VITAMIN E MEDANA

Package leaflet: Information for the user

Vitaminum E Medana, 300 mg, soft capsules
int-rac- α -Tocopherylis acetas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

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 in Vitaminum E Medana – vitamin E – is an essential factor for the proper functioning of the body. It 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 oxygen free radicals appears to be important for the development and function of the nervous and muscular systems. Vitamin E may also act as a cofactor in certain enzymatic systems (a necessary component in specific metabolic processes).

Indications
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 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, consult your doctor or
pharmacist.
Special caution is required when using Vitaminum E Medana in patients concurrently taking:

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

Vitaminum E Medana and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to 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, coenzyme Q10, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Simultaneous use of iron compounds reduces the effectiveness of vitamin E; therefore, a several-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 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 may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
There are no contraindications to driving vehicles or operating machinery during vitamin E use.

3. How to use Vitaminum E Medana

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Oral administration.
The capsule should be swallowed with water.
Secondary prevention of ischemic heart disease in adults: 1 or 2 capsules per day.
Use of a higher than recommended dose of Vitaminum E Medana
If you have taken much more medicine than recommended, you should immediately consult your
doctor or pharmacist.
In case of overdose, the following may occur: loss of appetite, diarrhea, abdominal pain, other gastrointestinal disturbances, feeling of fatigue and weakness, blurred vision, headache, rash,
disturbances in sexual gland function, decreased concentration of thyroid hormones in plasma.
Missed dose of Vitaminum E Medana
If you have missed 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 a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Doses exceeding 1200 mg per day may cause symptoms such as:

• 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 a 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
Phone: +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 the medicine out of sight and reach of children.
Do not store at temperatures 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 the abbreviation EXP indicates the expiry date, and following the abbreviation 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 packaging and other information

What Vitaminum E Medana contains

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

What Vitaminum E Medana looks like and contents of the pack
Vitaminum E Medana is a gelatinous, light yellow, round capsule with a diameter of 8.0 mm to 9.8 mm,
filled with a light yellow oily liquid.
Aluminium/PVC/PVDC foil blister pack in a cardboard box.
The pack contains 20 capsules.
Marketing Authorisation 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