Arcoxia tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

etoricoxib

Available from:

Merck Sharp & Dohme B.V. Waarderweg 39

ATC code:

M01AH05

INN (International Name):

etoricoxib

Dosage:

120mg

Pharmaceutical form:

tablets film-coated

Units in package:

(7/1x7/) in blister, (28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-04-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS FOR ARMENIA
1. NAME OF THE MEDICINAL PRODUCT
ARCOXIA
2.
COMPOSITION
One tablet contains:
_ACTIVE SUBSTANCE_: 60 mg, 90 mg, 120 mg of etoricoxib.
Excipient:
60 mg: lactose 2.7 mg
90 mg: lactose 4.0 mg
120 mg: lactose 5.3 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_60 mg tablets:_ dark-green, apple-shaped, biconvex film-coated
tablets debossed 'ARCOXIA 60' on
one side and '200' on the other side.
_90 mg tablets: _white, apple-shaped, biconvex film-coated tablets
debossed 'ARCOXIA 90' on one
side and '202' on the other side.
_120 mg tablets:_ pale-green apple-shaped, biconvex film-coated
tablets debossed 'ARCOXIA 120'
on one side and '204' on the other side.
4. CLINICAL PARTICULARS
_4.1 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.
_ _
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION. _
ARCOXIA is administered orally and may be taken with or without food.
The onset of the effect of
the medicinal product may be faster when ARCOXIA is administered
before meals. This should be
considered when rapid symptomatic relief is needed.
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.
_Osteoarthritis_
The highest recommended dose is 60 mg once daily. In the absence of an
increase in therapeutic
benefit, other therapeutic options should be considered.
_Rheumatoid arthritis_
The recommended dose is 60 mg or 90 mg once daily. The min