Leidcox 120mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

Leiden Pharma B.V Galileiweg 8, 2333 BD, Leiden, Netherlands

ATC code:

M01AH05

INN (International Name):

ETORICOXIB 120 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 120 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2016-03-04

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEIDCOX 30 MG, FILM-COATED TABLETS
LEIDCOX 60 MG, FILM-COATED TABLETS
LEIDCOX 90 MG, FILM-COATED TABLETS
LEIDCOX 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 Leidcox is and what it is used for
2.
What you need to know before you take Leidcox
3.
How to take Leidcox
4.
Possible side effects
5.
How to store Leidcox
6.
Contents of the pack and other information
1.
WHAT LEIDCOX IS AND WHAT IT IS USED FOR
•
Leidcox contains the active substance etoricoxib. Leidcox 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).
•
Leidcox helps to reduce the pain and swelling (inflammation) in the
joints and muscles of
people with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
•
Leidcox is also used for the short-term treatment of moderate pain
after dental surgery.
Leidcox is indicated in adults and adolescents over 16 years of age.
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 in the joints it affects. It
may also cau

Summary of Product characteristics

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Leidcox 30 mg, film-coated tablets
Leidcox 60 mg, film-coated tablets
Leidcox 90 mg, film-coated tablets
Leidcox 120 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Leidcox 30 mg:
Each film-coated tablet contains 30 mg of etoricoxib.
Excipients with known effect: 2.52 mg lactose (as lactose monohydrate)
Leidcox 60 mg:
Each film-coated tablet contains 60 mg of etoricoxib.
Excipients with known effect: 5.04 mg lactose (as lactose monohydrate)
Leidcox 90 mg:
Each film-coated tablet contains 90 mg of etoricoxib.
Excipients with known effect: 7.56 mg lactose (as lactose monohydrate)
Leidcox 120 mg:
Each film-coated tablet contains 120 mg of etoricoxib.
Excipients with known effect: 10.08 mg lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Leidcox 30 mg: Blue-green, apple-shaped, biconvex film coated tablets
engraved ‘30’ on one face
and other face plain.
Leidcox 60 mg: Dark-green, apple-shaped, biconvex film coated tablets
engraved ‘60’ on one face
and other face plain.
Leidcox 90 mg: White, apple-shaped, biconvex film coated tablets
engraved ‘90’ on one face and
other face plain.
Leidcox 120 mg: Pale-green, apple-shaped, biconvex film coated tablets
engraved ‘120’ on one face
and other face plain.
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.
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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).
Leidcox is indicated in adults and adolescents over 16 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib