Vitaminum E Medana

Leaflet attached to the packaging: patient information

Vitaminum E Medana, 300 mg, soft capsules

int-rac-α -Tocopheryl acetate

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 using Vitaminum E Medana
• 3. How to use Vitaminum E Medana
• 4. Possible side effects
• 5. How to store Vitaminum E Medana
• 6. Package contents 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 using Vitaminum E Medana

When not to use Vitaminum E Medana:

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

Warnings and precautions

Before starting to use Vitaminum E Medana, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when using Vitaminum E Medanain people who are also taking:

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

Vitaminum E Medana and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Vitamin E may act antagonistically to vitamin K, especially in people taking oral anticoagulant drugs 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 drugs) reduce the absorption of vitamin E from the gastrointestinal tract.
Orlistat (a fat absorption inhibitor) 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Vitaminum E Medana

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Oral administration.
The capsule should be swallowed and washed down with water.
Secondary prevention of coronary heart disease in adults: 1 or 2 capsules per day.

Using a higher dose of Vitaminum E Medana than recommended

In case of taking a significantly higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
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 a dose is missed and it is almost time for the next dose, the missed dose should not be taken. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum E Medana 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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 gather more information on the safety of the medicine.

5. How to store Vitaminum E Medana

The medicine should be stored out of 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 inscription 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 containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vitaminum E Medana contains

• The active substance of the medicine is all-rac-α-tocopheryl acetate. Each capsule contains 300 mg of all-rac-α-tocopheryl acetate.
• The other ingredients are: gelatin, glycerol, purified water.

What Vitaminum E Medana looks like and what the package contains

Vitaminum E Medana is a gelatin, light yellow, round capsule with a diameter of 8.0 mm to 9.8 mm, filled with a light yellow, oily liquid.
Blister pack of aluminum/PVC/PVDC in a cardboard box.
The package contains 20 capsules.

Marketing authorization holder

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A. Pharmaceutical Works
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of the last update of the leaflet: