Naproxen 250mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NAPROXEN

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

M01AE02

INN (International Name):

NAPROXEN 250 mg

Pharmaceutical form:

TABLET

Composition:

NAPROXEN 250 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2007-08-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXEN 250MG AND 500MG TABLETS
NAPROXEN
(Referred to as Naproxen Tablets in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it onto
others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Naproxen Tablets are and what they are used for
2. What you need to know before you take Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Contents of the pack and other information
1. WHAT NAPROXEN TABLETS ARE AND WHAT THEY ARE USED FOR
Naproxen belongs to a group of medicines called non-steroidal
anti-inflammatory drugs
(NSAID). It is a painkiller and antipyretic (reduces fever). Naproxen
works by reducing
inflammation and relieving pain, swelling and stiffness in the joints
and muscles. There are a
number of painful conditions that can affect your joints and muscles,
which can be helped by
taking Naproxen. These conditions include:
•
rheumatoid arthritis
•
juvenile rheumatoid arthritis
•
osteoarthritis
•
ankylosing spondylitis (arthritis in the spine)
•
acute gout
•
musculo-skeletal disorders such as sprains, back pains and fibrositis
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN TABLETS
DO NOT TAKE NAPROXEN TABLETS:
•
if you are allergic to naproxen or any of the other ingredients of
this medicine (listed
in section 6)
•
if you have taken another non-steroidal anti-inflammatory drug before
(including
aspirin) and suffered an unpleasant or allergic reaction including
asthma, redness and
itching of the skin or an itchy, running nose
•
if you are taking Mifamurtide (used

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Naproxen 250mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Naproxen 250mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet for oral use
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naproxen is indicated for the treatment of rheumatoid arthritis,
osteoarthritis, ankylosing
spondylitis, juvenile rheumatoid arthritis, acute gout and acute
musculoskeletal
disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
To be taken preferably with or after food.
Adults:-
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis:
The usual dose is 500mg to 1g daily in two doses at 12 hour intervals.
_Acute gout: _
The usual dose is 750mg initially followed by 250mg every eight hours
until
the attack has passed.
_Acute musculoskeletal disorders: _
The usual dose is 500mg initially followed by 250mg
at 6-8 hour intervals up to a maximum daily dose after the first day
of 1250mg.
Elderly:
Elderly: The elderly are at increased risk of the serious consequences
of adverse
reactions. If an NSAID is considered necessary, the lowest effective
dose should be
used and for the shortest possible duration. The patient should be
monitored regularly
for GI during NSAID therapy.
CHILDREN OVER 5 YEARS:
For the treatment of juvenile rheumatoid arthritis the usual dose is
10mg/kg daily in two
doses at 12 hour intervals.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the constituents:
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity
reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response
to ibuprofen,
aspirin, or other non-steroidal anti-inflammatory drugs.
Severe hepatic, renal and cardiac failure (See section 4.4 - Special
warnings and
precautions for use).
High doses of non-steroidal anti-inflammatory drugs are
contraindicated with
concomitan