Patient Information

Auxina A+E Soft Capsules

Vitamin A (retinol palmitate)/ vitamin E (dl-alfa-tocopherol acetate)

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 10 days.

Contains the liposoluble vitamins A and E.

Vitamin A acts in a large number of important functions in the body; it is necessary, among other processes, for vision, skin integrity, bone development, and for the body's defenses.

The most well-known function of vitamin E is its ability to act as a fatty substance antioxidant, preventing the propagation of free radical reactions.

Auxina A+E capsules is indicated for:

Treatment of vitamin A and E deficiency caused by insufficient diet, convalescence, or other reasons; to promote overall health, among other actions, of vision, skin, mucous membranes, and defenses.

Auxina A+E capsules is indicated for adults and children over 14 years old.

Do not take Auxina A+E:

• If you are allergic to vitamin A, vitamin E, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have hypervitaminosis A (excessive storage of vitamin A in the body).
• Children under 14 years old (due to their doses).

Warnings and precautions

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

• Do not take doses higher than recommended.
• If you take high doses of fat-soluble vitamins such as A or E, especially A continuously, they may accumulate in your body and cause side effects associated with hypervitaminosis and toxicity.
• Patients with liver or kidney disease:Before taking this medication, consult your doctor, who will evaluate the possible risks and benefits, as these patients may have more adverse effects due to vitamin A, especially with prolonged use.
• The risk of vitamin A toxicity may also increase if you have low body weight, protein malnutrition, or high protein levels in the blood (hyperlipoproteinemia), high triglycerides in the blood (hypertriglyceridemia), consume alcohol, or have a vitamin C deficiency.
• If you have thrombophlebitis or are at risk of developing it (formation of a blood clot in the circulatory system) or have bleeding disorders with vitamin K deficiency, or are undergoing anticoagulant treatment, see the risk of vitamin E overdose in the sectionIf you take more Auxina A+E than you shouldand the sectionTaking Auxina A+E with other medications.
• You may develop a deficiency of vitamin A over time if you have gastrointestinal diseases (such as chronic diarrhea), in the case of suffering from a disorder characterized by abnormal storage and transport of the vitamin, such as ina hereditary disease (abetalipoproteinemia), if you have a lack of proteins, diabetes, hyperthyroidism, fever, liver diseases, and cystic fibrosis with liver involvement (hereditary disease, characterized by the formation and accumulation of thick mucus mainly in the lungs and digestive system).
• If you have a disorder of fat absorption, you may have a deficiency of vitamin E and need supplementation.
• Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc...) inform your doctor that you are taking this medication, as it may alter the results. For example, in some tests for determining bilirubin and cholesterol.

Children and adolescents

Auxina A+E is contraindicated in children under 14 years old.

Taking Auxina A+E 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 A+E when used at the same time:

• Vitamin A analogs such as retinoids, used for the skin like isotretinoin and acitretin, or to treat certain types of cancer, like tretinoin and bexarotene
• Oral anticoagulants, like acenocoumarol, warfarin, dicumarol,andinjectable anticoagulants, like heparin, abciximab, antithrombin III human, and fondaparinux (blood circulation medications)
• Antiplatelet agents, like: clopidogrel, eptifibatide, tirofiban (blood circulation medications)
• Antibiotics (to treat infections), like minocycline and tetracycline
• Oral contraceptives
• Iron supplements

Medications that affect the gastrointestinal absorption of Vitamins A and E:

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

When taken together, doses should be spaced at least 2 hours apart.

Taking Auxina A+E with alcohol

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Auxina A+E is contraindicated during pregnancy, in women planning to become pregnant, and during breastfeeding.

Driving and operating machinery

No effects are expected in this regard.

Auxina A+E contains glycerol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and yellow orange S (E-110)

This medication may cause headaches, stomach discomfort, and diarrhea due to glycerol.

It may cause allergic reactions (possibly delayed) due to methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medication may cause allergic reactions due to yellow orange S (E-110).It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 14 years old:

Consider your intake of vitamin A through diet to avoid accumulating the dose.

It is recommended to take 1 capsule per day. In some cases, your doctor may indicate taking 2 or up to 3 capsules per day.

If symptoms worsen or do not improve after 10 days of treatment, you must consult your doctor.

Generally, treatment should not exceed two weeks, but at your doctor's discretion, it may be prolonged for a longer period.

Oral administration.

Capsules should be taken with a little water or other liquid, preferably during meals.

Use in children and adolescents

Children under 14 years old should not take this medication due to its doses.

If you take more Auxina A+E than you should

If you have taken more Auxina A+E than recommended in this leaflet or by your doctor (high doses), you may experience vitamin A toxicity. Within a few hours of administering an overdose of vitamin A, symptoms such as irritability, drowsiness, seizures, headache, increased intracranial pressure, nausea, vomiting, diarrhea, visual disturbances, and nervous system disorders may occur; days after the overdose, skin redness and peeling, bleeding gums, etc. may appear.

With chronic vitamin A overdose, hypervitaminosis A may occur. The risk of toxicity is higher if you have kidney or liver disease, low weight or malnutrition, or consume alcohol; you may experience: fatigue, irritability, mental alterations, loss of appetite, digestive discomfort, mild fever, children may stop growing normally; hair loss, skin eruptions, mucous dryness; other symptoms include liver alterations with changes in liver function test results and even permanent liver damage. Other symptoms include urinary alterations and changes in blood counts and calcifications (nodules) in tendons, muscles, and subcutaneous tissue.

Vitamin E in excessive doses, rarely causes nausea, diarrhea, and other intestinal disorders, and in predisposed individuals may cause thrombophlebitis and exacerbate coagulation problems; it may also cause gonadal dysfunction, breast pain, increased cholesterol and triglycerides, and reduced thyroid hormone levels in the blood.

Normally, hypervitaminosis A is reversible, and symptoms improve within a few days of treatment interruption. Symptoms of excessive vitamin E doses generally disappear after treatment interruption.

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 forgot to take Auxina A+E

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 may experience them.

The possible adverse effects, mainly due to vitamin A, especially with the use of large doses and/or prolonged use, are:

Bleeding disorders, headache, insomnia or drowsiness, double vision, gum inflammation, loss of appetite, nausea, vomiting, stomach discomfort, lip inflammation (cheilitis), skin rash, hair dryness and mucous membranes, hair loss, skin dryness and changes in color, photosensitivity reactions (skin rash upon sun exposure), osteoporosis (bone loss), appearance of nodules (calcifications) in tendons, muscles, and subcutaneous tissue, bone or muscle pain, liver disorders, and emotional disturbances.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the outer packaging to protect it from light.

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.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Auxina A+E soft capsules

• The active principles are Vitamin A (as retinol palmitate) and Vitamin E (dl-alfa-tocoferol acetate). Each soft capsule contains 5,000 IU of vitamin A and 10 mg of vitamin E.
• The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and yellow-orange S (E-110).

Appearance of the product and content of the packaging

It is presented in the form of soft gelatin capsules, round, transparent orange, unmarked, containing yellow oily solution.

The content of the packaging is 20 or 30 soft capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat (Barcelona)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: November 2013.

Other sources of information

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