Naprosyn EC 250mg Gastro-resistant Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Naproxen

Διαθέσιμο από:

Atnahs Pharma UK Limited

Φαρμακολογική κατηγορία (ATC):

M01AE; M01AE02

INN (Διεθνής Όνομα):

Naproxen

Δοσολογία:

250 milligram(s)

Φαρμακοτεχνική μορφή:

Gastro-resistant tablet

Οδός χορήγησης:

oral use

Μονάδες σε πακέτο:

blisters of 56 tablets

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική ομάδα:

Anti-inflammatory and antirheumatic products, non- steroids

Θεραπευτική περιοχή:

Propionic acid derivatives; naproxen

Θεραπευτικές ενδείξεις:

Naprosyn EC is indicated in adults and adolescents (16 years and above) for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculo-skeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1990-07-04

Φύλλο οδηγιών χρήσης

BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
● Keep this
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
possible side effects not listed in this
1. What Naprosyn EC is and what it is
used for
2. What you need to know before you take
Naprosyn EC
3. How to take Naprosyn EC
4. Possible side effects
5. How to store Naprosyn EC
6. Contents of the pack and other
information
1. WHAT NAPROSYN EC IS AND
WHAT IT IS USED FOR
Naprosyn EC contains a medicine called
naproxen. This is a ‘Non Steroidal Anti
Drug’ or NSAID.
Naprosyn EC can lessen pain, swelling,
redness and heat
and is
used to:
● relieve problems with your muscles,
joints and tendons, e.g. strains, back
pain, ankylosing spondylitis (pain and
stiffness in the neck and back), gout,
rheumatoid arthritis or osteoarthrosis.
● relieve period pain in women.
Naprosyn EC tablets are used to treat
adults and adolescents (16 years and
above).
2. WHAT YOU NEED TO KNOW
BEFORE
YOU TAKE NAPROSYN EC
DO NOT TAKE NAPROSYN EC IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
● Naproxen, naproxen sodium or any of
the other ingredients of Naprosyn EC
(listed in section 6).
● Aspirin, other NSAIDs or any other pain
relief medicines (such as ibuprofen or
diclofenac).
DO NOT TAKE NAPROSYN EC IF:
● you have now or have ever had any
problems with your stomach or gut
(intestine) e.g. an ulcer or bleeding.
● you have previously experienced
bleeding or perforation in your stomach
while taking NSAIDs.
● you have
SEVERE
problems with your
kidneys, liver or heart.
● you are in the last three months of
pregnancy.
Do not take Naprosyn EC if any of the
above apply to you.
If you are not sure,
talk to your doctor or
pharmacist before taking Naprosyn EC.
WA

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
01 October 2018
CRN008MFY
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naprosyn EC 250mg Gastro-resistant Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Naproxen
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets.
Round, white film-coated tablet marked ‘NPR EC 250’ in black ink
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naprosyn EC is indicated in adults and adolescents (16 years and
above) for the
treatment of rheumatoid arthritis, osteoarthrosis (degenerative
arthritis), ankylosing
spondylitis, acute gout, acute musculo-skeletal disorders (such as
sprains and strains,
direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis
and fibrositis) and
dysmenorrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For oral administration
Naprosyn EC tablets should be swallowed whole and not broken or
crushed.
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 daily taken in two doses at 12-hour
intervals. Where
1g per day is needed one 500mg tablet twice daily or two 500mg tablets
in a single
administration (morning or evening) is recommended.
_ACUTE GOUT:_
The recommended dosage is 750mg initially, then 250mg every eight
hours until the
attack has passed.
Health Products Regulatory Authority
01 October 2018
CRN008MFY
Page 2 of 15
_ACUTE MUSCULO-SKELETAL DISORDERS AND DYSMENORRHOEA:_
The recommended dose is 500mg initially followed by 250mg at 6 - 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 Nap