Vitamin e medana

Package leaflet: Information for the user

Vitaminum E Medana, 200 mg, soft capsules
int-rac- α -Tocopherylis acetas
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

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

Contents of the leaflet

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 related to 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, please consult your doctor or
pharmacist.
Special caution is required 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 must tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
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, ubiquinone, 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 enhances the absorption, utilization, and storage of vitamin A.
Cholestyramine and colestipol (cholesterol-lowering agents) reduce gastrointestinal absorption of vitamin E.
Orlistat (a fat absorption-reducing medicine) and mineral oils may interfere with 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 regarding driving vehicles or operating machinery during vitamin E use.
Vitaminum E Medana contains ethyl parahydroxybenzoate (E214)
This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Vitaminum E Medana

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
For oral use.
The capsule should be swallowed with water.
Usually
Adults: 1 or 2 capsules per day.
For therapeutic use in vitamin E deficiency, the dosage should be determined by a doctor.

Taking more Vitaminum E Medana than recommended
If you have taken significantly more medicine than recommended, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: loss of appetite, diarrhoea, abdominal pain, other gastrointestinal disturbances, fatigue and weakness, blurred vision, headache, rash, disturbances in gonadal gland 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Doses exceeding 1200 mg of vitamin E per day may lead to the following symptoms:

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

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

5. How to store Vitaminum E Medana

Keep this medicine out of the sight and reach of children.
Do not store 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 specified month.
Medicines must 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 packaging and other information

What Vitaminum E Medana contains:

• The active substance is all-rac-α-tocopheryl acetate. Each capsule contains 200 mg of all-rac-α-tocopheryl acetate.
• Other ingredients are: gelatin, glycerol, ethyl parahydroxybenzoate (E214), carmine (E120), purified water.

What the medicine looks like and contents of the pack
Vitaminum E Medana is red, round, gelatin capsules with a diameter between 7.1 mm and 8.7 mm,
filled with a clear, pale yellow oily liquid.
The pack contains 25 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