RELIFEX

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

NABUMETONE

Saatavilla:

Meda Health Sales Ireland Limited

ATC-koodi:

M01AX01

INN (Kansainvälinen yleisnimi):

NABUMETONE

Annos:

500 MG/5ml

Lääkemuoto:

Oral Suspension

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

nabumetone

Valtuutuksen tilan:

Not Marketed

Valtuutus päivämäärä:

1990-12-17

Valmisteyhteenveto

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Relifex 500 mg / 5 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of suspension contains 500 mg nabumetone.
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Oral suspension.
White to off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic management of various arthritides, such as
rheumatoid arthritis, osteoarthritis, spondylitis, gout,
etc., and of acute musculoskeletal disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Oral.
Recommended Dosage
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms_ (see section 4.4)._
Adults: The recommended daily dose is 10 ml (1g) taken as a single
night time dose.
For severe or persistent
symptoms, or during acute exacerbations, an additional 5 ml or 10 ml
(500 mg to 1g) may be given as a morning dose.
Elderly: Total daily dosage should not exceed 1g.
Non-steroidal anti-inflammatory drugs should be used with particular
caution in elderly patients who are more prone to
adverse events.
The lowest dose compatible with adequate safe clinical control should
be employed.
_(See also section_
_4.4)._
Prolonged use of non-steroidal anti-inflammatory drugs is not
recommended in the elderly.
However, where prolonged
treatment proves necessary, patients should be reviewed regularly.
Children: There are no clinical data to recommend use of ‘Relifex’
in children.
Where appropriate for acute conditions, including sports injuries,
10ml (1g) may be given as a loading dose.
Total
dosage should not exceed 2g a day.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
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