NAPROSYN naproxen 250 mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

naproxen, Quantity: 250 mg

Mevcut itibaren:

Atnahs Pharma Australia Pty Ltd

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: croscarmellose sodium; iron oxide yellow; povidone; magnesium stearate

Uygulama yolu:

Oral

Paketteki üniteler:

50 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

For the treatment of Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, 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.

Ürün özeti:

Visual Identification: Round yellow tablets debossed NPR LE 250 on one side and a break-bar on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

1998-09-24

Bilgilendirme broşürü

NAPROSYN
®
N
A
P
R
O
S
Y
N
®
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 NAPROSYN?
NAPROSYN contains the active ingredient naproxen. NAPROSYN is used to
relieve pain and reduces inflammation (swelling,
redness and soreness) that may occur with different types of
arthritis, muscle and bone injuries, after setting broken or
dislocated
bones, with period pain, headache, migraines, after surgery, or dental
pain. For more information, see Section 1. Why am I using
NAPROSYN? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NAPROSYN?
Do not use if you have ever had an allergic reaction to naproxen,
aspirin or any other NSAID medicine, 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 NAPROSYN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NAPROSYN 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 NAPROSYN?
•
Your doctor will tell you how many NAPROSYN 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 NAPROSYN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NAPROSYN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NAPROSYN.
•
Tell your doctor if you get an infection while using NAPROSYN.
•
Tell your doctor if you feel the tablets are not helping your
condition.
•
Call your doctor straight away if you become pregnant while taking
NAPROSYN.
THINGS YOU
SHOULD NOT DO
•
Do not give NAPROSYN to anyone else, even if they have the same
condition a

Ürün özellikleri

1
AUSTRALIAN PRODUCT INFORMATION – NAPROSYN
® AND
NAPROSYN
® 500 (NAPROXEN)
1. NAME OF THE MEDICINE
Naproxen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NAPROSYN is available as a tablet containing 250 mg of naproxen.
NAPROSYN 500 is available as a tablet containing 500 mg of naproxen.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
NAPROSYN is available as round yellow tablets debossed NPR LE 250 on
one side and a break-bar on the
other.
NAPROSYN 500 is available as oblong yellow tablets debossed NPR LE 500
on one side and break-bar on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NAPROSYN 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 DOSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ration in each individual patient,
the lowest effective dose for the shortest
possible duration should be used.
CHRONIC CONDITIONS
_OSTEOARTHRITIS / RHEUMATOID ARTHRITIS / ANKYLOSING SPONDYLITIS /
CHRONIC PAIN STATES IN WHICH THERE IS _
_AN INFLAMMATORY COMPONENT _
The dosage range of NAPROSYN 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 NAPROSYN 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 NAPROSYN tablets is
500 mg initially, at the first sign of dysmenorrhoea or menstrual
bleeding (which