RELIFEX 1 Grams Film Coated Tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

NABUMETONE

Disponibil de la:

Meda AB

Codul ATC:

M01AX01

INN (nume internaţional):

NABUMETONE

Dozare:

1 Grams

Forma farmaceutică:

Film Coated Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Other antiinflammatory and antirheumatic agents, non-steroids

Statutul autorizaţiei:

Transfer Pending

Data de autorizare:

2009-10-16

Prospect

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

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Relifex 1g film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1g of nabumetone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white oblong film-coated tablets with a break-line on
both sides.
The tablet can be divided into equal doses.
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_
Adults:
The recommended daily dose is one tablet (1 g) taken as a single night
time dose with or without food. For severe or
persistent symptoms, or during acute exacerbations, an additional 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, one
tablet (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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