Naproxen 250mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Naproxen

Beschikbaar vanaf:

Viatris UK Healthcare Ltd

ATC-code:

M01AE02

INN (Algemene Internationale Benaming):

Naproxen

Dosering:

250mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 10010100

Bijsluiter

8543
8543
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXEN TABLETS 250MG AND 500MG
[naproxen]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS 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 is one of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
Naproxen can relieve pain, stiffness and inflammation caused
by: rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis
(arthritis of the spine and pelvis) and juvenile rheumatoid
arthritis.
It is also used to treat acute gout and acute musculoskeletal
disorders such as sprains, strains, trauma, lower back pain,
neck pain and inflammation of tendons and muscles.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NAPROXEN TABLETS
DO NOT TAKE NAPROXEN TABLETS IF YOU:
•
Are allergic to naproxen or any other ingredients of this
medicine (listed in section 6)
•
Have a peptic ulcer (ulcer in your stomach or duodenum)
or bleeding in your stomach, or have had two or more
episodes of peptic ulcers, stomach bleeding or perforation
•
Have a history of stomach bleeding or perforation which
may be related to the use of NSAIDs (Mefenamic acid,
ibuprofen, diclofenac) or aspirin
•
Have a history of allergy to aspirin, ibuprofen or NSAIDs,
which includes atta

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naproxen 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Naproxen BP
Also contains Lactose and Sunset yellow (E110)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Pale yellow, flat bevelled edge tablets with N breakline 250 on one
side and
BL on the other
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_ADULTS _
Naproxen is indicated for the treatment of rheumatoid arthritis,
osteoarthrosis
(degenerative arthritis), ankylosing spondylitis, acute gout, acute
musculoskeletal disorders and dysmenorrhoea.
_CHILDREN _
_ _
Juvenile rheumatoid arthritis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
_ADULTS _
_ _
_RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS _
_ _
The usual dose is 500mg to 1g per day taken in two doses at 12-hour
intervals
or alternatively, as a single administration. In the following cases a
loading
dose of 750mg or 1g per day for the acute phase is recommended:
1. In patients reporting severe night-time pain and / or morning
stiffness.
2. In patients being switched to naproxen from a high dose of another
antirheumatic compound.
3. In osteoarthrosis where pain is the predominant symptom.
_ACUTE GOUT _
_ _
The recommended dosage is 750mg at once then 250mg every eight hours
until the attack has passed.
_ACUTE MUSCULOSKELETAL DISORDERS AND DYSMENORRHOEA _
_ _
The recommended dosage is 500mg initially followed by 250mg at 6 to 8
hour
intervals as needed, with a maximum daily dose after the first day of
l250mg.
_ELDERLY_
Studies indicate that although total plasma concentration of naproxen
is
unchanged, the unbound plasma fraction of naproxen is increased in the
elderly. The implication of this finding for naproxen dosing is
unknown. As
with