Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryonic/fetal development. Data from epidemiological studies suggests an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryonic/fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

Swiss Relief Dual Release should not be administered during the first and second trimesters of pregnancy unless absolutely necessary. If Swiss Relief Dual Release is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low as possible, and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors: - may expose the foetus to:
•       Cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension) •       Renal dysfunction (see above)

- At the end of pregnancy, expose the mother and the neonate to:
•        Possible prolongation of bleeding time, an antiplatelet effect, that may occur even at very low doses •        Inhibition of uterine contractions resulting in delayed or prolonged labor 
Consequently, Swiss Relief Dual Release is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3).

Fetal Toxicity
Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs, including Swiss Relief Dual Release, in pregnant women at about 28 weeks gestation and later.
NSAIDs, including Swiss Relief Dual Release, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment:
Use of NSAIDs, including Swiss Relief Dual Release, 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.
If NSAID treatment is necessary between about 20 weeks and 28 weeks gestation, limit Swiss Relief Dual Release use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Swiss Relief Dual Release treatment extends beyond 5 days. Discontinue Swiss Relief Dual Release if oligohydramnios occurs and follow up according to clinical practice.
Breastfeeding:

Diclofenac and its metabolites pass into breast milk in small amounts. Since there are to date no known adverse effects on infants, discontinuation of breastfeeding is usually not required with short-term use. Early ablactation, however, should be considered if prolonged use/increased doses are prescribed to treat inflammatory disorders.

Fertility:
As with other medicinal products known to inhibit cyclo-oxygenase/prostaglandin synthesis, the use of Swiss Relief Dual Release may impair female fertility and is not recommended in women attempting to conceive. Discontinuation of Swiss Relief Dual Release should be considered in women who have difficulties conceiving or who are undergoing investigations of infertility.