Package leaflet: Information for the patient

Vitaminum E Medana, 400 mg, soft capsules
int-rac- α -Tocopherylis acetas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Vitaminum E Medana is and what it is used for
Important information before taking Vitaminum E Medana
How to take Vitaminum E Medana
Possible side effects
How to store Vitaminum E Medana
Contents of the pack and other information

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

The active substance in Vitaminum E Medana – vitamin E – is an essential factor 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 caused by oxygen 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 component necessary for certain metabolic processes).

Indications for use
Treatment of vitamin E deficiency caused by prolonged improper nutrition and metabolic disorders. Supportive treatment in atherosclerosis, ischemic heart disease and its secondary prevention, and 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 to any of the other ingredients of this medicine (listed in section 6),
if vitamin K deficiency is present (risk of bleeding).

Warnings and precautions
Before starting treatment with Vitaminum E Medana, discuss it with your doctor or
pharmacist.
Particular caution is required when using Vitaminum E Medana in patients concurrently taking:

oral anticoagulants (e.g. dicoumarol, warfarin),
estrogens (e.g. oral contraceptives),
vitamin K.

Vitaminum E Medana and other medicines
You must inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Vitamin E may act antagonistically to vitamin K, especially in patients taking oral anticoagulants or estrogens (e.g. oral contraceptives).
Concomitant use of other antioxidant agents (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Simultaneous administration of iron compounds reduces the effectiveness of vitamin E; therefore, a several-hour interval between administration of these agents should be maintained.
Vitamin E increases the absorption, utilization, and storage of vitamin A.
Cholestyramine and colestipol (cholesterol-lowering drugs) reduce gastrointestinal absorption of vitamin E.
Orlistat (a drug reducing fat absorption) and mineral oils may interfere with gastrointestinal absorption of vitamin E.

Vitaminum E Medana with food and drink
This medicine should be taken during or after a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
There are no contraindications to driving vehicles or operating machinery while taking vitamin E.

3. How to use Vitaminum E Medana

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The dosage is determined by the physician.
For oral administration.
The capsule should be swallowed with water.
Use of a higher than recommended dose of Vitaminum E Medana
If a significantly larger dose than recommended has been taken, consult a physician or pharmacist immediately.
Symptoms following overdose may include: loss of appetite, diarrhoea, abdominal pain, other gastrointestinal disturbances, feeling of fatigue and weakness, blurred vision, headache, rash, disturbances in gonadal function, and decreased concentration of thyroid hormones in plasma.
Missed dose of Vitaminum E Medana
If a dose has been 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 a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everybody experiences them.
Doses exceeding 1200 mg per day may cause the following symptoms:

headache,
visual disturbances,
nausea, diarrhoea,
rash,
weakness, fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum E Medana

Keep this medicine 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 pack. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 is gelatinous, light yellow, oval capsules with a shorter diameter ranging from 7.8 mm to 9.5 mm and a longer diameter ranging from 12.3 mm to 15.1 mm, filled with a clear, light yellow oily liquid.
Aluminium/PVC/PVDC blister in a cardboard box.
The pack contains 30 capsules.
Marketing Authorization Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz