Vitamin a hasco

Package leaflet: Information for the patient

VITAMINUM A HASCO
2500 IU, soft capsules
(Retinoli palmitas)
Read this leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact a doctor.

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 the visual process (ensuring proper retinal function),
is necessary for growth, tissue regeneration, cell differentiation, and for the normal function of skin, epithelial cells, 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.
The medicine is used prophylactically to prevent vitamin A deficiency.

2. Important information before using VITAMINUM A HASCO

When not to use VITAMINUM A HASCO

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• during hypervitaminosis A, in severe hypertension, glaucoma or myasthenia gravis.

Warnings and precautions
Before starting treatment with VITAMINUM A HASCO, consult your doctor or pharmacist.
Exercise particular caution when using VITAMINUM A HASCO:

• in patients with liver disorders (e.g. liver cirrhosis, viral hepatitis);
• during concomitant administration with other medicinal products containing vitamin A, due to the risk of overdose. Absorption of vitamin A is reduced in cases of fat malabsorption and low protein intake.

VITAMINUM A HASCO and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Gastrointestinal absorption of vitamin A is reduced in the presence of neomycin, cholestyramine, or liquid paraffin.
Concomitant use of synthetic retinoids (e.g. acitretin, isotretinoin, tretinoin) with VITAMINUM A HASCO may cause symptoms of hypervitaminosis A.
Vitamin A may enhance the effect of certain anticoagulant drugs (e.g. warfarin derivatives).
Oral contraceptives may enhance the effects of vitamin A.
Administration of vitamin A may affect the results of certain biochemical tests (blood and urine nitrogen levels, plasma calcium, plasma cholesterol and triglycerides) as well as certain haematological tests (number of erythrocytes and leukocytes in blood).

Pregnancy, breastfeeding and fertility
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
Pregnant women may take VITAMINUM A HASCO only after consultation with a doctor and at doses specifically recommended by the doctor, because excessive intake of vitamin A may be harmful to the foetus.
During treatment, avoid excessive consumption of foods rich in vitamin A (e.g. liver), as this may lead to overdose.

Breastfeeding
Women who are breastfeeding may take VITAMINUM A HASCO only after consultation with a doctor and at doses specifically recommended by the doctor, because excessive intake of vitamin A may be harmful to the infant.

Driving and operating machinery
Taking VITAMINUM A HASCO has no effect on the ability to drive or operate machinery.

VITAMINUM A HASCO contains peanut oil. If the patient is allergic to peanuts or soy, this medicine should not be used.

3. How to use VITAMINUM A HASCO

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
This medicine is taken orally.
Recommended dose
Unless otherwise prescribed by a physician, the usual dose is 1 or 2 capsules per day.
If the effect of VITAMINUM A HASCO appears too strong or too weak, consult a physician.
Use of a higher than recommended dose of VITAMINUM A HASCO
When vitamin A is used at recommended doses, adverse effects are not observed. Symptoms
of acute vitamin A poisoning may occur after exceeding a dose of 75,000–350,000 IU in children and
1,000,000 IU in adults. Characteristic symptoms of hypervitaminosis A include headache, nausea,
vomiting, optic disc swelling, auditory hallucinations, visual disturbances (mainly in children due to
increased intracranial pressure), subcutaneous tissue swelling and swelling of tissues around long bones,
musculoskeletal and joint pain, and symptoms affecting the skin and mucous membranes (dry, itchy skin,
erythematous dermatitis, cracking of the lip epidermis; generalized desquamation of the epidermis may occur within 24 hours after ingestion of a toxic dose). Additionally, hypercalcemia, petechiae, bleeding,
nervousness, fatigue, irritability, and drowsiness have been observed. Very high and prolonged
overdosing of vitamin A may be accompanied by other adverse effects involving the circulatory system
(hematological changes, anemia, thrombocytopenia, neutropenia), central nervous system (neurological and psychiatric symptoms, anorexia, pseudotumor cerebri), as well as gingivitis, liver damage symptoms (cirrhosis, fibrosis, portal circulation disorders), visual disturbances (double vision), respiratory dysfunction, dermatological changes (alopecia, dermatitis, rash, erythema, pruritus), skin discoloration, osteoporosis, bone hardening (osteosclerosis), and other changes considered less specific.
If any of the above-mentioned symptoms of overdose occur, discontinue use of the medicine and contact a physician or pharmacist.
Missed dose of VITAMINUM A HASCO
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The medicine is usually well tolerated; however, if any disturbing symptoms occur,
you should contact your doctor (see also section 3).
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
you should consult your doctor.

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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: Al. 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 may also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store VITAMINUM A HASCO

Keep this medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C, and 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What VITAMINUM A HASCO contains

• The active substance is vitamin A in the form of retinyl palmitate (Retinoli palmitas). One capsule contains 2500 IU of vitamin A.
• Other components are: all-rac-α-tocopherol, purified arachis oil, gelatin, glycerol, patent blue (E 131).

What VITAMINUM A HASCO looks like and contents of the pack
Oval, light green, transparent capsules with a smooth, glossy surface.
One pack contains 50 soft capsules.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242E
Information on the Medicine
tel. +48 (22) 742 00 22
e-mail: [email protected]