Vitaminum A Medana

Leaflet attached to the packaging: patient information

VITAMINUM A Medana, 50,000 IU/ml, oral liquid

Retinol palmitate

Read the leaflet carefully before using 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 pass it on 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Vitamin A is necessary for the proper course of growth processes in a young organism, 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, a pigment that determines the ability to see in the dark. It participates in the metabolism of proteins, fats, and carbohydrates, and cooperates with some endocrine glands (thyroid, adrenal glands, gonads). It affects the immune mechanisms of the body. Prolonged vitamin A deficiency leads to drying of the conjunctiva and cornea of the eye (xerophthalmia), night blindness, and in severe cases to permanent damage to the visual organ and blindness; additionally, changes on the skin and mucous membranes may occur. Retinol is easily absorbed from the small intestine into the lymph, and then stored in the liver. Liver stores can cover the body's need for vitamin A for several months. The level of vitamin A in the blood of a healthy person undergoes slight fluctuations, depending on the time of year, age, and consumed products.

Indications for use

Prevention and treatment of vitamin A deficiency, leading to night blindness, corneal inflammation, or xerophthalmia (dry eye syndrome).
Supplementation of the diet in conditions where increased demand for vitamin A may occur, such as:

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

Supportive treatment in skin diseases related to 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 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
• in newborns up to 4 weeks of age (due to the content of sodium benzoate).

Warnings and precautions

Particular caution should be exercised when using Vitaminum A Medana:

• if the patient has severe hypertension, kidney and liver diseases, alcoholic disease, glaucoma, or myasthenia;
• if the patient is 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Absorption of vitamin A may be impaired when taking cholestyramine, colestipol, orally administered neomycin, or mineral oil. In such cases, it may be necessary to increase the dose of vitamin A.
• Orlistat may also cause reduced absorption of vitamin A.
• Oral contraceptives increase the concentration of vitamin A in the blood.
• 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.

Vitaminum A Medana with food, drink, and alcohol

Concomitant use with alcohol may lead to enhanced hepatotoxic effects.
The medicine should be administered in a spoonful of liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 harmful effects on the fetus.

Driving and operating machinery

Vitaminum A Medana does not affect the ability to drive and operate machinery.

The medicine Vitaminum A Medana contains macrogolglycerol ricinoleate, sucrose, sodium, sodium benzoate (E 211), propylene glycol (E 1520), and ethanol (from flavor)

The medicine may cause gastrointestinal disorders and diarrhea.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per ml of liquid, which means it 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 whites of the eyes) in newborns (up to 4 weeks of age).
The medicine contains 6 mg of propylene glycol per ml of liquid. It is not recommended to use the medicine 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) per 4 ml of liquid]. The amount of alcohol in 4 ml of this medicine (which corresponds 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 have noticeable effects.

3. How to use Vitaminum A Medana

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Administer in a spoonful of liquid.
To accurately measure the dose, the bottle should be held at a 45-degree angle while counting the drops.
The medicine should not be administered directly from the packaging to the child's mouth due to the risk of overdose.
In the prevention of vitamin A deficiency

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

In the treatment of vitamin A deficiency, the dosage should be determined by a doctor, depending on the degree of deficiency.
Xerophthalmia

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

Measles

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

Using a higher dose of Vitaminum A Medana than recommended

If a higher dose of the medicine is taken than the recommended dose, the patient should immediately consult a doctor or pharmacist.
In acute vitamin A poisoning, especially in children, there is an increase in intracranial pressure and vomiting.
In chronic vitamin A poisoning, the following occur:

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

Missing a dose of Vitaminum A Medana

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are unlikely to occur when the medicine is taken in the recommended doses.
Taking vitamin A in higher doses may lead to the development of hypervitaminosis A. The following may then occur:

• dizziness and headaches;
• irritability;
• loss of appetite;
• nausea;
• hair loss;
• dry skin;
• vomiting;
• abdominal pain;
• anemia;
• increased calcium levels in the blood;
• swelling of subcutaneous tissue;
• bone and joint pain.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should consult a 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
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 Medana

The medicine should be stored 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.
The opened packaging should be used within 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vitaminum A Medana contains

• The active substance of the medicine 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.
• The other ingredients are: macrogolglycerol ricinoleate, sucrose, anise flavor [(contains, among others, propylene glycol (E 1520), ethanol], sodium benzoate, sodium salicylate, citric acid, purified water.

What Vitaminum A Medana looks like and what the packaging contains

10 ml of liquid in an orange glass bottle with a polyethylene HDPE cap with a security ring, a polyethylene LDPE dropper, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +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 leaflet: