ISOX

CELECOXIB ZENTIVA is indicated in adults for the relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on the assessment of all the risks specific to each patient (see sections 4.3 and 4.4).

Pregnancy

Studies in animals (rat and rabbit) have shown reproductive toxicity including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis might have a deleterious effect on pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy.

In humans, the risk during pregnancy is unknown but cannot be excluded. Like other drugs that inhibit prostaglandin synthesis, celecoxib may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester of pregnancy.

During the second or third trimester of pregnancy, NSAIDs including celecoxib may cause fetal renal dysfunction which may result in a reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after initiation of treatment and are usually reversible upon discontinuation of treatment.

Celecoxib is contraindicated during pregnancy and in women who can become pregnant (see sections 4.3 and 4.4). If pregnancy is discovered during treatment, celecoxib should be discontinued.

Breastfeeding

Celecoxib is excreted in the milk of rats at concentrations similar to those found in plasma. Administration of celecoxib to a limited number of breastfeeding women has shown very low transfer of celecoxib into breast milk. Patients treated with CELECOXIB ZENTIVA should not breastfeed.

Fertility

Based on their mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.

CELECOXIB ZENTIVA 100 mg, capsule has a minor influence on the ability to drive vehicles and use machines. Patients experiencing dizziness, vertigo or drowsiness when taking CELECOXIB ZENTIVA, must refrain from driving or using machines.