Package leaflet: Information for the user

Belbital, 10 mg, tablets
Biotinum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet

What Belbital is and what it is used for
Important information before taking Belbital
How to take Belbital
Possible side effects
How to store Belbital
Contents of the pack and other information

1. What Belbital is and what it is used for

Belbital belongs to the group of vitamin preparations. Its active component, biotin, is a water-soluble vitamin belonging to the vitamin B group.
Belbital is used in the treatment of biotin deficiency associated with symptoms such as hair loss, impaired growth of nails and hair, increased brittleness of hair and nails, and inflammatory skin conditions around the eyes, nose, mouth, and groin, after exclusion of other causes by a physician.
If there is no improvement after 4 weeks of treatment, or if you feel worse, consult your doctor.

2. Important information before taking Belbital

When not to take Belbital:

if the patient is allergic to biotin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Belbital, discuss this with a doctor or pharmacist.
Effect on laboratory tests
Belbital contains 10 mg of biotin per tablet. If the patient is due to have laboratory tests,
he/she must inform the doctor or laboratory staff that he/she has recently taken Belbital,
because biotin may interfere with test results. Depending on the test, results may be
falsely elevated or falsely low due to biotin. The doctor may instruct the patient to stop
taking Belbital before undergoing laboratory tests. It should also be remembered
that other products being taken, such as multivitamin medicines or dietary supplements used for
improving hair, skin, and nails, may also contain biotin and affect laboratory test results.
If the patient is taking such products, he/she should inform the doctor or laboratory staff.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to insufficient data.
Belbital and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has taken recently, as well as any medicines the patient plans to take.
Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) may reduce biotin levels in the blood.
Steroid hormones may accelerate the breakdown of biotin in tissues.
Valproic acid inhibits the breakdown of biotin (by reducing the activity of enzymes that degrade biotin).
Antibiotics may reduce the concentration and effectiveness of biotin by affecting intestinal microflora.
Belbital with food, drink, or alcohol
While taking this medicine, do not consume raw egg white simultaneously,
as this may inhibit the absorption of biotin.
Alcohol reduces biotin levels in the blood.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The amount of biotin in Belbital significantly exceeds the recommended daily intake for pregnant women; therefore, this medicine should not be used during pregnancy.
Breastfeeding
The amount of biotin in Belbital significantly exceeds the recommended daily intake for breastfeeding women; therefore, this medicine should not be used during breastfeeding.
Effects on fertility
Animal studies are insufficient with regard to reproductive toxicity.
Driving and operating machinery
Belbital has no influence on the ability to drive or operate machinery.
Belbital contains isomalt
This medicine contains 288.50 mg of isomalt per tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Belbital

This medicine should always be taken exactly as described in this patient leaflet, or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults
The recommended dose of biotin is 5 mg to 10 mg per day.
The recommended dose of Belbital is 1 tablet per day.
The duration of treatment depends on the type and course of the disease. Symptoms improve after approximately 4 weeks
of taking the medicine.
If there is no improvement after 4 weeks, the patient should contact a physician to
exclude other causes.
Use in children and adolescents
Not recommended for children and adolescents under 18 years of age due to insufficient data.
Elderly patients
Dosage as in adults.
Patients with renal or hepatic impairment
No special dosage recommendations.
Taking more Belbital than recommended
Cases of biotin overdose have not been reported.
Missing a dose of Belbital
Do not take a double dose to make up for a missed tablet.
Stopping Belbital
To correct biotin deficiency, Belbital should be taken in accordance with
recommendations.
If you have any further questions about the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Gastrointestinal disorders and urticaria may occur in individual cases.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 provide more information on the safety of this medicine.

5. How to store Belbital

Keep this medicine out of sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the specified month.
Medicines must 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 Belbital contains

The active substance is biotin. Each tablet contains 10 mg of biotin.
Other components are: isomalt (E 953) and magnesium stearate.

What Belbital looks like and contents of the pack
The tablets are white or almost white, round, flat on both sides, with an embossed mark "10" on one side, approximately 8.5 mm in diameter.
The immediate packaging consists of PVC/PVDC/Aluminium foil blisters. The blisters and the patient leaflet are packed into a cardboard box. The pack contains 30, 60 or 90 tablets.

Marketing Authorisation Holder
Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warszawa
tel. +48 22 569 82 10

Manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
tel. +48 29 644 29 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Belbital Белбитал
Lithuania Beicap 10 mg tabletės
Romania Belbital 10 mg comprimate
Slovakia Belbital