Auxina A+E Fuerte soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Auxina A+E Fuerte soft capsules

Vitamin A (retinol palmitate) / vitamin E (dl-alpha-tocopheryl acetate)

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Auxina A+E Fuerte capsules are and what they are used for
2. What you need to know before taking Auxina A+E Fuerte capsules
3. How to take Auxina A+E Fuerte capsules
4. Possible side effects
5. How to store Auxina A+E Fuerte capsules
6. Contents of the pack and other information

1. What Auxina A+E Fuerte capsules is and what it is used for

Contains the fat-soluble vitamins A and E.

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

The best-known function of vitamin E is its ability to act as an antioxidant of fats, preventing the spread of free radical reactions.

Auxina A+E Fuerte is indicated for:

• Treatment of marked deficiency of vitamins A and E.
• Xerophthalmia (an eye disease characterized by dryness and opacity of the two outer layers of the eye).

Auxina A+E Fuerte is indicated for adults and patients over 14 years of age.

2. What you need to know before taking Auxina A+E Fuerte capsules

Do not take Auxina A+E Fuerte:

• If you are allergic to vitamin A, vitamin E, or any of the other ingredients 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 its dosage).

Warnings and precautions

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

• You must not take doses higher than those recommended.
• If you take high doses of fat-soluble vitamins such as A or E, especially vitamin A over a prolonged period, they may accumulate in your body and cause side effects associated with hypervitaminosis and lead to toxicity.
• Patients with liver or kidney disease: before taking this medicine, consult your doctor, who will assess the potential risks and benefits, as these patients may experience 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, excess protein in the blood (hyperlipoproteinemia), elevated blood triglycerides (hypertriglyceridemia), if you consume alcohol, or have vitamin C deficiency.
• If you have thrombophlebitis or are at risk of developing it (formation of a blood clot in the circulatory system), or suffer from coagulation disorders due to vitamin K deficiency, or are being treated with anticoagulant medicines, see the risk of vitamin E overdose (in the section If you take more Auxina A+E Fuerte than you should and the section Taking Auxina A+E Fuerte with other medicines).
• You may develop vitamin A deficiency over time if you have gastrointestinal diseases (such as chronic diarrhea), or suffer from a disorder characterized by abnormal storage and transport of the vitamin, such as in an inherited disease (abetalipoproteinemia), if you have protein deficiency, diabetes, hyperthyroidism, fever, liver diseases, or cystic fibrosis with liver involvement (an inherited disease characterized by the formation and accumulation of thick mucus, mainly in the lungs and digestive system).
• If you have impaired fat absorption, you may develop vitamin E deficiency and require supplementation.
• Interference with laboratory tests: If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results. For example, in certain tests for bilirubin and cholesterol determination.

Children and adolescents

Auxina A+E Fuerte is contraindicated in children under 14 years of age.

Taking Auxina A+E Fuerte with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with Auxina A+E Fuerte when used simultaneously:

• Medicines that are analogs of vitamin A, such as retinoids, used for skin conditions like isotretinoin and acitretin, or to treat certain types of cancer, such as tretinoin and bexarotene.
• Oral anticoagulant medicines, 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 (to treat infections), such as minocycline and tetracycline.
• Oral contraceptives.
• Iron supplements.

Medicines that affect gastrointestinal absorption of vitamins A and E:

• Cholestyramine and colestipol (to reduce cholesterol levels).
• Orlistat (to reduce fat absorption).
• Mineral oil or liquid paraffin (used to aid intestinal evacuation).

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

Taking Auxina A+E Fuerte with alcohol

Excessive alcohol intake reduces the absorption of vitamins.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Auxina A+E Fuerte is contraindicated during pregnancy, in women planning pregnancy, and during breastfeeding.

Driving and using machines

Effects of this kind are not expected.

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

This medicine may cause headache, stomach discomfort, and diarrhea due to glycerol.

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

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Auxina A+E Fuerte capsules

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

Recommended dose:

Adults and patients over 14 years of age:

You should consider your dietary intake of vitamin A as well to avoid excessive accumulation of the vitamin.

• The usual recommended dose is 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 therapy, if necessary, patients should switch to another medicine with a lower dose, such as Auxina A+E soft capsules (containing 5,000 IU of vitamin A and 10 mg of vitamin E); a daily intake of 10,000–20,000 IU of vitamin A is recommended for 2 months.
• In cases of xerophthalmia, the recommended dose of vitamin A is 200,000 IU (4 capsules) immediately after diagnosis by the physician; a second dose of 200,000 IU of vitamin A should be taken the following day, and at least 2 weeks later, a third dose of 200,000 IU (4 capsules) of vitamin A should be administered.

Route of administration: Oral.

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

Use in children and adolescents

This medicine must not be used in children under 14 years of age due to its dosage.

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

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

With prolonged (chronic) vitamin A overdose, hypervitaminosis A may occur. The risk of toxicity is higher if you have kidney or liver disease, low body weight, malnutrition, or consume alcohol. Symptoms may include: fatigue, irritability, psychiatric disturbances, loss of appetite, gastrointestinal discomfort, mild fever; children may stop gaining weight normally; hair loss, skin rashes, dryness of mucous membranes. Other symptoms include liver abnormalities with altered liver function test results and even permanent liver damage. Additional symptoms may include urinary disturbances, abnormalities in blood test counts, and calcifications (nodules) in tendons, muscles, and subcutaneous tissue.

Excessive doses of vitamin E rarely cause nausea, diarrhea, and other intestinal disorders; in predisposed individuals, it may cause thrombophlebitis and worsen coagulation disorders. It may also lead to gonadal dysfunction (sex glands), breast tenderness, increased cholesterol and triglycerides, and reduced thyroid hormone levels in blood.

Hypervitaminosis A is usually reversible, and symptoms improve within a few days after stopping treatment. Symptoms due to excessive vitamin E doses generally disappear after discontinuation of treatment.

In case of overdose or accidental ingestion, contact 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+E Fuerte

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

If you have any further 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.

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

Blood coagulation disorders, headache, insomnia or drowsiness, double vision, gum inflammation, 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 due to sun exposure), osteoporosis (loss of bone mass), appearance of nodules (calcifications) in tendons, muscles, and subcutaneous tissue, bone or muscle pain, liver disorders, and 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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

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

5. Storage of Auxina A+E Fuerte capsules

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

Store in the outer packaging to protect from light.

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

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

6. Contents of the pack and other information

Composition of Auxina A+E Fuerte soft capsules

• The active substances 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, methylparaben (E-218), propylparaben (E-216), and sunset yellow FCF (E-110).

Appearance of the product and contents of the pack

It is presented as soft gelatin capsules, round, transparent orange, unmarked, containing a yellow oily solution.

Each pack contains 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)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this leaflet: March 2014

Other sources of information

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