AUXINA A MASIVA 50,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Auxina A Masiva 50,000 IU Soft Capsules

Vitamin A (Retinol Palmitate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Auxina A Masiva and what is it used for
2. What you need to know before you take Auxina A Masiva
3. How to take Auxina A Masiva
4. Possible side effects
5. Storage of Auxina A Masiva
6. Contents of the pack and other information

1. What is Auxina A Masiva and what is it used for

It contains Vitamin A as the active ingredient. This vitamin has a large number of 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 IU soft capsules are indicated in:

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

Auxina A Masiva is indicated in adults and adolescents over 14 years of age.

2. What you need to know before you take Auxina A Masiva

Do not take Auxina A Masiva:

• If you are allergic to retinol (Vitamin A) or any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.

• If you have hypervitaminosis A (too much Vitamin A stored in the body).
  • Children under 14 years of age (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 can cause side effects.
  • The risk of Vitamin A toxicity may increase if you have low body weight, protein malnutrition, or excess lipoproteins or triglycerides in the blood, if you consume alcohol, or have a Vitamin C deficiency.
  • Patient with liver or kidney disease: before taking this medicine, they should consult their doctor, who will assess the possible risks and benefits, as these patients may have more side effects, especially with prolonged use.

• You may have a Vitamin A deficiency over time if you have: gastrointestinal diseases (such as chronic diarrhea), in case you suffer from a disorder characterized by abnormal storage and transport of Vitamin A, such as in a hereditary disease (abetalipoproteinemia), if you have protein deficiency, diabetes, hyperthyroidism, fever, liver disease, and cystic fibrosis with liver involvement (hereditary disease, characterized by the formation and accumulation of thick mucus mainly in the lungs and digestive system).
• Interference with laboratory tests: If you are going to undergo any diagnostic test (including blood, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results. For example, in some bilirubin and cholesterol tests.

Children and Adolescents

Auxina A Masiva is contraindicated in children under 14 years of age.

Taking Auxina A Masiva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

The following medicines may interact with Auxina A Masiva when used at the same time:

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

Medicines that affect the gastrointestinal absorption of Vitamin A:

• Colestyramine and colestipol (to reduce cholesterol levels)
• Orlistat (to reduce fat absorption)
• Laxatives, such as mineral oil or liquid paraffin

If taken together, the 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 medicine.

Auxina A Masiva 50,000 IU soft capsules are contraindicated during pregnancy, in women planning a pregnancy, and during breastfeeding.

Driving and Using Machines

No effects have been described in this regard.

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

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

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

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt, and propyl parahydroxybenzoate, sodium salt.

3. How to take Auxina A Masiva

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

The intake of Vitamin A through diet or other medicines should also be considered to avoid accumulating the dose.

The recommended dose is:

Adults and adolescents over 14 years of age:

• It is generally recommended to take 1 capsule per day.

The treatment duration should not be more than two weeks.

• In case of severe Vitamin A deficiency, the recommended dose is 2 capsules (100,000 IU of Vitamin A) per day for 3 days, followed by 1 capsule (50,000 IU of Vitamin A) per day for 2 weeks. As a maintenance dose, if necessary, 10,000-20,000 IU of Vitamin A per day are recommended for 2 months; for this, you should switch to another medicine that contains a lower dose of Vitamin A.

• In case of xerophthalmia, the recommended dose of Vitamin A is 200,000 IU (4 capsules) immediately after the doctor diagnoses it; the next day, another dose of 200,000 IU of Vitamin A will be taken, and at least 2 weeks later, a third dose of 200,000 IU (4 capsules) of Vitamin A will be taken.

Oral use.

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

Use in Children

In children under 14 years of age, this medicine is contraindicated 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), toxicity may appear; within a few hours of administration of an overdose, symptoms such as irritability, drowsiness, convulsions, headache, increased pressure inside the head, nausea, vomiting, diarrhea, visual disturbances, and other important disorders may occur; days after the overdose, redness and peeling of the skin, bleeding gums, etc. may appear.

With continuous overdoses over time (chronic), hypervitaminosis A may occur. The risk of toxicity is greater if you have kidney or liver disease, if you have low weight or malnutrition, or if you consume alcohol. You may suffer: fatigue, irritability, emotional changes, loss of appetite, digestive discomfort, mild fever; children may stop gaining weight normally; hair loss, skin rashes, and changes in skin color, dryness of mucous membranes; liver damage may also occur, with changes in liver test results and even permanent damage; other symptoms are: changes in urination and blood test results and calcifications (nodules) in tendons, muscles, and tissue under the skin.

Normally, hypervitaminosis A is reversible, and symptoms subside a few days after treatment is discontinued.

In case of overdose, treatment with this medicine should be discontinued, and symptomatic treatment should be initiated.

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 medicine and the amount ingested.

If you forget to take Auxina A Masiva

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects of Vitamin A, especially with the use of high doses and/or prolonged use (see Warnings and Precautionssection), are:

Blood coagulation disorders, headache, insomnia or drowsiness, double vision, gum inflammation, loss of appetite, nausea, vomiting, gastric discomfort, lip inflammation (cheilitis), skin rash, dryness of hair and mucous membranes, hair loss, dryness, and changes in skin color, photosensitivity reactions (skin rash due to sun exposure), osteoporosis (loss of bone mass), appearance of nodules (calcifications) in tendons, muscles, and tissue under the skin, bone or muscle pain, liver disorders, emotional changes.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Auxina A Masiva

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

Store in the original package to protect it from moisture.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Other Information

Auxina A Masiva Composition

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

Appearance of the Product and Contents of the Pack

Auxina A Masiva is presented in soft, elastic, spherical capsules containing a clear, yellow, oily solution with a characteristic odor.

Each package contains 10 or 20 soft capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d'Europa 41-43, 10th floor

08908 - L'Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

LABORATORIOS ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares

Madrid (Spain)

Date of the Last Revision of this Leaflet: October 2013.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.