Tocofersolan

For tocofersolan no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development. Caution should be exercised when prescribing to pregnant women.

It is unknown whether tocofersolan is excreted in human breast milk. The excretion of tocofersolan in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Vedrop should be made taking into account the benefit of breast-feeding to the child and the benefit of tocofersolan therapy to the woman.

Fertility

No data is available.

Tocofersolan has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most commonly reported adverse reaction during treatment is diarrhoea.

List of adverse reactions

Reported adverse reactions are listed below, by system organ class and by frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Gastrointestinal disorders

Common: diarrhoea

Not known: abdominal pain

Skin and subcutaneous tissue disorders

Uncommon: alopecia, pruritus, rash

General disorders and administration site conditions

Uncommon: asthenia, headache

Investigations

Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase