Package leaflet: information for the patient

Vitaminum E Hasco
300 mg/ml, oral drops, solution
(int-rac - α - Tocopherylis acetas)
Read the entire leaflet carefully before using the medicine, because it contains important information for the patient.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or worsens, contact your doctor.

Table of contents:

What Vitaminum E Hasco is and what it is used for
Important information before taking Vitaminum E Hasco
How to take Vitaminum E Hasco
Possible side effects
How to store Vitaminum E Hasco
Contents of the pack and other information

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

Vitamin E is one of the essential nutrients, although its exact role has not yet been fully elucidated. Together with catalase, superoxide dismutase, glutathione peroxidase, and selenium, it forms part of the cellular defense system protecting against the action of reactive oxygen species. It protects polyunsaturated fatty acids in cell membranes and other cellular structures, stabilizes cellular and subcellular membranes, and prevents hemolysis of red blood cells. Protection against oxidative damage 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. It participates in glucose oxidation and glycogenolysis. It is involved in lipid metabolism, including prostaglandins and cholesterol.

Epidemiological studies suggest an association between daily intake of vitamin E and the risk of coronary heart disease, atherosclerosis, and other diseases whose pathogenesis is linked to oxidative stress. Vitamin E reduces platelet aggregatory activity.

The medicine is used in the treatment and prevention of vitamin E deficiency caused by prolonged improper nutrition or metabolic disorders (e.g. inherited lipid metabolism disorders: abetalipoproteinemia, malabsorption syndromes, cystic fibrosis). It is also used as supportive therapy in atherosclerosis, coronary heart disease and its secondary prevention, as well as in all diseases whose etiology is associated with oxidative stress.

2. Information before using Vitaminum E Hasco

When not to use Vitaminum E Hasco

if the patient is allergic to the active substance (vitamin E) or to any of the other ingredients of this medicine (listed in section 6);
in case of vitamin K deficiency.

Warnings and precautions
Exercise special caution when using Vitaminum E Hasco in patients taking concomitantly oral anticoagulant drugs (e.g. dicoumarol, warfarin) or estrogens (e.g. oral contraceptives).
Vitaminum E Hasco and other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Vitamin E may act antagonistically to vitamin K, especially in patients treated with oral anticoagulant drugs or estrogens.
The concomitant use of other antioxidant agents (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Concomitant use of iron preparations reduces the effect of vitamin E; therefore, a several-hour interval should be maintained between taking these medicines.
Vitamin E may reduce the requirement for insulin and cardiac glycosides, and may increase the absorption, utilization, and storage of vitamin A.
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.
This medicine may be used in pregnant women only on a doctor's prescription.
This medicine may be used in breastfeeding women only on a doctor's prescription.
Driving and operating machinery
Vitaminum E Hasco has no influence on the ability to drive vehicles or operate machinery.
Vitaminum E Hasco contains peanut oil (arachis oil).
If the patient is allergic to peanuts or soy, this medicine should not be used.

3. How to use Vitaminum E Hasco

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral use.

Recommended dose
Unless otherwise advised by a doctor, the usual doses are:

Prophylactic use:

Newborns, infants and children up to 6 years of age: 10 mg (1 drop) per day;
Children from 7 to 15 years of age: 20 mg (2 drops) per day;
Adolescents and adults: 30 mg (3 drops) per day.

Therapeutic use:

Cystic fibrosis
- Newborns and infants (up to 1 year of age): 50 mg (5 drops) per day;
- Children over 1 year of age: 100 mg (10 drops) per day;
- Adolescents and adults: 100 to 200 mg (10 to 20 drops) per day;
Abetalipoproteinemia
- Children and adults: 50 to 100 mg/kg body weight (5 to 10 drops/kg body weight) per day.

The medicine may be administered undiluted or mixed with a beverage to infants and young children.
If you feel that the effect of Vitaminum E Hasco is too strong or too weak, you should consult your doctor.

Due to the risk of overdose, the medicine should not be administered directly from the bottle into the patient's mouth.

Use of more than the recommended dose of Vitaminum E Hasco
If more medicine has been taken than recommended, consult a doctor or pharmacist immediately.
Doses many times higher than recommended, when used over a prolonged period, may cause diarrhoea, abdominal pain and other gastrointestinal disturbances, as well as fatigue, blurred vision, headache, skin rash, disturbances in gonadal gland function, and decreased concentration of thyroid hormones in plasma.

Missed dose of Vitaminum E Hasco
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 any medicine, this medicine may cause adverse reactions, although not in everyone.
Vitamin E is generally well tolerated. In adults, after long-term use of doses multiple times higher than recommended, symptoms such as fatigue, weakness, headache, gastrointestinal disturbances, or rash may occur.
Other adverse reactions may also occur in some individuals during treatment with Vitaminum E Hasco.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: [email protected] .
Reporting adverse reactions helps to enhance the information on the safety of using this medicine.

5. How to store Vitaminum E Hasco

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum E Hasco contains

The active substance is vitamin E. 1 ml of the medicine (approximately 30 drops) contains 300 mg of all-rac-α-tocopheryl acetate (vitamin E). 1 drop of the medicine contains approximately 10 mg of all-rac-α-tocopheryl acetate (vitamin E).
The other constituent is: purified arachis oil.

What Vitaminum E Hasco looks like and contents of the pack
Vitaminum E Hasco is a clear oily solution (opalization is acceptable), yellowish, with a characteristic odour.
One pack contains 10 ml of solution.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. +48 (22) 742 00 22
email: [email protected]