Biotebal Max

Package Leaflet: Information for the Patient

BIOTEBAL MAX, 10 mg, tablets

Biotin

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 weeks, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is BIOTEBAL MAX and what is it used for
• 2. Important information before using BIOTEBAL MAX
• 3. How to use BIOTEBAL MAX
• 4. Possible side effects
• 5. How to store BIOTEBAL MAX
• 6. Package contents and other information

1. What is BIOTEBAL MAX and what is it used for

BIOTEBAL MAX contains biotin in the form of d-biotin, the only biologically active isomer of biotin (d-Biotin isomer). Biotin is also known as water-soluble vitamin H, which belongs to the group of B vitamins.
BIOTEBAL MAX is used to treat biotin deficiency with symptoms such as: hair loss, hair and nail growth disorders and their excessive brittleness, skin inflammation localized around the eyes, nose, mouth, and ears, as well as to prevent its consequences, after excluding other causes by a doctor.
Biotin supports the processes of keratin formation and differentiation of skin, hair, and nail cells.

2. Important information before using BIOTEBAL MAX

When not to use BIOTEBAL MAX

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 use BIOTEBAL MAX, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
BIOTEBAL MAX contains 10 mg of biotin in each tablet. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory staff that they have recently taken BIOTEBAL MAX, as biotin may interfere with the results of such tests.
Depending on the test, the results may be falsely elevated or falsely low due to biotin. The doctor may recommend stopping the use of BIOTEBAL MAX before undergoing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin preparations or dietary supplements used to improve hair, skin, and nails, may also contain biotin and affect laboratory test results. If the patient is taking such products, they should inform their doctor or laboratory staff.
It is recommended to discontinue the use of BIOTEBAL MAX for 3 days before a planned test, unless the laboratory provides other recommendations in this regard.

Children and adolescents

In children and adolescents, the medicine can only be used after a doctor's recommendation. The doctor will determine the optimal dosage and duration of treatment.

BIOTEBAL MAX and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin levels in the blood. Valproic acid lowers the activity of biotinidase (an enzyme involved in biotin metabolism).
In preclinical studies, it has been shown that pantothenic acid in high doses and lipoic acid reduce the effectiveness of biotin, but clinical studies do not confirm this.
Alcohol causes a decrease in biotin levels in the blood.
Steroid hormones may accelerate biotin breakdown in tissues.
Antibiotics may decrease biotin levels or activity by disrupting the function of the intestinal microflora.
Avidin, a basic glycoprotein found in egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In the case of biotin deficiency or the use of its preparations, raw egg white should not be consumed.
Smoking accelerates biotin processing, which may cause its deficiency and reduced treatment efficacy in smokers.

BIOTEBAL MAX with food, drinks, and alcohol

While taking the medicine, the patient should 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 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 using this medicine.
Pregnancy
The amount of biotin in BIOTEBAL MAX significantly exceeds the recommended daily intake for pregnant women, so the medicine should not be used in this period.
Breastfeeding
The amount of biotin in BIOTEBAL MAX significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but it has not been found to affect breastfed infants. The medicine should not be used in breastfeeding women.

Driving and using machines

The properties of biotin and the type of reported side effects indicate that the medicine does not have a negative effect on these activities.

BIOTEBAL MAX contains lactose monohydrate and sodium

Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use BIOTEBAL MAX

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose:
Adults: 5 mg to 10 mg per day.
The usual recommended dose is 5 mg (available on the market) per day or, in the case of severe symptoms, 10 mg per day.
The treatment duration depends on the patient's condition and the course of the disease. Improvement of symptoms is usually observed after about 4 weeks of use.
Children and adolescents
In children and adolescents, the medicine can only be used after a doctor's recommendation. The doctor will determine the optimal dosage and duration of treatment.
Method of administration
Oral use.
The tablet should be swallowed with a sufficient amount of water (e.g., ½ glass).

Using a higher dose of BIOTEBAL MAX than recommended

There are no reports of biotin overdose in humans.

Missing a dose of BIOTEBAL MAX

A double dose should not be taken to make up for a missed dose.
In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, BIOTEBAL MAX can cause side effects, although not everybody gets them.
Frequency of side effects
Very rare (less than 1 in 10,000 people):
allergic reactions (hives).

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they 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
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 medicine.

5. How to store BIOTEBAL MAX

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging after "EXP".
The expiration date means the last day of the specified month.
The entry on the packaging after the abbreviation EXP means the expiration date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What BIOTEBAL MAX contains

• The active substance of the medicine is biotin. Each tablet contains 10 mg of biotin.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone K 30, sodium croscarmellose, colloidal silica anhydrous, magnesium stearate.

What BIOTEBAL MAX looks like and what the package contains

BIOTEBAL MAX is a round, white or almost white, biconvex tablet with the imprint "10" on one side, with a diameter of 7.8-8.2 mm.
BIOTEBAL MAX is available in PVC/Aluminum blisters.
The packaging - a cardboard box contains 10, 20, 30, 60, 90, or 120 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the package leaflet: