AUXINA E-50 IU SOFT GEL CAPSULES
How to use AUXINA E-50 IU SOFT GEL CAPSULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Auxina E 50 UI Soft Capsules
Vitamin E (dl-alpha tocopheryl acetate)
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication 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 side effects not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Auxina E 50 and what is it used for
- What you need to know before taking Auxina E 50
- How to take Auxina E 50
- Possible side effects
- Storage of Auxina E 50
- Package Contents and Additional Information
1. What is Auxina E 50 and what is it used for
It contains vitamin E (liposoluble). The most well-known function of vitamin E is its ability to act as an antioxidant for fats. It prevents the oxidation of essential cellular elements and/or prevents the formation of toxic oxidation products.
Auxina E 50 is indicated in:
- Prevention and treatment of vitamin E deficiency; in diseases with malabsorption syndrome (difficulty absorbing nutrients) that present with steatorrhea (excessive fat in feces), such as total or partial surgical removal of the gastrointestinal tract and celiac disease (gluten intolerance).
- Cystic fibrosis (hereditary disease characterized by the formation and accumulation of thick mucus affecting primarily the lungs, intestines, pancreas, and liver).
- Disease of the hepato-biliary tract (such as bile retention, obstruction of the bile ducts).
- Abetalipoproteinemia (genetic disease that causes inability to digest fats).
2. What you need to know before taking Auxina E 50
Do not take Auxina E 50
- If you are allergic to vitamin E or any of the other components of this medication (listed in section 6).
- If you have any blood coagulation disorder, see the following section and "Taking Auxina E 50 with other medications"
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Auxina E 50.
- Do not take higher doses than recommended.
- If you are at risk of developing thrombophlebitis (swelling of a vein caused by a blood clot), high doses of vitamin E may increase your risk, including women taking estrogen-containing contraceptives (female sex hormones).
- If you have vitamin K deficiency (vitamin involved in blood coagulation), high doses of vitamin E may increase coagulation defects.
Children and Adolescents
This medication can be administered to children. However, the pharmaceutical form may not be suitable for young children, as they may have difficulty swallowing it.
Taking Auxina E 50 with other medications
Tell 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 E 50 when used at the same time:
- Oral anticoagulants (medications to make blood more fluid), such as acenocoumarol, warfarin, dicumarol, as vitamin E increases their effect.
- Tocoferol (a form of vitamin E), which may increase the effect of this medication.
- Estrogens, including oral contraceptives.
Medications that affect gastrointestinal absorption of vitamin E:
- Colestyramine and colestipol (to reduce cholesterol levels)
- Orlistat (to reduce fat absorption)
- Mineral oil or liquid paraffin (to aid in bowel evacuation)
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 plan to become pregnant, consult your doctor before using this medication.
As a precaution, do not take Auxina E 50 during pregnancy.
There is no information on the excretion of vitamin E in breast milk, so this medication may have some effect on the newborn/child.
This medication should not be used during breastfeeding.
Driving and Using Machines
The influence of Auxina E 50 on the ability to drive and use machines is nil.
Auxina E 50 contains methyl parahydroxybenzoate (sodium salt) (E-219), propyl parahydroxybenzoate (sodium salt) (E-217), and Red Ponceau 4R colorant (E-124)
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medication may cause allergic reactions because it contains Red Ponceau 4R colorant.
It may trigger asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Auxina E 50
Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Auxina E 50 is taken orally. The recommended dose is:
Adults and children over 10 years:
- Vitamin E deficiency: 1 capsule per day (50 UI of dl-alpha tocopheryl acetate). In certain cases, the doctor may indicate taking 2 or 3 capsules (100-150 UI) per day, or up to a maximum of 6 capsules (300 UI or mg) per day.
- Malabsorption syndromes: generally, 4 to 8 capsules (200-400 UI) per day are recommended, or 15-25 mg per kg of body weight per day.
- Cystic fibrosis: between 100 and 400 UI of vitamin E (2-8 capsules) per day.
- Hepato-biliary tract disease: the dose that supplements the vitamin E deficiency will be administered. In chronic cholestasis, 50-400 UI per day (1-8 capsules) are recommended.
- Abetalipoproteinemia: 50-300 UI (1-6 capsules) per kg of body weight per day are recommended.
The capsules should be swallowed whole with a little water or other liquid, during or after meals.
Use in Children
Auxina E 50 soft capsules can be administered to children. However, the pharmaceutical form of this medication may not be suitable for young children, as they may have difficulty swallowing them.
If you take more Auxina E 50 than you should
Vitamin E in excessive doses (generally doses over 300 mg) may cause nausea, diarrhea, and other digestive disorders, and in predisposed individuals, may produce thrombophlebitis and worsen coagulation problems; it may also cause malfunction of the gonads (sex glands), breast pain, increased cholesterol and triglycerides, and reduced thyroid hormones in the blood.
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, Tel.: 91 5620420, indicating the medication and the amount ingested.
If you forget to take Auxina E 50
Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
Among these side effects, whose frequency is not exactly known, are:
Digestive disorders (in prolonged treatment and with high doses), such as diarrhea, nausea, gastric discomfort, intestinal cramps, gum bleeding.
Circulatory disorders, more likely in predisposed patients, such as thrombophlebitis (swelling of a vein caused by a blood clot) and tendency to bleed (in prolonged treatment and with high doses).
In prolonged treatment and with high doses, fatigue, weakness, dizziness, headache; some cases of cerebral infarction have been reported.
Rarely, emotional changes, fatigue.
Blurred vision, in prolonged treatment and with high doses.
Breast pain, alteration in the functioning of the gonads (sex glands).
Changes in clinical analysis results, such as creatine, creatine kinase, sex hormones, and thyroid hormones.
Reporting Side Effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the national reporting system, Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Auxina E 50
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Auxina E 50
- The active ingredient is dl-alpha tocopheryl acetate (vitamin E). Each capsule contains 50 mg of dl-alpha tocopheryl acetate (equivalent to 50 UI of vitamin E).
- The other components (excipients) are: olive oil, gelatin, glycerol (E-422), purified water, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), Red Ponceau 4R colorant (E-124).
Appearance of the Product and Package Contents
Auxina E 50 are soft gelatin capsules, round, transparent red with yellowish oily solution.
It is presented in packages of 20 and 60 capsules.
- Other presentations:
Auxina E 200 UI
Auxina E 400 UI
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 (Spain)
Tel 934948000
Manufacturer
Laboratorios Alcalá Farma S.L.
Avenida de Madrid, 82
28802 - Alcalá de Henares
Madrid
Date of the Last Revision of this Package Leaflet: March 2014.
Other Sources of Information
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Average pharmacy price2.37 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to AUXINA E-50 IU SOFT GEL CAPSULESDosage form: CAPSULE, 2000 mgActive substance: tocopherol (vit E)Manufacturer: Chiesi España S.A.U.Prescription requiredDosage form: CAPSULE, 400 mgActive substance: tocopherol (vit E)Manufacturer: Chiesi España S.A.U.Prescription requiredDosage form: TABLET, 300 mg pyridoxine hydrochlorideActive substance: pyridoxine (vit B6)Manufacturer: Teofarma S.R.L.Prescription not required
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