Vitamin e medana

Package leaflet: Information for the patient

Vitaminum E Medana, 300 mg/ml, oral solution
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 so that you can read it again if necessary.
• 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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

Vitaminum E Medana is a vitamin preparation. Its active substance – all-rac-α-tocopheryl acetate (vitamin E) – is essential for the proper functioning of the body. It exhibits strong antioxidant properties, thereby protecting the body against the harmful effects of oxygen free radicals and lipid peroxides.

Vitaminum E Medana is indicated for use:

• in the treatment of deficiency states due to prolonged improper nutrition or metabolic disorders. Deficiencies may be associated with inherited lipid (fat) metabolism disorders such as abetalipoproteinemia, malabsorption syndrome, or cystic fibrosis;
• as supportive therapy in diseases originating from increased production of free radicals, e.g. atherosclerosis and ischemic heart disease;
• as supportive therapy in the treatment of thrombophlebitis; in ophthalmology, for the treatment of atherosclerotic and hypertensive retinopathy.

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 simultaneously with:

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

Vitaminum E Medana and other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking or have
recently taken, 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, 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
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 vehicles or operating machinery while taking
vitamin E.
Vitaminum E Medana contains purified peanut oil (from peanuts)
Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use Vitaminum E Medana

This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt,
consult a doctor or pharmacist.
Oral use.
Administer using the dropper provided.
To measure the dose accurately, hold the bottle at a 45° angle while counting drops.
Due to the risk of overdose, do not administer the medicine directly from the bottle into the child's mouth.

Adults and adolescents over 15 years of age:

• Prophylactically: 3 drops per day;
• Cystic fibrosis: 100–200 mg per day (on prescription);
• Abetalipoproteinemia: 50–100 mg/kg body weight per day (on prescription).

Children (on prescription):

• Prophylactically, newborns, infants, and children up to 6 years of age: 1 drop per day;
• Children aged 7 to 15 years: 2 drops per day;
• Cystic fibrosis: children under 1 year of age: 50 mg per day;
  children over 1 year of age: 100 mg per day;
• Abetalipoproteinemia: 50–100 mg/kg body weight per day;
• Chronic cholestasis in children up to 2 years of age: 150–200 mg/kg body weight per day.

In other cases of vitamin E deficiency, dosage should be determined by a doctor depending on the severity of deficiency.

Use of a higher than recommended dose of Vitaminum E Medana
If a significantly larger dose than recommended has been taken, consult a 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 function, and decreased plasma thyroid hormone levels.

Missed dose of Vitaminum E Medana
If a dose is missed and it is almost time for the next dose, do not take the missed dose. Do not use a double dose to make up for a missed dose.

If you have any further doubts regarding 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 everyone will experience them.
Doses exceeding 1200 mg of vitamin E per day may cause symptoms such as:

• 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, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 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 the medicine out of the sight and reach of children.
Store below 25°C.
Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the specified month.
After first opening the bottle, the medicine should be used within 2 months.
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 ml (approximately 27 drops) contains 300 mg of all-rac-α-tocopheryl acetate. Each drop contains approximately 11 mg of all-rac-α-tocopheryl acetate.
• Other ingredients: purified arachis oil.

What the medicine looks like and contents of the pack
Vitaminum E Medana is a yellow, oily liquid with a characteristic odour and taste.
Brown glass bottle with a dropper and cap containing 10 ml of solution, in a cardboard box.

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