Dompé

Rigentex 400 IU

Soft Capsules

Composition :

RIGENTEX 200 IU soft capsules 1 capsule contains: Active ingredient: RRR-α- Tocopherol oil solution mg 200 (equal to 200 IU of vitamin E) .RIGENTEX 400 IU soft capsules 1 capsule contains: Active ingredient: RRR-α- Tocopherol oil solution 400 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.

Therapeutic indications

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

Contraindications

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

Dosage

200 - 400 mg per day, divided into 1 - 2 administrations, according to the doctor's judgment.

Warnings and Precautions

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.

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.

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.

Format of 30 soft capsules