Prescribing Information

Evion® 200, Evion® 400 and Evion® 600
VITAMIN E CAPSULES USP 200 mg / 400 mg / 600 mg

Composition

Vitamin E Capsules 200 mg	Vitamin E Capsules 400 mg	Vitamin E Capsules 600 mg
Each soft gelatin capsule contains: Tocopheryl Acetate IP - 200 mg equivalent to alpha tocopherol -91 mg Colours in capsule shell: Sunset Yellow FCF, Ponceau 4 R Preservatives in capsule shell: Methylparaben IP and Propylparaben IP	Each soft gelatin capsule contains: Tocopheryl Acetate IP - 400 mg equivalent to alpha tocopherol -182 mg Colours in capsule shell: Tartrazine, Brilliant Blue FCF. Preservatives in capsule shell: Methylparaben IP and Propylparaben IP	Each soft gelatin capsule contains: Tocopheryl Acetate IP - 600 mg equivalent to alpha tocopherol - 273 mg Preservatives in capsule shell: Methylparaben IP and Propylparaben IP
Excipient: Arachis Oil IP	Excipient: Arachis Oil IP	Excipient: Arachis Oil IP

Read all of this leaflet carefully before you start using Evion because it contains important information for you.

• Ask your doctor if you need more information or advice. Usage in/for certain conditions may need doctor’s consultation and advice – if not sure about usage, please consult doctor.
• If you experience any side effects, talk to your doctor. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What is Evion and what is it used for?
What you need to know before you take Evion
How to take Evion?
Possible side effects
How to store Evion capsules?
Contents of the pack and other information

Evion capsule contains tocopheryl acetate (all-rac-α-tocopheryl acetate) i.e. Vitamin E as an active ingredient.

Vitamin E is a fat-soluble nutrient found in many foods. In the body it acts as an antioxidant, helping to protect cells from the damage caused by free radicals.

Free radicals are compounds formed when our bodies convert the food we eat into energy. People are also exposed to free radicals in the environment from cigarette smoke, air pollution, and ultraviolet light from the sun. Vitamin E prevents production of free radicals during fat oxidation. It is mainly located in the cell membrane where it provides maximum protective action. In addition, cells use vitamin E to interact with each other and to carry out many important functions. Vitamin E is widely used in the treatment of many diseases.

Evion is used to prevent Vitamin E deficiency and for antioxidant effects in certain therapeutic conditions. Consult a healthcare professional to help determine which product is right for you and your needs.

Do not take Evion:

• If you are allergic to Vitamin E or any other ingredients of Evion capsule (listed in section 6).

This product contains arachis oil, which is derived from peanuts.

Warnings and precautions

Talk to your doctor before taking Evion:

If you have a bleeding condition or blood clotting disorder, including but not limited to vitamin K deficiency.
If you have ever had a thrombosis (a clot inside a blood vessel).
If you have gastrointestinal problems especially pancreatic dysfunction or bile duct disorders.
If you have diabetes.
If you have any cardiovascular disorders.

Speak to your doctor before you take this product if any of these points affect you or if you have other questions or concerns.

If you need any other medical treatment or surgery whilst taking Evion, remember to tell the doctor or dentist treating you that you are taking this medicine. You may be advised to stop taking this medicine 2-4 weeks before your treatment or surgery.

Other medicines and Evion

Concomitant use of other medicines could influence the effect of Vitamin E or the other medicine’s effect.

Tell your doctor if you are taking or have recently taken any other medicines with and without prescription including oral contraceptive pills, anticoagulants (medicines to thin your blood), food supplements, or complementary therapies. Inform your doctor that you are taking Vitamin E if any other medicine is prescribed to you during treatment.

Taking Vitamin E with food and drinks

Take this medicine during or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The effect of high doses of vitamin E during pregnancy and breastfeeding is not known. Consequently, Evion is not recommended during pregnancy and breastfeeding.

Children

This product is not recommended for use in children unless recommended by a physician.

Driving and using machines

No data are available about contraindications for driving and using machines during vitamin E treatment.

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.

It may be necessary that your dose be increased or decreased. Your doctor will recommend a dose and duration after evaluating your clinical condition.

Evion 200 – Adult dose: One capsule once or twice a day or as suggested by physicians

Evion 400 – Adult dose: One capsule once a day or as suggested by physicians

Evion 600 – Adult dose: One capsule once a day or as suggested by physicians These products are not intended for chronic use unless directed to by a physician.

If you are suffering from a medical or surgical condition, then kindly consult your physician for recommended dose.

Evion should be taken by mouth. Take capsule(s) with cold water while upright, or as suggested by your physician. If you have any doubts about the correct dosage, ask your doctor to explain it to you.

If you take more Evion capsule dose than you should

If you or anyone else accidentally swallows more than the recommended dose, do not panic as it is unlikely to cause any serious harm. You may experience stomach upset. Obtain medical advice from your doctor immediately.

If you forget to take Evion dose

Evion should be taken every day as recommended, but it is not important to take it at any particular time. There is no need to take extra the following day if you forget to take a dose. If you have any further questions on the use of this product, ask your doctor.

Like all medicines, Evion can cause transient side-effects in some individuals. It is possible that you might develop diarrhoea, or a stomach upset.

Reporting of side effects

The reporting of suspected adverse reactions after medicinal product approval is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. If you experience any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You are requested to report any suspected adverse reactions.

Contact us: Phone - tel:912224942113 or write to us at: https://in.pg.com/contact-us/. By reporting side effects, you can help provide more information on the safety of this medicine

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

Do not use this medicine after the expiry date which is stated on the package.

Store in a dry place at or below 25º C. Protect from light.

What Evion capsule contains

The active substance is tocopheryl acetate (all-rac-α-tocopheryl acetate). The other ingredients are arachis oil (derived from peanut), gelatin (bovine), glycerine, sorbitol solution (70% non-crystallising), methylparaben, propylparaben, liquid paraffin, approved colours (as described in product composition on pack), purified water.

Disclaimer

This patient information leaflet provides information that should not take the place of medical advice. We encourage you to talk to your healthcare provider about your interest in, questions about, or use of Evion and what may be best for your overall health.

Additional information is available on request.
For your feedback or queries
Call us: tel:912224942113
Write to us: https://in.pg.com/contact-us/

Marketed by:

Procter & Gamble Health Limited,
Registered office:
Godrej One, 8th Floor,
Pirojshanagar, Eastern Express Highway,
Vikhroli East, Mumbai 400079, India

Manufacturer:

Please refer manufacturer address on pack.

Date or revision:

29/04/2024

References:

Vitamin E - Fact Sheet for Consumers. Available at: https://ods.od.nih.gov/factsheets/VitaminE-Consumer/. Accessed on 7th February 2020
VITAMIN E 400-ZENTIVA. Available at: http://www.sukl.cz/modules/medication/detail.php?code=0010432&tab=texts. Accessed on 7th February 2020
Vitamin E - Fact Sheet for Health Professionals. Available at: https://ods.od.nih.gov/factsheets/VitaminE-HealthProfessional/. Accessed on 7th February 2020
Vitamin E Suspension 100mg/ml. Available at: https://www.medicines.org.uk/emc/product/3734/pil. Accessed on 7th February 2020
Vitamin E. Available at: https://lpi.oregonstate.edu/mic/vitamins/vitamin-E#toxicity. Accessed on 7th February 2020.
Package leaflet: Information for the patient. Available at: https://mri.ctsmrp.eu/human/downloads/LVH0136001FinalPL.pdf. Accessed on 7th February 2020
Ge B, Zhang Z, Zuo Z. 2014. Updates on the clinical evidenced herb–warfarin interactions. Evid Based Complement Alternat Med 2014: 957362.
Heck AM, DeWitt BA, Lukes AL. Potential interactions between alternative therapies and warfarin. Am J Health System Pharm 2000; 57(13): 1221–7
Vitamin E. Available at: https://www.mayoclinic.org/drugs-supplements-vitamin-e/art20364144. Accessed on 31st July 202

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