ISOX

CELECOXIB HCS 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 cyclo-oxygenase-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 conducted in animals (rats and rabbits) have shown toxicity on reproductive functions including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis could have a deleterious effect on pregnancy. Data from epidemiological studies suggest an increase in the risk of spontaneous miscarriage after the use of prostaglandin synthesis inhibitors in early pregnancy.

In the human species, the risk during pregnancy is unknown but cannot be excluded. Like other drugs inhibiting prostaglandin synthesis, celecoxib can lead to 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 célécoxib can cause fetal renal dysfunction which may result in a reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects can appear rapidly after initiation of treatment and are generally reversible upon discontinuation of treatment.

Celecoxib is contraindicated during pregnancy and in women of childbearing age (see sections 4.3 and 4.4). In case of discovery of pregnancy during treatment, celecoxib must be discontinued.

Breastfeeding

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

Fertility

Due to their mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent ovulation (rupture of ovarian follicles), which has been associated with reversible sterility in some women.

CELECOXIB HCS has a minor influence on the ability to drive vehicles and use machines. Patients experiencing dizziness, vertigo, or drowsiness when taking célécoxib should refrain from driving or using machines.