Biotebal

Package Leaflet: Information for the Patient

Biotebal, 5 mg, Tablets

Biotin

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

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

Table of Contents of the Leaflet

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

1. What is Biotebal and what is it used for

The medication belongs to the group of vitamin preparations. The biotin it contains is a water-soluble vitamin, classified as a vitamin B.
Biotebal is used in cases of biotin deficiency.
The medication may be used in cases resulting from biotin deficiency: hair loss, nail and hair growth disorders, and excessive brittleness, as well as skin inflammation around the eyes, nose, and mouth.
Biotin supports the processes of keratin formation and differentiation of skin, hair, and nail cells, improving their condition.

2. Important information before using Biotebal

When not to use Biotebal

If the patient is allergic to biotin or any other ingredient of this medication (listed in section 6).

Warnings and precautions

Before starting to use Biotebal, discuss it with your doctor or pharmacist.

Biotebal and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Biotin affects some laboratory test methods, which means it can distort some laboratory test results, but it does not affect the actual hormone, factor, parameter, and drug values in the blood. Therefore, before performing tests (such as FT4, FT3, 25(OH)D, cortisol, digoxin, TSH, hCG, troponin, PSA), it is recommended to stop using Biotebal for 3 days before the planned test, unless the laboratory provides other recommendations in this regard. Also, remember that other products you are taking, such as multivitamin preparations or dietary supplements used to improve hair, skin, and nails, may also contain biotin and affect laboratory test results.
Antiepileptic medications (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin levels in the blood.
Steroid hormones can accelerate the breakdown of biotin in tissues.

Biotebal with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
Pregnancy
The amount of biotin in Biotebal significantly exceeds the recommended daily intake for pregnant women, so the medication should not be used during this period.
Breastfeeding
The amount of biotin in Biotebal significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into breast milk, but it has not been found to affect the breastfed infant. The medication should not be used during breastfeeding.

Driving and using machines

The properties of biotin and the type of reported side effects indicate that the medication does not adversely affect these activities.

Biotebal contains sorbitol (E 420)

Biotebal contains 111.50 mg of sorbitol (E 420) in each tablet.

3. How to use Biotebal

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Recommended dose:
usually 5 mg per day.
Note: the medication should be used regularly.

Using a higher dose of Biotebal than recommended

There are no reports of biotin overdose in humans.

Missing a dose of Biotebal

Do not take a double dose to make up for a missed dose.
In case of any further doubts about using this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Biotebal can cause side effects, although they may not occur in everyone.
In individual cases, gastrointestinal disorders and hives may occur.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or 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 181 C
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Biotebal

Store at a temperature not exceeding 30°C.
Store in the original packaging to protect from moisture.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after "EXP".
The expiration date refers to the last day of the specified month.
The entry on the packaging after the abbreviation "EXP" indicates the expiration date, and after the abbreviation "Lot/LOT" indicates the batch number.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Biotebal contains

• The active substance of the medication is biotin. Each tablet contains 5 mg of biotin.
• The other ingredients of the medication are: sorbitol (E 420), magnesium stearate, colloidal silica.

What Biotebal looks like and what the pack contains

Biotebal tablets are white, flat on both sides, with a smooth surface.
A cardboard box contains:
30, 60, or 90 tablets in blisters of aluminum/PVC foil.
Not all pack sizes and types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Date of last revision of the leaflet:December 2024