ETORICOXIB AUXILTO FILM-COATED TABLETS 120MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Etoricoxib

Available from:

AUXILTO IMPEX PTE. LTD.

ATC code:

M01AH05

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Etoricoxib 120mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Atlantic Pharma - Producoes Farmaceuticas, S.A.

Authorization status:

ACTIVE

Authorization date:

2022-05-20

Summary of Product characteristics

Etoricoxib Auxilto Film-Coated Tablets
1.
Name of the medicinal product
Etoricoxib Auxilto Film-Coated Tablets 90 mg
Etoricoxib Auxilto Film-Coated Tablets 120 mg
2.
Composition
Active ingredient:
Each film-coated tablet contains 90 or 120 mg of etoricoxib.
Excipients:
Core: Microcrystalline cellulose, calcium hydrogen phosphate
anhydrous, croscarmellose
sodium, magnesium stearate.
Tablet coating: Lactose monohydrate, hypromellose, titanium dioxide
(E171), triacetin.
The 120mg tablets also contain indigo carmine aluminium lake (E132)
and iron oxide
yellow (E172).
3.
Pharmaceutical form
Film-coated tablet.
90 mg: Circular, white film-coated tablets.
120 mg: Circular, green film-coated tablets.
4.
Indications
Etoricoxib is indicated for:

Symptomatic relief of osteoarthritis (OA),

Rheumatoid arthritis (RA),

Symptomatic relief of ankylosing spondylitis (AS),

Pain and signs of inflammation associated with acute gouty arthritis,

Treatment of acute pain, including that related to primary
dysmenorrhea and minor
dental procedures.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment
of the individual patient’s overall risks, taking into consideration
other available therapeutic
options. (see Section 6 ‘Contraindications’ and Section 7
‘Special warning and precautions
for use’).
5.
Dosage and administration
Etoricoxib is administered orally and may be taken with or without
food. The onset of drug
effect may be faster when etoricoxib is administered without food.
This should be
considered when rapid symptomatic relief is needed. Etoricoxib should
be administered
for the shortest duration possible and the lowest effective daily dose
should be used.
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