RELIFEX

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

NABUMETONE

Dostupné z:

Imbat Limited

ATC kód:

M01AX01

INN (Medzinárodný Name):

NABUMETONE

Dávkovanie:

500 Milligram

Forma lieku:

Film Coated Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

nabumetone

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2009-11-13

Príbalový leták

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
RELIFEX
® 500MG FILM-COATED TABLETS
(nabumetone)
The name of your medicine is Relifex 500mg film coated
tablets, but will be referred to as Relifex tablets throughout
this leaflet.
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.
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

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Relifex 500mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of nabumetone.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
Dark red, film-coated tablets marked “Relifex” on one side and
“500” on the other.
4 CLINICAL PARTICULARS
As per PA1051/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1051/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium starch glycollate
Sodium lauryl sulphate
Hypromellose
Magnesium stearate
Microcrystalline cellulose
Saccharin sodium
Liquid caramel flavour
Red carmine (E120)
Iron oxide yellow (E172)
Titanium dioxide (E171)
Talc
Polyethylene glycol 400
Carnauba wax
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the tablets in the original container in order to protect from
light.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing a plastic bottle with a screw top cap.
Pack size: 56 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE