Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy:
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
• Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1 %, up to approximately 1.5 %. The risk is believed to increase with the dose and duration of therapy.
• Animal studies have shown reproductive toxicity. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and postimplantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low (< 30% of the body surface) and duration of treatment as short as possible (not longer than 3 weeks).
If NSAID treatment is necessary between about 20 weeks and 28 weeks gestation, limit Sunactic use to the lowest effective dose and shortest duration possible.
During the second and third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
• Functional renal injury in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment), or anamnios (particularly with prolonged exposure). After birth: kidney failure may persist (particularly with late or prolonged exposure).
• Pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with premature closure of the ductus arteriosus). This risk exists from the beginning of the 6th month and increases if administration is close to full term.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate, to:
• Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
• Inhibition of uterine contractions resulting in delayed or prolonged labour.
• Increased risk of oedema formation in the mother.
Consequently, Sunactic is contraindicated during the third trimester of pregnancy (see section 4.3)
Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs, including Sunactic, in pregnant women at about 28 weeks gestation and later. NSAIDs, including Sunactic, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment:
Use of NSAIDs, including Sunactic, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
Consider ultrasound monitoring of amniotic fluid if Sunactic treatment extends beyond 5 days. Discontinue Sunactic if oligohydramnios occurs and follow up according to clinical practice.


Breastfeeding:
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at the recommended therapeutic doses of Sunactic no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional.
Under this circumstance, Sunactic should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).