Vitamin e medana

Package leaflet: Information for the user

Vitaminum E Medana, 100 mg, soft capsules
int-rac- α -Tocopherylis acetas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, consult your doctor.

Leaflet contents

1. What Vitaminum E Medana is and what it is 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 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. 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 caused by reactive oxygen species 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 some metabolic processes).

Therapeutic 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, peanut oil, or any of the other ingredients of this medicine (listed in section 6),
• in case of vitamin K deficiency (risk of bleeding).

Warnings and precautions
Before starting treatment with Vitaminum E Medana, please discuss it with your doctor or
pharmacist.
Special caution is needed when using Vitaminum E Medana concomitantly with:

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

Vitaminum E Medana and other medicines
You should inform your doctor or pharmacist about all medicines currently used, recently used, or which you plan to use.
Vitamin E may act antagonistically to vitamin K, especially in individuals taking oral anticoagulants or estrogens (e.g. oral contraceptives).
Concomitant use of other antioxidants (vitamin C, selenium, coenzyme Q10, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Simultaneous use of iron-containing compounds reduces the effectiveness of vitamin E; therefore, an interval of several hours should be maintained between the administration of these medicines.
Vitamin E increases the absorption, utilization, and storage of vitamin A.
Cholestyramine and colestipol (cholesterol-lowering agents) reduce the gastrointestinal absorption of vitamin E.
Orlistat (a fat absorption-reducing medicine) and mineral oils may interfere with the gastrointestinal absorption of vitamin E.
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 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 and operating machinery during vitamin E use.
Vitaminum E Medana contains peanut oil
Do not use if hypersensitivity to peanuts or soybeans has been diagnosed.

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.
If in doubt, consult a doctor or pharmacist.
For oral use.
The capsule should be swallowed with water.
Typically:
Adults: 2 or 3 capsules per day.
Children above 8 years: 1 capsule per day.
Therapeutic dosing in cases of vitamin E deficiency is determined by a doctor.
Note: Children under 8 years of age should be given vitamin E in the form of an oral liquid.

Taking more Vitaminum E Medana than recommended
If you have taken much more of the medicine than recommended, seek immediate advice from a doctor or pharmacist.
After an overdose, the following may occur: loss of appetite, diarrhoea, abdominal pain, other gastrointestinal disturbances, fatigue and weakness, blurred vision, headache, rash, disturbances in gonadal gland function, decreased concentration of thyroid hormones in plasma.

Missing a 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 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 of vitamin E 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 safe use of the medicine.

5. How to store Vitaminum E Medana

Keep this medicine out of sight and reach of children.
Do not store at temperatures above 25°C. Do not freeze.
Store in the original packaging to 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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 100 mg of all-rac-α-tocopheryl acetate.
• Other ingredients are: purified arachis oil, gelatin, glycerol, purified water.

What the medicine looks like and contents of the pack
Vitaminum E Medana is gelatinous, light yellow, round capsules with a diameter of 6.2 mm to 7.6 mm,
filled with a light yellow oily liquid.
The pack contains 30 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 Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz