Label: information for the user

Auxina A+E Strong Soft Capsules

Vitamin A (retinol palmitate)/ vitamin E (dl-alpha-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 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 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 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 Strong is indicatedin:

• Treatment of a marked deficiency of vitamins A and E.
• Xeroftalmia (eye disease, with dryness and opacity of two superficial layers of the eyes).

Auxina A+E Strong is indicated in adults and patients older than 14 years.

Do not take Auxina A+E Fuerte:

• 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 before starting to take Auxina A+E Fuerte.

• Do not take doses higher than recommended.
• If you take high doses of fat-soluble vitamins like 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 to assess the potential 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 coagulation disorders with vitamin K deficiency, or are being treated with anticoagulant medications, see the risk of vitamin E overdose (in the sectionIf you take more Auxina A+E Fuerte than you shouldand the sectionTaking Auxina A+E Fuerte with other medications).
• You may develop vitamin A deficiency over time if you have gastrointestinal diseases (such as chronic diarrhea), in the case of a disorder characterized by abnormal storage and transport of the vitamin, such as a hereditary disease (abetalipoproteinemia), if you have protein deficiency, diabetes, hyperthyroidism, fever, liver diseases, and cystic fibrosis with liver involvement (a hereditary disease characterized by the formation and accumulation of thick mucus mainly in the lungs and digestive system).
• If you have altered fat absorption, you may have vitamin E deficiency and require 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 Fuerte is contraindicated in children under 14 years old.

Taking Auxina A+E Fuerte 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 Fuerte 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, such as tretinoin and bexarotene
• Oral anticoagulants, such as acenocoumarol, warfarin, dicumarol, and injectable anticoagulants, such as heparin, abciximab, antithrombin III human, and fondaparinux (blood circulation medications)
• Antiplatelet agents, such as: clopidogrel, eptifibatide, tirofiban (blood circulation medications)
• Antibiotics (to treat infections), such as 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 intestines)

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

Taking Auxina A+E Fuerte with alcohol

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy, lactation, and fertility

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

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

Driving and operating machinery

No effects are expected in this regard.

Auxina A+E Fuerte 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 delayed allergic reactions 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 administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults and patients over 14 years:

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

- Generallyit is recommended to take 1 capsule per day.

The treatment duration in general should not be more than two weeks.

• In case of severe deficiency of vitamin A, the recommended dose is 2 capsules (100,000 UI of vitamin A) per day for 3 days, followed by 1 capsule (50,000 UI of vitamin A) per day for 2 weeks. As amaintenancedosage, if necessary, the patient should switch to another medication such asAuxina A+Soft Capsules, with a lower dose (contains 5,000 UI of vitamin A and 10 mg of vitamin E); 10,000-20,000 UI of vitamin A per day for 2 months are recommended.
• In case of xeroftalmia, the recommended dose of vitamin A is 200,000 UI (4 capsules) immediately after the doctor establishes the diagnosis; the next day, another dose of 200,000 UI of vitamin A will be taken, and at least 2 weeks later, a third dose of 200,000 UI (4 capsules) of vitamin A will be taken.

Oral route.

The capsules should be taken with the help of a little water or other liquid, preferably during meals.

Use in children and adolescents

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

If you take more Auxina A+E Strong than you should

If you have taken more Auxina A+E than indicated (high doses) you may experience vitamin A toxicity. Within a few hours after administration of a vitamin A overdose, symptoms such as: irritability, drowsiness, convulsions, headache, increased pressure inside the head, nausea, vomiting, diarrhea, visual disturbances, and nervous system disturbances may occur; days after the overdose, redness and peeling of the skin, 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 if you consume alcohol; you may experience: fatigue, irritability, mental disturbances, loss of appetite, digestive discomfort, mild fever, children may not gain weight normally; hair loss, skin eruptions, dryness of mucous membranes; other symptoms are liver disturbances with alteration in liver function test results and even permanent damage. Other symptoms are: disturbances in urination (urination) and in blood test results and calcifications (nodules) in tendons, muscles, and tissue under the skin.

Vitamin E in excessive doses, rarely causes nausea, diarrhea, and other intestinal disturbances and in predisposed individuals 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.

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 Strong

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 due to 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 trash.Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. In case of doubt, please ask 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 Strong Soft Capsules

• The active principles are Vitamin A (as retinol palmitate) and Vitamin E (dl-alpha-tocopheryl acetate). Each soft capsule contains 50,000 IU of vitamin A and 100 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.

Each package contains 20 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: March 2014.

Other sources of information

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