Package leaflet: Information for the patient

Vitaminum A + E Medana, 2500 IU + 200 mg, soft capsules
Retinoli palmitas + int-rac-α-Tocopherylis acetas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

What Vitaminum A + E Medana is and what it is used for
Important information before taking Vitaminum A + E Medana
How to take Vitaminum A + E Medana
Possible side effects
How to store Vitaminum A + E Medana
Contents of the pack and other information

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

Vitaminum A + E Medana contains vitamin A and vitamin E.
Vitamin A is essential for growth processes, including the growth and development of bones, reproduction, fetal development, differentiation and maintenance of epithelial tissue integrity, immunological processes, and normal function of the visual organ. Vitamin A plays an important role in rhodopsin formation, the pigment responsible for twilight vision. It participates in the metabolism of proteins, fats, and carbohydrates and interacts with certain endocrine glands (thyroid, adrenal glands, gonads). Long-term deficiency of vitamin A leads to night blindness, and severe deficiency results in xerophthalmia (corneal keratinization). In severe cases, permanent damage to the visual organ may occur, including loss of vision; additionally, skin and mucous membrane changes may appear. Reduced resistance to infections may also be observed.
Vitamin E is a vital factor for normal body function, protecting against the harmful effects of excessive amounts of strongly oxidizing compounds and preventing hemolysis of red blood cells. Protection against damage by oxygen free radicals appears important for the development and function of the nervous and muscular systems. Vitamin E may also act as a cofactor in certain enzymatic systems (an essential component in specific metabolic processes).
Combined administration of vitamin A and vitamin E enhances protective action against oxygen free radicals that damage body cells and accelerate the aging process.

Indications for Vitaminum A + E Medana
Treatment of deficiencies of vitamin A and vitamin E manifested by:

night blindness;
growth disorders;
prolonged improper nutrition;
metabolic disturbances;
reduced body resistance to infections;
pathological changes in epithelia and mucous membranes.

As supportive therapy:

in cardiovascular diseases (ischaemic heart disease, arterial hypertension, thrombophlebitis);
in the prevention of diseases whose aetiology is associated with "free radicals", e.g. atherosclerosis, ischaemic heart disease, tumours, particularly in individuals exposed to polluted environments, stress, or smokers;
in the prevention of vascular atherosclerosis;
in diabetic and hypertensive retinopathy;
in haemolytic anaemia;
in diabetes mellitus;
in collagenoses.

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 to any of the other ingredients of this medicine (listed in section 6);
if the patient has vitamin K deficiency (risk of bleeding);
if the patient has malabsorption syndrome with steatorrhea;
if the patient has severe liver failure or cirrhosis;
if the patient has biliary tract obstruction;
if the patient has undergone jejunoileal bypass;
if the patient is breastfeeding.

Warnings and precautions
Special caution is required when using Vitaminum A + E Medana

in patients concurrently receiving oral anticoagulants or estrogens (prothrombin time should be monitored);
in patients with renal or hepatic impairment;
in pregnant women. The decision to use Vitaminum A + E Medana during pregnancy must be made by a physician after careful consideration of risks and benefits (see section "Pregnancy and breastfeeding").

Vitaminum A + E Medana with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Do not use other vitamin A-containing medicines due to the risk of hypervitaminosis A.
The gastrointestinal absorption of vitamin A and E is reduced in the presence of cholestyramine, colestipol, neomycin, or mineral oil. If concomitant administration of Vitaminum A + E Medana and the above-mentioned medicines is necessary, the longest possible interval between doses should be maintained or the vitamin dosage increased.
Both vitamin A and vitamin E may enhance the effect of oral anticoagulants of the coumarin or indandione group.
Vitamin E may act antagonistically to vitamin K, especially in patients treated with oral anticoagulants or estrogens.
The use of other antioxidants (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency.
Concurrent use of iron preparations reduces the effect of vitamin E; therefore, a several-hour interval between administration of these medicines should be maintained.
Vitamin E may reduce the need for insulin and cardiac glycosides, while increasing the absorption, utilization, and storage of vitamin A.
Concomitant use of vitamin A and retinoids, e.g. isotretinoin or etretinate, may intensify their effects, including adverse effects.

Vitaminum A + E Medana with food, drink, and alcohol
This medicine should be taken during or after a meal.
Alcohol should not be consumed during treatment with Vitaminum A + E Medana.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Vitaminum A + E Medana may be used during pregnancy only on a physician's recommendation, when in his or her opinion the benefit to the mother outweighs the potential risk to the fetus.
The use of Vitaminum A + E Medana in women during breastfeeding is contraindicated.

Driving and operating machinery
This medicine does not impair psychophysical performance and has no effect on the ability to drive or operate machinery.

3. How to use Vitaminum A + E Medana

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
The capsule should be swallowed with water.

Recommended dose
Prophylactic use in adolescents over 15 years of age and adults:
1 or 2 capsules daily.

Therapeutic use in vitamin A and E deficiency: dosage to be determined by a doctor.

Use of a higher than recommended dose of Vitaminum A + E Medana
If more than the recommended dose has been taken, consult a doctor or pharmacist immediately.
After long-term administration of excessive doses of vitamins A and E, symptoms may include:

irritability, headache, increased intracranial pressure,
decreased appetite, stomach pain, nausea, vomiting,
excessive ossification with hypertrophy of bone tissue,
swelling and periosteal hypertrophy leading to severe pain and restricted movement,
skin damage and skin changes: itching, dryness and cracking of the skin, ichthyosis, skin discoloration, hair loss,
damage and inflammation of the conjunctiva, double vision and blurred vision,
feeling of fatigue and weakness,
disturbances in gonadal function,
reduced concentration of thyroid hormones in plasma.

Missed dose of Vitaminum A + E Medana
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The medicine is well tolerated at the recommended dosage. Long-term use of high doses of the medicine
(more than 4 capsules per day) may cause:

diarrhea, abdominal pain, nausea and other gastrointestinal disturbances,
feeling of fatigue, muscle weakness, headache, blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vitaminum A + E Medana

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vitaminum A + E Medana contains

The active substances are retinol palmitate and all-rac-α-tocopheryl acetate. Each 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 contents of the pack
Blister packs made of Aluminium/PVDC foil in a cardboard box.
The pack contains 25 or 50 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz