ETORICOXIB 90 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

ETORICOXIB

可用日期:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC代码:

M01AH05

INN（国际名称）:

ETORICOXIB

剂量:

90 Milligram

药物剂型:

Film Coated Tablet

给药途径:

oral use

每包单位数:

2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets

处方类型:

Product subject to prescription which may be renewed (B)

厂商:

Mylan Hungary Kft, Mylan Hungary Kft, Mylan B.V,, McDermott Laboratories Limited trading as Gerard Laboratories,

治疗组:

Antiinflammatory and antirheumatic products, non-steroids, coxibs

治疗领域:

Coxibs

疗效迹象:

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 cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks

授权状态:

Authorised

授权日期:

2015-09-11

资料单张

26
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 Etoricoxib is and what it is used for
2.
What you need to know before you take Etoricoxib
3.
How to take Etoricoxib
4.
Possible side effects
5.
How to store Etoricoxib
6.
Contents of the pack and other information
1.
WHAT ETORICOXIB IS AND WHAT IT IS USED FOR
Etoricoxib is one of a group of medicines called selective cyclooxygenase-2 (COX-2) inhibitors. These 
belong to a family of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
-
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

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 90 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg of etoricoxib.
Excipients with known effect:
Each film-coated tablet contains 2.39 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, round, biconvex, bevelled edge tablet debossed with ‘M’ on one side and ‘EC3’ on the other side,
approximately 9 mm in diameter.
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 cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the
individual patient's overall risks (see sections 4.3 and 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 therap