Vedrop · 4.3 Contraindications · 1

HOS-154360 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most commonly reported adverse reaction during treatment is diarrhoea. Tabulated 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. 4 System organ class Adverse reactions Gastrointestinal disorders Common: diarrhoea Not known: abdominal pain Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site Uncommon: asthenia, headache conditions Investigations Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase 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 the national reporting system listed in Appendix V.

HOS-154356 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Vedrop must not be used in preterm newborn infants.

HOS-154355 · has-indication-information · PDF-Seite 2

Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age.

HOS-154358 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment (see section 4.4). Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as steroids, antibiotics, antihistamines, cyclosporine, tacrolimus). Therefore, monitoring should be performed and, when necessary, doses should be adjusted.

HOS-154359 · has-pregnancy-information · PDF-Seite 4

Pregnancy 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 (see section 5.3). Caution should be exercised when prescribing to pregnant women. Breast-feeding 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

HOS-154357 · has-warning-information · PDF-Seite 3

As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR). A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary. As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2). Vedrop should be administered with caution in patients with underlying liver impairment and under close monitoring of the hepatic functions in such patients (see section 4.2). Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed). 3 This medicinal product contains sodium. It should be taken into consideration by patients on a controlled sodium diet.