Vitamin a medana

Package leaflet: Information for the patient

VITAMINUM A Medana, 50,000 IU/ml, oral liquid
Retinoli palmitas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What is Vitaminum A Medana and what is it used for
2. Important information before taking Vitaminum A Medana
3. How to take Vitaminum A Medana
4. Possible side effects
5. How to store Vitaminum A Medana
6. Contents of the pack and other information

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

Vitamin A is essential for normal growth processes in the developing organism, as well as for regeneration processes by regulating the formation of new cells, particularly 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, gonads). It affects the body's immune mechanisms. Long-term deficiency of vitamin A leads to drying of the conjunctiva and cornea of the eye (xerophthalmia), night blindness, and in severe cases, permanent damage to the visual organ and blindness; in addition, skin and mucous membrane changes may occur.
Retinol is readily absorbed from the small intestine into the lymph and subsequently stored in the liver. Liver reserves may meet the body's requirement for vitamin A for several months.
The level of vitamin A in the blood of healthy individuals varies slightly depending on the season, age, and diet.

Indications for use
Prophylaxis and treatment of vitamin A deficiency leading to night blindness, corneal inflammation, or xerophthalmia (dry eye syndrome).
Dietary supplementation in conditions associated with increased requirement for vitamin A, such as:

• diarrhea;
• gastrectomy (partial or total surgical removal of the stomach);
• hyperthyroidism;
• chronic infections;
• gastrointestinal diseases (celiac disease, Crohn's disease);
• malabsorption due to pancreatic insufficiency;
• measles;
• severe protein deficiency.

Adjunctive treatment of skin disorders associated with vitamin A deficiency.

2. Important information before using Vitaminum A Medana

When not to use Vitaminum A Medana:

• if the patient is allergic to vitamin A, to plants from the Apiaceae family (formerly Umbelliferae), such as anise, dill, caraway, celery, coriander, parsley, or to anethole, or to any of the other components of this medicine (listed in section 6);
• if the patient has hypervitaminosis A;
• in newborns up to 4 weeks of age (due to the presence of sodium benzoate).

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

• if the patient has severe hypertension, kidney or liver disease, alcoholic disease, glaucoma, or myasthenia gravis;
• if the patient is concurrently taking other medicines containing vitamin A (see section: "Vitaminum A Medana and other medicines");
• in pregnant and breastfeeding women.

Vitaminum A Medana and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Absorption of vitamin A may be impaired when used concomitantly with cholestyramine, colestipol, oral neomycin, or mineral oil. In such cases, an increased dose of vitamin A may be necessary.
• Reduced absorption of vitamin A may also occur with orlistat.
• Oral contraceptives increase vitamin A plasma concentration.
• Concurrent use of vitamin A with other retinoids may increase its toxicity.
• High doses of vitamin A, exceeding 50,000 IU, in combination with tetracyclines, may cause intracranial hypertension.

Vitaminum A Medana with food, drink and alcohol
Concomitant use with alcohol may intensify hepatotoxic effects.
The medicine should be administered with a spoonful of liquid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Vitamin A should not be used in doses exceeding 6,000 IU per day during pregnancy and breastfeeding due to its potential teratogenic effects.
Driving and operating machinery
Vitaminum A Medana has no influence on the ability to drive or operate machinery.
Vitaminum A Medana contains macrogol glycerol ricinoleate, sucrose, sodium, sodium benzoate (E 211), propylene glycol (E 1520), and ethanol (from flavouring).
The medicine may cause indigestion and diarrhoea.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per ml of liquid, meaning the medicine is considered "sodium-free".
The medicine contains 5 mg of sodium benzoate per ml of liquid. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
The medicine contains 6 mg of propylene glycol per ml of liquid. Use of the medicine is not recommended in newborns (under 4 weeks of age).
The medicine contains 6 mg of alcohol (ethanol) per 1 ml of liquid [24 mg of alcohol (ethanol) in 4 ml of liquid]. The amount of alcohol in 4 ml of this medicine (corresponding to approximately 120 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.

3. How to use Vitaminum A Medana

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The medicine is taken orally.
Administer with a dropper.
To ensure accurate dosing, hold the bottle at a 45° angle while counting drops.
Do not administer the medicine directly from the container into the child's mouth due to the risk of overdose.

For vitamin A deficiency prophylaxis:

• Infants over 4 weeks of age and children up to 10 years: 1 drop per day (i.e. approximately 1,670 IU per day)
• Men (adolescents and adult men): 2 drops per day (i.e. approximately 3,330 IU per day)
• Women (adolescents and adult women): 1 drop per day (i.e. approximately 1,670 IU per day)
  Pregnant women: 1 drop per day (i.e. approximately 1,670 IU per day)
• Breastfeeding women: 3 drops per day (i.e. approximately 5,000 IU per day)

For treatment of deficiency, the dosage should be determined by a physician depending on the severity
of the deficiency.

Xerophthalmia:

• Infants from 6 months to 1 year of age: 60 drops per day (i.e. approximately 100,000 IU per day)
• Children over 1 year of age: 120 drops per day (i.e. approximately 200,000 IU per day)
• Adults: 15 to 30 drops per day (i.e. approximately 25,000–50,000 IU per day)

Measles:

• Infants from 6 months to 1 year of age: single dose of 60 drops (approximately 100,000 IU)
• Children over 1 year of age: single dose of 120 drops (approximately 200,000 IU)

Use of a higher than recommended dose of Vitaminum A Medana
If more medicine has been taken than recommended, consult your doctor or pharmacist immediately.
In acute vitamin A poisoning, especially in children, increased intracranial pressure and vomiting occur.
In chronic vitamin A poisoning the following may occur:

• loss of appetite;
• double vision;
• malaise;
• headache, hair loss, cracking of lips;
• excessive irritability;
• subperiosteal thickening of bones and bone pain;
• enlargement of the liver and spleen;
• hypoplastic anemia, leukopenia;
• sometimes increased intracranial pressure and hydrocephalus;
• premature epiphyseal closure of long bones in children.

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

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody experiences them.
Adverse reactions generally do not occur when the medicine is administered at the recommended doses.
Taking vitamin A in higher doses may lead to the development of hypervitaminosis A. In such cases, the following may occur:

• dizziness and headache;
• irritability;
• loss of appetite;
• cheilitis;
• hair loss;
• dry skin;
• vomiting;
• abdominal pain;
• anemia;
• elevated calcium levels in the blood;
• subcutaneous tissue edema;
• bone and joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician 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 Medana

Keep the medicine out of the 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 package following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Once opened, the container should be used within 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Vitaminum A Medana contains

• The active substance is retinol palmitate (vitamin A). Each ml of oral liquid (approximately 30 drops) contains 50,000 IU of retinol palmitate. Each drop contains approximately 1,670 IU of vitamin A.
• Other ingredients are: macrogol glycerol ricinoleate, sucrose, anise flavour [(contains, among others, propylene glycol (E 1520), ethanol], sodium benzoate, sodium salicylate, citric acid, purified water.

What Vitaminum A Medana looks like and contents of the pack
10 ml of liquid in an amber glass bottle with a tamper-evident cap made of HDPE polyethylene, with a dropper made of LDPE polyethylene, packed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz