Tokovit a + e
Poland
Table of Contents
It is important to read this entire leaflet carefully, as it contains essential information for the patient.
- This medicine is available without a prescription, allowing treatment of certain conditions without a doctor's intervention. However, to achieve effective treatment, it is essential to use TOKOVIT A + E carefully and strictly according to the instructions in this leaflet.
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you need advice or further information.
- If symptoms worsen or do not improve, contact your doctor.
TOKOVIT A + E
(Retinol palmitate + RRR-α-tocopherol)
2500 IU + 70 IU, soft capsules
Composition
Each capsule contains:
Active substances:
Retinol palmitate (stabilized retinol palmitate with tocopherol, vitamin A) 2500 IU
RRR-α-tocopherol (RRR-α-tocopherol, natural vitamin E) 70 IU
Excipients:
all-rac-α-tocopherol, peanut oil, gelatin, glycerol.
Available packaging
One package contains 30 capsules.
Marketing Authorization Holder
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E
51-131 Wrocław
Leaflet contents:
- What TOKOVIT A + E is and what it is used for
- Before taking TOKOVIT A + E
- How to take TOKOVIT A + E
- Possible side effects
- How to store TOKOVIT A + E
- Further information
1. What TOKOVIT A + E is and what it is used for
Vitamin A plays a crucial role in the visual process (ensuring proper retinal function), and is essential for growth, regeneration, differentiation, and function of epithelial tissues, skin, and mucous membranes. It participates in bone mineralization and bone structure formation, in reproductive processes, and in embryonic fetal development.
Vitamin E is a substance derived from natural plant oils and is necessary for proper body function. Its biological activity is 50% stronger than that of commonly used synthetic vitamin E.
Epidemiological studies indicate a correlation between daily intake of vitamin E and reduced risk of coronary heart disease, carotid atherosclerosis, and other diseases whose etiology is linked to oxidative stress.
TOKOVIT A + E is intended for the prevention and supplementation of deficiencies in vitamins A and E:
- during periods of increased demand for these vitamins,
- in preventing certain skin disorders, e.g. keratosis,
- in preventing deficiencies that may lead to growth and developmental disorders, pathological changes in epithelia and mucous membranes, and night blindness,
- in reducing the effects of stress (due to its antioxidant properties),
- during increased physical exertion,
- on elimination diets,
- in individuals exposed to polluted environments and in smokers.
2. Before taking TOKOVIT A + E
Do not take TOKOVIT A + E if you have:
- hypersensitivity to any component of the medicine,
- vitamin K deficiency,
- vitamin A overdose (so-called hypervitaminosis A),
- severe hypertension, glaucoma, or myasthenia gravis.
Exercise special caution when using TOKOVIT A + E
- in patients with liver disorders (e.g. cirrhosis, viral hepatitis), who may require lower doses as advised by a physician,
- when taking other medicines containing vitamin A, due to the risk of vitamin A overdose,
- in patients concurrently taking oral anticoagulants or estrogens (e.g. oral contraceptives).
Vitamin A absorption is reduced in cases of fat malabsorption and low protein intake.
Consult your doctor, even if the above warnings relate to conditions you have experienced in the past.
Pregnancy
Consult your doctor before taking this medicine.
Pregnant women may take TOKOVIT A + E only after consulting a doctor and at doses prescribed by the doctor, as excessive intake of vitamin A may be harmful to the fetus.
Administration of high doses of vitamin E during pregnancy is not recommended due to lack of safety data.
Breast-feeding
Consult your doctor before taking this medicine.
Vitamin A passes into breast milk, which may lead to overdose in the infant. Breastfeeding women may take TOKOVIT A + E only after consulting a doctor and at doses prescribed by the doctor, as excessive intake of vitamin A may be harmful to the infant.
Administration of high doses of vitamin E during breastfeeding is not recommended due to lack of safety data.
Driving and operating machinery
Taking TOKOVIT A + E has no effect on the ability to drive mechanical vehicles or operate moving machinery.
Important information about certain components of TOKOVIT A + E
This medicine contains peanut oil. If you are allergic to peanuts or soy, do not take this medicine.
Taking other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
Neomycin, cholestyramine (colestipol), and liquid paraffin reduce vitamin A absorption. Concurrent use of products containing vitamin A (carotenoids), synthetic vitamin A analogs (acitretin, etretinate, tretinoin), and bexarotene may lead to symptoms of hypervitaminosis A. Vitamin A administered in doses several times higher than recommended may enhance the effect of anticoagulant drugs (warfarin derivatives). Oral contraceptives may increase vitamin A plasma concentration.
Vitamin E may act antagonistically to vitamin K, especially in patients treated with oral anticoagulants or estrogens. Concurrent use of other antioxidant agents (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency. Concurrent 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.
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3. How to use TOKOVIT A + E
The medicine is intended for oral use.
For prophylactic use, unless otherwise directed by a physician, the usual dose taken with the first meal is:
for adolescents and adults – 1 or 2 capsules per day.
For therapeutic use: as directed by the physician – depending on the degree of deficiency.
If you feel that the effect of TOKOVIT A + E is too strong or too weak, consult your doctor.
If you take more TOKOVIT A + E than recommended
If you take a significantly larger dose than recommended, consult your doctor or pharmacist immediately.
Symptoms of acute vitamin A toxicity may occur in children after ingestion of 75,000 to 350,000 IU, and in adults after ingestion of 1,000,000 IU. Characteristic symptoms of vitamin A overdose include headache, nausea, vomiting, auditory hallucinations, visual disturbances, subcutaneous tissue and periosseous tissue swelling, musculoskeletal pain, and symptoms affecting the skin and mucous membranes. Additionally, hypercalcemia, petechiae, hemorrhages, nervousness, fatigue, irritability, and drowsiness have been observed.
Very significant and prolonged vitamin A overdose may be accompanied by other adverse effects involving the circulatory system, central nervous system, gingivitis, liver damage symptoms, respiratory dysfunction, dermatological changes, skin pigmentation disorders, osteoporosis, bone sclerosis, and other less specific changes.
High doses of vitamin E (400 to 800 IU per day) used over a prolonged period may cause diarrhea, abdominal pain, and other gastrointestinal disturbances, as well as fatigue, blurred vision, headache, skin rash, disturbances in gonadal function, and decreased concentration of thyroid hormones in plasma.
If symptoms of overdose occur, discontinuation of the product and medical consultation are necessary.
If you miss a dose of TOKOVIT A + E
Do not take a double dose to make up for the missed dose.
4. Possible adverse reactions
Like any medicine, TOKOVIT A + E may cause adverse reactions.
Vitamins A and E are generally well tolerated, and their use at recommended doses
is not associated with a significant risk of adverse reactions. Symptoms of adverse
reactions are related to overdose of the product (see section 3).
In some individuals, other adverse reactions may occur during treatment. If any adverse
reactions occur that are not listed in this leaflet,
they should be reported to a physician.
5. Storage of the medicinal product TOKOVIT A + E
Keep the medicinal product out of sight and reach of children.
Do not use TOKOVIT A + E after the expiry date stated on the
packaging.
Store in the original packaging, at a temperature below 25°C.
6. Other information
For more detailed information, please contact the marketing authorization holder:
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
tel. (071) 352 95 22
fax (071) 352 76 36
Medical Information Department
tel. (22) 742 00 22
email: [email protected]
Date of leaflet preparation:
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