VEDROP Oral solution Ref.[9886] Active ingredients: Tocofersolan

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).

This medicinal product contains sodium. It should be taken into consideration by patients on a controlled sodium diet.

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.

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.

Vedrop 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.

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.

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

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

United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Ireland, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.