Vitaminum A Hasco

Package Leaflet: Information for the Patient

VITAMINUM A HASCO

2500 IU, soft capsules
(Retinol palmitate)

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section
• 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is VITAMINUM A HASCO and what is it 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. Package contents and other information

1. What is VITAMINUM A HASCO and what is it used for

Vitamin A plays a crucial role in the process of vision (ensuring proper retina function),
is necessary for growth, regeneration, cell differentiation, skin and mucous membrane function, and
mucous membrane function. It increases resistance to infections, participates in bone formation and structure, in
reproduction, fertilization, and embryonic development.
The medicine is used prophylactically to prevent vitamin A deficiencies.

2. Important information before taking VITAMINUM A HASCO

When not to take VITAMINUM A HASCO

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

Warnings and precautions

Before starting to take VITAMINUM A HASCO, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking VITAMINUM A HASCO:

• in patients with liver diseases (liver cirrhosis, viral hepatitis);
• during concurrent administration with other medicines containing vitamin A, due to the risk of overdose. Vitamin A absorption is reduced in cases of fat absorption disorders and low protein intake.

VITAMINUM A HASCO and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Vitamin A absorption from the gastrointestinal tract is reduced in the presence of neomycin, cholestyramine, and liquid paraffin.
Taking synthetic retinoids (e.g., acitretin, isotretinoin, tretinoin) with VITAMINUM A HASCO may cause symptoms of hypervitaminosis A.
Vitamin A enhances the effect of some anticoagulant medicines (e.g., warfarin derivatives).
Oral contraceptives may enhance the effect of vitamin A.
Taking vitamin A may affect the results of some biochemical tests (blood and urine nitrogen levels, serum calcium, cholesterol, and triglyceride levels) and some hematological tests (erythrocyte and leukocyte counts in blood).

Pregnancy, breastfeeding, and fertility

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 taking this medicine.

Pregnancy

Pregnant women may take VITAMINUM A HASCO only after consulting their doctor and only in the doses prescribed by them, as taking excessive amounts of vitamin A may be hazardous to the fetus.
During treatment, the patient should not consume excessive amounts of foods rich in vitamin A (e.g., liver), as this may lead to overdose.

Breastfeeding

Breastfeeding women may take VITAMINUM A HASCO only after consulting their doctor and only in the doses prescribed by them, as taking excessive amounts of vitamin A may be hazardous to the child.

Driving and using machines

Taking VITAMINUM A HASCO does not affect the ability to drive and use machines.
VITAMINUM A HASCO containspeanut oil (from peanuts). If the patient is allergic to peanuts or soy, they should not take this medicine.

3. How to take VITAMINUM A HASCO

This medicine should always be taken exactly as described in the patient information leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Recommended dose
Unless the doctor has prescribed otherwise, the usual dose is 1 or 2 capsules per day.
If the patient feels that the effect of VITAMINUM A HASCO is too strong or too weak, they should consult their doctor.

Taking a higher dose of VITAMINUM A HASCO than recommended

When taking vitamin A in the recommended doses, no side effects are observed. Symptoms of acute vitamin A poisoning may occur after exceeding the dose of 75,000 - 350,000 IU in children and 1,000,000 IU in adults. Characteristic symptoms of hypervitaminosis A are headaches, nausea, vomiting, optic disc swelling, auditory hallucinations, vision disturbances (mainly in children, due to increased intracranial pressure), subcutaneous tissue and periosteal edema, muscle and bone pain, skin and mucous membrane symptoms (dry skin, itching, erythematous rash, lip cracking; generalized exfoliation of the skin may occur within 24 hours of taking a toxic dose). Additionally, hypercalcemia, petechiae, 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, psychiatric symptoms, anorexia, pseudo-brain tumor) and gum inflammation, liver damage symptoms (cirrhosis, fibrosis, portal circulation disorders), vision disturbances (double vision), respiratory function disorders, dermatological changes (alopecia, skin inflammation, rash, erythema, pruritus) and skin discoloration, osteoporosis ,bone hardening (osteosclerosis) and other changes considered less specific.
In case of any of the above-mentioned overdose symptoms, the patient should stop taking the medicine and consult their doctor or pharmacist.

Missing a dose of VITAMINUM A HASCO

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, VITAMINUM A HASCO can cause side effects, although not everybody gets them.
The medicine is usually well-tolerated, but if the patient experiences any worrying symptoms, they should consult their doctor (see also section 3).
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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, 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 help to gather more information on the safety of the medicine.

5. How to store VITAMINUM A HASCO

The medicine should be stored out of sight and reach of children.
Store in the original package, at a temperature below 25°C, protected from light.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What VITAMINUM A HASCO contains

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

What VITAMINUM A HASCO looks like and what the package contains

Oval, light green, transparent capsules with a smooth, shiny surface.
One package of the medicine contains 50 soft capsules.

Marketing authorization holder and manufacturer

“HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242E
Medicine Information
tel. +48 (22) 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet: