Belbital

Package Leaflet: Information for the Patient

Belbital, 10 mg, Tablets

Biotin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

• 1. What is Belbital and what is it used for
• 2. Important information before taking Belbital
• 3. How to take Belbital
• 4. Possible side effects
• 5. How to store Belbital
• 6. Contents of the pack and other information

1. What is Belbital and what is it used for

This medicine belongs to the group of vitamin medicines. The biotin contained in it is a water-soluble vitamin, classified as a vitamin B.
Belbital is used to treat biotin deficiency with symptoms such as hair loss, nail and hair growth disorders, and excessive brittleness, skin inflammation around the eyes, nose, mouth, genital area, after excluding other causes by the doctor.
If after 4 weeks there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Belbital

When not to take Belbital:

• if you are allergic to biotin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Belbital, discuss it with your doctor or pharmacist.
Effect on laboratory tests
Belbital contains 10 mg of biotin per tablet. If you are to undergo laboratory tests, you must inform your doctor or laboratory personnel that you have recently taken Belbital, as biotin may interfere with the results of these tests. Depending on the test, the results may be falsely elevated or falsely low due to biotin. Your doctor may instruct you to stop taking Belbital before undergoing laboratory tests. You should also remember that other products you are taking, such as multivitamins or dietary supplements used to improve hair, skin, and nails, may also contain biotin and affect laboratory test results. If you are taking such products, you should tell your doctor or laboratory personnel.
Children and adolescents
It is not recommended to use in children and adolescents under 18 years of age due to insufficient data.

Belbital with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) reduce biotin levels in the blood.
Steroid hormones may accelerate biotin breakdown in tissues.
Valproic acid inhibits biotin breakdown (by reducing the activity of biotin-degrading enzymes).
Antibiotics may reduce biotin levels and activity by affecting gut microflora.

Belbital with food, drink, or alcohol

While taking the medicine, do not consume raw egg white at the same time, as it may inhibit biotin absorption.
Alcohol reduces biotin levels in the blood.

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.
Pregnancy
The amount of biotin in Belbital far exceeds the recommended daily intake for pregnant women, so the medicine should not be used in pregnant women.
Breastfeeding
The amount of biotin in Belbital far exceeds the recommended daily intake for breastfeeding women, so the medicine should not be used in breastfeeding women.
Fertility
Animal studies are insufficient with regard to reproductive toxicity.

Driving and using machines

Belbital does not affect the ability to drive and use machines.

Belbital contains isomalt

This medicine contains 288.50 mg of isomalt in each tablet. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Belbital

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor 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 subside after about 4 weeks of taking the medicine.
If after 4 weeks there is no improvement, you should consult your doctor to rule out other causes.
Use in children and adolescents
It is not recommended to use in children and adolescents under 18 years of age due to insufficient data.
Elderly patients
Dosing is the same as for adults.
Patients with kidney or liver impairment
No special dosing recommendations.

Overdose of Belbital

No cases of biotin overdose have been reported.

Missed dose of Belbital

Do not take a double dose to make up for a missed tablet.

Stopping Belbital treatment

To supplement biotin deficiency, Belbital should be taken as directed.
If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In individual cases, gastrointestinal disorders and hives may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Belbital

Keep the medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry Date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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.
• The other ingredients 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 the inscription "10" on one side, with a diameter of about 8.5 mm.
The immediate packaging consists of PVC/PVDC/Aluminum blisters. The blisters and the package leaflet are packed in a cardboard box. The pack contains 30, 60, or 90 tablets.

Marketing authorization holder

Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warsaw
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 medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Belbital Белбитал
Lithuania
Beicap 10 mg tablets
Romania
Belbital 10 mg tablets
Slovakia
Belbital

Date of last revision of the leaflet: