Naproxen 250mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Naproxen

Beschikbaar vanaf:

Milpharm 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; GTIN: 8901175745111

Bijsluiter

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 or pharmacist.
-
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
or pharmacist. This includes any 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 Tablets contain a medicine called
naproxen. This is a 'Non Steroidal Anti
Inflammatory Drug' or NSAID.
Naproxen Tablets can lessen pain, swelling,
redness and heat (inflammation) and is used to
treat adults for:
•
Problems with your muscles, joints and
tendons, like strains, gout, ankylosing
spondylitis (pain and stiffness in the neck and
back) or arthritis.
•
Women, while having period pain. It can also
be used in children over 5 years with
rheumatoid arthritis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NAPROXEN TABLETS
DO NOT TAKE NAPROXEN TABLETS
•
if you are ALLERGIC (hypersensitive) to
naproxen or any of the other
ingredients of Naproxen Tablets (listed in
section 6)
•
if you are allergic to or have ever had a
reaction to ASPIRIN or another NSAID (non-
steroidal anti-inflammatory drug) such as
ibuprofen, diclofenac or meloxicam
•
if you have a stomach ulcer or if you
often get stomach ulcers
•
if you have a duodenal ulcer (in the first part
of the small intestine) or if you often get
duodenal ulcers
•
if you have serious liver or kidney disease
•
if you are suffering or have ever suffered from
bleeding in the stomach or intestines whil

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naproxen Tablets BP 250mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Naproxen BP.
Excipient with known effect: Lactose. For full list of excipients, see
section
6.1.
3
PHARMACEUTICAL FORM
Tablets.
Naproxen Tablets BP 250mg are yellow coloured, round shaped, flat
bevelled
edge uncoated tablets with score lines between ‘NPY’ and ‘250’
embossed on
one side and plain on the other side.
4.1
THERAPEUTIC INDICATIONS
_Adults_:_ _
Naproxen is used in the treatment of rheumatoid arthritis,
osteoarthrosis
(degenerative
arthritis),
ankylosing
spondylitis,
acute
musculoskeletal
disorders, dysmenorrhoea and acute gout.
_Children_:_ _
Juvenile rheumatoid arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 alkylosing spnodylitis
500mg to 1g taken in 2 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:
a)
In patients reporting severe night-time pain/or morning stiffness.
b)
In patients being switched to Naproxen from a high dose of another
anti-
rheumatic compound.
c)
In osteoarthrosis where pain is the predominant symptom.
Acute gout
In acute gout, an initial dose of 750 mg followed by 250 mg every 8
hours until the
attack has passed.
Acute musculoskeletal disorders and dysmenorrhoea
500 mg may be given initially, followed by 250 mg every 6 to 8 hour
intervals as
needed, with a maximum daily dose after the first day of 1250mg.
Older people
Studies indicate that although total plasma concentration of naproxen
is unchanged,
the
unbound
plasma
fraction
of
naproxen
is
increased
in
older
people.
The
implication of this finding for Naproxen dosing is unknown. The
elderly are at
increased
risk
of
the
serious
conseque