, sulfites and sugars as lactose.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
INZA 250 mg tablets: white, flat bevelled edged, marked NP/250 on one
side, G on reverse.
INZA 500 mg tablets: white, oblong shaped, marked NP500 on one side, G
on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INZA is indicated for the treatment of rheumatoid arthritis,
osteoarthritis, juvenile rheumatoid arthritis and
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
DOSE 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.
CHRONIC CONDITIONS
Rheumatoid
arthritis/osteoarthritis/ankylosing
spondylitis/chronic
pain
states
in
which
there
is
an
inflammatory component
The dosage range of INZA is 375 mg to 1000 mg daily in two divided
doses. The starting dose should not be
less than 500 mg daily and may be varied stepwise within the range of
375 mg 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
The recommended dose of INZA tablets is 500 mg initially followed by
250 mg every six to eight hours as
required. The total daily dose should not exceed 1250 mg.
DYSMENORRHOEA
In the symptomatic treatment of primary dysmenorrhoea, the recommended
dose of INZA is 500 mg initially,
at the first sign of dysmenorrhoea or menstrual bleeding (whichever
occurs first), followed by 250 mg every
six to eight hours as requi