Etoricoxib 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Etoricoxib

Available from:

Aspire Pharma Ltd

ATC code:

M01AH05

INN (International Name):

Etoricoxib

Dosage:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5060209731650

Patient Information leaflet

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

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of etoricoxib.
Excipient with known effect:
Each film-coated tablet contains 0.84mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Bluish green, round (approx. 6.0mm diameter), biconvex, film-coated
tablets
debossed with “443” on one side and “L” on the other side
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 30mg once daily. In some patients with
insufficient
relief from symptoms, an increased dose of 60mg 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 60mg once daily. In some patients with
insufficient
relief from symptoms, an increased dose of 90mg once daily may
increase
efficacy. Once the patient is clinically stabil