Vitaminum A + E Medana

Package Leaflet: Information for the Patient

Vitaminum A + E Medana, 2500 IU + 200 mg, Soft Capsules

Retinol Palmitate + all-rac-α-Tocopheryl Acetate

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product must be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the package leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

• 1. What is Vitaminum A + E Medana and What is it Used For
• 2. Important Information Before Using Vitaminum A + E Medana
• 3. How to Use Vitaminum A + E Medana
• 4. Possible Side Effects
• 5. How to Store Vitaminum A + E Medana
• 6. Package Contents and Other Information

1. What is Vitaminum A + E Medana and What is it Used For

Vitaminum A + E Medana contains vitamin A and vitamin E.
Vitamin Ais essential for growth processes, including bone growth and development, reproduction, fetal development, differentiation, and maintenance of epithelial tissue integrity, immune processes, and proper vision function. Vitamin A plays a crucial role in the process of creating rhodopsin, the pigment that determines the ability to see in the dark. It participates in protein, fat, and carbohydrate metabolism and cooperates with some endocrine glands (thyroid, adrenal glands, gonads). Prolonged vitamin A deficiency is the cause of night blindness, and significant deficiency leads to xerophthalmia (corneal keratinization). In severe cases, there is permanent damage to the visual organ, including vision loss; additionally, skin and mucous membrane changes may occur. A decrease in resistance to infections can also be observed.
Vitamin Eis a factor necessary for the proper functioning of the body, which protects against the harmful effects of excessive amounts of compounds with strong oxidizing properties and prevents hemolysis of red blood cells. Protection against damage by oxygen free radicals appears to be important in the development and functioning of the nervous and muscular systems. Vitamin E may also act as a cofactor in certain enzymatic systems (a necessary component in certain metabolic processes).
The combined use of vitamins A and E increases the protective effect against free oxygen radicals that damage the body's cells and accelerate their aging.

Indications for Use of Vitaminum A + E Medana

Treatment of vitamin A and vitamin E deficiencies manifesting as:

• night blindness;
• growth disorders;
• prolonged improper nutrition;
• metabolic disorders;
• decreased immunity to infections;
• diseases of the epithelium and mucous membranes.

Supportively:

• in cardiovascular diseases (ischemic heart disease, hypertension, thrombophlebitis);
• in the prevention of diseases whose etiology is associated with "free radicals", e.g., atherosclerosis, ischemic heart disease, tumors, especially in people living in a polluted environment, exposed to stress or smokers;
• in the prevention of atherosclerosis of blood vessels;
• in hypertensive and atherosclerotic retinopathy;
• in hemolytic anemia;
• in diabetes;
• in collagen diseases.

2. Important Information Before Using Vitaminum A + E Medana

When Not to Use Vitaminum A + E Medana:

• if the patient is allergic to vitamin A or E or any other component of this medicinal product (listed in section 6);
• if the patient has a vitamin K deficiency (possibility of bleeding);
• if the patient has a syndrome of poor absorption with fatty stools;
• if the patient has severe liver failure or cirrhosis;
• if the patient has bile duct obstruction;
• if the patient has undergone ileal bypass surgery;
• if the patient is breastfeeding.

Warnings and Precautions

Particular caution should be exercised when using Vitaminum A + E Medana

• in patients taking oral anticoagulant medications or estrogens simultaneously (prothrombin time should be monitored);
• in patients with renal or liver failure;
• in pregnant women. The decision to use Vitaminum A + E Medana during pregnancy should be made only by a doctor after weighing the risks and benefits (see "Pregnancy and Breastfeeding").

Vitaminum A + E Medana with Other Medicinal Products

Inform your doctor or pharmacist about all medicinal products currently being used or recently used, as well as those planned for use.

• Do not use other medicinal products containing vitamin A due to the possibility of hypervitaminosis.
• Absorption of vitamins A and E from the gastrointestinal tract is reduced in the presence of cholestyramine, colestipol, neomycin, and mineral oil. If it is necessary to administer Vitaminum A + E Medana and the above-mentioned medicinal products simultaneously, the longest possible interval between the administered preparations should be maintained or the vitamin dose increased.
• Both vitamins A and E enhance the effect of oral anticoagulant medications of the coumarin or indandione type.
• Vitamin E may act antagonistically to vitamin K, especially in individuals treated with oral anticoagulant medications or estrogens.
• The use of other antioxidants (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
• Concomitant use of iron preparations weakens the effect of vitamin E, so an interval of several hours should be maintained between taking these medicinal products.
• Vitamin E may reduce the need for insulin and digitalis glycosides and increase the absorption, utilization, and storage of vitamin A.
• The combined use of vitamin A and retinoids, e.g., isotretinoin or etretinate, may enhance their effects, including undesirable ones.

their effects, including undesirable ones.

Vitaminum A + E Medana with Food, Drink, and Alcohol

The medicinal product should be taken during or after a meal.
Do not consume alcohol while taking Vitaminum A + E Medana.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicinal product.
Vitaminum A + E Medana may be used during pregnancy only on the advice of a doctor, when in his opinion the benefit to the mother outweighs the potential risk to the fetus.
The use of Vitaminum A + E Medana in breastfeeding women is contraindicated.

Driving and Operating Machinery

The medicinal product does not reduce psychophysical fitness, does not affect driving vehicles or operating machinery.

3. How to Use Vitaminum A + E Medana

This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The medicinal product is administered orally.
Swallow the capsule and drink water.
Recommended dose
Prophylactically for adolescents over 15 years and adults:
1 or 2 capsules daily.
Therapeutically, in cases of vitamin A and E deficiency, the dosage is determined by a doctor.

Use of a Higher Than Recommended Dose of Vitaminum A + E Medana

In case of ingestion of a higher dose than recommended, consult a doctor or pharmacist immediately.
After prolonged administration of increased doses of vitamins A and E, symptoms such as:

• irritability, headaches, increased intracranial pressure,
• decreased appetite, stomach pain, nausea, vomiting,
• excessive calcification with bone hypertrophy,
• edema and periosteal hypertrophy leading to severe pain and limited mobility,
• skin damage and skin changes: itching, dryness, and cracking of the skin, fish scales, skin discoloration, hair loss,
• damage and inflammation of the conjunctiva, double and blurred vision,
• feeling of fatigue and weakness,
• disorders of sex gland function,
• decreased thyroid hormone levels in serum.

Missed Dose of Vitaminum A + E Medana

Do not take a double dose to make up for a missed dose.
In case of further doubts regarding the use of this medicinal product, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Vitaminum A + E Medana can cause the following side effects, although they may not occur in everyone.
At the recommended dosage, the medicinal product is well tolerated. Long-term use of high doses of the medicinal product (more than 4 capsules per day) may cause:

• diarrhea, abdominal pain, nausea, and other gastrointestinal disorders,
• feeling of fatigue, muscle weakness, headaches, blurred vision.

Reporting Side Effects

If you experience any side effects, including those not listed in the package leaflet, inform your 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. By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. How to Store Vitaminum A + E Medana

Keep the medicinal product out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Do not use this medicinal product after the expiry date stated on the carton and blister. The expiry date refers to the last day of the given month.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Vitaminum A + E Medana Contains

• The active substances of the medicinal product are retinol palmitate and all-rac-α-tocopheryl acetate. One capsule contains 2500 IU of retinol palmitate and 200 mg of all-rac-α-tocopheryl acetate.
• Other ingredients are: gelatin, glycerol, and purified water.

What Vitaminum A + E Medana Looks Like and What the Package Contains

Aluminum/PVDC foil blisters in a cardboard box.
20 pieces (1 blister of 20 pieces)
40 pieces (2 blisters of 20 pieces)

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of the Last Update of the Package Leaflet: