Vitamin e synteza

Patient Information Leaflet

Vitaminum E Synteza, 200 mg, soft capsules
int-rac-a-Tocopherylis acetas
Please read this leaflet carefully before using 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 directed by the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, consult your doctor.

Table of Contents

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. Contents of the pack and other information

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

Vitaminum E Synteza contains all-rac-a-tocopheryl acetate, which is one of the forms of vitamin E.
Fat-soluble vitamin E acts as an antioxidant protecting polyunsaturated fatty acids and phospholipids in cell membranes. It also participates in certain metabolic processes. It stabilizes the membranes of red and white blood cells. It protects red blood cells against hemolysis. Chronic vitamin E deficiency may lead to neurological disorders. This deficiency usually occurs in malabsorption syndromes with steatorrhea and metabolic disorders. Vitamin E penetrates into all tissues and is excreted in urine as metabolites.

Vitaminum E Synteza is indicated for:

• Treatment and prevention of vitamin E deficiency states;
• Supportive prophylaxis against atherosclerosis, myocardial infarction, and ischemic heart disease;
• Protection of red blood cells;
• Dietary supplementation in patients with hyperlipoproteinemia.

2. Information before using Vitaminum E Synteza

When not to use Vitaminum E Synteza:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Vitaminum E Synteza.
Exercise particular caution when using Vitaminum E Synteza:

• if the patient has vitamin K deficiency.

1/4
Children
Vitaminum E Synteza must not be used in children.
Vitaminum E Synteza and other medicines
Tell your doctor or pharmacist about all 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. Iron preparations reduce the effectiveness of vitamin E; therefore, a several-hour interval should be maintained between doses of both agents.
Vitamin E enhances the action 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, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
High doses of vitamin E are not recommended due to lack of safety data regarding its use.
Driving and operating machinery
Vitaminum E Synteza has no effect or negligible effect on the ability to drive and operate machinery.
Use in elderly patients
Elderly patients may use Vitaminum E Synteza in the same manner as younger patients.
Vitaminum E Synteza contains soybean oil, ethyl parahydroxybenzoate, and carmine (E 120)
Soybean oil
Do not use if hypersensitivity to peanuts or soy has been diagnosed.
Ethyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).
Carmine (E 120)
This medicine may cause allergic reactions.

3. How to use Vitaminum E Synteza

This medicine should be used exactly as described in this patient information leaflet, or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Oral administration.
Recommended dose: Adults – 1 capsule per day.
Use of a higher than recommended dose of Vitaminum E Synteza
Taking more than the recommended dose of vitamin E usually does not cause symptoms of toxicity.
However, prolonged use of high doses of vitamin E may lead to adverse reactions (see section 4).
Missed dose of Vitaminum E Synteza
Do not take a double dose to make up for a missed dose.
2/4
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Prolonged use of high doses of vitamin E may cause adverse reactions:
General disorders
Frequency unknown: fatigue, weakness.
Eye disorders
Frequency unknown: blurred vision.
Skin disorders
Frequency unknown: skin rash.
Nervous system disorders
Frequency unknown: headache.
Gastrointestinal disorders
Frequency unknown: diarrhoea, abdominal pain, gastrointestinal disturbances.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Vitaminum E Synteza

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
3/4

6. Contents of the packaging and other information

What Vitaminum E Synteza contains

• The active substance is all-rac-α-tocopheryl acetate (int-rac-α-Tocopherylis acetas). Each capsule contains 200 mg of vitamin E.
• Other ingredients are: soybean oil, gelatin, glycerol, ethyl parahydroxybenzoate, cochineal (E120), purified water.

What Vitaminum E Synteza looks like and contents of the pack
Vitaminum E Synteza is a round, soft gelatin capsule, pink in colour, packed in aluminium/PVC blisters and a cardboard box.
1 pack contains 30 capsules (2 blisters of 15 pieces each).

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

For further information, please contact the local representative of the Marketing Authorisation Holder:

Poland
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
4/4