SELESYN Oral solution Ref.[49863] Active ingredients: Sodium selenite

None.

It must be ensured that Selesyn is not administered orally at the same time as reducing substances (e.g. vitamin C), as precipitation of elemental selenium cannot be excluded (see section 6.2).

Elemental selenium is not soluble in an aqueous medium and has no biological availability. Oral administration of Selesyn and vitamin C should be given at an interval of 4 hours.

Pregnancy

There are no data from the use of Selesyn in pregnant woman. Limited published data from animal studies reveal only evidence for toxicity to reproduction at maternally toxic dose.

No adverse effect of sodium selenite on the pregnancy or unborn child is expected, provided that it is used in case of proven selenium deficiency.

Lactation

Selenium is excreted in breast milk. Doses correcting selenium deficiency in breast feeding woman are not expected to exert adverse effects on the suckling infant.

None.

None known to date when Selesyn is used as directed.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

When preparing an oral solution with Selesyn as a supplement, it must be ensured that the pH value does not fall below 7.0 and that the solution is not mixed with reducing substances (e.g. vitamin C), as a precipitate of elemental selenium may possibly result. Elemental selenium is not soluble in an aqueous medium and has no biological availability. Oral administration of Selesyn and vitamin C should be given at an interval of 4 hours.