Relifex 1g film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nabumetone

Available from:

Mylan IRE Healthcare Limited

ATC code:

M01AX; M01AX01

INN (International Name):

Nabumetone

Dosage:

1 gram(s)

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; nabumetone

Authorization status:

Marketed

Authorization date:

2009-10-16

Patient Information leaflet

PACKAGE 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 section
6). An allergic reaction may include rash, itching, difficulty
breathing or swelling of
the face, lips throat or tongue.
–
If you have or have had a peptic ulcer (ulcer in your stomach or
duodenum) or
bleeding in your stomach (2

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2022
CRN00D6KP
Page 1 of 9
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.
4.3 CONTRAINDICATIONS

In patients with a history of hypersensitivity to nabumetone or
excipients (see section 6.1)

In patients with active, or a history of recurrent, peptic
ulcer/haemorrhage (two or more distinct episodes of
proven ulceration or bleeding)

In patients hypersensitive (e.g. bronchospasm, rhinitis, urticaria) to
na