Etoricoxib 30mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Etoricoxib

Commercializzato da:

Teva UK Ltd

Codice ATC:

M01AH05

INN (Nome Internazionale):

Etoricoxib

Dosaggio:

30mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 10010100; GTIN: 5017007027577

Foglio illustrativo

TEVA UK Ref:
231-30-32574-B LEA ETORICOXIB 30MG, 60MG, 90MG AND 120MG FC TABS TUK

Leggi il documento completo

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of etoricoxib.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Blue, round biconvex film-coated tablet, debossed "30" on one side and
plain
on the other, approx. 6 mm diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib 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.
Etoricoxib 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 (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 for the
acute
symptomatic period.
_Acute gouty arthritis_
The recommended dose is 120 mg once daily. In clinical trials for
acute gout