Relifex 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nabumetone

Available from:

Viatris UK Healthcare Ltd

ATC code:

M01AX01

INN (International Name):

Nabumetone

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 7317510000011 5060035249190

Patient Information leaflet

Patient Information Leaflet
Relifex 500 mg & 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.
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
•
In this leaflet, Relifex 500 mg & 1 g Film-coated Tablets
will be called Relifex.
What is in this leaflet:
1. What Relifex is and what it is used for
2. What you need to know before you take Relifex
3. How to take Relifex
4. Possible side effects
5. How to store Relifex
6. Contents of the pack and other information
1. What Relifex is and what it is used for
Relifex belongs to a group of medicines called non-steroi-
dal anti-inflammatory drugs (known as NSAIDs).
It works by reducing the production of some natural
chemicals found in the body. These chemicals (prosta-
glandins) cause the symptoms of inflammation such as
pain and swelling.
Relifex is used to treat the pain, stiffness and swelling of
joints which are affected by osteoarthritis or rheumatoid
arthritis.
2. What you need to know before you take Relifex
Do not take Relifex if:
•
You are allergic to nabumetone
•
You are allergic to any of the other ingredients of Relifex
(see section 6)
•
You have ever had an allergic reaction like a rash, itchy,
runny or bleeding nose, or become short of breath when
you have taken aspirin or other NSAID medicines. Such
medicines
include
ibuprofen,
acetylsalicylic
acid,
diclofenac or naproxen. Some people who have had
previous allergic reactions to NSAID medicines have
very serious, sometimes fatal reactions if they take this
kind of medicine again.
•
You have, or have ever had a stomach (

Summary of Product characteristics

OBJECT 1
RELIFEX 500MG
Summary of Product Characteristics Updated 19-Apr-2018 | Meda
Pharmaceuticals
1. Name of the medicinal product
Relifex 500 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 500 mg nabumetone.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Dark red, film-coated tablets marked Relifex on one side and "500" on
the other.
4. Clinical particulars
4.1 Therapeutic indications
Nabumetone is a non-acidic non-steroidal anti-inflammatory agent which
is a relatively weak inhibitor of
prostaglandin synthesis. However, following absorption from the
gastrointestinal tract it is rapidly
metabolised in the liver to the principal active metabolite,
6-methoxy-2-naphthylacetic acid (6-MNA), a
potent inhibitor of prostaglandin synthesis.
It is indicated for the treatment of osteoarthritis and rheumatoid
arthritis requiring anti-inflammatory and
analgesic treatment.
4.2 Posology and method of administration
For oral administration.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Relifex 500 mg film-coated tablets should be taken preferably with or
after food.
ADULTS
The recommended daily dose is two tablets (1 g) taken as a single dose
at bedtime.
For severe or persistent symptoms, or during acute exacerbations, an
additional one or two tablets (500
mg-1 g) may be given as a morning dose.
ELDERLY
In common with many drugs, blood levels may be higher in elderly
patients. The recommended daily
dose of two tablets (1 g) should not be exceeded in this age group and
in some cases one tablet (500 mg)
may give satisfactory relief.
The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for
the shortest possible duration. The
patients should be monitored for gastrointestinal bleeding during
NSAID therapy.
CHILDREN
There are no clinical data to recommend