Rigentex 400 U.i Tocoferolo Vitamina e 30 Capsule Molli

Soft Capsules based on Tocopherol.

Therapeutic indications

Rigentex is used in the treatment of vitamin E deficiencies related to malabsorption or in conditions where the prevention of excessive cellular lipid peroxidation is required.

Dosage and Posology

The drug should be taken according to the following doses and methods: 200 - 400 mg per day, divided into 1 - 2 administrations, according to the doctor's judgment.

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. With daily doses greater than 1 g transient gastrointestinal disturbances such as nausea, diarrhea, flatulence have been reported. 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.

Contraindications

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 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.

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.

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 800 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.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 soft capsule of Rigentex contains:

Active principle

RRR-α- Tocopherol oil solution mg 400 (equal to 400 IU of vitamin E).

Excipients

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