Naproxen 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naproxen

Available from:

Wockhardt UK Ltd

ATC code:

M01AE02

INN (International Name):

Naproxen

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012727902937

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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 in anti-tumour treatment)
•
if you have or have had a history of recurrent stomach ulcer/bleeding
or know that you have suffered with ulcers in the past
•
if you have serious problems with your liver, kidney or heart
•
if you are in the last three months of pregnancy
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Naproxen Tablets:
•
if you have any problems with your stomach or bowel
•
if you have problems with your liver or kidneys
•
if you have haemophilia or problems

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 bleeding 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 wit