Vitaminum E Medana

Leaflet attached to the packaging: patient information

Vitaminum E Medana, 300 mg/ml, oral liquid

all-rac-α-Tocopheryl acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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. Package contents and other information

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

Vitaminum E Medana is a vitamin product. The active substance contained in it, all-rac-α-tocopheryl acetate (vitamin E), is necessary for the proper functioning of the body. It has strong antioxidant properties, which protects the body from the harmful effects of oxygen free radicals and lipid peroxides.

Vitaminum E Medana is indicated for use:

• in the treatment of deficiency states in prolonged, improper nutrition and metabolic disorders. Deficiencies may be associated with hereditary lipid metabolism disorders (fats), such as abetalipoproteinemia, with malabsorption syndrome or cystic fibrosis.
• as a supplement in diseases of origin related to increased production of free radicals, e.g. in atherosclerosis and coronary heart disease.
• as a supplement in the treatment of thrombophlebitis; in ophthalmology in the treatment of atherosclerotic and hypertensive retinopathy.

2. Important information before taking Vitaminum E Medana

When not to take Vitaminum E Medana:

• if you are allergic to vitamin E, peanut oil or any of the other ingredients of this medicine (listed in section 6),
• if you have a vitamin K deficiency (possibility of bleeding).

Warnings and precautions

Before starting to take Vitaminum E Medana, discuss it with your doctor or pharmacist.

Be particularly cautious when taking Vitaminum E Medanaat the same time as:

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

Vitaminum E Medana and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.

Vitamin E may act antagonistically to vitamin K, especially in people taking oral anticoagulant medicines or estrogens (e.g. oral contraceptives).

Taking other agents with antioxidant effects (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.

Concomitant use of iron compounds weakens the effect of vitamin E, so a few-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 medicines) reduce the absorption of vitamin E from the gastrointestinal tract.

Orlistat (a medicine that reduces fat absorption) and mineral oils may disrupt the absorption of vitamin E from the gastrointestinal tract.

Vitaminum E Medana with food and drink

Take the medicine during or after a meal (see section 3 below).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Vitaminum E Medana contains purified peanut oil (from peanuts)

Do not use if you have a known hypersensitivity to peanuts or soybeans.

3. How to take Vitaminum E Medana

Always take this medicine exactly as your doctor or pharmacist has told you.

If you are unsure, consult your doctor or pharmacist.

Oral administration.

Administer in a spoonful of liquid.

To measure the dose accurately, hold the bottle at a 45° angle while counting the drops.

Due to the risk of overdose, do not administer the medicine directly from the bottle to the child's mouth.

Adults and adolescents over 15 years:

prophylactically: 3 drops per day;

cystic fibrosis:

• 100 - 200 mg per day (on a doctor's prescription); abetalipoproteinemia: 50 - 100 mg/kg body weight per day (on a doctor's prescription).

Children (on a doctor's prescription):

prophylactically

newborns, infants, and children up to 6 years: 1 drop per day;

children from 7 to 15 years: 2 drops per day;

cystic fibrosis:

children under 1 year: 50 mg per day;

children over 1 year: 100 mg per day;

abetalipoproteinemia: 50 - 100 mg/kg body weight per day;

chronic cholestasis in children up to 2 years: 150 - 200 mg/kg body weight per day.

In other states of vitamin E deficiency, the dosage is determined by the doctor depending on the degree of deficiency.

Taking a higher dose of Vitaminum E Medana than recommended

If you have taken a significantly higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

After an overdose, the following may occur: loss of appetite, diarrhea, abdominal pain, other gastrointestinal disorders, fatigue and weakness, blurred vision, headache, rash, disorders of the sex glands, decreased thyroid hormone levels in the blood.

Missing a dose of Vitaminum E Medana

If you miss 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 the missed dose.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum E Medana can cause side effects, although not everybody gets them.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vitaminum E Medana

Keep the medicine out of the sight and reach of children.

Store in a temperature 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 opening the bottle, use the medicine within 2 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vitaminum E Medana contains:

• The active substance of the medicine 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.
• The other ingredients are: purified peanut oil.

What Vitaminum E Medana looks like and what the package contains

Vitaminum E Medana is a yellow, oily liquid with a characteristic odor and taste.

A brown glass bottle with a dropper and screw cap, containing 10 ml of solution, in a cardboard box.

Marketing authorization 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., Oddział Medana w Sieradzu, ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last update of the leaflet: