ETORICAN 120 mg film-coated tablets

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

Etoricoxib

Disponibil de la:

Generic Health Sdn. Bhd.

INN (nume internaţional):

Etoricoxib

Unități în pachet:

10 Tablets

Produs de:

Rontis Hellas Medical and Pharmaceutical Products S.A.

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ETORICAN 30MG, 60MG, 90MG, 120MG
FILM-COATED TABLETS
Etoricoxib (30mg, 60mg, 90mg, 120mg)
1
WHAT IS IN THIS LEAFLET
1.
What ETORICAN is used for
2.
How ETORICAN works
3.
Before you use ETORICAN
4.
How to use ETORICAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ETORICAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ETORICAN IS USED FOR
ETORICAN helps to reduce the pain
and swelling (inflammation) in the
joints and muscles of people with
osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis and gout. It is
also use for the treatment of acute
pain, including that related to
menstrual pain and minor dental
procedures.
_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 longterm
inflammatory disease of the joints. It
causes pain,
stiffness, swelling, and
increasing loss of movement in
the joints it affects. It may also
cause inflammation in other
areas of the body.
_What is gout? _
Gout is a disease of sudden,
recurring attacks of very
painful inflammation and
redness in the joints. It is
caused by deposits of mineral
crystals in the joint.
_What is ankylosing spondylitis? _
Ankylosing spondylitis is an
inflammatory disease of the
spine and large joints.
HOW ETORICAN WORKS
ETORICAN 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), that reduces pain
and inflammation.
BEFORE YOU USE ETORICAN
_ _
_- When you must not use it _
You must not use ETORICAN if
you:
•
are allergic to etoricoxib or any
of the other ingredients
of ETORICAN
•
have heart failure, a heart attack,
bypass surgery, chest pain,
narrow or blocked arte

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
ETORICAN 30 mg film-coated tablets
ETORICAN 60 mg film-coated tablets
ETORICAN 90 mg film-coated tablets
ETORICAN 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect:
30 mg tablet: 1.3 mg lactose (as monohydrate)
60 mg tablet: 2.7 mg lactose (as monohydrate)
90 mg tablet: 4.0 mg lactose (as monohydrate)
120 mg tablet: 5.3 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
• 30 mg: Blue-green, apple-shaped, biconvex film coated tablet,
debossed with "30" on one side and plain on the other side.
• 60 mg: Dark green, apple-shaped, biconvex film coated tablet,
debossed with "60" on one side and plain on the other side.
• 90 mg: White, apple-shaped, biconvex film coated tablet, debossed
with "90" on one side and plain on the other side.
• 120 mg: Pale green, apple-shaped, biconvex film coated tablet,
debossed with "120" on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etoricoxib is indicated for:
• Acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA) and rheumatoid arthritis (RA)
• Treatment of ankylosing spondylitis (AS)
• Treatment of acute gouty arthritis
• Treatment of acute pain, including that related to primary
dysmenorrhoea and minor dental procedures.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual patient's overall risks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Etoricoxib is administered orally. Etoricoxib may be taken with or
without food. Etoricoxib should be administered for the shortest
duration possible and the lowest
effective daily dose should be used.
_Osteoarthritis _
The recommended dose is 30 mg or 60 mg once daily.
_Rheumatoid arthritis _
The recommended dose is 60 mg once daily. In some patients with
insufficient relie