Vitamin a 12000 + e 70 hasco

Package leaflet: information for the patient

VITAMINUM A 12000 + E 70 HASCO
12,000 IU + 70 mg, soft capsules
Retinol palmitate + int-rac-α-Tocopheryl acetate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents

1. What VITAMINUM A 12000 + E 70 HASCO is and what it is used for
2. Important information before taking VITAMINUM A 12000 + E 70 HASCO
3. How to take VITAMINUM A 12000 + E 70 HASCO
4. Possible side effects
5. How to store VITAMINUM A 12000 + E 70 HASCO
6. Contents of the pack and other information

1. What VITAMINUM A 12000 + E 70 HASCO is and what it is used for

Vitamin A plays an essential role in vision (ensuring proper function of the retina), is necessary for growth, regeneration, and cell differentiation, as well as for the function of skin, epithelial tissues, and mucous membranes. It enhances resistance to infections and participates in bone formation, bone structure development, reproduction, fertilization, and embryonic development. Vitamin E is involved in many important metabolic processes of carbohydrates (e.g., glucose oxidation and glycogen breakdown) and fats (by preventing oxidation of polyunsaturated fatty acids, it influences the formation of prostaglandins, which regulate, among other things, blood flow through blood vessels). Vitamin E stabilizes cell membranes and intracellular structures, thus preventing damage to red blood cells (so-called hemolysis).
VITAMINUM A 12000 + E 70 HASCO is used as supportive treatment in geriatrics, ophthalmology (e.g., in cases of corneal softening—so-called xerophthalmia—and night blindness), atherosclerosis, disorders of male reproductive gland function, disturbances during puberty, and excessive keratinization of the skin.

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,
• in patients with malabsorption syndrome,
• in cases of hypervitaminosis (excess vitamin A or E, e.g. due to overdose),
• in patients with severe hypertension, glaucoma, myasthenia, or vitamin K deficiency.

Warnings and precautions
Before starting treatment with VITAMINUM A 12 000 + E 70 HASCO, consult a doctor, pharmacist, or nurse.
Exercise particular caution when using this medicine:

• in patients with liver diseases (e.g. cirrhosis, viral hepatitis), in whom the doctor may recommend lower doses of this medicine,
• in patients concurrently taking oral anticoagulants or estrogens, e.g. oral contraceptives,
• when other medicines containing vitamin A are administered simultaneously, due to the risk of vitamin A overdose. Women of childbearing potential should use effective contraception during treatment with this medicine. Absorption of vitamin A is reduced in fat malabsorption disorders and when dietary protein intake is low.

VITAMINUM A 12 000 + E 70 HASCO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Administration of neomycin, cholestyramine (colestipol), or liquid paraffin reduces the absorption of vitamin A. Concurrent use of products containing vitamin A, synthetic vitamin A analogs (e.g. acitretin, etretinate, tretinoin), or bexarotene may lead to symptoms of hypervitaminosis (vitamin A overdose). Vitamin A, when administered in high doses, enhances the effect of anticoagulant drugs (hydroxycoumarin derivatives). Oral contraceptives may enhance the effects of vitamin A.
Vitamin E may inhibit the action of vitamin K, especially in patients taking anticoagulants or estrogens. Concurrent use of other antioxidants (vitamin C, selenium, ubiquinone, sulfur-containing amino acids) may alleviate some symptoms of vitamin E deficiency. Simultaneous use of iron preparations reduces the effectiveness of vitamin E; therefore, a several-hour interval between taking these medicines is recommended. Vitamin E enhances the absorption, utilization, and storage of vitamin A and may reduce the requirement for insulin and certain cardiac drugs (so-called cardiac glycosides).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
VITAMINUM A 12 000 + E 70 HASCO must not be used in pregnant women.
Vitamin A passes into breast milk, which may lead to overdose in the infant. Excessive intake of vitamin A may be harmful to the fetus and infant.
Administration of high doses of vitamin E during pregnancy and breastfeeding is not recommended due to lack of safety data.

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

VITAMINUM A 12 000 + E 70 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 12000 + E 70 HASCO

This medicine should always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
This medicine is taken orally.
Unless otherwise advised by a doctor, the usual dose is 1 or 2 capsules per day.
Taking more than the recommended dose of VITAMINUM A 12000 + E 70 HASCO
If a significantly higher than recommended dose is taken, consult your doctor or
pharmacist.
Long-term use of VITAMINUM A 12000 + E 70 HASCO may lead to
overdosing on the vitamins it contains (vitamin A or E).
A daily dose of 30 mg of retinol (approximately 100,000 IU of vitamin A) is considered toxic for adults; however, even prolonged intake of 10 mg doses may lead to symptoms of overdose. In children, daily doses of 7.5–15 mg of retinol administered over 30 days may result in overdose (so-called hypervitaminosis). 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 (elevated calcium levels in blood plasma), petechiae, hemorrhages, nervousness, fatigue, irritability, and drowsiness may be observed. Very significant and prolonged vitamin A overdose 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), gingivitis, liver damage symptoms (cirrhosis, fibrosis, disturbances in portal circulation pressure and blood flow), visual disturbances (double vision), respiratory dysfunction, dermatological changes (alopecia, dermatitis, rash, erythema, pruritus), and skin pigmentation disorders, osteoporosis, bone hardening (osteosclerosis), and other less specific changes.
High doses of vitamin E (400–800 IU, i.e., 400–800 mg of all-rac-α-tocopheryl acetate per day) used over a prolonged period may cause diarrhea, abdominal pain, and other gastrointestinal disturbances, as well as fatigue and weakness, blurred vision, headache, rash, disturbances in sexual gland function, and decreased concentration of thyroid hormones in blood plasma.
If any of the above-mentioned overdose symptoms occur, discontinue use of the medicine and contact your doctor or pharmacist.
Missed dose of VITAMINUM A 12000 + E 70 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.
Vitamins A and E are generally well tolerated.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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

Store below 25°C.
Store in the original 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the package and other information

What VITAMINUM A 12000 + E 70 HASCO contains

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

What VITAMINUM A 12000 + E 70 HASCO looks like and contents of the pack
The medicine is in the form of oval, tightly filled soft capsules with a smooth and glossy surface.
One pack contains 30 soft capsules.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: +48 (22) 742 00 22
e-mail: [email protected]