Vitaminum E Sinteza

Leaflet attached to the packaging: patient information

Vitaminum E Synteza, 200 mg, soft capsules

all-rac-α-Tocopheryl acetate

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

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Vitaminum E Synteza and what is it used for
• 2. Important information before taking Vitaminum E Synteza
• 3. How to take Vitaminum E Synteza
• 4. Possible side effects
• 5. How to store Vitaminum E Synteza
• 6. Package contents and other information

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

Vitaminum E Synteza contains all-rac-α-tocopheryl acetate, which is one of the variants of vitamin E.
Fat-soluble vitamin E is an antioxidant of polyunsaturated fatty acids and phospholipids that make up cell membranes. It also participates in some metabolic processes. It has a stabilizing effect on the cell membranes of red and white blood cells. It protects red blood cells from hemolysis. Chronic vitamin E deficiency can lead to neurological disorders. This deficiency usually occurs in the course of malabsorption syndromes with steatorrhea and metabolic disorders. Vitamin E penetrates all tissues and is excreted in the urine in the form of metabolites.
Vitaminum E Synteza is used:

• to treat and prevent vitamin E deficiency states;
• as a supportive agent in the prevention of atherosclerotic, myocardial infarction, and ischemic heart disease;
• to protect red blood cells;
• as a dietary supplement in people with hyperlipoproteinemia.

2. Important information before taking Vitaminum E Synteza

When not to take Vitaminum E Synteza:

• if the patient is allergic to vitamin E or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Vitaminum E Synteza, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Vitaminum E Synteza:

• if the patient has a vitamin K deficiency.

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Children

Vitaminum E Synteza should not be taken by children.

Vitaminum E Synteza and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Vitamin E may act antagonistically to vitamin K. Iron compounds weaken the effect of vitamin E, so a few hours' break should be kept between doses of both medicines.
Vitamin E enhances the effect and storage of vitamin A.

Taking Vitaminum E Synteza with food and drink

Vitaminum E Synteza can be taken independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
It is not recommended to take high doses of vitamin E due to the lack of data on safety.

Driving and operating machinery

Vitaminum E Synteza has no effect or has a negligible effect on the ability to drive and operate machinery.

Taking Vitaminum E Synteza in older people

Older people can take Vitaminum E Synteza in the same way as younger patients.

Vitaminum E Synteza contains soybean oil, ethyl parahydroxybenzoate, and cochineal (E 120)

Soybean oil

Do not take if there is a known hypersensitivity to peanuts or soy.

Ethyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

Cochineal (E 120)

The medicine may cause allergic reactions.

3. How to take Vitaminum E Synteza

This medicine should be taken exactly as described in this patient leaflet or as advised by a doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Oral administration.
Recommended dose: adults 1 capsule per day.

Taking a higher dose of Vitaminum E Synteza than recommended

Taking a higher dose of vitamin E than recommended usually does not cause symptoms of toxicity.
Taking high doses of vitamin E for a long time may cause side effects (see section 4).

Missing a dose of Vitaminum E Synteza

A double dose should not be taken to make up for a missed dose.
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In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum E Synteza can cause side effects, although not everybody gets them.
Long-term use of high doses of vitamin E may cause side effects:
General disorders
Frequency not known: fatigue, weakness.
Eye disorders
Frequency not known: blurred vision.
Skin disorders
Frequency not known: skin rash.
Nervous system disorders
Frequency not known: headache.
Gastrointestinal disorders
Frequency not known: diarrhea, abdominal pain, gastrointestinal disorders.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vitaminum E Synteza

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.
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6. Package contents and other information

What Vitaminum E Synteza contains

• The active substance of the medicine is all-rac-α-tocopheryl acetate (all-rac-α-Tocopheryl acetate). One capsule contains 200 mg of vitamin E.
• The other ingredients are: soybean oil, gelatin, glycerol, ethyl parahydroxybenzoate, cochineal (E 120), purified water.

What Vitaminum E Synteza looks like and what the package contains

Vitaminum E Synteza is a round, soft gelatin capsule, pink in color, packaged in blisters of aluminum/PVC and a cardboard box.
1 package contains 30 capsules (2 blisters of 15 each)

Marketing authorization holder and manufacturer

Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Poland
Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

Date of last revision of the leaflet:

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