RIGENTEX * SOFT 30CPS 400UI

RIGENTEX * SOFT 30CPS 400UI

Therapeutic indications

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

Dosage and method of use

140-280 mg per day, divided into 1 - 2 administrations, according to the doctor's judgment.

Contraindications

Known hypersensitivity to the active substance or to any of the excipients.

Side effects

After taking high dosages, fatigue and muscle weakness may appear. Adverse reactions derive from spontaneous reports and therefore it is not possible to establish their frequency.Disorders of the immune systemAllergic 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 disordersDiarrhea, abdominal pain, epigastric pain, nausea, flatulence.Skin and subcutaneous tissue disordersSkin rash, itching.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special 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.

Pregnancy and breastfeeding

During pregnancy and lactation the product 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.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

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.

Overdose

In case of overdose it is possible the appearance of gastrointestinal disorders (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. Where necessary, general supportive measures should be taken.

Active principles

RIGENTEX 200 IU soft capsules1 capsule contains: Active principle : RRR-α-Tocopherol 140 mg (equal to 200 IU of vitamin E).RIGENTEX 400 IU soft capsules1 capsule contains:Active principle: RRR-α-Tocopherol 280 mg (equal to 400 IU of vitamin E). For the full list of excipients, see section 6.1

Excipients

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