AUXINA A+E SOFT GEL CAPSULES

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

Do not take Auxina A+E:

• If you are allergic to vitamin A, vitamin E, or any of the other components of this medication (included 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 or pharmacist before starting to take Auxina A+E.

• Do not take higher doses than recommended.
• If you take high doses of liposoluble vitamins such as A or E, especially A continuously, they can accumulate in your body and cause side effects associated with hypervitaminosis and produce toxicity.
• Patient with liver or kidney disease: before taking this medication, they must consult their doctor, who will assess the possible risks and benefits, as these patients may have more adverse effects due to vitamin A, especially with prolonged use.
• The risk of toxicity from vitamin A 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 suffering from 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 overdose of vitamin E in the section If you take more Auxina A+E than you shouldand the section Taking Auxina A+E with other medications.
• 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 medication, as it may alter the results. For example, in some bilirubin and cholesterol determination tests.

Children and adolescents

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

Taking Auxina A+E with other medications

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

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

• Medications similar to vitamin A, such as retinoids, used for the skin, such as 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, human antithrombin III, and fondaparinux (medications for blood circulation)
• Antiplatelet agents, such as clopidogrel, eptifibatide, and tirofiban (medications for blood circulation)
• Antibiotics (to treat infections), such as minocycline and tetracycline
• Oral contraceptives
• Iron supplements

Medications 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 with alcohol

Excessive alcohol consumption decreases the absorption of vitamins.

Pregnancy, breastfeeding, and fertility

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

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

This medication 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 medication 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 capsules

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 14 years of age:

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

It is recommended to take 1 capsule per day. In some cases, your doctor may indicate taking 2 or up to 3 capsules per day.

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

In general, the treatment should not exceed two weeks, but at the discretion of your doctor, it may be extended for a longer period.

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 of age should not take this medication due to their doses.

If you take more Auxina A+E than you should

If you have taken more Auxina A+E than recommended in this prospectus or by your doctor (high doses), you may experience toxicity from vitamin A. 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 desquamation of the skin, bleeding gums, etc. may appear.

With continuous overdoses over time (chronic) of vitamin A, hypervitaminosis A can 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 alterations, loss of appetite, digestive discomfort, mild fever, children may stop gaining weight normally; hair loss, skin eruptions, dryness of mucous membranes; other symptoms are alterations in the liver with alterations in liver test results and even permanent liver damage. Other symptoms are: alterations in urination (urinating) and in blood test counts 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 discontinued. The symptoms of excessive doses of vitamin E usually disappear after treatment is discontinued.

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 medication and the amount ingested.

If you forget to take Auxina A+E

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people 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, lip inflammation (cheilitis), skin eruption, dryness of hair and mucous membranes, hair loss, dryness, and changes in skin color, photosensitivity reactions (skin eruption 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Auxina A+E capsules

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

Store in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Auxina A+E soft capsules

• The active ingredients 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, 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 yellow oily solution.

The package contents are 20 or 30 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 prospectus: November 2013.

Other sources of information

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