AUXINA A+E FORTE SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Auxina A+E Strong Soft Capsules

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

Read this entire leaflet carefully before starting to take 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 to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Auxina A+E Strong and what is it used for
2. What you need to know before taking Auxina A+E Strong
3. How to take Auxina A+E Strong
4. Possible side effects
5. Storage of Auxina A+E Strong
6. Package Contents and Additional Information

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

It contains the fat-soluble vitamins A and E.

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

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

Auxina A+E Strong is indicated in:

• Treatment of marked deficiency of vitamins A and E.
• Xeroftalmia (eye disease, with dryness and opacity of the two superficial layers of the eyes).

Auxina A+E Strong is indicated for adults and patients over 14 years old.

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

Do not take Auxina A+E Strong:

• If you are allergic to vitamin A, vitamin E, 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 old (due to their doses).

Warnings and Precautions

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

• Do not take higher doses than recommended.
• If you take high doses of fat-soluble vitamins such as A or E, especially A continuously, they can accumulate in your body and cause side effects associated with hypervitaminosis and toxicity.
• 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 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, or excess protein in the blood (hyperlipoproteinemia), increased triglycerides in the blood (hypertriglyceridemia), if you consume alcohol, or have a vitamin C deficiency.
• If you have thrombophlebitis or are at risk of developing it (formation of a thrombus in the circulatory system) or suffer from coagulation disorders with vitamin K deficiency, or are being treated with anticoagulant medications, see the risk of vitamin E overdose (in the section If you take more Auxina A+E Strong than you shouldand the section Taking Auxina A+E Strong with other medicines).
• 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, such as in a hereditary disease (abetalipoproteinemia), if you have a lack of protein, 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).
• If you have altered fat absorption, you may have a vitamin E deficiency and need supplementation.
• Interference with analytical tests: If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results. For example, in some tests for determining bilirubin and cholesterol.

Children and Adolescents

Auxina A+E Strong is contraindicated in children under 14 years old.

Taking Auxina A+E Strong with other medicines

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

The following medicines may interact with Auxina A+E Strong when used at the same time:

• Medicines similar to vitamin A, such as retinoids, used for the skin like isotretinoin and acitretin, or to treat certain types of cancer, such as tretinoin and bexarotene
• Oral anticoagulant medications, 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

• Iron supplements.

Medicines that affect the gastrointestinal absorption of Vitamins A and E:

• Colestyramine and colestipol (to reduce cholesterol levels)
• Orlistat (to reduce fat absorption)
• Mineral oil or liquid paraffin (helps with bowel evacuation)

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

Taking Auxina A+E Strong with alcohol

Excessive alcohol consumption decreases the absorption of vitamins.

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+E Strong is contraindicated during pregnancy, in women planning a pregnancy, and during breastfeeding.

Driving and Using Machines

No effects are expected in this regard.

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

This medicine may cause headache, stomach upset, and diarrhea because it contains glycerol.

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

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

3. How to take Auxina A+E Strong capsules

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

The recommended dose is:

Adults and patients over 14 years old:

You should consider your intake of vitamin A also through your diet to avoid accumulating the dose.

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

The treatment duration should not be longer than two weeks.

• In case of severe vitamin A deficiency, it is recommended to take 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, the patient should switch to another medicine like Auxina A+E capsules, with a lower dose (contains 5,000 IU of vitamin A and 10 mg of vitamin E); 10,000-20,000 IU of vitamin A per day are recommended for 2 months.
• In case of xeroftalmia, the recommended dose of vitamin A is 200,000 IU (4 capsules) immediately after the doctor establishes the diagnosis; 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 route.

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

Use in Children and Adolescents

Children under 14 years old should not take this medicine due to their doses.

If you take more Auxina A+E Strong 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 administration of a vitamin A overdose, symptoms such as irritability, drowsiness, convulsions, headache, increased pressure inside the head, nausea, vomiting, diarrhea, visual disturbances, and nervous system disorders may occur; days after the overdose, redness and peeling of the skin, bleeding gums, etc. may appear.

With continued overdoses over time (chronic) of vitamin A, 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, psychological changes, loss of appetite, digestive discomfort, mild fever, children may stop gaining weight normally; hair loss, skin rashes, dryness of mucous membranes; other symptoms are changes in liver function 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.

Vitamin E in excessive doses rarely causes nausea, diarrhea, and other intestinal disorders, and in predisposed individuals, it can cause thrombophlebitis and worsen coagulation problems; it can also cause malfunction of the gonads (sex glands), breast pain, increased cholesterol and triglycerides, and reduced thyroid hormones in the blood.

Normally, hypervitaminosis A is reversible, and symptoms improve a few days after treatment is stopped. The symptoms of excessive vitamin E doses usually disappear after treatment is stopped.

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+E Strong

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

If you have any other 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 everyone gets them.

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

Blood coagulation disorders, headache, insomnia or drowsiness, double vision, gum inflammation, loss of appetite, nausea, vomiting, stomach 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, and emotional changes.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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+E Strong capsules

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

Store in the outer packaging to protect it from light.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Auxina A+E Strong soft capsules

• The active ingredients 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 ingredients (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and orange yellow S (E-110).

Appearance of the Product and Package Contents

It is presented in the form of soft gelatin capsules, round, transparent orange, unmarked, containing a yellow oily solution.

Each package contains 20 soft capsules.

Marketing Authorization Holder and Manufacturer

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 Last Revision of this Leaflet: March 2014.

Other Sources of Information

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