Vitaminum E Medana

Package Leaflet: Information for the Patient

Vitaminum E Medana, 100 mg, Soft Capsules

int-rac-α -Tocopheryl acetate

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

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 seems 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 component necessary 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 the patient is allergic to vitamin E, peanut oil, 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 take Vitaminum E Medana, discuss it with your doctor or pharmacist.

Particular caution should be exercised when taking Vitaminum E Medanaat the same time as:

• oral anticoagulant drugs (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 now or have taken recently, as well as the medicines you 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-hour 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 (see section 3 below).

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 machinery while taking vitamin E.

Vitaminum E Medana contains peanut oil (from peanuts)

Do not use in case of known hypersensitivity to peanuts or soy.

3. How to take Vitaminum E Medana

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Oral administration.

Swallow the capsule and drink water.

Usually

Adults: 2 or 3 capsules a day.

Children over 8 years old: 1 capsule a day.

Therapeutically, in cases of vitamin E deficiency, the dosage is determined by a doctor.

Note: Children under 8 years old should be given vitamin E in the form of an oral liquid.

Using a higher dose of Vitaminum E Medana than recommended

In case of taking a significantly higher dose of the medicine than recommended, consult a doctor or pharmacist 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 one dose is missed 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.

In case of any further doubts about taking this medicine, consult a 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 of vitamin E per day may cause the occurrence of such symptoms as:

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

Reporting side effects

If you experience any side effects, including those not listed in the 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

Tel.: +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 the 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.

Store in the original package to 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 stated.

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 of the medicine is all-rac-α-tocopheryl acetate. Each capsule contains 100 mg of all-rac-α-tocopheryl acetate.
• The other ingredients are: purified peanut oil, gelatin, glycerol, purified water.

What Vitaminum E Medana looks like and contents of the pack

Vitaminum E Medana is a gelatin, light yellow, round capsule with a diameter of 6.2 mm to 7.6 mm, filled with a light yellow oily liquid.

The pack contains 30 capsules.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Medana Branch in Sieradz

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: