Naproxen 250mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Naproxen

Dostopno od:

DE Pharmaceuticals

Koda artikla:

M01AE02

INN (mednarodno ime):

Naproxen

Odmerek:

250mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 10010100

Navodilo za uporabo

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

Lastnosti izdelka

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