AUXINA E-400 IU SOFT GEL CAPSULES

Introduction

Patient Information Leaflet

Auxina E 400 UI Soft Capsules

Vitamin E (dl-alpha tocopheryl acetate)

Read this leaflet carefully before starting to take this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Auxina E 400 and what is it used for
2. What you need to know before taking Auxina E 400
3. How to take Auxina E 400
4. Possible side effects
5. Storage of Auxina E 400
6. Package contents and additional information

1. What is Auxina E 400 and what is it used for

It contains vitamin E (liposoluble). The most well-known function of vitamin E is its ability to act as an antioxidant for fats. It prevents the oxidation of essential cellular elements and/or prevents the formation of toxic oxidation products.

Auxina E 400 is indicated in:

• Prevention and treatment of vitamin E deficiency, in diseases with malabsorption syndrome (difficulty absorbing nutrients) that present with steatorrhea (excessive amount of fat in feces), such as surgical removal of the gastrointestinal tract and celiac disease (gluten intolerance).
• Cystic fibrosis (hereditary disease characterized by the formation and accumulation of thick mucus affecting primarily the lungs, pancreas, and liver).
• Disease of the hepato-biliary tract (such as bile retention, obstruction of the bile ducts).
• Abetalipoproteinemia (genetic disease that causes inability to digest fats).

This medicine, with a dose of 400 UI of vitamin E, will be administered according to the indications when a lower dose is not indicated (see "Other presentations" in section 6).

2. What you need to know before taking Auxina E 400

Do not take Auxina E 400

• If you are allergic to vitamin E or any of the other components of this medicine (listed in section 6).
• If you have a blood coagulation disorder, see the following section and "Taking Auxina E 400 with other medicines".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Auxina E 400.

• Do not take higher doses than recommended.
• If you are at risk of developing thrombophlebitis (swelling of a vein caused by a blood clot), high doses of vitamin E may increase your risk, including women taking estrogen-containing contraceptives.
• If you have a vitamin K deficiency, high doses of vitamin E may increase 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 400 with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

The following medicines may interact with Auxina E 400 when used at the same time:

• Oral anticoagulants (medicines to make blood more fluid), such as acenocoumarol, warfarin, dicumarol, as vitamin E increases their effect.
• Tocofersolan (a form of vitamin E), which may increase the effect of this medicine.
• Estrogens, including oral contraceptives.

Medicines that affect gastrointestinal absorption of vitamin E:

• Colestyramine and colestipol (to reduce cholesterol levels)
• Orlistat (to reduce fat absorption)
• Mineral oil or liquid paraffin (to aid bowel evacuation)

If taken together, the 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 plan to become pregnant, consult your doctor before using this medicine.

As a precaution, do not take Auxina E 400 during pregnancy.

There is no information on the excretion of vitamin E in breast milk, so this medicine may have some effect on the newborn/child.

Do not use this medicine during breastfeeding.

Driving and using machines

Auxina E 400 has no influence on the ability to drive and use machines.

Auxina E 400 contains methyl parahydroxybenzoate (sodium salt) (E-219), propyl parahydroxybenzoate (sodium salt) (E-217), and tartrazine (E-102)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine may cause allergic reactions because it contains tartrazine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Auxina E 400

Follow the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Auxina E 400 is taken orally. The recommended dose is:

Adults and children over 10 years:

• Vitamin E deficiency, when the dose of 400 UI is indicated by the doctor: 1 capsule per day. (See "Other presentations" in section 6)
• Malabsorption syndromes: when the dose of 400 UI is indicated by the doctor: 1 capsule per day or 15-25 mg per kg of body weight per day.
• Cystic fibrosis: when the dose of 400 UI is indicated by the doctor: 1 capsule per day.
• Disease of the hepato-biliary tract: when the dose of 400 UI is indicated by the doctor: 1 capsule per day. In chronic cholestasis, the dose of 400 UI per day (1 capsule) may be indicated in some cases.
• Abetalipoproteinemia: 50-300 UI per kg of body weight per day are recommended.

The capsules should be taken whole with a little water or other liquid, during or after meals.

Use in children

Auxina E 400 soft capsules can 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 400 than you should

Vitamin E in excessive doses (generally doses over 300 mg) can cause nausea, diarrhea, and other digestive disorders, and in predisposed individuals, it may cause thrombophlebitis and worsen coagulation problems; it may also cause malfunction of the gonads (sex glands), breast pain, increased cholesterol and triglycerides, and reduced thyroid hormones in the blood.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or 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 400

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Among these side effects, whose frequency is not exactly known, are:

Digestive disorders (in prolonged treatment in general and with high doses), such as diarrhea, nausea, gastric discomfort, intestinal cramps, gum bleeding.

Circulatory disorders, more likely in predisposed patients, such as thrombophlebitis (swelling of a vein caused by a blood clot) and tendency to bleed (in prolonged treatment in general and with high doses).

In prolonged treatment in general and with high doses, fatigue, weakness, dizziness, headache; there have been some cases of cerebral infarction.

Rarely, emotional changes, fatigue.

Blurred vision, in prolonged treatment in general and with high doses.

Breast pain, altered gonadal function (sex glands).

Changes in clinical analysis results, such as creatine, creatine kinase, sex hormones, and thyroid hormones.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system, Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Auxina E 400

Do not store above 25°C.

Keep in the original packaging to protect it from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Auxina E 400

• The active ingredient is dl-alpha tocopheryl acetate (vitamin E). Each capsule contains 400 mg of dl-alpha tocopheryl acetate (equivalent to 400 UI of vitamin E).
• The other ingredients (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), tartrazine (E-102).

Appearance of the product and package contents

Auxina E 400 are soft gelatin capsules, oval, transparent yellow with yellowish oily solution.

It is available in packages of 30 and 60 capsules.

• Other presentations:

Auxina E 50 UI

Auxina E 200 UI

Marketing authorization holder and manufacturer

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d´Europa, 41-43, 10th floor

08908, L´Hospitalet de Llobregat

Barcelona (Spain)

Tel 934948000

Manufacturer

Laboratorios Alcalá Farma S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares

Madrid

Date of last revision of this leaflet: May 2014.

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/