AUXINA E-200 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Auxina E 200 UI Soft Capsules

Vitamin E (dl-alpha tocopheryl acetate)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Auxina E 200 and what is it used for
2. What you need to know before taking Auxina E 200
3. How to take Auxina E 200
4. Possible side effects
5. Storage of Auxina E 200
6. Package Contents and Additional Information

1. What is Auxina E 200 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 200 is indicated in:

• Prevention and treatment of vitamin E deficiency, in diseases with malabsorption syndrome (difficulty absorbing nutrients) that occur with steatorrhea (excessive amount of 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 affecting primarily the lungs, intestines, 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 medication, with a dose of 200 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 200

Do not take Auxina E 200

• If you are allergic to vitamin E or any of the other components of this medication (listed in section 6).
• If you have a blood coagulation disorder, see the following section and "Taking Auxina E 200 with other medications".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Auxina E 200.

• 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 contraceptives.
• If you have a vitamin K deficiency, high doses of vitamin E may increase coagulation defects.

Children and adolescents

This medication 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 medications

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

The following medications may interact with Auxina E 200 when used at the same time:

• Oral anticoagulants (medications 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 medication.

Estrógenos, including oral contraceptives.

Medications 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 in bowel 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 plan to become pregnant, consult your doctor before using this medication.

As a precaution, do not take Auxina E 200 during pregnancy.

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

This medication 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 nil.

Auxina E 200 contains methylparaben (sodium salt) (E-219), propylparaben (sodium salt) (E-217), and tartrazine (E-102)

May cause allergic reactions (possibly delayed) because it contains methylparaben and propylparaben.

This medication may cause allergic reactions because it contains tartrazine. May trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Auxina E 200

Follow the administration instructions for this medication exactly as indicated 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:

• Vitamin E deficiency, when the doctor deems the 200 UI dose indicated: 1 capsule per day (200 UI of dl-alpha tocopheryl acetate).
• Malabsorption syndromes: generally, 1 to 2 capsules (200 to 400 UI) per day or 15-25 mg per kg of body weight per day are recommended.
• Cystic fibrosis: between 200 and 400 UI of vitamin E (1 to 2 capsules) per day. In other cases, a lower dose may be sufficient (see "Other presentations" in section 6).
• Hepato-biliary tract disease: the dose that supplements the vitamin E deficiency will be administered. In chronic cholestasis, 200 to 400 UI per day (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 UI 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 can be administered to children. However, the pharmaceutical form of this medication may not be suitable for young children, as they may have difficulty swallowing them.

If you take more Auxina E 200 than you should

Vitamin E in excessive doses (generally doses over 300 mg) may cause nausea, diarrhea, and other digestive disorders, and in predisposed individuals, may produce 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, Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Auxina E 200

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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; some cases of cerebral infarction have been reported.

Rarely, emotional changes, fatigue.

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

Breast pain, alteration in the functioning of the gonads (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 package leaflet. You can also report them directly through the national notification system, Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Auxina E 200

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

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

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

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

6. Package Contents and Additional Information

Composition of Auxina E 200

• The active ingredient is dl-alpha tocopheryl acetate (vitamin E). Each capsule contains 200 mg of dl-alpha tocopheryl acetate (equivalent to 200 UI of vitamin E).
• The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methylparaben, sodium salt (E-219), propylparaben, sodium salt (E-217), tartrazine (E-102).

Appearance of the product and package contents

Auxina E 200 are soft gelatin capsules, round, transparent yellow with yellowish oily solution.

Available in packages of 20 and 60 capsules.

• Other presentations:

Auxina E 50 UI

Auxina E 400 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)

Phone: 934948000

Manufacturer

Laboratorios Alcalá Farma S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares

Madrid

Date of the last revision of this package leaflet: May 2014.

Other sources of information

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