Abiogen Pharma Sursum 400 IU For Vitamin E Deficiencies 30 Softgels

Active ingredients A soft capsule of SURSUM 200 IU contains: Active ingredient: RRR – α – Tocopherol 140 mg (equal to 200 IU of vitamin E). A soft capsule of SURSUM 400 IU contains: Active ingredient: RRR – α – Tocopherol 280 mg (equal to 400 IU of vitamin E). Excipient with known effect: refined soybean oil. For the full list of excipients, see section 6.1.

Excipients Refined soybean oil. Constituents of the capsule: gelatin, glycerol.

Therapeutic indications Vitamin E deficiencies linked to malabsorption. Conditions in which the prevention of excessive cellular lipid peroxidation is required.

Contraindications / Undesirable effects Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Dosage 140–280 mg per day, divided into 1–2 administrations, according to the physician's judgment.

Storage Store at a temperature not exceeding 30 ° C.

Warnings Since vitamin E reduces the need for digitalis, in case of simultaneous intake of the two drugs, attention must be paid to any hyperdigitalization. Insulin dosages in diabetics treated with vitamin E must be carefully controlled, since vitamin E can considerably reduce the need for insulin (see also section 4.5). Prolonged use of doses above 560 mg per day has been associated with an increased bleeding tendency in patients with vitamin K deficiency. Excessive use of vitamin E can antagonize vitamin K function and should be under close supervision. . Therapeutic use of tocopherol is associated with an increased risk of hemorrhagic stroke.

Interactions High doses of vitamin E (1200 IU) can interfere with warfarin, resulting in a transient increase in bleeding time. Vitamin E can enhance the action of digitalis and insulin. Concomitant use of anticoagulants, thrombolytics, or inhibitors of platelet aggregation or haemostasis may increase the risk of bleeding. High doses of α – tocopherol can reduce the absorption of vitamin A and vitamin K.

Undesirable effects Fatigue and muscle weakness may occur following intake of high dosages. Adverse reactions are derived from spontaneous reports and therefore it is not possible to establish their frequency. Immune system disorders Allergic reaction, anaphylactic reaction. Symptoms may include hives (secondary mechanism), allergic edema, dyspnoea, erythema, rash and boils. If an allergic reaction appears, stop treatment and consult a doctor. Gastrointestinal disorders Diarrhea, abdominal pain, epigastric pain, nausea, flatulence. Skin and subcutaneous tissue disorders Rash, itching. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdose In case of overdose it is possible the appearance of gastrointestinal disturbances (nausea, diarrhea), fatigue, muscle weakness. Chronic phenomena of hypervitaminosis are not known E. Symptoms and signs of tocopherol overdose are non-specific. Transient gastrointestinal disturbances such as nausea, diarrhea, flatulence have been reported with daily dosages above 700 mg. Other symptoms may include fatigue, asthenia, headache, blurred vision and dermatitis. If overdose is suspected, treatment should be discontinued. If necessary, general supportive measures should be taken.

Pregnancy and lactation During pregnancy and lactation the medicine should only be used under strict medical supervision due to the high dosage of alpha-tocopherol in the medicine. In case the use of the medicinal product is necessary, the risk / benefit ratio for both the mother and the child must be considered, and the treatment must be adapted according to the serum tocopherol levels.