Package leaflet: Information for the user

Vitaminum A+D Medana, (20,000 IU + 10,000 IU)/ml, oral liquid
Retinol palmitate + Cholecalciferol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

Vitaminum A+D Medana oral liquid is an aqueous solution of vitamin A and vitamin D for oral use, containing 20,000 IU/ml of vitamin A and 10,000 IU/ml of vitamin D. Since each ml corresponds to approximately 34 drops, one drop contains about 588 IU of vitamin A and 294 IU of vitamin D.

Vitamin D is a fat-soluble vitamin that regulates calcium-phosphate metabolism in the body. It plays a key role in the intestinal absorption of calcium and phosphates, in the transport of mineral salts, and in the process of bone mineralization; it also regulates the renal excretion of calcium and phosphates. Vitamin D is an active antirachitic agent. It is essential for proper parathyroid function and for the immune system.

Deficiency of vitamin D in the diet, impaired absorption of vitamin D, calcium deficiency, and lack of exposure to sunlight during periods of rapid growth in children may lead to rickets; in adults, to osteomalacia (softening of the bones); in pregnant women, it may cause tetany and defective enamel formation in newborns. Women during menopause and those with osteoporosis, due to hormonal changes, should increase their daily intake of vitamin D.

Vitamin A is essential for normal growth processes in the young organism and for regenerative processes through its role in regulating the formation of new cells, especially epithelial cells. It plays an important role in the formation of rhodopsin, the pigment responsible for night vision. It participates in the metabolism of proteins, fats, and carbohydrates and interacts with certain endocrine glands (thyroid, adrenal glands, sex glands). It affects the body's immune mechanisms. Prolonged deficiency of vitamin A leads to drying of the conjunctiva and cornea of the eye (xerophthalmia), night blindness, and in severe cases, permanent eye damage and blindness; in addition, skin and mucous membrane changes may occur.

Vitamin A and vitamin D mutually regulate each other's actions. They similarly influence cell renewal and differentiation processes and are therefore used in the treatment of skin diseases.

Indications

Conditions associated with deficiency of vitamin A and D,
Supportive treatment in skin and mucous membrane disorders (e.g. psoriasis, ichthyosis, neoplastic dermatoses).

2. Important information before using Vitaminum A+D Medana

When not to use Vitaminum A+D Medana:

if the patient is allergic to vitamin A, vitamin D, plants from the Apiaceae family (formerly Umbelliferae), such as anise, dill, caraway, celery, coriander, parsley, or to anethole, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has hypervitaminosis A;
if the patient has hypervitaminosis D;
if the patient has renal failure;
if the patient has elevated calcium levels in the blood (hypercalcemia);
if the patient has malabsorption syndrome;
if the patient is taking other medicines containing vitamins A and D;
in children under 4 weeks of age.

Warnings and precautions
Before starting treatment with Vitaminum A+D Medana, consult a doctor or pharmacist if:

the patient is immobilized, takes thiazide diuretics or other diuretics, has kidney stones, heart disease, or is using digitalis glycosides;
the patient is using retinoids or oral contraceptives;
the woman is pregnant or breastfeeding;
the infant has been diagnosed at birth with a small anterior fontanelle.

During treatment, periodic monitoring of calcium and phosphate levels in blood and urine is recommended.

Vitaminum A+D Medana with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Absorption of vitamin A may be impaired when used concomitantly with:
- cholestyramine,
- colestipol,
- orally administered neomycin,
- mineral oil. In such cases, an increased dose of vitamin A may be necessary. Reduced absorption of vitamin A may also result from the use of orlistat.
Oral contraceptives increase serum vitamin A concentration.
Concurrent use of vitamin A with other retinoids may increase its toxicity.
High doses of vitamin A, exceeding 50,000 IU, combined with tetracyclines, may cause intracranial hypertension.
Concurrent use with alcohol may enhance hepatotoxic effects.
Long-term use of aluminium-containing antacids in combination with vitamin D may lead to increased aluminium levels in blood and, consequently, to toxic effects of aluminium on bones.
Concurrent use of magnesium-containing antacids and vitamin D may lead to hypermagnesemia, especially in patients with concomitant chronic renal failure.
Concomitant administration of vitamin D and phosphate-containing drugs increases the risk of hyperphosphatemia.

Vitaminum A+D Medana with food and drink
During treatment, avoid excessive intake of foods rich in vitamin A (e.g. liver).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

The decision on vitamin A supplementation during pregnancy or breastfeeding should be made by a doctor only when absolutely necessary due to clear deficiencies unmet by diet, and after thorough assessment of vitamin A status.

Pregnancy
Taking excessive amounts of vitamin A may be harmful to the fetus.
Do not use vitamin A in doses exceeding 4,000 IU per day during pregnancy.

Breastfeeding
Vitamin A passes into breast milk, which may lead to overdose in the infant.
Taking excessive amounts of vitamin A may be harmful to the infant.
Do not use vitamin A in doses exceeding 4,000 IU per day during breastfeeding.

Driving and operating machinery
Vitaminum A+D Medana does not affect the ability to drive or operate machinery.

Vitaminum A+D Medana contains benzyl alcohol, sodium, ethanol (from flavouring), and propylene glycol (E 1520)
This medicine contains 15 mg of benzyl alcohol per ml of solution.
Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before use, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (such as metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, meaning it is considered "sodium-free".
This medicine contains 6 mg of alcohol (ethanol) per ml of solution [less than 1 mg of alcohol (ethanol) in a 2-drop dose]. The amount of alcohol in 1 ml of this medicine (approximately 34 drops) is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce noticeable effects.
This medicine contains 106 mg of propylene glycol per ml of solution.

3. How to use Vitaminum A+D Medana

This medicine should always be taken as directed by a physician. In case of doubts, consult a
physician or pharmacist.
Infants from 4 weeks of age and children - 2 drops per day
Adolescents and adults - 2 drops per day
Pregnant and breastfeeding women - 2 drops per day.
Method of administration
The medicine is for oral use.
Administer the medicine in a spoonful of liquid.
Due to the risk of overdose, the medicine should not be administered directly from the container into the child's mouth.
Use of a higher than recommended dose of Vitaminum A+D Medana
If a larger than recommended dose of the medicine has been taken, consult a physician or
pharmacist immediately.
In acute vitamin A poisoning, especially in children, increased intracranial pressure and
vomiting occur. In chronic vitamin A poisoning the following symptoms occur: loss of appetite, double vision, malaise, headache, hair loss, cracking of the lips, subperiosteal thickening of bones and bone pain, enlargement of the liver and spleen, hypoplastic anemia (reduced production of blood cells: mainly red blood cells, but also granulocytes and platelets), leukopenia, sometimes increased intracranial pressure and hydrocephalus. In children, premature ossification of the metaphyses of long bones occurs.
Symptoms of vitamin D toxicity include: hypercalcemia, increased urinary calcium excretion (hypercalciuria), nephrocalcinosis and bone damage. Clinical signs of vitamin D overdose were: headache, lethargy, loss of appetite, excessive thirst, polyuria, nausea, vomiting, constipation, muscle weakness, weight loss, conjunctivitis, photophobia, pancreatitis, watery nasal discharge, itching, marked increase in body temperature (hyperthermia), decreased libido, increased blood cholesterol concentration (hypercholesterolemia), elevated aminotransferase activity, uremia, arterial hypertension and cardiac arrhythmias.
If you have any further doubts concerning the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Rarely (in less than 1 in 1,000 patients), hypersensitivity to the vitamins or prolonged use of excessive doses may lead to toxicities known as hypervitaminosis D or hypervitaminosis A.

Symptoms of hypervitaminosis D include:

loss of appetite, gastrointestinal disturbances (nausea, vomiting), constipation, dryness of the mouth;
headaches;
muscle and joint pain;
polyuria;
depression, psychotic disorders;
weight loss;
increased calcium levels in blood and/or urine, kidney stones, and tissue calcification may occur. Usually, these symptoms resolve after discontinuation of the vitamins.

Long-term use of vitamin A may cause liver damage.
The following may also occur:

dizziness and headaches, irritability;
cheilitis, hair loss, dry skin;
vomiting, abdominal pain;
anaemia, increased blood calcium concentration;
subcutaneous edema;
bone and joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum A+D Medana

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
Protect from light.
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.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Once opened, the container should be used within 4 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

The active substances in the medicine are vitamin A (retinol palmitate) and vitamin D (cholecalciferol). Each ml of the solution (approximately 34 drops) contains 20,000 IU of retinol palmitate and 10,000 IU of cholecalciferol. Each drop contains 588 IU of vitamin A and 294 IU of vitamin D.
Other ingredients are: polysorbate 80, benzyl alcohol, glycerol, propylene glycol (E 1520), citric acid, disodium phosphate, anise flavour (containing, among others, propylene glycol (E 1520) and ethanol), purified water.

What Vitaminum A+D Medana looks like and contents of the pack
A clear, yellow, viscous liquid with an anise odour, in a 10 ml amber glass bottle closed with a polyethylene cap and containing a dropper, packaged in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz