Beta-karoten Amara

Leaflet attached to the packaging: patient information

BETA CAROTENE - AMARA

Betacarotene
10 mg, tablets

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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, pharmacist, or nurse. 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 BETA CAROTENE - AMARA and what is it used for
• 2. Important information before taking BETA CAROTENE - AMARA
• 3. How to take BETA CAROTENE - AMARA
• 4. Possible side effects
• 5. How to store BETA CAROTENE - AMARA
• 6. Contents of the packaging and other information

• 1. What is BETA CAROTENE - AMARA and what is it used for

BETA CAROTENE - AMARA is an oral, vitamin medicine. Betacarotene is the most active precursor of vitamin A. It represents carotenoids, natural pigments found in vegetables and fruits. About 75% of betacarotene is converted to retinol - the active form of vitamin A, and small amounts are converted directly to vitamin A. Betacarotene also has antioxidant properties. It prevents the formation of free radicals, directly reacts with free radicals, or acts as their acceptor.
The medicine is used in the prevention of complications related to vitamin A deficiency.
Prophylactically in the spring-summer period in people with hypersensitivity to the effects of sunlight.
Supplementally for women taking oral contraceptives and those on a slimming diet.
Supportively in cases of skin diseases related to hypersensitivity to sunlight (erythropoietic protoporphyria), inflammatory skin conditions, and mucous membranes, pigmentation disorders (e.g., vitiligo), hypersensitivity to sunlight, solar urticaria, cataracts, leukoplakia, and atherosclerosis.

• 2. Important information before taking BETA CAROTENE - AMARA

When not to take BETA CAROTENE - AMARA:

• if the patient is allergic to betacarotene or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• severe liver and kidney failure,
• vitamin A hyperthyroidism,
• malabsorption from the gastrointestinal tract,
• diarrhea.

Warnings and precautions

Before starting to take BETA CAROTENE - AMARA, the patient should discuss it with their doctor, pharmacist, or nurse.
Betacarotene increases the toxic effect of neomycin administered parenterally (liver, kidneys). It acts synergistically with vitamins E and A. Its absorption is inhibited by cholestyramine.
Betacarotene may act antagonistically to vitamin K, especially in people treated with oral anticoagulants or estrogens. The simultaneous use of iron preparations weakens the effect of betacarotene. A few hours' interval should be maintained between the administration of these medicines.

Children and adolescents

Do not give to children under 7 years of age.

BETA CAROTENE - AMARA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking BETA CAROTENE - AMARA with food, drink, and alcohol

The presence of fat in food facilitates the absorption of betacarotene.
Tablets should be taken with a large amount of water.

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.

Driving and using machines

The medicine does not impair the ability to drive vehicles and operate machinery.
BETA CAROTENE - AMARA contains lactose.If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

• 3. How to take BETA CAROTENE - AMARA

Prophylactically:
Children 7-12 years old:
1 tablet every 2 days
Adolescents over 12 years old:
1 tablet daily
Adults:
1 tablet daily
Therapeutically: as directed by a doctor.
The medicine should be taken with water.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of BETA CAROTENE - AMARA than recommended

When taking the medicine for a long time in doses exceeding the recommended ones, side effects may occur as described in the section on undesirable effects.
Hypercarotenemia occurs after taking doses of 60-180 mg daily for 2-6 weeks of therapy and disappears after its completion.

Missing a dose of BETA CAROTENE - AMARA

The patient should continue taking the medicine without increasing the next dose.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with BETA CAROTENE - AMARA

In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, BETA CAROTENE - AMARA can cause side effects, although they may not occur in every patient.
Yellow discoloration of the skin in the shoulder, arm, and abdominal areas - carotenodermia, mild diarrhea. Very rare symptoms include: bruising, joint pain, dizziness, allergic reactions.
These symptoms disappear after stopping the use of the medicine.
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the patient 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; e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

• 5. How to store BETA CAROTENE - AMARA

BETA CAROTENE - AMARA should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging.
Do not use BETA CAROTENE - AMARA after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their 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 BETA CAROTENE - AMARA contains

The active substance of the medicine is crystalline betacarotene in the amount of 10 mg.
Excipients in BetaTab 20% S:
D, L-alpha-tocopherol
Modified starch
Glucose syrup
Sodium ascorbate
Corn starch
Excipients in the medicinal product:
Magnesium stearate
Ludipress:

• lactose monohydrate
• polyvinylpyrrolidone (Kollidon 30, Kollidon CL)

What BETA CAROTENE - AMARA looks like and what the packaging contains

A polyethylene container with a polyethylene cap, in a cardboard box with a patient leaflet, containing 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Zakład Farmaceutyczny "Amara" Sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel. 12 657 40 40
Fax 12 657 40 40 wew. 34
e-mail: amara@amara.pl
"CHANCE" Zakład Farmaceutyczny
Jerzy Jaworski, Maria Jaworska Spółka Jawna
Pieńków 11, 05-152 Czosnów
Tel.: 22 751 13 35
Fax.: 22 785 10 41
e-mail: amara.spj@amara.pl

Date of the last update of the leaflet: