ACOXXEL 30 Milligram Film Coated Tablet

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

ETORICOXIB

Tilgængelig fra:

Merck Sharp & Dohme Ireland (Human Health) Limited

INN (International Name):

ETORICOXIB

Dosering:

30 Milligram

Lægemiddelform:

Film Coated Tablet

Recept type:

Product subject to prescription which may be renewed (B)

Autorisation status:

Withdrawn

Autorisation dato:

2014-08-15

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ACOXXEL 30 mg film-coated tablets 
ACOXXEL 60 mg film-coated tablets 
ACOXXEL 90 mg film-coated tablets 
ACOXXEL 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.  

WHAT IS IN THIS LEAFLET 
1. What 
ACOXXEL is and what it is used for 
2. 
What you need to know before you take ACOXXEL 
3. 
How to take ACOXXEL 
4. 
Possible side effects 
5. 
How to store ACOXXEL 
6. 
 Contents of the pack and other information 

1. 
WHAT ACOXXEL IS AND WHAT IT IS USED FOR 

• 
ACOXXEL 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). 
• 
ACOXXEL helps to reduce the pain and swelling (inflammation) in the
joints and muscles of 
people with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.  
• 
ACOXXEL is also used for the short term treatment of moderate pain
after dental surgery. 

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 causes pain, stiffness, swelling, 
and increasing loss of movement i

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acoxxel 30 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of etoricoxib.
Excipients with known effect:
30 mg: lactose 1.3 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
30 mg Tablets: Blue-green, apple-shaped biconvex tablets marked ‘ACX 30’ on one side and ‘101’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and
signs of inflammation associated with acute gouty arthritis.
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 90 mg once daily.
_Ankylosing spondylitis_
The recommended dose is 90 mg once daily.
For acute pain conditions, etoricoxib should be used only�