RELIFEX 500 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NABUMETONE

Available from:

Meda AB

ATC code:

M01AX01

INN (International Name):

NABUMETONE

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiinflammatory and antirheumatic agents, non-steroids

Authorization status:

Transfer Pending

Authorization date:

1999-03-15

Patient Information leaflet

Package leaflet: 
Information for the user 
RELIFEX 
500 MG AND 1 G FILM-COATED TABLETS 
Nabumetone 

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. 

The name of your medicine is Relifex 500 mg and 1 g film-coated
tablets, which will be called Relifex 
tablets throughout this leaflet. 

WHAT IS IN THIS LEAFLET: 
1.  What Relifex tablets are and what they are used for 
2.  What you need to know before you take Relifex tablets 
3.  How you take Relifex tablets 
4.  Possible side effects 
5.  How to store Relifex tablets 
6.  Contents of the pack and other information 

1.  WHAT RELIFEX TABLETS ARE AND WHAT THEY ARE USED FOR 
Relifex tablets contain the active ingredient nabumetone, which
belongs to a group of medicines 
called non-steroidal anti-inflammatory drugs (NSAIDs). 
Relifex tablets are used for the management of arthritis such
as: 
- 
Osteoarthritis 
- 
Rheumatoid arthritis 
- 
Spondylitis (inflammation of the spine) 
- 
Gout (inflammation of a joint – often the big toe) and 
- 
Muscle injuries 

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE RELIFEX TABLETS 
DO NOT TAKE RELIFEX TABLETS: 
- 
If you are allergic to Nabumetone 
- 
If you have experienced asthma, hives or an allergic reaction to
other similar drugs (NSAIDs) 
- 
If you are allergic to any of the other ingredients of  Relifex
tablets (listed in sect

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Relifex 500 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of nabumetone.
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Film-coated tablet.
Dark red, film-coated, tablets marked “Relifex” on one side and
“500” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic management of various arthritides, such as
rheumatoid arthritis, osteoarthritis, spondylitis, gout, 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 two tablets (1 g) taken as a single
night time dose with or without food. For severe or
persistent symptoms, or during acute exacerbations, an additional one
or two tablets (500 mg to 1 g) may be given as a
morning dose.
Older patients:
Total daily dosage should not exceed 1 g. An initial dose of 500 mg
should be used. Blood levels may be higher.
NSAIDs should be used with particular caution in older patients who
are more prone to adverse events. The lowest
dose compatible with adequate safe clinical control should be
employed. See also 4.4.
Children:
There are no clinical data to enable a dosage recommendation to be
made for children.
Where appropriate for acute conditions, including sports injuries two
tablets (1g) may be given as a loading dose.
Total dosage should not exceed 2 g a day.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
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