NAPROXEN SODIUM HCS 550 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

NAPROXEN SODIUM

可用日期:

HCS bvba

ATC代码:

M01AE02

INN（国际名称）:

NAPROXEN SODIUM

剂量:

550 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Propionic acid derivatives

授权状态:

Authorised

授权日期:

2018-01-19

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXEN SODIUM HCS 550 MG FILM-COATED TABLETS
Naproxen sodium
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 any
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Naproxen sodium HCS is and what it is used for
2.
What you need to know before you take Naproxen sodium HCS
3.
How to take Naproxen sodium HCS
4.
Possible side effects
5.
How to store Naproxen sodium HCS
6.
Contents of the pack and other information
1.
WHAT NAPROXEN SODIUM HCS IS AND WHAT IT IS USED FOR
Naproxen sodium HCS contains as active substance naproxen sodium, a
substance belonging to the
group of medicines called nonsteroidal anti-inflammatory drugs
(NSAIDs).
Naproxen sodium HCS is used for:
-
treatment of mild to moderate pain,
-
symptomatic treatment of rheumatoid arthritis (inflammation of the
joints, usually including
those of hands and feet, resulting in swelling and pain),
osteoarthritis (chronic disorder
causing cartilage damage), acute gout attacks and ankylosing
spondylitis (inflammation that
affects the joints of the spine),
-
relief of menstrual pain,
-
relief of pain from acute migraine headaches,
-
treatment of pain due to bleeding associated with an insertion of
intrauterine device (IUD).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN SODIUM HCS
DO NOT TAKE NAPROXEN SODIUM HCS
-
if you are allergic to naproxen sodium or any of the other ingredients
of this medicine (listed in
section 6);
-
if you have experienced difficulty breathing (bronchial asthma), hives
(urticaria) or
inflammation of the mucous membrane of th

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naproxen sodium HCS 550 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 550 mg naproxen sodium, which is
equivalent to 500 mg naproxen.
Excipient with known effect :
-
sodium 2,17 mmol (50 mg) per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
The tablets are oval, slightly biconvex, one-side scored blue
film-coated tablets. Dimension: 18 x 8 mm
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naproxen sodium HCS is used for
-
treatment of mild to moderate pain,
-
symptomatic treatment of rheumatoid arthritis, osteoarthritis, acute
gout attacks and ankylosing spondylitis,
-
relief of primary dysmenorrhoea symptoms,
-
symptomatic treatment of acute migraine headaches,
-
symptomatic treatment of
primary and secondary menorrhagia associated with insertion of IUD.
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 and adolescents aged 16 years and over
The usual daily dose for pain relief ranges from 550 mg to 1100 mg
naproxen sodium. The recommended initial dose is
550 mg, followed by 275 mg every 6 to 8 hours, depending on the
severity of the process. When administered for
prolonged periods of time, the dose should be adjusted depending on
the patient's clinical response.
_Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis_
The recommended daily dose is1100 mg of naproxen sodium, divided into
a morning and an evening dose.
Alternatively a single daily dose of 550-1100 mg of naproxen sodium
can be taken in the morning or evening.
_Acute gout attacks_
The recommended initial dose is 825 mg of naproxen sodium, followed by
275 mg of naproxen sodium every 8 hours
until the attack diminish.
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