BETA-CAROTENE AMARA

Package leaflet: Information for the user

BETA KAROTEN - AMARA
Betacarotenum
10 mg, tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet:

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

2. Important information before taking BETA KAROTEN – AMARA

3. How to take BETA KAROTEN – AMARA

4. Possible side effects

5. How to store BETA KAROTEN – AMARA

6. Contents of the pack and other information

7. What BETA KAROTEN - AMARA is and what it is used for

BETA KAROTEN – AMARA is an oral vitamin preparation. Betacarotene is the most active precursor of vitamin A. It belongs to carotenoids, natural pigments found in vegetables and fruits. Approximately 75% of betacarotene is converted into retinol – the active form of vitamin A; small amounts are directly transformed into vitamin A. Betacarotene also has antioxidant properties. It prevents the formation of free radicals by directly reacting with them or acting as their acceptor.
The medicine is used for the prophylaxis of complications associated with vitamin A deficiency.
For prophylactic use in spring and summer in individuals with hypersensitivity to sunlight.
As a supplement for women taking oral contraceptives or following weight-loss diets.
As supportive treatment in skin disorders related to photosensitivity (erythropoietic protoporphyria), inflammatory conditions of the skin and mucous membranes, pigment disorders (e.g. vitiligo), photosensitivity, solar urticaria, cataract, leukoplakia and atherosclerosis.

2. Important information before taking BETA KAROTEN - AMARA

When not to take BETA KAROTEN – AMARA:

• if you are allergic to betacarotene or any of the other ingredients of this medicine (listed in section 6);
• if you have:
• severe liver or kidney failure,
• hypervitaminosis A,
• malabsorption disorders of the gastrointestinal tract,
• diarrhoea.

Warnings and precautions
Before starting treatment with BETA KAROTEN – AMARA, discuss it with your doctor, pharmacist or nurse.
Betacarotene increases the toxic effects of parenterally administered neomycin (on liver and kidneys). It acts synergistically with vitamins E and A. Its absorption is inhibited by cholestyramine.
Betacarotene may act antagonistically to vitamin K, especially in patients treated with oral anticoagulants or estrogens. Concurrent use of iron-containing preparations reduces the effect of betacarotene. An interval of several hours should be maintained between administration of these medicines.
Children and adolescents
Do not give to children under 7 years of age.
BETA KAROTEN – AMARA with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking BETA KAROTEN - AMARA with food, drink and alcohol
The presence of fat in food facilitates the absorption of betacarotene.
Tablets should be taken with plenty of water.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.
BETA KAROTEN - AMARA contains lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take BETA KAROTEN – AMARA

Prophylactically:
Children 7 – 12 years of age: 1 tablet every 2 days
Adolescents over 12 years of age: 1 tablet daily
Adults: 1 tablet daily
Therapeutically: as directed by the physician.
The medicine should be taken with water.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more BETA KAROTEN – AMARA than recommended
Long-term use of doses exceeding the recommended ones may lead to side effects described in section 4.
Hypercarotenemia may occur after administration of doses of 60–180 mg daily, after 2–6 weeks of therapy, and resolves after discontinuation of treatment.
If you forget to take BETA KAROTEN – AMARA
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping BETA KAROTEN - AMARA
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, BETA KAROTEN - AMARA can cause side effects, although not everybody gets them.
Yellow discoloration of the skin on the shoulders, arms and abdomen – carotenoderma, mild diarrhoea. Very rare side effects include: petechiae, joint pain, dizziness, allergic reactions.
These symptoms resolve after discontinuation of the medicine.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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: [email protected].
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store BETA KAROTEN - AMARA

Keep BETA KAROTEN – AMARA out of the sight and reach of children. Store below 25°C. Keep in the original packaging.
Do not use BETA KAROTEN - AMARA after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Beta-Karoten Amara contains
The active substance is crystalline beta-carotene in an amount of 10 mg.
Excipients contained in BetaTab 20% S:
D, L – alpha tocopherol
Modified starch
Glucose syrup
Sodium ascorbate
Corn starch

Excipients contained in the medicinal product:
Magnesium stearate
Ludipress:

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

What Beta-Karoten Amara looks like and contents of the pack
A polyethylene container closed with a polyethylene cap, placed in a cardboard box with a patient leaflet, containing 50 tablets or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Zakład Farmaceutyczny „Amara” Sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Phone: +48 12 657 40 40
Fax: +48 12 657 40 40 ext. 34
e-mail: [email protected]

„CHANCE” Zakład Farmaceutyczny
Jerzy Jaworski, Maria Jaworska Spółka Jawna
Pieńków 11, 05-152 Czosnów
Phone: +48 22 751 13 35
Fax: +48 22 785 10 41
e-mail: [email protected]