Vitaminum A Hasco

Package Leaflet: Information for the Patient

Vitaminum A Hasco

45,000 IU/ml, oral drops, solution
(Retinol palmitate)

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

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

Table of Contents of the Leaflet:

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

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

Vitamin A plays an essential role in the process of vision (ensuring proper functioning of the retina), is necessary for growth, regeneration, differentiation of cells, skin and mucous membrane functions, and mucous membrane protection. It increases resistance to infections, participates in bone calcification and structure formation, in the process of reproduction, fertilization, and embryonic development.
Vitaminum A Hasco is used to treat symptoms of avitaminosis (xerophthalmia), such as night blindness, dryness, keratinization, and corneal ulceration, as well as keratomalacia.
Vitamin A is also used in clinically justified prophylaxis (e.g., in infants and children with absorption disorders) and as an adjunct in the treatment of measles, skin diseases with excessive scaling and keratinization of the skin (psoriasis, acne, ichthyosis), gastrointestinal and respiratory diseases.

2. Important information before using Vitaminum A Hasco

When not to use Vitaminum A Hasco

Myasthenia gravis).

Warnings and precautions

Be particularly cautious when using Vitaminum A Hasco

You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Vitaminum A Hasco and other medicines

Tell your doctor about all the medicines you are taking now and any medicines you plan to take.
The absorption of vitamin A from the gastrointestinal tract is limited in the presence of neomycin, cholestyramine, and liquid paraffin. Concurrent use of medicines containing vitamin A (carotenes) and synthetic analogs of vitamin A (e.g., acitretin, isotretinoin, tretinoin) and bexarotene may lead to the occurrence of symptoms of hypervitaminosis A. Vitamin A administered in doses several times higher than recommended enhances the effect of anticoagulant medicines (warfarin derivatives). Oral contraceptives may increase the concentration of vitamin A in serum. Taking vitamin A may affect the results of some biochemical tests (nitrogen concentration in blood and urine, calcium in serum, cholesterol, and triglycerides in serum) and the results of some hematological tests (red and white blood cell count in blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The medicine can be used in pregnant women only under medical supervision.
During treatment, avoid excessive amounts of foods rich in vitamin A.
Breastfeeding
The medicine can be used in breastfeeding women only under medical supervision, as it may cause overdose symptoms in the child in higher doses.

Driving and using machines

Taking Vitaminum A Hasco does not affect the ability to drive and use machines.
Vitaminum A Hasco containsbutylhydroxyanisole, so the medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Vitaminum A Hasco

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor.
Oral administration.

• Prophylactically, in clinically justified cases
• infants and children up to 2 years: 1 drop (1,607 IU) per day;
• children from 2 to 15 years: 1 to 2 drops (1,607 IU to 3,214 IU) per day;
• adults: 2 to 3 drops (3,214 IU to 4,821 IU) per day.
• Therapeutically

Measles:

• infants from 6 months to 1 year: 100,000 IU, i.e., 62 drops (in a single dose);
• children over 1 year: 200,000 IU, i.e., 124 drops (in a single dose).

Xerophthalmia (keratomalacia):

• infants up to 6 months: 50,000 IU, i.e., 31 drops (in a single dose, repeated the next day and after four weeks);
• infants from 6 months to 1 year: 100,000 IU, i.e., 62 drops (in a single dose, repeated the next day and after four weeks);
• children over 1 year: 200,000 IU, i.e., 124 drops (in a single dose, repeated the next day and after four weeks);

adults: 25,000 IU to 50,000 IU, i.e., 16 to 31 drops per day.

Infants and young children can be given the medicine undiluted or mixed with a drink.
If you feel that the effect of Vitaminum A Hasco is too strong or too weak, consult your doctor.

Due to the risk of overdose, do not give the medicine directly from the bottle to the patient's mouth.

Using a higher dose of Vitaminum A Hasco than recommended

Symptoms of acute vitamin A poisoning may occur in children after exceeding the dose of 75,000 - 350,000 IU, and 1,000,000 IU in adults.
Characteristic symptoms of hypervitaminosis A are headaches, nausea, vomiting, swelling of the optic nerve heads, auditory hallucinations, vision disturbances (mainly in children, due to increased intracranial pressure), swelling of subcutaneous tissue and tissues around long bones, muscle and bone pain, skin and mucous membrane symptoms (dry skin, itching, redness, cracking of the skin around the mouth; generalized exfoliation of the skin may occur within 24 hours of taking a toxic dose). Additionally, hypercalcemia, bruising, bleeding, nervousness, fatigue, irritability, and drowsiness have been observed.
Very significant and prolonged overdose of vitamin A may be accompanied by other adverse symptoms related to the circulatory system (hematological changes, anemia, thrombocytopenia, neutropenia), central nervous system (neurological, mental symptoms, anorexia, pseudo-brain tumor) and gingivitis, liver damage symptoms (cirrhosis, fibrosis, disturbances of portal circulation), vision disturbances (double vision), respiratory function disorders, dermatological changes (hair loss, skin inflammation, rash, redness, itching) and skin discoloration, osteoporosis,bone hardening (osteosclerosis) and other changes considered less specific.
If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Vitaminum A Hasco

Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum A Hasco can cause side effects, although not everybody gets them.
Administration of vitamin A according to the indications and in the recommended doses is not associated with the risk of specific side effects.
Symptoms of side effects are related to overdose of the medicine (see also section 3).
In some people, during the use of Vitaminum A Hasco, other side effects may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 allow for more information to be collected on the safety of the medicine.

5. How to store Vitaminum A Hasco

Store in a temperature below 8°C. Store in closed containers to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
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. Contents of the pack and other information

What Vitaminum A Hasco contains

• The active substance of Vitaminum A Hasco is vitamin A in the form of retinol palmitate stabilized with tocopherol. 1 ml of the medicine (about 28 drops) contains 45,000 IU of vitamin A. 1 drop of the medicine contains about 1,607 IU of vitamin A.
• The other excipients are: all-rac-α-tocopherol, natural vitamin E, butylhydroxyanisole, citric acid monohydrate, disodium phosphate dodecahydrate, sodium saccharin, macrogol glycerol hydroxystearate, glycerol, lemon flavor, purified water.

What Vitaminum A Hasco looks like and what the pack contains

Vitaminum A Hasco is a clear (acceptable opalescence) yellow solution with a lemon scent.
One pack contains 10 ml of the medicine.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. +48 (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: