FLAMIX

Short-term symptomatic treatment of acute osteoarthritis flares.

Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

MELOXICAM ZENTIVA is indicated in adults and children aged 16 years and older.

Pregnancy

Inhibition of prostaglandin synthesis may have a deleterious effect on pregnancy and/or embryonic or fetal development. Data from epidemiological studies, following the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy, suggest an increased risk of miscarriage, cardiac malformation and gastroschisis. The absolute risk of cardiac malformation is increased from less than 1 % to about 1,5 %. This risk is assumed to increase with dose and duration of treatment.

In animals, administration of a prostaglandin synthesis inhibitor results in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been observed in animals that received a prostaglandin synthesis inhibitor during the organogenesis period.

From the 20th week of amenorrhoea, the use of meloxicam may cause oligohydramnios resulting from fetal renal dysfunction. This effect may occur shortly after the start of treatment and is generally reversible upon discontinuation. In addition, cases of ductus arteriosus constriction have been reported following treatment during the second trimester, most of which resolved after discontinuation of treatment. Therefore, unless clearly necessary, the use of meloxicam should be avoided during the first and second trimester of pregnancy.

In case of use of meloxicam in a woman wishing to conceive, or during the first or second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Prenatal monitoring for oligohydramnios should be considered after exposure to meloxicam for several days from the 20th week of amenorrhoea. Treatment with meloxicam should be discontinued in case of oligohydramnios.

During the third trimester, all prostaglandin synthesis inhibitors may expose:

· the fetus:

o to cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension),

o to renal dysfunction (see above).

· the mother and the child, at the end of pregnancy:

o to an increase in bleeding time, an anti-aggregating effect, which may occur even at very low doses,

o to inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, meloxicam is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3).

Breastfeeding

Although no specific data in humans are available for meloxicam, NSAIDs are known to pass into breast milk. Meloxicam has been found in the milk of lactating animals. Administration of MELOXICAM ZENTIVA is therefore not recommended during breastfeeding.

Fertility

Meloxicam, like any drug that inhibits cyclooxygenase and prostaglandin synthesis, may impair fertility. Its use is not recommended in women attempting to conceive. In women who have difficulties conceiving, or who are undergoing investigation of reproductive function, withdrawal of meloxicam should be considered.

No specific study on the ability to drive and use machines has been carried out.

However, given its pharmacodynamic profile and the reported adverse effects, it is unlikely that MELOXICAM ZENTIVA will affect the ability to drive or use machines. However, in the event of vision disturbances, notably blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, it is recommended to refrain from driving or using machines.