Etoricoxib 30 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Etoricoxib

Disponible desde:

Bristol Laboratories Limited

Código ATC:

M01AH; M01AH05

Designación común internacional (DCI):

Etoricoxib

Dosis:

30 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Coxibs; etoricoxib

Estado de Autorización:

Not marketed

Fecha de autorización:

2017-06-16

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETORICOXIB 30 MG FILM-COATED TABLETS
ETORICOXIB 60 MG FILM-COATED TABLETS
ETORICOXIB 90 MG FILM-COATED TABLETS
ETORICOXIB 120 MG FILM-COATED TABLETS
ETORICOXIB
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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
WHAT IS ETORICOXIB?
•
Etoricoxib contains the active substance etoricoxib. Etoricoxib is one
of a group of
medicines called selective COX-2 inhibitors. These belong to a family
of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
WHAT IS ETORICOXIB USED FOR?
•
Etoricoxib helps to reduce the pain and swelling (inflammation) in the
joints and
muscles of people 16 years of age and older with osteoarthritis,
rheumatoid
arthritis, ankylosing spondylitis and gout.
SAME SIZE ARTWORK
520 mm x 150 mm
•
Etoricoxib is also used for the short term treatment of moderate pain
after dental
surgery in people 16 years of age and older.
WHAT IS OSTEOARTHRITIS?
Osteoarthritis is a disease of the joints. It results from the gradual
breakdown of
cartilage that cushions the ends of the bones. This causes swelling
(inflammation),
pain, tenderness, stiffness and disability.
WHAT IS RHEUMATOID ARTHRITIS?
Rheumatoid arthritis is a long term inflammatory disease of the
joints. It cau

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of etoricoxib.
Excipient with known effect: Also contains 0.84 mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Bluish green, round, biconvex, film-coated tablets debossed with
‘443’ on one side and ‘L’ on other side. The tablet
diameter is 6.00 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etoricoxib is indicated in adults and adolescents 16 years of age and
older for the symptomatic relief of osteoarthritis
(OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain
and signs of inflammation associated with acute
gouty arthritis.
Etoricoxib is indicated in adults and adolescents 16 years of age and
older for the short-term treatment of moderate pain
associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual patient's
overall risks (see sections 4.3, 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest duration
possible and the lowest effective daily dose should be used. The
patient's need for symptomatic relief and response to
therapy should be re-evaluated periodically, especially in patients
with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
_Osteoarthritis_
The recommended dose is 30 mg once daily. In some patients with
insufficient relief from symptoms, an increased dose
of 60 mg once daily may increase efficacy. In the absence of an
increase in therapeutic benefit, other therapeutic
options should be considered.
_Rheumatoid arthritis_
The recommended dose is 60 mg once daily. In some patients with
insufficient relief from symptoms, an increased dose
of 90 mg once daily may increase efficacy. Once the patient is
clinically stabilised, down-ti