Label: information for the user

Auxina A Massive 50,000 UI soft capsules

Vitamin A (retinol palmitate)

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 to 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 A as the active ingredient. This vitamin has numerous important functions in the body; it plays a fundamental role in vision, is essential for skin integrity, bone development, and the body's defenses.

Auxina A Masiva 50,000 UI soft capsules is indicated for:

• Significant Vitamin A deficiency. Symptoms of deficiency include, among others, vision disorders, skin disorders, and mucous membrane disorders.
• Xeroftalmia (eye disease, with dryness and opacity of two superficial layers of the eyes).

Auxina A Masiva is indicated for adults and adolescents 14 years of age and older.

Do not take Auxina A Masiva:

• If you are allergic to retinol (vitamin A)or to 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 Masiva.

- Do not take high doses continuously, as hypervitaminosis A may cause side effects.

• The risk of vitamin A toxicity may increase if you have low body weight, protein malnutrition, or excessive lipoproteins or triglycerides in the blood, if you consume alcohol, or have vitamin C deficiency.
• Patients with liver or kidney disease: before taking this medication, consult your doctor to evaluate the possible risks and benefits, as these patients may have more adverse effects, especially with prolonged use.

- You may develop vitamin A deficiency over time if you have: gastrointestinal diseases (such as chronic diarrhea), a condition characterized by abnormal storage and transport of the vitamin, such as a genetic disorder (abetalipoproteinemia), protein deficiency, diabetes, hyperthyroidism, fever, liver diseases, and cystic fibrosis with liver involvement (a genetic disorder characterized by the formation and accumulation of thick mucus mainly in the lungs and digestive system).

- Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood and urine analysis, etc...) inform your doctor that you are taking this medication, as it may alter the results. For example, in some tests for bilirubin and cholesterol determination.

Children and adolescents

Auxina A Masivais contraindicatedin children under 14 years old.

Taking Auxina AMasiva 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 Masiva when used at the same time:

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

Medications that affect the gastrointestinal absorption of Vitamin A:

- Colestiramine and cholestyramine (to reduce cholesterol levels)

- Orlistat (to reduce fat absorption)

- Laxatives such as mineral oil or liquid paraffin

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

Pregnancy, breastfeeding, and fertility

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

Auxina A Masiva 50,000 UI soft capsules is contraindicated during pregnancy, in women planning pregnancy, and during lactation.

Driving and operating machinery

No effects have been described.

Auxina A Masiva contains parahydroxybenzoic acid methyl ester, sodium salt (E-219), parahydroxybenzoic acid propyl ester, sodium salt (E-217), and Red Ponceau 4 R (E-124)

This medication may cause allergic reactions because it contains Red Ponceau 4R (E-124).

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

It may cause delayed allergic reactions because it contains parahydroxybenzoic acid methyl ester sodium salt and parahydroxybenzoic acid propyl ester sodium salt.

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

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

The recommended dose is:

Adults and adolescents over 14 years:

- Generally, it is recommended to take 1 capsule per day.

The treatment duration should not exceed two weeks in general.

- In case of severe vitamin A deficiency, it is recommended to take 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 a maintenance dose, if necessary, it is recommended to take between 10,000-20,000 UI of vitamin A per day for 2 months; for this, you should switch to another medication containing lower doses of vitamin A.

- In case of xeroftalmia, the recommended dose of vitamin A is 200,000 UI (4 capsules) immediately after the doctor diagnoses it; the next day, take another dose of 200,000 UI of vitamin A, and at least 2 weeks later, take a third dose of 200,000 UI (4 capsules) of vitamin A.

Oral route.

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

Use in children

This medication is contraindicated in children under 14 years due to its doses.

If you take more Auxina A Masiva than you should

If you have taken more Auxina A Masiva than indicated (high doses), you may experience toxicity; within a few hours of administering an overdose, symptoms such as irritability, drowsiness, seizures, headache, increased intracranial pressure, nausea, vomiting, diarrhea, visual disturbances, and other important disturbances may occur; days after the overdose, you may experience skin redness and peeling, bleeding gums, etc.

With chronic overdoses, you may experience hypervitaminosis A. 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, psychological alterations, loss of appetite, digestive discomfort, mild fever; children may fail to gain weight normally; hair loss, skin eruptions, and changes in skin color, mucous dryness; liver damage may also occur, with alterations in liver function test results and even permanent damage; other symptoms include: urinary and blood count alterations, and calcifications (nodules) in tendons, muscles, and subcutaneous tissue.

Normally, hypervitaminosis A is reversible, and symptoms resolve within a few days of discontinuing treatment.

In case of overdose, discontinue treatment with this medication and initiate symptomatic treatment.

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 Masiva

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 of Vitamin A, especially with the use of large doses and/or prolonged use (see sectionWarnings and Precautions), are:

Bleeding disorders, headaches, 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, 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 original packaging to protect it from moisture.

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. 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 A Masiva

• The active principle is Vitamin A (as retinol palmitate). Each capsule contains 50,000 UI of Vitamin A.
• The other components (excipients) are:olive oil, gelatin, glycerol (E-422), purified water, methyl parahydroxybenzoate sodium salt, propyl parahydroxybenzoate sodium salt, andRed 4R (E-124).

Appearance of the product and contents of the packaging

Auxina A Masivais presented in soft, spherical gelatin capsules, with an elastic consistency, containing a yellow transparent oily solution with a characteristic odor.

Each package contains 10 or 20 soft capsules.

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)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares

Madrid (Spain)

Last review date ofthis leaflet: October 2013.

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.