Package Insert: Information for the Patient

Auxina E 400 UI Soft Capsules

Vitamin E (dl-alfa tocopheryl acetate)

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contains vitamin E (liposoluble). The most well-known function ofvitamin Eis its ability to act as a fatty substance antioxidant. It prevents the oxidation of essential cellular elements and/or avoids the formation of toxic oxidation products.

Auxina E 400 is indicated for:

• Prevention and treatment of vitamin E deficiency, in diseases with malabsorption syndrome (difficulty absorbing nutrients) that are accompanied by steatorrhea (excessive amount of fats 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 mainly lungs, pancreas, and liver).
• Cholestatic liver disease (such as bile retention, obstruction of bile ducts).
• ApoB-48 deficiency (genetic disease that causes inability to digest fats).

This medication, 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).

Do not take Auxina E 400

• If you are allergic tovitamin Eor to any of the other components of this medication (listed in section 6).
• If you have any bleeding disorder, see the following section and “Taking Auxina E 400 with other medications”.

Warnings and precautions

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

• Do not take doses higher than recommended.
• If you are at risk of developing thrombophlebitis (swelling of a vein caused by a blood clot), high doses of vitamin E increase your risk, including women taking estrogen-containing contraceptives (female sex hormones).
• If you have a vitamin K deficiency (vitamin involved in blood clotting), large doses of vitamin E may increase bleeding defects.

Children and adolescents

This medication 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 400 with other medications

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

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

- Oral anticoagulants (medications to make the blood more fluid), such as acenocoumarol, warfarin, dicumarol, asvitamin Eincreases its effect.

- Tocopherol acetate (a form of vitamin E), which may increase the effect of this medication.

- Estrogens, including oral contraceptives.

Medications affecting the gastrointestinal absorption of vitamin E:

• Colestiramine and colestipol (to reduce cholesterol levels)
• Orlistat (to reduce fat absorption)
• Mineral oil or liquid paraffin (helps to evacuate the intestine)

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 400 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 operating machinery

Auxina E 400 has no influence on the ability to drive and operate machinery.

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

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Adults and children over 10 years old:

• Vitamin E deficiency, when the doctor considers a dose of 400 UI to be indicated: 1 capsule per day. (See “Other presentations” in section 6)
• Malabsorption syndromes: when the doctor considers a dose of 400 UI to be necessary: 1 capsule per day or 15-25 mg per kg of body weight per day.
• Cystic fibrosis: when the doctor considers a dose of 400 UI to be necessary: 1 capsule per day.
• Bile duct and liver disease: when the doctor considers a dose of 400 UI to be necessary: 1 capsule per day. In chronic cholestasis, a dose of 400 UI per day (1 capsule) may be indicated in some cases.
• Abetalipoproteinemia: doses of 50-300 UI per kg of body weight per day are recommended.

The capsules should be swallowedwhole 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 medication 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 above 300 mg) can cause nausea, diarrhea, and other gastrointestinal disturbances, and in predisposed individuals, can cause thrombophlebitis and exacerbate coagulation problems; it can also cause gonadal dysfunction, 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 Toxicological Information Service, Tel.: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Auxina E 400

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Digestive disorders (in general, prolonged treatment and high doses), such asdiarrhea, nausea, stomach discomfort, intestinal cramps, gum bleeding.

Circulation disorders, more likely in predisposed patients, such asthrombophlebitis (swelling of a vein caused by a blood clot) and bleeding tendency (in general, prolonged treatment and high doses).

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

Rarely, emotional disturbances, fatigue.

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

Mastalgia, alteration in the functioning of the gonads (sex glands).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system, Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not store at a temperature above25ºC.

Store in the original packaging to protect it from humidity.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Auxina E 400

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

Appearance of the product and contents of the packaging

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

It is presented in packaging of 30 and 60 capsules.

• Other presentations:

Auxina E 50 UI

Auxina E 200 UI

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d´Europa, 41-43, 10th floor

08908, L´Hospitalet de Llobregat

Barcelona (Spain)

Tel 934948000

Responsible for manufacturing

Laboratorios Alcalá Farma S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares

Madrid

Last review date of this leaflet: May 2014.

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:/www.aemps.gob.es/