Roticox 60 mg film-coated tablets

Keep out of reach of children. Read the manual carefully before use

If need more information please consult with your doctor

COMPOSITION:

Active: Etoricoxib 60 mg.
Excipients ..q.s for 1 film-coated caplet

INDICATION:

Roticox 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

Roticox 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 patien's overall risks

POSOLOGY AND METHOD OF ADMINISTRATION:

METHOD OF ADMINISTRATION: 

Roticox is administered orally and may be taken with or without food. The onset of the effect of the medicinal product may be faster when Roticox is administered without food. This should be considered when rapid symptomatic relief is needed.

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.

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 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient has clinically stabilized. a dose reduction to 60 mg once daily may be appropriate. In the absence of an increase in therapeutic benefit. other therapeutic options should be considered..

Ankylosing spondylitis: The recommended dose a 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient has clinically stabilized, a dose reduction to 60 mg once daily may be appropriate. In the absence of an increase In therapeutic benefit, other therapeutic options should be considered.

Treatment of acute pain: For the treatment of alum pain, etoricoxib should be taken only during the acute symptomatic period.

Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis. Etoricoxib was given for 8 days.
Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days. Some patients may require other postoperative analgesia in addition to Roticox during the three-day treatment period.

Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore:
- The dose for OA should not exceed Cern daily.
- The dose for RA and ankylosing spondylitis should not exceed 90 mg daily
- The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
- The dose for Postoperative acute dental surgery pain should not exceed 90 mg daily, limited to a maximum of 3 days.

Special populations

Eiciedy patients: No dosage adjustment Is necessary for elderly patients. As with other drugs. caution should be exercised in elderly patients.

Patients troth hepatic impairment: Regardless of Indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a nose of 60 mg once daily should not be exceeded. In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 30 mg once daily should not be exceeded. Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised. There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥ 10)); therefore, its use is contra-indicated in these patients

Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min. The use of etoricoxib In patients with creatinine clearance < 30 ml/min is contraindicated.

Paectialdc population: Ebricoxib is Contra-Indicated in children and adolescents under 16 years of age.

OTHER INFORMATION: Please refer to the Instruction sheet included in the package

MANUFACTURER: KRKA, D.D., NOVO MESTO (SLOVENIA)

DISTRIBUTOR: GLOBAL PHARMACEUTICAL JOINT-STOCK COMPANY