Naproxen sodium Krka 550 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

NAPROXEN SODIUM

Διαθέσιμο από:

Krka d.d., Novo mesto

Φαρμακολογική κατηγορία (ATC):

M01AE; M01AE02

INN (Διεθνής Όνομα):

NAPROXEN SODIUM

Δοσολογία:

550 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Propionic acid derivatives; naproxen

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2018-01-19

Φύλλο οδηγιών χρήσης

_ - PMS-433U-KRKA_
_NA.NAPROXEN SODIUM KRKA IE_
first page
PACKAGE LEAFLET: INFORMATION FOR THE USER
Naproxen sodium Krka 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 Krka is and what it is used for
2. What you need to know before you take Naproxen
sodium Krka
3. How to take Naproxen sodium Krka
4. Possible side effects
5. How to store Naproxen sodium Krka
6. Contents of the pack and other information
1. What Naproxen sodium Krka is and
what it is used for
Naproxen sodium Krka contains as active substance
naproxen sodium, a substance belonging to the group of
medicines called nonsteroidal anti-inflammatory drugs
(NSAIDs).
Naproxen sodium Krka 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 Krka
DO NOT TAKE NAPROXEN SODIUM KRKA
• 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 b

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 February 2019
CRN008QCV
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naproxen sodium Krka 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 Krka 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