VITAMIN E HASCO

Patient Information Leaflet

Vitaminum E Hasco
300 mg, soft capsules
int-rac-α-Tocopherylis acetas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Vitaminum E Hasco is and what it is used for
2. Important information before taking Vitaminum E Hasco
3. How to take Vitaminum E Hasco
4. Possible side effects
5. How to store Vitaminum E Hasco
6. 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. It is part of the cellular defense system against oxygen free radicals. 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 in 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 a relationship 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 aggregation activity.

Indications:

• Treatment of vitamin E deficiency caused by prolonged improper nutrition or metabolic disorders;
• As adjunctive therapy: 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 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);
• if the patient is allergic to peanuts or soya;
• if vitamin K deficiency is present.

Warnings and precautions
Before starting to use Vitaminum E Hasco, discuss this with your doctor, pharmacist,
or nurse.
Exercise particular caution when using Vitaminum E Hasco in patients who are simultaneously taking oral anticoagulant drugs (e.g. dicoumarol, warfarin) or estrogens (e.g. oral contraceptives).
Vitaminum E Hasco and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Vitamin E may act antagonistically to vitamin K, especially in patients treated with oral anticoagulant drugs (e.g. dicoumarol, warfarin) 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 preparations reduces the effectiveness of vitamin E; therefore, a several-hour interval should be maintained between taking these medicines.
Vitamin E may reduce the need for insulin and cardiac glycosides (e.g. digoxin), while increasing the absorption, utilization, and storage of vitamin A.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy or breastfeeding, this medicine should be used only on a doctor's prescription.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.
Vitaminum E Hasco contains refined peanut oil (from peanuts)
If the patient is allergic to peanuts or soya, this medicine should not be used.
Vitaminum E Hasco contains carmine red (E 124)
This medicine may cause allergic reactions.

3. How to use Vitaminum E Hasco

This medicine should always be taken according to the instructions provided by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The medicine is taken orally.
The recommended dose is usually 1 capsule per day.
Taking a higher than recommended dose of Vitaminum E Hasco
If a significantly higher than recommended dose of the medicine is taken, consult your doctor or
pharmacist.
Large doses of vitamin E used over a prolonged period may cause diarrhea, abdominal pain and
other gastrointestinal disturbances, as well as fatigue, blurred vision, headache, rash, disturbances in gonadal 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.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Vitamin E is generally well tolerated. After taking high doses (above 800 mg/day), fatigue, weakness,
headaches, gastrointestinal disturbances, or skin rash may occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
inform a 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,
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to obtain further information on the safety of the medicine.

5. How to store Vitaminum E Hasco

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging, protected from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
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 all-rac-α-tocopheryl acetate (vitamin E). One soft capsule contains 300 mg of vitamin E.
• The other ingredients (excipients) are: purified arachis oil, gelatin, glycerol, carmine red (E 124).

What Vitaminum E Hasco looks like and contents of the pack
Vitaminum E Hasco is light red, oval soft capsules filled with an oily solution.
One pack contains 30 soft capsules.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]