Auxina E-50 IU soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Auxina E 50 IU soft capsules
Vitamin E (dl-alpha tocopheryl acetate)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Auxina E 50 is and what it is used for
- What you need to know before taking Auxina E 50
- How to take Auxina E 50
- Possible adverse effects
- How to store Auxina E 50
- Contents of the pack and other information
1. What Auxina E 50 is and what it is used for
Contains vitamin E (fat-soluble). The best-known function of vitamin E is its ability to act as an antioxidant for fats. It prevents the oxidation of essential cellular components and/or avoids the formation of toxic oxidation products.
Auxina E 50 is indicated for:
- Prevention and treatment of vitamin E deficiency; in diseases with malabsorption syndrome (difficulty in absorbing nutrients) associated with steatorrhea (excessive fat in feces), such as total or partial surgical removal of the gastrointestinal tract and celiac disease (gluten intolerance).
- Cystic fibrosis (hereditary disease characterized by the formation and accumulation of thick mucus, primarily affecting the lungs, intestines, pancreas, and liver).
- Hepatobiliary tract diseases (such as bile retention, obstruction of bile ducts).
- Abetalipoproteinemia (genetic disease causing inability to digest fats).
2. What you need to know before starting to take Auxina E 50
Do not take Auxina E 50
- If you are allergic to vitamin E or to any of the other ingredients of this medicine (listed in section 6).
- If you have a blood coagulation disorder, see the next section and “Taking Auxina E 50 with other medicines”
Warnings and precautions
Consult your doctor or pharmacist before starting to take Auxina E 50.
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Do not take doses higher than those recommended.
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If you are at risk of thrombophlebitis (swelling of a vein due to a blood clot), high doses of vitamin E increase this risk, including in women taking estrogen-containing contraceptives (female sex hormones).
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If you have vitamin K deficiency (a vitamin involved in blood coagulation), large doses of vitamin E may worsen coagulation defects.
Children and adolescents
This medicine may be administered to children. However, the pharmaceutical form may not be suitable for young children, as they may have difficulty swallowing it.
Taking Auxina E 50 with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
The following medicines may interact with Auxina E 50 when used at the same time:
- Oral anticoagulants (medicines to make the blood less likely to clot), such as acenocoumarol, warfarin, dicoumarol, since vitamin E enhances their effect.
- Tocopheryl succinate (a form of vitamin E), which may increase the effect of this medicine.
- Estrogens, including oral contraceptives.
Medicines affecting gastrointestinal absorption of vitamin E:
- Cholestyramine and colestipol (used to reduce cholesterol levels)
- Orlistat (used to reduce fat absorption)
- Mineral oil or liquid paraffin (used to assist intestinal evacuation)
If taken concomitantly, doses should be spaced at least 2 hours apart.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
As a precautionary measure, you should not take Auxina E 50 during pregnancy.
There is no information on the excretion of vitamin E in breast milk, so this medicine could have some effect on the newborn/child.
This medicine should not be used during breastfeeding.
Driving and using machines
The influence of Auxina E 50 on the ability to drive and use machines is negligible.
Auxina E 50 contains the colour Ponceau 4R (E-124)
This medicine may cause allergic reactions because it contains the colour Ponceau 4R.
It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Auxina E 50
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Auxina E 50 is taken orally. The recommended dose is:
Adults and children over 10 years:
- Vitamin E deficiency: 1 capsule daily (50 IU of dl-alpha-tocopheryl acetate). In certain cases, the physician may prescribe 2 or 3 capsules (100–150 IU) daily, or up to a maximum of 6 capsules (300 IU or mg) daily.
- Malabsorption syndromes: generally, 4 to 8 capsules (200 to 400 IU) daily or 15–25 mg per kg of body weight daily are recommended.
- Cystic fibrosis: 100 to 400 IU of vitamin E (2 to 8 capsules) daily.
- Hepatobiliary tract disease: the dose should be sufficient to correct vitamin E deficiency. In chronic cholestasis, 50 to 400 IU daily (1 to 8 capsules) are recommended.
- Abetalipoproteinemia: 50 to 300 IU (1 to 6 capsules) per kg of body weight daily are recommended.
The capsules should be swallowed whole with a little water or another liquid, during or after meals.
Use in children
Auxina E 50 soft capsules can be administered to children. However, the pharmaceutical form of this medicine may not be suitable for young children, as they might have difficulty swallowing them.
If you take more Auxina E 50 than you should
Excessive doses of vitamin E (generally doses starting from 300 mg) may cause nausea, diarrhea, and other digestive disorders and, in predisposed individuals, may lead to thrombophlebitis and worsen coagulation problems; it may also cause gonadal dysfunction (sex glands), breast pain, increased cholesterol and triglycerides, and reduced thyroid hormones in the blood.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service, Tel.: 91 5620420, indicating the medicine and the amount ingested.
If you forget to take Auxina E 50
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Among these adverse effects, whose frequency is not exactly known, are included:
Digestive disorders (during prolonged treatment in general and with high doses), such as diarrhea, nausea, gastric discomfort, intestinal cramps, and bleeding gums.
Circulatory disorders, more likely in predisposed patients, such as thrombophlebitis (swelling of a vein caused by a blood clot) and tendency to bleeding (during prolonged treatment in general and with high doses).
During prolonged treatment in general and with high doses: fatigue, weakness, dizziness, headache; there have been some cases of cerebral infarction.
Rarely, emotional disturbances, fatigue.
Blurred vision, during prolonged treatment in general and with high doses.
Breast pain, alteration in gonadal function (sex glands).
Changes in clinical laboratory test results, such as measurements of creatine, creatine kinase, sex hormones, and thyroid hormones.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system, the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Auxina E 50
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Auxina E 50
- The active substance is dl-alpha tocopheryl acetate (vitamin E). Each capsule contains 50 mg of dl-alpha tocopheryl acetate (equivalent to 50 IU of vitamin E).
- The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, red Ponceau 4R dye (E-124).
Appearance of the product and contents of the pack
Auxina E 50 consists of soft, round, transparent red gelatin capsules containing a yellowish oily solution.
It is available in packs of 20 and 60 capsules.
- Other presentations:
Auxina E 200 IU
Auxina E 400 IU
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHIESI ESPAÑA, S.A.U.
Plaça d'Europa, 41-43, planta 10
08908, L'Hospitalet de Llobregat
Barcelona (Spain)
Tel: 934948000
Manufacturer
Laboratorios Liconsa S.A.
Av. de Miralcampo 7 – Polígono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara (Spain)
Date of the most recent revision of this leaflet: July 2025
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/