Vitaminum A 12000 + E 70 Hasco

Leaflet attached to the packaging: patient information

VITAMINUM A 12000 + E 70 HASCO

12,000 IU + 70 mg, soft capsules
Retinol palmitate + all-rac-α-Tocopheryl acetate

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is VITAMINUM A 12,000 + E 70 HASCO and what is it used for
• 2. Important information before using VITAMINUM A 12,000 + E 70 HASCO
• 3. How to use VITAMINUM A 12,000 + E 70 HASCO
• 4. Possible side effects
• 5. How to store VITAMINUM A 12,000 + E 70 HASCO
• 6. Contents of the packaging and other information

1. What is VITAMINUM A 12,000 + E 70 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 function, and mucous membrane function. It increases resistance to infections, participates in bone formation and structure, reproduction, fertilization, and embryonic development. Vitamin E participates in many important metabolic processes of carbohydrates (e.g., glucose oxidation and glycogen breakdown) and fats (preventing the oxidation of polyunsaturated fatty acids, which affects the formation of so-called prostaglandins that regulate blood flow through blood vessels). Vitamin E stabilizes cell membranes and intracellular structure membranes, which, for example, prevents damage to red blood cells (so-called hemolysis). VITAMINUM A 12,000 + E 70 HASCO is used as a supplement in geriatrics, ophthalmology (e.g., in cases of corneal softening - so-called xerophthalmia and night blindness), atherosclerosis, disorders of male sexual glands, disorders of puberty, and excessive skin keratinization.

2. Important information before using VITAMINUM A 12,000 + E 70 HASCO

When not to use VITAMINUM A 12,000 + E 70 HASCO:

• if the patient is allergic to the active substances (vitamin A or vitamin E), peanut oil, or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women,
• if the patient has so-called malabsorption syndrome,
• in cases of so-called hypervitaminosis (excess of vitamin A or E, e.g., after overdose),
• if the patient has severe hypertension, glaucoma, or myasthenia, and in the case of vitamin K deficiency.

Warnings and precautions

Before starting to use VITAMINUM A 12,000 + E 70 HASCO, you should discuss it with your doctor, pharmacist, or nurse.
Particular caution should be exercised when using the medicine:

• in people with liver disease (cirrhosis, viral hepatitis), in whom the doctor recommends lower doses of this medicine,
• in people taking oral anticoagulant medications or estrogens, e.g., oral contraceptives,
• when administering other medicines containing vitamin A, due to the possibility of its overdose. Patients who may become pregnant should use effective contraception while taking this medicine. The absorption of vitamin A is reduced in the case of impaired fat absorption and low protein intake.

VITAMINUM A 12,000 + E 70 HASCO and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Administration of neomycin, cholestyramine (cholestypol), or liquid paraffin reduces the absorption of vitamin A. Concurrent use of products containing vitamin A, synthetic analogs of vitamin A (such as acitretin, etretinate, tretinoin), and bexarotene may lead to the occurrence of symptoms of so-called hypervitaminosis (vitamin A overdose). Vitamin A, when administered in high doses, enhances the effect of anticoagulant medications (hydroxycoumarin derivatives). Oral contraceptives may enhance the effect of vitamin A.
Vitamin E may inhibit the effect of vitamin K, especially in people taking anticoagulant medications or estrogens. The use of other antioxidants (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency. Concurrent use of iron preparations weakens the effect of vitamin E, so a few-hour interval should be maintained between taking these medicines. Vitamin E increases the absorption, utilization, and storage of vitamin A and may reduce the need for insulin and some heart medications (so-called cardiac glycosides).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
VITAMINUM A 12,000 + E 70 HASCO should not be used in pregnant women.
Vitamin A passes into breast milk, which may lead to its overdose in the child.
Taking increased amounts of vitamin A may be hazardous to the fetus and child.
Administration of high doses of vitamin E during pregnancy and breastfeeding is not recommended due to the lack of data on the safety of its use.

Driving and operating machinery

Taking VITAMINUM A 12,000 + E 70 HASCO has no effect on the ability to drive vehicles and operate machinery.

VITAMINUM A 12,000 + E 70 HASCO contains peanut oil (peanut oil)

If the patient is allergic to peanuts or soy, this medicine should not be used.

3. How to use VITAMINUM A 12,000 + E 70 HASCO

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The medicine is taken orally.
Unless the doctor recommends otherwise, usually 1 or 2 capsules are taken per day.

Using a higher dose of VITAMINUM A 12,000 + E 70 HASCO than recommended

In case of taking a significantly higher dose of the medicine than recommended, you should consult a doctor or pharmacist.
Long-term use of VITAMINUM A 12,000 + E 70 HASCO may lead to an overdose of the vitamins it contains (vitamin A or E).
A daily dose of 30 mg of retinol (about 100,000 IU of vitamin A) is considered toxic to adults; however, even after taking doses of 10 mg for a longer period, overdose symptoms may occur. In children, daily doses of 7.5-15 mg of retinol given for 30 days may lead to its overdose (so-called hypervitaminosis). Characteristic symptoms of hypervitaminosis A are headaches, nausea, vomiting, swelling of the optic nerve, auditory hallucinations, vision disturbances (mainly in children, due to increased intracranial pressure), swelling of subcutaneous tissue and tissues around long bones, muscle-bone-joint pain, skin and mucous membrane symptoms (dry skin, itching, erythematous rash, cracking of the skin around the mouth; generalized exfoliation of the skin may occur within 24 hours of taking a toxic dose). Additionally, so-called hypercalcemia (elevated calcium levels in the blood), 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, mental, anorexia, pseudo-brain tumor), gum inflammation, symptoms of liver damage (cirrhosis, fibrosis, blood pressure and flow disorders in the portal circulation), 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.
High doses of vitamin E (400-800 IU, i.e., 400-800 mg of all-rac-α-tocopheryl acetate per day) taken for a longer period may cause diarrhea, abdominal pain, and other gastrointestinal disorders, as well as fatigue, weakness, blurred vision, headaches, rash, disorders of sexual gland function, and decreased levels of thyroid hormones in the blood.
In case of any of the above-mentioned overdose symptoms, the use of the medicine should be discontinued, and a doctor or pharmacist should be consulted.

Missing a dose of VITAMINUM A 12,000 + E 70 HASCO

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vitamins A and E are usually well-tolerated.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should inform your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store VITAMINUM A 12,000 + E 70 HASCO

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging.
The expiration date means the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What VITAMINUM A 12,000 + E 70 HASCO contains

• The active substances of the medicine are vitamin A and vitamin E. One soft capsule contains: retinol palmitate (vitamin A) 12,000 IU, all-rac-α-tocopheryl acetate (vitamin E) 70 mg.
• The other ingredients (excipients) are: all-rac-α-tocopherol, purified peanut oil, gelatin, glycerol.

What VITAMINUM A 12,000 + E 70 HASCO looks like and what the packaging contains

The medicine is in the form of oval, tightly filled soft capsules with a smooth and shiny surface. One packaging of the medicine contains 30 soft capsules.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: +48 (22) 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet: