Vitaminum A + D3 Medana

Leaflet attached to the packaging: patient information

Vitaminum A+D Medana, (20,000 IU + 10,000 IU)/ml, oral liquid
Retinol palmitate + Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vitaminum A+D Medana and what is it used for
• 2. Important information before taking Vitaminum A+D Medana
• 3. How to take Vitaminum A+D Medana
• 4. Possible side effects
• 5. How to store Vitaminum A+D Medana
• 6. Package contents and other information

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

Vitaminum A+D Medana, oral liquid is an aqueous solution of vitamin A and vitamin D for oral administration, containing 20,000 IU/ml of vitamin A and 10,000 IU/ml of vitamin D. Since each ml corresponds to approximately 34 drops - 1 drop contains approximately 588 IU of vitamin A and 294 IU of vitamin D.
Vitamin D is a fat-soluble vitamin that regulates calcium and phosphorus metabolism in the body. It plays a crucial role in the absorption of calcium and phosphates from the intestines, in the transport of mineral salts, and in the calcification of bones; it also regulates the excretion of calcium and phosphates by the kidneys.
Vitamin D is an active antirachitic factor. It is necessary for the proper functioning of the parathyroid glands and the immune system.
A deficiency of vitamin D in the diet, impaired absorption, calcium deficiency, and lack of exposure to sunlight can lead to rickets in children, osteomalacia (softening of bones) in adults, and may cause symptoms of tetany and enamel underdevelopment in newborns in pregnant women. Women in the menopausal period, with osteoporosis, due to hormonal changes, should increase their daily intake of vitamin D.
Vitamin A is necessary for the proper course of growth processes in young organisms, as well as regeneration processes by participating in the regulation of new cell formation, especially epithelial cells. It plays an important 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, cooperates with some endocrine glands (thyroid, adrenal glands, sex glands), and acts on the body's immune mechanisms. Prolonged deficiency of vitamin A leads to dryness of the conjunctiva and cornea of the eye (xerophthalmia), night blindness, and in severe cases to permanent eye damage and blindness; additionally, skin and mucous membrane changes may occur.
Vitamins A and D mutually regulate their action. Similarly, they affect the process of cell renewal and differentiation, and are used in the treatment of skin diseases.

Indications for use

• states of vitamin A and D deficiency,
• supportive treatment in skin and mucous membrane disorders (including psoriasis, fish scales, dermatoses of tumor origin).

2. Important information before taking Vitaminum A+D Medana

When not to take Vitaminum A+D Medana:

• if the patient is allergic to vitamin A, vitamin D, to plants of the Apiaceae family (formerly Umbelliferae), such as anise, dill, caraway, celery, coriander, 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 blood calcium levels (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 Vitaminum A+D Medana, discuss it with your doctor or pharmacist if:

• the patient is immobilized, taking thiazides and other diuretics, has kidney stones, heart disease, and is taking digitalis glycosides;
• the patient is taking retinoids and oral contraceptives;
• the woman is pregnant or breastfeeding;
• in infants, small anterior fontanelle has been detected since birth.

During treatment, it is recommended to periodically monitor blood and urine calcium and phosphate levels.

Vitaminum A+D Medana and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• The absorption of vitamin A may be impaired when taken with:
• cholestyramine,
• cholestypol,
• orally administered neomycin,
• mineral oil. In such cases, it may be necessary to increase the dose of vitamin A. The reason for decreased absorption of vitamin A may also be the use of orlistat.
• Oral contraceptives increase the concentration of vitamin A in serum.
• Taking vitamin A with other retinoids may lead to increased toxicity.
• High doses of vitamin A, above 50,000 IU, in combination with tetracycline, may cause increased intracranial pressure.
• Concomitant use with alcohol may lead to enhanced hepatotoxic effect.
• Prolonged use of antacids containing aluminum in combination with vitamin D may contribute to increased aluminum levels in the blood and, consequently, to toxic effects of aluminum on bones.
• Concomitant use of antacids containing magnesium and vitamin D may lead to hypermagnesemia, especially in patients with chronic renal failure.
• Concomitant administration of vitamin D and phosphorus-containing medicines increases the risk of hyperphosphatemia.

Vitaminum A+D Medana with food and drink

During treatment, do not consume excessive amounts 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 have a child, she should consult a doctor before taking this medicine.
The decision to supplement vitamin A in pregnant or breastfeeding women will be made by the doctor only in cases where there are absolute deficiencies of this vitamin, and the diet is not sufficient to cover them, and after a thorough assessment of the vitamin A status.
Pregnancy
Taking increased amounts of vitamin A may be hazardous to the fetus.
Do not take 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 child.
Taking increased amounts of vitamin A may be hazardous to the child.
Do not take 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 and operate machinery.

Vitaminum A+D Medana contains benzyl alcohol, sodium, ethanol (from anise flavor) and propylene glycol (E 1520)

The medicine contains 15 mg of benzyl alcohol in each ml of liquid.
Benzyl alcohol may cause allergic reactions.
Do not give to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before taking the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium in each ml of liquid, which means the medicine is considered "sodium-free".
The medicine contains 6 mg of alcohol (ethanol) in each ml of liquid [less than 1 mg of alcohol (ethanol) in a dose of 2 drops of liquid]. The amount of alcohol in 1 ml of this medicine (which corresponds to 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 cause noticeable effects.
The medicine contains 106 mg of propylene glycol in each ml of liquid.

3. How to take Vitaminum A+D Medana

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor 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, do not administer the medicine directly from the packaging to the child's mouth.

Using a higher dose of Vitaminum A+D Medana than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
In acute vitamin A poisoning, especially in children, there is an increase in intracranial pressure and vomiting. In chronic vitamin A poisoning, the following symptoms occur: loss of appetite, double vision, poor well-being, headaches, hair loss, cracking of the lips, excessive excitability, subperiosteal thickening of bones and bone pain, liver and spleen enlargement, hypoplastic anemia (reduced production of blood morphological components: mainly red blood cells, but also granulocytes and platelets), leukopenia, and sometimes increased intracranial pressure and hydrocephalus. In children, premature closure of the epiphyseal plates of long bones occurs.
Symptoms of toxic effects of vitamin D include: hypercalcemia, increased excretion of calcium in the urine (hypercalciuria), kidney calcification, and bone damage. Clinical symptoms of vitamin D overdose were: headaches, lethargy, loss of appetite, excessive thirst, polyuria, nausea, vomiting, constipation, muscle weakness, weight loss, conjunctivitis, photophobia, pancreatitis, rhinorrhea, pruritus, significant increase in body temperature (hyperthermia), decreased libido, increased blood cholesterol levels (hypercholesterolemia), elevated aminotransferase activity, uremia, arterial hypertension, and cardiac arrhythmias.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum A+D Medana can cause side effects, although not everybody gets them.
In rare cases (in less than 1 in 1,000 patients) of hypersensitivity to vitamins or when taking too high doses for a longer period, there may be poisoning referred to as hypervitaminosis D or hypervitaminosis A.
Symptoms of hypervitaminosis D include:

• loss of appetite, gastrointestinal disorders (nausea, vomiting), constipation, dryness of the mouth;
• headaches;
• muscle and joint pain;
• polyuria;
• depression, psychotic disorders;
• weight loss;
• there may be an increase in blood and/or urine calcium levels, kidney stones, and tissue calcification. These symptoms usually disappear after discontinuation of vitamins.

Prolonged intake of vitamin A may cause liver damage.
The following may also occur:

• dizziness and headaches, irritability;
• itching, hair loss, dry skin;
• vomiting, abdominal pain;
• anemia, increased blood calcium levels;
• subcutaneous tissue edema;
• bone and joint pain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather 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 in a temperature 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 stated on the packaging is the last day of the given month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Once opened, the packaging should be used within 4 months.
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. Package contents and other information

• The active substances of the medicine are vitamin A (retinol palmitate) and vitamin D (cholecalciferol). Each ml of liquid (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.
• The other ingredients are: polysorbate 80, benzyl alcohol, glycerol, propylene glycol (E 1520), citric acid, disodium phosphate, anise flavor (contains, among others, propylene glycol (E 1520) and ethanol), purified water.

What Vitaminum A+D Medana looks like and what the package contains

A clear, yellow, viscous liquid with an anise flavor in a 10 ml brown glass bottle, closed with a polyethylene cap with a dropper in a cardboard box.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: