Vitaminum a hasco

Package leaflet: Information for the patient

Vitaminum A Hasco
12000 IU, soft capsules
(Retinoli palmitas)
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please 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 you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Do not use in pregnant women.
Table of contents of the leaflet:

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 package and other information

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

Vitamin A plays an important role in the visual process (ensures proper functioning of the retina), is essential for growth, regeneration, cell differentiation, and for the function of skin and mucous membranes and epithelial linings. It enhances resistance to infections, participates in bone formation and bone structure, in reproduction, fertilization, and embryonic development.
Vitaminum A Hasco is used in the treatment of vitamin A deficiency and as an adjunct in the treatment of skin diseases (e.g. acne, ichthyosis).

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 pregnancy; in cases of hypervitaminosis A (excess vitamin A, e.g. due to overdose); in severe arterial hypertension, glaucoma, or myasthenia gravis (Myasthenia gravis).

Warnings and precautions
Exercise particular caution when using Vitaminum A Hasco:

• in patients with liver diseases (e.g. liver cirrhosis, viral hepatitis) – the physician will recommend appropriately lower doses;
• when administered concurrently with other medicines containing vitamin A, due to the risk of overdose. Female patients of childbearing potential should use effective contraception during treatment with this medicine.

Vitamin A absorption is reduced in the case of fat malabsorption and when dietary protein intake is low.

Interaction of Vitaminum A Hasco with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to use.
Absorption of vitamin A from the gastrointestinal tract is reduced by neomycin, cholestyramine (colestipol), and liquid paraffin.
Concurrent use of synthetic retinoids (e.g. acitretin, isotretinoin, tretinoin) and bexarotene with Vitaminum A Hasco may cause symptoms of hypervitaminosis A.
Vitamin A, when administered in high doses, may enhance the effect of certain anticoagulant drugs (e.g. hydroxycoumarin derivatives).
Oral contraceptives may potentiate the effects of vitamin A.

Pregnancy, breastfeeding, and effects on 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 before taking this medicine.

Pregnancy
Vitaminum A Hasco must not be used during pregnancy.

Breastfeeding
Vitamin A passes into breast milk, which may lead to overdose in the infant. Taking excessive amounts of vitamin A may be harmful to 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 peanut oil (arachis 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. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Recommended dose
Unless otherwise advised by a physician, the usual dose is 1 or 2 capsules per day.
If you feel that the effect of Vitaminum A Hasco is too strong or too weak, consult your doctor.
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 doses 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
periosseous tissue edema, musculoskeletal pain, and skin and mucous membrane symptoms
(dry, itchy skin, erythematous dermatitis, cracking of the lip epithelium; 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 have been
observed. Very significant and prolonged vitamin A overdose may be accompanied by other
adverse effects affecting the circulatory system (hematological changes, anemia, thrombocytopenia,
neutropenia), the 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) and skin pigmentation, osteoporosis, bone
sclerosis, and other less specific changes.
If any of the above-mentioned symptoms of overdose occur, discontinue use of the medicine and
contact a doctor 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, but 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, medical advice should be sought.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions 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, phone: +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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum A Hasco

Keep the medicine out of sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from moisture.
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 pack 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 12,000 IU of vitamin A.
• The other excipients are: all-rac-α-tocopherol, purified arachis oil, gelatin, glycerol, carmine red (E 124).

What Vitaminum A Hasco looks like and contents of the pack
Oval, smooth, glossy, red soft capsules.
One pack contains 50 soft capsules.

Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
tel. +48 (71) 352 95 22
Information on the medicinal product
tel. +48 (22) 742 00 22
e-mail: [email protected]