Coversyl Plus Use In Pregnancy & Lactation

Given the effects of the individual components in this combination product on pregnancy and lactation, Coversyl Plus 5mg/1.25 mg and 10mg/2.5mg is not recommended during the first trimester of pregnancy. Coversyl Plus 5mg/1.25 mg and 10mg/2.5mg is contraindicated during the second and third trimesters of pregnancy.
Coversyl Plus 5mg/1.25 mg and 10mg/2.5mg is contraindicated during lactation. A decision should therefore be made whether to discontinue nursing or to discontinue Coversyl Plus 5mg/1.25 mg and 10mg/2.5mg taking account the importance of this therapy for the mother.
Pregnancy: Linked to perindopril: The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see Warnings). The use of ACE inhibitors is contra-indicated during the second and third trimesters of pregnancy (see Contraindications and Warnings).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see Contraindications and Warnings).
Linked to indapamide: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of indapamide in pregnant women. Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a foeto-placental ischemia and growth retardation.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, it is preferable to avoid the use of Indapamide during pregnancy.
Breast-feeding: Coversyl Plus 5mg/1.25 mg and 10mg/2.5mg is contraindicated during breast-feeding.
Linked to perindopril: Because no information is available regarding the use of perindopril during breast-feeding, perindopril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Linked to indapamide: There is insufficient information on the excretion of indapamide/metabolites in human milk. Hypersensitivity to sulfonamide-derived drugs, hypokalaemia might occur. A risk to the newborns/infants cannot be excluded.
Indapamide is closely related to thiazide diuretics which have been associated, during breast-feeding, with decrease or even suppression of milk lactation.
Indapamide is contra-indicated during breast-feeding.
Fertility: Common to perindopril and indapamide: Reproductive toxicity studies showed no effect on fertility in female and male rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). No effects on human fertility are anticipated.