Vitaminum A + E Sinteza

Leaflet attached to the packaging: patient information

Vitaminum A+E Synteza,

30,000 IU + 70 mg, soft capsules

Retinol palmitate + all-rac-α-Tocopheryl acetate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Vitaminum A+E Synteza and what is it 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 necessary for the proper functioning of the vision and reproductive processes, and also participates in the body's immune mechanisms. It plays an important role in the growth process of the body and the differentiation and regeneration of epithelial tissue. A deficiency of vitamin A can lead to night blindness, corneal damage, and other eye problems (xerophthalmia), and in severe cases, to loss of vision. It can also cause skin changes, such as excessive keratinization of the skin, and a decrease in the body's immunity.
Vitamin E is an antioxidant of polyunsaturated fatty acids and phospholipids that make up cell membranes. It counteracts the oxidation of cellular components and the formation of active oxygen free radicals that accelerate cell aging.
Chronic deficiency of vitamin E can lead to neurological disorders.
Vitaminum A+E Synteza is used to treat clinical symptoms (diseases) resulting from a deficiency of vitamins A and E.

2. Important information before using Vitaminum A+E Synteza

When not to use Vitaminum A+E Synteza:

• 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 possibility of overdose symptoms.

Warnings and precautions

Particular caution should be exercised when using Vitaminum A+E Synteza:

Children and adolescents

After long-term use in children or after overdose, symptoms of vitamin A poisoning may occur.

Vitaminum A+E Synteza and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant treatment with retinoids (isotretinoin, etretinate, bexarotene) and vitamin A in doses above 4,000-5,000 IU per day may cause overdose symptoms of vitamin A. During retinoid treatment, it is not recommended to take vitamin A in doses higher than those mentioned above. Alcohol enhances the toxic effects of vitamin A, while cholestyramine, colestipol, mineral oils, and neomycin reduce the absorption of vitamin A and vitamin E from the gastrointestinal tract.
Vitamin E may act antagonistically to vitamin K, so in patients taking oral anticoagulant medicines or estrogens (female sex hormones) at the same time, the risk of bleeding increases. In high doses, vitamin E may reduce the effectiveness of iron preparations, so it is recommended to maintain a few-hour interval between taking these medicines. Vitamin E may increase the absorption of cyclosporine.

Using Vitaminum A+E Synteza with food and drink

Vitaminum A+E Synteza can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
Vitaminum A+E Synteza should not be used during pregnancy.
Breastfeeding
Vitamin A passes into breast milk. Vitaminum A+E Synteza should not be used during breastfeeding.

The medicine contains peanut oil (from peanuts).

Do not use if you are hypersensitive to peanuts or soy.
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The medicine contains ethyl parahydroxybenzoate

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

Driving and using machines

Vitaminum A+E Synteza has no influence or negligible influence on the ability to drive and use machines.

3. How to use Vitaminum A+E Synteza

This medicine should be used exactly as described in this patient leaflet or as directed by your doctor. If you are unsure, consult your doctor.
Oral administration.
Recommended dose: adults and children over 12 years - 1 capsule per day, taken with a sufficient amount of liquid, e.g., a glass of water.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use in children and adolescents

Vitaminum A+E can be used in children over 12 years of age.

Using a higher dose of Vitaminum A+E Synteza than recommended

If you have taken a dose higher than recommended, stop taking the medicine and consult your doctor or pharmacist immediately.
Taking a single dose of vitamin A by adults in a dose of 1,000,000 IU (International Unit) or more and by children in a dose of 30,000 IU may lead to symptoms of toxicity. Symptoms of acute poisoning may occur 6 to 24 hours after ingestion and are characterized by drowsiness, irritability, dizziness, and headache, as well as hallucinations and convulsions, and intolerance to food and diarrhea.
Symptoms of overdose occur more frequently in patients whose liver is burdened by taking medicines, those with viral hepatitis, and malnourished patients. Children on a low-protein diet may tolerate vitamin A less well.
After long-term use of vitamin A in high doses, side effects may occur (see section 4).

Missing a dose of Vitaminum A+E Synteza

Do not take a double dose to make up for a missed dose. Continue treatment according to the dosage recommended by your doctor.

Stopping the use of Vitaminum A+E Synteza

No symptoms associated with stopping the medicine have been observed.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you follow the recommended dosage, the medicine usually does not cause side effects.
Long-term use of vitamin A in doses above 10,000 IU may cause overdose symptoms:
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General disorders
Frequency not known: malaise, fever.
Nervous system disorders
Frequency not known: increased intracranial pressure, dizziness, and chronic headache.
Eyes disorders
Frequency not known: nystagmus, photophobia.
Skin and subcutaneous tissue disorders
Frequency not known: excessive drying and peeling of the skin, skin discoloration, hair loss.
Gastrointestinal disorders
Frequency not known: gastrointestinal disorders, diarrhea, nausea, and vomiting, as well as liver and spleen enlargement.
Musculoskeletal and connective tissue disorders
Frequency not known: bone and joint pain.
Investigations
Frequency not known: increased blood and urine nitrogen levels, increased blood calcium, cholesterol, and triglyceride levels, as well as decreased white blood cell and red blood cell counts.
Using high doses of vitamin E may cause side effects:
General disorders
Frequency not known: fatigue, weakness.
Musculoskeletal and connective tissue disorders
Frequency not known: muscle weakness.
Gastrointestinal disorders
Frequency not known: gastrointestinal disorders, diarrhea, nausea, and vomiting.
Reporting suspected adverse reactions
After the medicinal product has been authorized, it is important to report any suspected adverse reactions. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.
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5. How to store Vitaminum A+E Synteza

Store in 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vitaminum A+E Synteza contains

• The active substances are: retinol palmitate (vitamin A) and all-rac-α-tocopheryl acetate (vitamin E). One capsule contains 30,000 IU of vitamin A and 70 mg of vitamin E.
• The other ingredients are: peanut oil, gelatin, glycerol, ethyl parahydroxybenzoate, purified water.

What Vitaminum A+E Synteza looks like and what the pack contains

Vitaminum A+E Synteza is a round, soft gelatin capsule, yellow 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 and Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
To obtain more detailed information, please contact your local representative of the marketing authorization holder:
Poland
Pharmaceutical and Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

Date of the last update of the leaflet:

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