Naproxen 250 mg Gastro-resistant Tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Naproxen

から入手可能:

Azure Pharmaceuticals Ltd

ATCコード:

M01AE02

INN（国際名）:

Naproxen

投薬量:

250 milligram(s)

医薬品形態:

Gastro-resistant tablet

治療領域:

naproxen

認証ステータス:

Marketed

承認日:

2020-04-24

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXEN 250 MG GASTRO-RESISTANT TABLETS
NAPROXEN 500 MG GASTRO-RESISTANT TABLETS
naproxen
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. 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, back
pain, ankylosing spondylitis (pain
and stiffness in the neck and back) or arthritis
•
Women, while having period pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN TABLETS
DO NOT TAKE NAPROXEN TABLETS IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:
•
Naproxen, naproxen sodium or any of the other ingredients of Naproxen
Tablets (listed in section 6).
•
Aspirin, other NSAIDs or any other pain relief medicines (such as
ibuprofen or diclofenac).
DO NOT TAKE NAPROXEN TABLETS IF:
•
You have now or have ever had any problems with your stomach or gut
(intestine) like an ulcer or
bleeding
•
You have previously experienced bleeding or perforation in your
stomach while taking NSAIDs
•
You have severe problems with your kidneys,

製品の特徴

Health Products Regulatory Authority
31 July 2023
CRN00DJ4R
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naproxen 250 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg naproxen.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets.
White colour, circular shaped biconvex enteric coated tablets debossed
with "250" on one side and plain on the other side.
Diameter: 9.70 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naproxen Gastro-resistant Tablets are indicated in adults for the
treatment of rheumatoid arthritis, osteoarthrosis
(degenerative arthritis), ankylosing spondylitis, acute
musculoskeletal 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
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
_ADULTS_
Therapy should be started at the lowest recommended dose, especially
in older people.
_RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS_
The usual dose is 500mg to 1g daily taken in 2 doses at 12-hour
intervals. Where 1g per day is needed either one 500mg tablet
twice daily or two 500mg tablets in a single administration (morning
or evening) is recommended. 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 MUSCULOSKELETAL DISORDERS AND DYSMENORRHOEA_
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
i