Etoricoxib 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Etoricoxib

Available from:

Brown & Burk UK Ltd

ATC code:

M01AH05

INN (International Name):

Etoricoxib

Dosage:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5060124640990

Patient Information leaflet

Artwork Code
FRONT SIDE
Size: 280 x 420 mm
BACK SIDE
Size: 280 x 420 mm
1
2
3
4
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Etoricoxib Tablets is and what it is used for
2.
What you need to know before you take Etoricoxib Tablets
3.
How to take Etoricoxib Tablets
4.
Possible side effects
5.
How to store Etoricoxib Tablets
6.
Contents of the pack and other information
WHAT IS ETORICOXIB TABLETS?
•
Etoricoxib film-coated Tablets 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 TABLETS 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.
•
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 l

Summary of Product characteristics

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.
Excipients with known effect: 1.40 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Blue-green, apple-shaped, biconvex film coated tablets engraved
‘30’ on one
face and other face plain, approximately 6.4 mm length and 6.2 mm
width.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib Tablets 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 Tablets 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 s