Vitamin a hasco

Package leaflet: Information for the patient

Vitaminum A Hasco
45,000 IU/ml, oral drops, solution
(Retinoli palmitas)
Please read the entire leaflet carefully before use, as it contains important information for the patient.

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

Table of contents:

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

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

Vitamin A plays an essential role in vision (ensuring proper retinal function), is necessary for growth, tissue regeneration, cell differentiation, and the proper functioning of the skin and mucous membranes. It enhances resistance to infections, participates in bone formation and bone structure development, and is involved in reproduction, fertilization, and embryonic development.
Vitaminum A Hasco is used in the treatment of symptoms of vitamin A deficiency (avitaminosis), such as night blindness, dryness, keratinization and corneal ulceration, and keratomalacia.
Vitamin A is also used clinically for prophylaxis in justified cases (e.g., in infants and children with malabsorption disorders), and as adjunctive therapy in measles, skin diseases with excessive desquamation and keratinization of the epidermis (psoriasis, acne, ichthyosis), and gastrointestinal and respiratory tract diseases.

2. Important information before using Vitaminum A Hasco

When not to use Vitaminum A Hasco

• if the patient is allergic to the active substance (vitamin A) or to any of the other ingredients of this medicine (listed in section 6);
• in case of vitamin A overdose (so-called hypervitaminosis A);
• in patients with severe hypertension, glaucoma, or myasthenia gravis.

Warnings and precautions
Exercise special caution when using Vitaminum A Hasco

• in patients with liver disorders (liver cirrhosis, viral hepatitis);
• when administering concurrently with other medicinal products containing vitamin A, due to the risk of overdose. The absorption of vitamin A is reduced in cases of fat malabsorption and low protein intake.

Consult a physician, even if the above warnings refer to conditions that occurred
in the past.
Vitaminum A Hasco and other medicines
Inform your doctor about all medicines currently used, as well as any medicines you plan to use.
The absorption of vitamin A from the gastrointestinal tract is reduced in the presence of neomycin, cholestyramine, or liquid paraffin. Concurrent use of medicinal products containing vitamin A (carotenoids) and synthetic vitamin A analogs (e.g. acitretin, isotretinoin, tretinoin) as well as bexarotene may lead to symptoms of hypervitaminosis A. Vitamin A administered in doses several times higher than recommended may enhance the effect of anticoagulant drugs (warfarin derivatives). Oral contraceptives may increase serum vitamin A concentration. Vitamin A intake may affect the results of certain biochemical tests (blood and urine nitrogen, serum calcium, serum cholesterol and triglycerides) and certain hematological tests (number of erythrocytes and leukocytes in blood).

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

Pregnancy
This medicine may be used in pregnant women only on prescription.
During treatment, excessive intake of foods rich in vitamin A should be avoided.

Breastfeeding
This medicine may be used in breastfeeding women only on prescription, as higher doses may cause symptoms of overdose in the infant.

Driving and operating machinery
Taking Vitaminum A Hasco has no influence on the ability to drive or operate machinery.

Vitaminum A Hasco contains butylhydroxyanisole, therefore the medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes.

3. How to use Vitaminum A Hasco

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor.
Oral administration.

• Prophylactically, in clinically justified cases:
• infants and children up to 2 years of age: 1 drop (1,607 IU) per day;
• children from 2 to 15 years of age: 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 of age: 100,000 IU, i.e. 62 drops (as a single dose);
• children over 1 year of age: 200,000 IU, i.e. 124 drops (as a single dose).

Xerophthalmia (keratomalacia):

• infants up to 6 months of age: 50,000 IU, i.e. 31 drops (as a single dose, repeated the following day and after four weeks);
• infants from 6 months to 1 year of age: 100,000 IU, i.e. 62 drops (as a single dose, repeated the following day and after four weeks);
• children over 1 year of age: 200,000 IU, i.e. 124 drops (as a single dose, repeated the following day and after four weeks);
• adults: 25,000 IU to 50,000 IU, i.e. 16 to 31 drops per day.

The medicine may be given undiluted or mixed with a beverage to infants and young children.
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, the medicine should not be administered directly from the bottle into the patient's mouth.
Use of a higher than recommended dose of Vitaminum A Hasco
Symptoms of acute vitamin A toxicity may occur in children after exceeding a dose of 75,000–350,000
IU, and 1,000,000 IU in adults.
Characteristic symptoms of hypervitaminosis A include headache, nausea, vomiting, optic disc
edema, auditory hallucinations, visual disturbances (mainly in children, due to increased intracranial
pressure), subcutaneous and periosseous tissue swelling, musculoskeletal pain, and skin and epithelial
symptoms (dry, itchy skin, erythematous dermatitis, cracking of the lips; generalized desquamation of
the epidermis may occur within 24 hours after ingestion of a toxic dose). Additionally, hypercalcemia,
petechiae, hemorrhages, nervousness, fatigue, irritability, and drowsiness may be observed.
Very significant and prolonged vitamin A overdose may be accompanied by other adverse
effects affecting the circulatory system (hematological changes, anemia, thrombocytopenia, neutropenia),
central nervous system (neurological and psychiatric symptoms, anorexia, pseudotumor cerebri), as
well as gingivitis, signs of liver damage (cirrhosis, fibrosis, portal circulation disorders), visual disturbances
(diplopia), respiratory dysfunction, dermatological changes (alopecia, dermatitis, rash, erythema, pruritus)
and skin pigmentation, osteoporosis, bone hardening (osteosclerosis), and other changes considered less
specific.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Vitaminum A Hasco
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Administration of vitamin A according to the indications and at recommended doses does not involve the risk of specific adverse reactions.
Symptoms of adverse reactions are associated with overdose (see also section 3).
In some individuals, other adverse reactions may occur during treatment with Vitaminum A Hasco.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 .
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Vitaminum A Hasco

Store below 8 °C. Keep in closed packaging to protect from light.
Keep the medicine out of 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 specified month.
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 Hasco contains

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

What Vitaminum A Hasco looks like and contents of the pack
Vitaminum A Hasco is a yellow, transparent solution (slight opalescence is acceptable) with a lemon odor.
One package contains 10 ml of the medicinal product.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel. + 48 (22) 742 00 22
email: [email protected]