Biotilek Max

Package Leaflet: Information for the Patient

BIOTYLEK MAX, 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 the package leaflet or as directed 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

This medicine belongs to the group of vitamin preparations. The biotin it contains is a water-soluble vitamin, classified as a vitamin B.
BIOTYLEK MAX is used to treat biotin deficiencies with symptoms such as hair loss, nail and hair growth disorders, and their excessive brittleness, skin inflammation around the eyes, nose, mouth, and genital area, as well as to prevent the consequences of deficiencies, after excluding other causes by a doctor.
Biotin supports the processes of keratin formation and differentiation of skin, hair, and nail cells, improving their condition.

2. Important information before taking BIOTYLEK MAX

When not to take BIOTYLEK 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 take BIOTYLEK MAX, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
BIOTYLEK MAX contains 10 mg of biotin in one tablet. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory staff that they have recently taken BIOTYLEK 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 BIOTYLEK 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.

Children and adolescents

In children and adolescents, the medicine can only be used after a doctor's recommendation.

BIOTYLEK MAX and other medicines

The patient should tell 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) reduce biotin levels in the blood.
• Steroid hormones may accelerate biotin breakdown in tissues.
• 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 when taking its preparations, raw egg white should not be consumed.
• Valproic acid lowers the activity of enzymes that metabolize biotin.
• Antibiotics may reduce the concentration or potency of biotin by disrupting the gut microflora.

BIOTYLEK MAX with food, drink, and alcohol

While taking the medicine, the patient should not consume raw egg white at the same time, as this may inhibit biotin absorption.
Alcohol reduces 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 taking this medicine.
Pregnancy
The amount of biotin in BIOTYLEK MAX far exceeds the recommended daily intake for pregnant women, so the medicine should not be used in this period.
Breastfeeding
The amount of biotin in BIOTYLEK MAX far exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but it has not been found to affect the breastfed infant. The medicine should not be used in breastfeeding women.

Driving and using machines

BIOTYLEK MAX has no influence or negligible influence on the ability to drive and use machines.

BIOTYLEK MAX contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodiumper tablet, which means the medicine is considered "sodium-free".

3. How to take BIOTYLEK MAX

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
The recommended dose is 5 mg to 10 mg of biotin per day. The tablet can be divided into equal doses.
In cases where the treatment is initiated by a doctor, they may recommend a different dosing regimen.
The duration of treatment depends on the nature and course of the disease. Improvement of symptoms is usually observed after about 4 weeks of use.
In cases where the patient has difficulty swallowing the tablet, it can be crushed and dissolved in a small amount of water.
Note: The medicine should be taken regularly.

Use in children and adolescents

In children and adolescents, the medicine can only be used after a doctor's recommendation.
The doctor will determine the optimal dosing regimen for the medicine.

Overdose of BIOTYLEK MAX

There are no reports of biotin overdose in humans.

Missed dose of BIOTYLEK MAX

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, BIOTYLEK MAX can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with the medicine:
Frequency not known(cannot be estimated from the available data)

• gastrointestinal disorders,
• urticaria.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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:
Aleje Jerozolimskie 181C,
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store BIOTYLEK MAX

There are no special recommendations for the storage temperature of the medicinal product.
Store in the original packaging to protect from light.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BIOTYLEK MAX contains

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

What BIOTYLEK MAX looks like and contents of the pack

BIOTYLEK MAX is a white, oval, biconvex tablet with a score line on both sides, approximately 11.1 mm x 6.3 mm x 3.6 mm in size.
The tablet can be divided into equal doses.
One pack of the medicine contains 15, 30, or 45 tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel. 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: