Etoricoxib Zentiva 60 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

M01AH05

INN (International Name):

ETORICOXIB 60 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 60 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2016-06-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Etoricoxib Zentiva 30 mg film-coated tablets
Etoricoxib Zentiva 60 mg film-coated tablets
Etoricoxib Zentiva 90 mg film-coated tablets
Etoricoxib Zentiva 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 Zentiva is and what it is used for
2. What you need to know before you take Etoricoxib Zentiva
3. How to take Etoricoxib Zentiva
4. Possible side effects
5. How to store Etoricoxib Zentiva
6. Contents of the pack and other information
1.
WHAT ETORICOXIB ZENTIVA IS AND WHAT IT IS USED FOR
Etoricoxib Zentiva contains the active substance etoricoxib.
Etoricoxib Zentiva 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).
Etoricoxib Zentiva 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 Zentiva 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 c

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib Zentiva 30 mg film-coated tablets
Etoricoxib Zentiva 60 mg film-coated tablets
Etoricoxib Zentiva 90 mg film-coated tablets
Etoricoxib Zentiva 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Etoricoxib Zentiva 30 mg film-coated tablets:
White to off white round biconvex film-coated tablets, approx. 6 mm in
diameter.
Etoricoxib Zentiva 60 mg film-coated tablets:
Light brown round biconvex film-coated tablets, approx. 8 mm in
diameter.
Etoricoxib Zentiva 90 mg film-coated tablets:
Light yellow round biconvex film-coated tablets, approx. 9 mm in
diameter.
Etoricoxib Zentiva 120 mg film-coated tablets:
Light pink round biconvex film-coated tablets, approx. 10 mm in
diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib Zentiva 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 Zentiva 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).
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_Osteoarthritis _
The recommended dos