Arcoxia tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

etoricoxib

Disponibil de la:

Merck Sharp & Dohme B.V. Waarderweg 39

Codul ATC:

M01AH05

INN (nume internaţional):

etoricoxib

Dozare:

120mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

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

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-04-20

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDICAL USE OF DRUG
1. NAME OF THE MEDICINAL PRODUCT
ARCOXIA 60 mg film-coated tablets
ARCOXIA 90 mg film-coated tablets
ARCOXIA 120 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1. Qualitative composition
Etoricoxib.
2.2 Quantitative composition
Each film-coated tablet contains
_active substance_:
60, 90 or 120 mg of etoricoxib
.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
_60 mg tablets_: Dark green, apple-shaped, biconvex tablets debossed
‘ARCOXIA 60’ on one side and
‘200’ on the other side.
_90 mg tablets_: White, apple-shaped, biconvex tablets debossed
‘ARCOXIA 90’ on one side and ‘202’
on the other side.
_120 mg tablets_: Pale-green, apple-shaped, biconvex tablets debossed
‘ARCOXIA 120’ on one side and
‘204’ on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARCOXIA 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.
ARCOXIA 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 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
patien