Naprosyn EC 500mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Naproxen

Available from:

Atnahs Pharma Netherlands B.V.

ATC code:

M01AE; M01AE02

INN (International Name):

Naproxen

Dosage:

500 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Propionic acid derivatives; naproxen

Authorization status:

Marketed

Authorization date:

1990-07-04

Patient Information leaflet

_1 _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NAPROSYN
® EC 250MG GASTRO-RESISTANT TABLET
NAPROSYN
® EC 500MG GASTRO-RESISTANT TABLET
Naproxen
PLEASE 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 possible side effects not
listed in this leaflet.
IN THIS LEAFLET:
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
Naprosyn EC contains a medicine called naproxen. This is a ‘Non
Steroidal Anti Inflammatory Drug’ or
NSAID.
Naprosyn EC can lessen pain, swelling, redness and heat (inflammation)
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

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2021
CRN00C851
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naprosyn EC 500mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Naproxen.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets.
Capsule-shaped, white film-coated tablet marked ‘NPR EC 500’ 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.
_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
Naprosyn EC dosing is unknown. As with other drugs used in
older people it