Auxina A+E soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Auxina A+E soft capsules

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

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 10 days.

Contents of the leaflet

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

1. What Auxina A+E capsules are and what they are used for

Contains the fat-soluble vitamins A and E.

Vitamin A acts on a wide range of 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 for fats, preventing the spread of free radical reactions.

Auxina A+E capsules are indicated for:

Treatment of deficiencies of vitamins A and E caused by inadequate diet, convalescence, or other reasons; to support general health, including vision, skin, mucous membranes, and immune defenses.

Auxina A+E capsules are indicated for adults and children over 14 years of age.

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

Do not take Auxina A+E:

• 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 the dosage).

Warnings and precautions

Talk to your doctor or pharmacist before taking Auxina A+E.

• Do 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, leading to toxicity.
• Patients with liver or kidney disease: you should consult your doctor before taking this medicine, as your doctor will assess the potential risks and benefits. These patients may experience more adverse effects from vitamin A, especially with long-term 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), 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 sections If you take more Auxina A+E than you should and Taking Auxina A+E with other medicines.
• You may develop vitamin A deficiency over time if you have gastrointestinal diseases (such as chronic diarrhea), disorders characterized by abnormal storage and transport of the vitamin, such as in an inherited condition (abetalipoproteinemia), protein deficiency, diabetes, hyperthyroidism, fever, liver diseases, or cystic fibrosis with liver involvement (an inherited disease characterized by the production and accumulation of thick mucus, primarily 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 test results. For example, in certain tests measuring bilirubin and cholesterol levels.

Children and adolescents

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

Taking Auxina A+E with other medicines

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

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

• Vitamin A analogues such as retinoids used for skin conditions, such as isotretinoin and acitretin, or for treating certain types of cancer, such as tretinoin and 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.
• Iron supplements.

Medicines affecting gastrointestinal absorption of vitamins A and E:

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

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

Taking Auxina A+E with alcohol

Excessive alcohol intake reduces vitamin absorption.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

No effects of concern are expected in this regard.

Auxina A+E contains glycerol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and sunset yellow FCF (E-110).

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

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

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

3. How to take Auxina A+E capsules

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and children over 14 years of age:

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

The recommended dose is 1 capsule per day. In some cases, your doctor may advise taking 2 or even up to 3 capsules per day.

If symptoms worsen or do not improve after 10 days of treatment, you must consult your doctor.

In general, treatment should not exceed two weeks, but your doctor may decide to extend it for a longer period.

Route of administration:

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

Use in children and adolescents

Children under 14 years of age must not take this medicine due to its dosage.

If you take more Auxina A+E than you should

If you have taken more Auxina A+E than recommended in this leaflet or by your doctor (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 overdosage, 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, and in children, failure to gain weight normally; hair loss, skin rashes, and 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, changes 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 disturbances. In predisposed individuals, it may cause thrombophlebitis and worsen coagulation disorders. It may also lead to impaired gonadal (sex gland) function, breast tenderness, increased cholesterol and triglycerides, and reduced thyroid hormone levels in the blood.

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

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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Auxina A+E

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.

Possible adverse effects, mainly due to vitamin A, especially when used in high doses and/or over a prolonged period, include:

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), development 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 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+E 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 which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Auxina A+E soft capsules

• The active substances are Vitamin A (as retinol palmitate) and Vitamin E (dl-alpha-tocopheryl acetate). Each soft capsule contains 5,000 IU of vitamin A and 10 mg of vitamin E.
• The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), and orange yellow S (E-110).

Appearance of the product and contents of the pack

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

Pack contents: 20 or 30 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)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this leaflet: November 2013.

Other sources of information

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