Auxina A Masiva 50,000 IU soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Auxina A Masiva 50,000 IU soft capsules

Vitamin A (retinol palmitate)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Contains Vitamin A as the active substance. This vitamin has a wide range of important functions in the body; it plays a fundamental role in vision, is essential for the integrity of the skin, bone development, and the body's immune defenses.

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

• Significant Vitamin A deficiency. Symptoms of deficiency include, among others, disturbances in vision, skin, and mucous membranes.
• Xerophthalmia (an eye disease characterized by dryness and opacity of the two superficial layers of the eye).

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

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

Do not take Auxina A Masiva:

• If you are allergic to retinol (vitamin A) or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have hypervitaminosis A (excess vitamin A stored in the body).
• Children under 14 years of age (due to the dosage).

Warnings and precautions

Consult your doctor before starting to take Auxina A Masiva.

• Do not take high doses continuously, as hypervitaminosis A may cause adverse effects.

  • The risk of vitamin A toxicity may increase if you have low body weight, protein malnutrition, excess lipoproteins or triglycerides in the blood, if you consume alcohol, or if you have vitamin C deficiency.
  • Patients with liver or kidney disease: consult your doctor before taking this medicine, as they will assess the potential risks and benefits, since these patients may experience 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 disorder characterized by abnormal storage and transport of the vitamin, such as in an inherited disease (abetalipoproteinemia), protein deficiency, diabetes, hyperthyroidism, fever, liver diseases, or cystic fibrosis with hepatic involvement (an inherited disease characterized by the formation and accumulation of thick mucus, mainly in the lungs and digestive system).

Interference with diagnostic tests: If you are scheduled to undergo any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results. For example, in certain tests measuring bilirubin and cholesterol.

Children and adolescents

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

Taking Auxina A Masiva with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The following medicines may interact with Auxina A Masiva when used simultaneously:

• Medicines that are analogues of vitamin A, such as retinoids used for skin conditions (e.g., isotretinoin, acitretin) or to treat certain types of cancer (e.g., tretinoin, bexarotene).
• Oral anticoagulants such as acenocoumarol, warfarin, dicoumarol, and injectable anticoagulants such as heparin, abciximab, human antithrombin III, and fondaparinux (medicines for blood circulation).
• Antiplatelet agents such as clopidogrel, eptifibatide, tirofiban (medicines for blood circulation).
• Antibiotics (for treating infections), such as minocycline and tetracycline.
• Oral contraceptives.

Medicines affecting gastrointestinal absorption of Vitamin A:

• Cholestyramine and colestipol (used to reduce cholesterol levels).
• Orlistat (used 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, think you may be pregnant, or are planning 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 pregnancy, and during breastfeeding.

Driving and use of machines

No effects of this nature have been reported.

Auxina A Masiva contains methylparahydroxybenzoate sodium salt (E-219), propylparahydroxybenzoate sodium salt (E-217), and Ponceau 4R (E-124).

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

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

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

3. How to take Auxina A Masiva

Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor again.

Your intake of vitamin A through diet or other medications should also be considered to avoid excessive accumulation of the dose.

The recommended dose is:

Adults and adolescents over 14 years of age:

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

The duration of treatment should generally not exceed two weeks.

• In cases 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 maintenance dose, if necessary, 10,000–20,000 IU of vitamin A per day for 2 months is recommended; for this, you must switch to another medication containing a lower dose of vitamin A.

• In cases of xerophthalmia, the recommended dose of vitamin A is 200,000 IU (4 capsules) immediately after diagnosis by your doctor; the following day, another dose of 200,000 IU of vitamin A should be taken, and at least 2 weeks later, a third dose of 200,000 IU (4 capsules) of vitamin A.

Oral use.

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

Use in children

This medicine is contraindicated in patients under 14 years of age due to its dosage.

If you take more Auxina A Masiva than you should

If you have taken more Auxina A Masiva than indicated (high doses), toxicity may occur. Within a few hours of an overdose, symptoms such as irritability, drowsiness, seizures, headache, increased pressure inside the head, nausea, vomiting, diarrhea, visual disturbances, and other serious disorders may appear. Days after the overdose, redness and peeling of the skin, bleeding gums, etc., may develop.

Repeated or prolonged (chronic) overdosing may lead to hypervitaminosis A. The risk of toxicity is higher if you have kidney or liver disease, low body weight, malnutrition, or consume alcohol. You may experience: fatigue, irritability, psychological disturbances, loss of appetite, gastrointestinal discomfort, mild fever; children may stop gaining weight normally; hair loss, skin rashes, and changes in skin color, dryness of mucous membranes; liver involvement may also occur, with abnormal liver function test results and even permanent liver damage; other symptoms include: urinary disturbances, abnormalities in blood test counts, and calcifications (nodules) in tendons, muscles, and subcutaneous tissue.

Normally, hypervitaminosis A is reversible, and symptoms resolve within a few days after stopping treatment.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Possible adverse effects of Vitamin A, especially with the use of high doses and/or prolonged use (see section Warnings and precautions), include:

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

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

5. Storage of Auxina A Masiva

Keep this medicine out of sight and reach of children.

Store in the original container to protect it from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Auxina A Masiva

• The active substance is Vitamin A (as retinol palmitate). Each capsule contains 50,000 IU of Vitamin A.
• The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, sodium methylparahydroxybenzoate, sodium propylparahydroxybenzoate and Ponceau 4R (E-124).

Appearance of the product and contents of the pack

Auxina A Masiva is presented as soft, spherical capsules with an elastic consistency, containing a transparent yellow oily solution with a characteristic odour.

Each pack contains 10 or 20 soft capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d'Europa 41-43, Planta 10

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 most recent revision of this leaflet: October 2013.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.