Auxina E-200 IU soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Auxina E 200 IU soft capsules
Vitamin E (dl-alpha tocopheryl acetate)
Read this 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 other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of this leaflet
- What Auxina E 200 is and what it is used for
- What you need to know before taking Auxina E 200
- How to take Auxina E 200
- Possible adverse effects
- How to store Auxina E 200
- Contents of the pack and other information
1. What is Auxina E 200 and what is it 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 200 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 production and accumulation of thick mucus, primarily affecting the lungs, intestines, pancreas, and liver).
- Hepatobiliary tract diseases (such as bile retention, obstruction of the bile ducts).
- Abetalipoproteinemia (genetic disease causing inability to digest fats).
This medicine, with a dose of 200 IU of vitamin E, should be administered according to indications when a lower dose is not recommended (see “Other presentations” in section 6).
2. What you need to know before starting to take Auxina E 200
Do not take Auxina E 200
- If you are allergic to vitamin E or to any of the other components of this medicine (listed in section 6).
- If you have any blood coagulation disorders, see the following section and “Taking Auxina E 200 with other medicines”.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Auxina E 200.
- Do not take doses higher than those recommended.
- If you are at risk of thrombophlebitis (swelling of a vein due to a blood clot), high doses of vitamin E may increase this risk, including in women taking estrogen-containing contraceptives (female sex hormones).
- If you have vitamin K deficiency (a vitamin involved in blood clotting), large doses of vitamin E may worsen coagulation defects.
Children and adolescents
This medicine can 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 200 with other medicines
Tell 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 200 when used simultaneously:
- Oral anticoagulants (medicines to make the blood less thick), such as acenocoumarol, warfarin, dicoumarol, since vitamin E increases their effect.
- Tocofersolan (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 together, 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 200 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 200 on the ability to drive and use machines is negligible.
Auxina E 200 contains the colouring agent tartrazine (E-102)
This medicine may cause allergic reactions because it contains tartrazine. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Auxina E 200
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 200 is taken orally.
The recommended dose is:
Adults and children over 10 years of age:
- Vitamin E deficiency, when in the physician's judgment a dose of 200 IU is indicated: 1 capsule daily (200 IU of dl-alpha-tocopheryl acetate).
- Malabsorption syndromes: generally, 1 to 2 capsules (200 to 400 IU) daily or 15–25 mg per kg of body weight per day are recommended.
- Cystic fibrosis: between 200 and 400 IU of vitamin E (1 to 2 capsules) daily. In other cases, a lower dose may be sufficient (see “Other presentations” in section 6).
- Hepatobiliary tract disease: the dose required to correct vitamin E deficiency should be administered. In chronic cholestasis, doses of 200 to 400 IU daily (1 to 2 capsules) may be indicated. In other cases, a lower dose may be sufficient (see “Other presentations” in section 6).
- Abetalipoproteinemia: 50 to 300 IU per kg of body weight per day are recommended.
The capsules should be swallowed whole with a little water or other liquid, during or after meals.
Use in children
Auxina E 200 soft capsules may be administered to children. However, the pharmaceutical form of this medicine may not be suitable for young children, as they may have difficulty swallowing them.
If you take more Auxina E 200 than you should
Excessive doses of vitamin E (generally doses starting from 300 mg) may cause nausea, diarrhea, and other gastrointestinal disturbances, 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.: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Auxina E 200
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 cause adverse effects, although not everyone will experience 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, 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 Pharmacovigilance System for 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 200
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 container after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Auxina E 200
- The active substance is dl-alpha tocopheryl acetate (vitamin E). Each capsule contains 200 mg of dl-alpha tocopheryl acetate (equivalent to 200 IU of vitamin E).
- The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, tartrazine (E-102).
Appearance of the product and contents of the pack
Auxina E 200 are soft gelatin capsules, round, transparent yellow, containing a yellowish oily solution.
They are available in packs of 20 and 60 capsules.
- Other presentations:
Auxina E 50 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 review of this package leaflet: October 2025
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/