Etoricoxib Krka 120 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoricoxib

Available from:

KRKA, d.d., Novo mesto

ATC code:

M01AH; M01AH05

INN (International Name):

Etoricoxib

Dosage:

120 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Coxibs; etoricoxib

Authorization status:

Marketed

Authorization date:

2016-11-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETORICOXIB KRKA 30 MG FILM-COATED TABLETS
ETORICOXIB KRKA 60 MG FILM-COATED TABLETS
ETORICOXIB KRKA 90 MG FILM-COATED TABLETS
ETORICOXIB KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Etoricoxib Krka
3.
How to take Etoricoxib Krka
4.
Possible side effects
5.
How to store Etoricoxib Krka
6.
Contents of the pack and other information
1.
WHAT ETORICOXIB KRKA IS AND WHAT IT IS USED FOR
WHAT IS ETORICOXIB KRKA
•
Etoricoxib Krka contains the active substance etoricoxib. Etoricoxib
Krka 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 KRKA USED FOR?
•
Etoricoxib Krka 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 Krka 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 di

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2024
CRN00F1QJ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib Krka 120 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 120 mg etoricoxib.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Brownish red, round (diameter: 10 mm), slightly biconvex, film coated
tablets with beveled edges, scored on one side of the
tablet. The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etoricoxib Krka 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 Krka 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 in