Vitamin a + e synteza

Package leaflet: Information for the patient

Vitaminum A+E Synteza,
30,000 IU + 70 mg, soft capsules
Retinol palmitate + all-rac-α-Tocopheryl acetate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Vitaminum A+E Synteza is and what it is used for
2. Important information before taking Vitaminum A+E Synteza
3. How to take Vitaminum A+E Synteza
4. Possible side effects
5. How to store Vitaminum A+E Synteza
6. Contents of the pack and other information

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

Vitaminum A+E Synteza contains a mixture of retinol palmitate (vitamin A) and all-rac-α-tocopheryl acetate (vitamin E) in peanut oil.
Vitamin A is essential for normal vision and reproduction, and also participates in the body's immune mechanisms. It plays an important role in growth processes, as well as in the differentiation and regeneration of epithelial tissue. Vitamin A deficiency leads to night blindness, corneal damage and other eye disorders (xerophthalmia), and in severe cases, to loss of vision. It may also cause skin changes, such as excessive skin keratinization, and reduced immunity.
Vitamin E acts as an antioxidant for polyunsaturated fatty acids and phospholipids that are components of cell membranes. It prevents oxidation of cellular components and formation of reactive oxygen species that accelerate the cellular aging process.
Chronic deficiency of vitamin E may lead to neurological disorders.
Vitaminum A+E Synteza is used in the treatment of clinical (disease-related) symptoms resulting from deficiencies of vitamins A and E.

2. Important information before using Vitaminum A+E Synteza

When not to use Vitaminum A+E Synteza:

• if the patient is allergic to vitamin A or vitamin E, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypervitaminosis A (excess vitamin A in the body);
• if the patient has fat malabsorption syndrome;
• during pregnancy and breastfeeding.

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During treatment, do not use other medicines containing vitamin A and/or vitamin E due to the risk of overdose symptoms.

Warnings and precautions

Use Vitaminum A+E Synteza with special caution:

• if the patient has liver or kidney function disorders, low body weight, hypoproteinemia (decreased blood protein levels), or is an alcoholic and requires long-term treatment (for several weeks or months) with Vitaminum A+E Synteza, due to the risk of overdose;
• if the patient has liver disease or alcohol-related liver disease, due to the risk of further liver damage;
• if the patient is concurrently using anticoagulant medicines (dicoumarol, warfarin), due to reduced effectiveness and possible bleeding;
• if the patient is allergic to peanuts or soya, do not use the medicine due to the presence of peanut oil.

Children and adolescents

Prolonged use in children or overdose may lead to vitamin A toxicity symptoms.

Vitaminum A+E Synteza and other medicines

Inform 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 use.

Concurrent treatment with retinoids (isotretinoin, etretinate, bexarotene) and vitamin A in doses exceeding 4,000–5,000 IU per day may cause symptoms of vitamin A overdose. During retinoid therapy, vitamin A supplementation in doses higher than those mentioned above is not recommended. Alcohol intensifies the toxic effects of vitamin A, while cholestyramine, colestipol, mineral oils, and neomycin reduce gastrointestinal absorption of vitamin A and vitamin E.

Vitamin E may act antagonistically to vitamin K; therefore, in patients concurrently taking oral anticoagulants or estrogens (female sex hormones), the risk of bleeding increases. In high doses, vitamin E may reduce the effectiveness of iron therapy; therefore, a several-hour interval should be maintained between administration of these medicines. Vitamin E may increase cyclosporine absorption.

Taking Vitaminum A+E Synteza with food and drink

Vitaminum A+E Synteza may 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 child, she should consult a doctor before using this medicine.

Pregnancy

Vitaminum A+E Synteza should not be used during pregnancy.

Breastfeeding

Vitamin A passes into the breast milk of nursing mothers. Vitaminum A+E Synteza should not be used during breastfeeding.

The medicine contains peanut oil (from peanuts).

Do not use if hypersensitivity to peanuts or soya has been diagnosed.

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The medicine contains ethyl parahydroxybenzoate

The medicine may cause allergic reactions (including delayed-type reactions).

Driving and operating machinery

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

3. How to use Vitaminum A+E Synteza

This medicine should be used exactly as described in this patient information leaflet or as prescribed by a physician.
If in doubt, consult a doctor.
For oral administration.
Recommended dose: Adults and children over 12 years of age – 1 capsule per day, taken with an adequate amount of liquid, e.g. a glass of water.
If the effect of the medicine seems too strong or too weak, consult a doctor.
Use in children and adolescents
Vitaminum A+E may be used in children over 12 years of age.
Taking more than the recommended dose of Vitaminum A+E Synteza
In case of overdose, discontinue use of the medicine immediately and seek medical advice from a doctor or pharmacist without delay.
Single ingestion of vitamin A in doses of 1,000,000 IU (International Unit) or higher in adults, or 30,000 IU in children, may lead to symptoms of toxicity. Acute poisoning symptoms may appear between 6 and 24 hours after ingestion and include drowsiness, irritability, dizziness, headache, as well as delirium and convulsions, food intolerance, and diarrhea.
Symptoms of overdose occur more frequently in patients with liver burden due to concomitant medication, patients with viral hepatitis, and in malnourished individuals. Children on a low-protein diet may tolerate vitamin A less well.
Adverse effects may occur after prolonged administration of high doses of vitamin A (see section 4).
Missed dose of Vitaminum A+E Synteza
Do not take a double dose to make up for a missed dose. Continue treatment according to the dose recommended by the physician.
Stopping treatment with Vitaminum A+E Synteza
No symptoms related to discontinuation of the medicine have been observed.
If you have any further questions about 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 everyone experiences them.
If dosage recommendations are followed, the medicine usually does not cause adverse symptoms.

Long-term use of vitamin A in doses exceeding 10,000 IU may lead to symptoms of overdose:

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General disorders
Frequency unknown: malaise, fever.

Nervous system disorders
Frequency unknown: increased intracranial pressure, dizziness, and chronic headache.

Eye disorders
Frequency unknown: nystagmus, photophobia.

Skin disorders
Frequency unknown: excessive drying and peeling of the stratum corneum, skin discoloration, hair loss.

Gastrointestinal disorders
Frequency unknown: gastric and intestinal disturbances, diarrhoea, nausea and vomiting, as well as enlargement of the liver and spleen.

Musculoskeletal system disorders
Frequency unknown: bone and joint pain.

Diagnostic investigations
Frequency unknown: increased blood and urinary nitrogen levels, increased plasma calcium, cholesterol and triglyceride concentrations, and decreased leukocyte and erythrocyte counts.

High-dose vitamin E use may cause the following adverse reactions:

General disorders
Frequency unknown: fatigue, weakness.

Musculoskeletal system disorders
Frequency unknown: muscle weakness.

Gastrointestinal disorders
Frequency unknown: gastrointestinal disturbances, diarrhoea, nausea and vomiting.

Reporting suspected adverse reactions

After marketing authorization of the medicinal product, it is important to report suspected adverse reactions. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions 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.

Reporting adverse reactions allows collection of further information on the safety of the medicine.

Adverse reactions may also be reported to the responsible entity.

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5. How to store Vitaminum A+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 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 packaging and other information

What Vitaminum A+E Synteza contains

• The active substances are: retinyl palmitate (vitamin A) and all-rac-α-tocopheryl acetate (vitamin E). Each capsule contains 30,000 IU of vitamin A and 70 mg of vitamin E.
• Other components are: arachis oil, gelatin, glycerol, ethyl parahydroxybenzoate, purified water.

What Vitaminum A+E Synteza looks like and contents of the packaging
Vitaminum A+E Synteza is a round, soft gelatin capsule of light yellow colour,
packed in aluminium/PVC blisters in a cardboard box.
1 pack contains 30 capsules (2 blisters with 15 capsules 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
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