Label: information for the patient

Auxina E 50 UI soft capsules

Vitamin E (dl-alfa tocopheryl acetate)

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read 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 even if they 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 label.See section 4.

Contains vitamin E (liposoluble). The most well-known function of vitamin E is 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 50 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, intestines, pancreas, and liver).
• Cholestatic disease (such as bile retention, obstruction of the bile ducts).
• ApoB-48 deficiency (genetic disease that causes inability to digest fats).

Do not take Auxina E 50

• If you are allergic to vitamin E or 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 50 with other medications”

Warnings and precautions

Consult your doctor or pharmacist before starting to take Auxina E 50.

• 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 blood clotting 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 50 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 50 when used at the same time:

- Oral anticoagulants (medications to make the blood more fluid), such as acenocoumarol, warfarin, dicumarol, as vitamin E increases their effect.

- Tocopherol succinate (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:

- Cholestyramine and cholestipol (to reduce cholesterol levels)

- Orlistat (to reduce fat absorption)

- Mineral oil or liquid paraffin (helping 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, or think you may be pregnant, consult your doctor before using this medication.

As a precaution, do not take Auxina E 50 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 machines

Auxina E 50 has no influence on the ability to drive and operate machines.

Auxina E 50 contains sodium methylparahydroxybenzoate (E-219), sodium propylparahydroxybenzoate (E-217) and Red Ponceau 4R (E-124)

It may cause allergic reactions (possibly delayed) because it contains sodium methylparahydroxybenzoate and sodium propylparahydroxybenzoate.

This medication may cause allergic reactions because it contains Red Ponceau 4R.

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Auxina E 50 is taken orally. The recommended dose is:

Adults and children over 10 years old:

• Vitamin E deficiency: 1 capsule per day (50 UI of dl-alpha tocopheryl acetate). In certain cases, the doctor may indicate taking 2 or 3 capsules (100-150 UI) per day, or up to a maximum of 6 capsules (300 UI or mg) per day.
• Malabsorption syndromes: generally, 4 to 8 capsules (200 to 400 UI) per day or 15-25 mg per kg of weight per day are recommended.
• Cystic fibrosis: between 100 and 400 UI of vitamin E (2 to 8 capsules) per day.
• Bile duct disease: the dose that supplements the vitamin E deficiency will be administered. In chronic cholestasis, 50 to 400 UI per day (1 to 8 capsules) are recommended.
• Abetalipoproteinemia: 50 to 300 UI (1 to 6 capsules) per kg of weight per day are recommended.

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

Use in children

Auxina E 50 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 50 than you should

Vitamin E in excessive doses (generally doses above 300 mg) can cause nausea, diarrhea, and other digestive disorders, and in predisposed individuals, it can cause thrombophlebitis and worsen 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 Toxicology Information Service, Tel.: 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Auxina E 50

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

If you have any other doubts 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 Medicinal Products 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 of the month 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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Auxina E 50

• The active principle 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, methyl parahydroxybenzoate, sodium chloride (E-219), propyl parahydroxybenzoate, sodium chloride (E-217), and red Ponceau 4R (E-124) colorant.

Appearance of the product and contents of the packaging

Auxina E 50 are soft, round, transparent red gelatin capsules with a yellowish oily solution.

It is presented in packaging of 20 and 60 capsules.

• Other presentations:

Auxina E 200 UI

Auxina E 400 UI

Holder of the marketing authorization and 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: March 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/