Vitaminum E Medana

Package Leaflet: Information for the Patient

Vitaminum E Medana, 400 mg, Soft Capsules

int-rac-α -Tocopheryl acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Vitaminum E Medana and what is it used for
• 2. Important information before taking Vitaminum E Medana
• 3. How to take Vitaminum E Medana
• 4. Possible side effects
• 5. How to store Vitaminum E Medana
• 6. Contents of the pack and other information

1. What is Vitaminum E Medana and what is it used for

The active substance of the medicine - vitamin E is a factor necessary for the proper functioning of the body, which protects against the harmful effects of excessive amounts of compounds with strong oxidizing properties and prevents hemolysis of red blood cells. Protection against damage by free radicals appears to be important in the development and functioning of the nervous and muscular systems. Vitamin E may also act as a cofactor in certain enzymatic systems (a necessary component in certain metabolic processes).
Indications for use
Treatment of vitamin E deficiency caused by prolonged improper nutrition and metabolic disorders. Supportively in atherosclerosis, coronary heart disease, and its secondary prevention, as well as in all diseases whose etiology is associated with oxidative stress.

2. Important information before taking Vitaminum E Medana

When not to take Vitaminum E Medana:

• if you are allergic to vitamin E or any of the other ingredients of this medicine (listed in section 6),
• if you have a deficiency of vitamin K (possibility of bleeding).

Warnings and precautions

Before taking Vitaminum E Medana, discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking Vitaminum E Medanain people who are also taking:

• oral anticoagulant medicines (e.g., dicumarol, warfarin),
• estrogens (e.g., oral contraceptives),
• vitamin K.

Vitaminum E Medana and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, as well as any medicines you plan to take.
Vitamin E may act antagonistically to vitamin K, especially in people taking oral anticoagulant medicines or estrogens (e.g., oral contraceptives).
Taking other agents with antioxidant effects (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Concomitant use of iron compounds weakens the effect of vitamin E, so a few hours' interval should be maintained between taking these medicines.
Vitamin E increases the absorption, utilization, and storage of vitamin A.
Cholestyramine and colestipol (cholesterol-lowering medicines) reduce the absorption of vitamin E from the gastrointestinal tract.
Orlistat (a medicine that reduces fat absorption) and mineral oils may disrupt the absorption of vitamin E from the gastrointestinal tract.

Vitaminum E Medana with food and drink

The medicine should be taken during or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

There are no contraindications to driving vehicles and operating machines while taking vitamin E.

3. How to take Vitaminum E Medana

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Dosage is determined by the doctor.
Oral administration.
Swallow the capsule and drink water.

Taking a higher dose of Vitaminum E Medana than recommended

If you have taken a significantly higher dose of the medicine than recommended, seek medical attention immediately.
After an overdose, the following may occur: loss of appetite, diarrhea, abdominal pain, other gastrointestinal disorders, feeling of fatigue and weakness, blurred vision, headache, rash, disorders of the sex glands, decreased levels of thyroid hormones in the blood.

Missing a dose of Vitaminum E Medana

If you miss a dose and it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Doses exceeding 1200 mg per day may cause the following symptoms:

• headache,
• vision disturbances,
• nausea, diarrhea,
• rash,
• weakness, fatigue.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Vitaminum E Medana

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum E Medana contains

• The active substance is all-rac-α-tocopheryl acetate. Each capsule contains 400 mg of all-rac-α-tocopheryl acetate.
• The other ingredients are: gelatin, glycerol, purified water.

What Vitaminum E Medana looks like and contents of the pack

Vitaminum E Medana are gelatin, light yellow, oval capsules with a shorter diameter of 7.8 mm to 9.5 mm and a longer diameter of 12.3 mm to 15.1 mm, filled with a light yellow oily liquid.
Blister pack of aluminum/PVC/PVDC in a cardboard box.
The pack contains 30 capsules.

Marketing authorization holder

PHARMACEUTICAL WORKS POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

PHARMACEUTICAL WORKS POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of the last revision of the leaflet: