Naproxen 500mg Tablets tablets

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

naproxen

Saatavilla:

Accord Healthcare Limited

ATC-koodi:

M01AE02

INN (Kansainvälinen yleisnimi):

naproxen

Annos:

500mg

Lääkemuoto:

tablets

Kpl paketissa:

(28/2x14/), in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2015-12-22

Pakkausseloste

PACKAGE LEAFLET:
INFORMATION FOR THE USER
NAPROXEN 250 mg TABLETS
NAPROXEN 500 mg TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
- 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- If any of the side effects gets 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. Before you take Naproxen tablets
3. How to take Naproxen tablets
4. Possible side effects
5. How to store Naproxen tablets
6. Further 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 (NSAIDs),
which are used to reduce inflammation and pain in
joints and muscles.
Naproxen tablets are used to treat:
•
diseases of joints such as rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis. Naproxen
cannot cure arthritis but is used to give relief of
some symptoms such as inflammation, swelling,
stiffness and joint pain.
•
attacks of gout
•
muscle and bone disorders such as cervical
spondylitis, low back pain, strains and sprains,
muscular
pain
and
stiffness
(fibrositis)
and
inflammation of tendons (tenosynovitis).
•
It is also used to treat painful menstrual periods. 2.
BEFORE YOU TAKE NAPROXEN
TABLETS
DO NOT TAKE NAPROXEN TABLETS :
•
if you are allergic (hypersensitive) to naproxen or
to any of the other ingredients of Naproxen
Tablets (see section 6).
•
if you are in the last three months of pregnancy
or if you are breast-feeding
•
if you are allergic to aspirin or other non-steroidal
anti-inflammatory medicines (NSAIDs), or you
have developed signs of asthma (wheezing),
runny nose, swelling of the skin or rash when
taking these medicines
•
if you have or have had s

Valmisteyhteenveto

Summary
of
Product Characteristics
lJpdated 08-Nov-2016lAccord
Healthcare
Limited
|. Name
of the medicinal
p r o d u c t
f,laproxen
500m9
Tablets
21.
Qualitative
and
quantitative
c o m p o s i t i o n
Eiach
tablet
contains
500m9
naproxen
[:xcipients
: Lactose
monohydrate
Each
tablet
contains
144 mg of lactose
monohydrate
[:or
a full list
of excipients,
see section
6.'1
.
ll. Pharmaceutical
form
-l-ablet
\lVhite
to
off
white capsule
shaped
biconvex
,
uncoated
tablet
with
inscription
'AR'
on one side
and
breakline
on the
other
s i d e
4.
Clinical
p a r t i c u l a r s
4.
1
Therapeutic
i n d i c a t i o n s
r \ d u l t s :
-freatment
of rheumatoid
arthritis,
osteoarthritis
(degenerative
arthritis),
ankylosing
s p o n d y l i t i s ,
acute
gout,
acute
musculoskeletal
disorders
and
dysmenorrhoea.
( l h i l d r e n
.Juvenile
rheumatoid
a r t h r i t i s
,1.2
Posology
and
method
of
a d m i n i s t r a t i o n
lFor
oral
a d m i n i s t r a t i o n
Etderly.
The elderly
are
at
increased
risk
of the serious
consequences
of
adverse
reactions.
lf an
I\SAID
is
considered
necessary,
the
lowest
dose should
be used
and
for the shortest
possible
rluration
The
patient
should
be monitored
regularly
for
Gl bleeding
during
NSAID
t h e r a p y .
'fo
be taken
preferably
wtth or
after
food
lRheumatic
Disorders
(Ad
ults):
,SOOmg
to
1g taken
in 2 doses
at
12-hour
intervals
or
alternatively,
as a
single
administration.
I n
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
Naprosyn
from
a
high
dose
of another
anti-rheumatic
compound.
c)
ln
osteoarthrosis
where
pain
is the
predominant
symptom
Children
(over
5
years)
:
A dose
of
1Omg
per
kg body
weight
daily
in two
divided
doses
has been
used
in children
over
5
years
of
age
with
juvenile
rheumatoid
a r t h r i t i s .
Rcute
Coirt
(ROults):
In acute
gout
an
initial
dose
of
750
mg followed
by
250m9
every
8 hours
untrl
attack
has
passed;
has been
sugge