Biotilek

Package Leaflet: Information for the Patient

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

1. What is BIOTYLEK 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 is used to treat biotin deficiencies with symptoms such as hair loss, nail and hair growth disorders, and excessive brittleness, skin inflammation around the eyes, nose, mouth, and genital area, as well as to prevent the consequences of deficiencies, after other causes have been ruled out 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

When not to take BIOTYLEK:

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

Warnings and precautions

Before starting to take BIOTYLEK, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
BIOTYLEK contains 5 mg of biotin in one tablet. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory personnel that they have recently taken BIOTYLEK, 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 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 takes such products, they should inform their doctor or laboratory personnel.

Children and adolescents

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

BIOTYLEK 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 case of biotin deficiency or when taking biotin preparations, raw egg white should not be consumed.
• Valproic acid decreases the activity of enzymes that metabolize biotin.
• Antibiotics may reduce the concentration or potency of biotin by disrupting the gut microflora.

BIOTYLEK 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 far exceeds the recommended daily intake for pregnant women, so the medicine should not be used during this period.
Breastfeeding
The amount of biotin in BIOTYLEK far exceeds the recommended daily intake for breastfeeding women. Biotin passes into breast milk, but it has not been shown to affect the breastfed infant. The medicine should not be used during breastfeeding.

Driving and using machines

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

BIOTYLEK contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult 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

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.
If 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 treatment.
In case of difficulty swallowing, the tablet 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.

Overdose of BIOTYLEK

There are no reports of biotin overdose in humans.

Missed dose of BIOTYLEK

A double dose should not be taken 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 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 to gather more information on the safety of the medicine.

5. How to store BIOTYLEK

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 the 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 month.
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. Contents of the pack and other information

What BIOTYLEK contains

• The active substance of the medicine is biotin. Each tablet contains 5 mg of biotin.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

What BIOTYLEK looks like and contents of the pack

BIOTYLEK is a white, round, biconvex tablet with beveled edges, approximately 6.1 mm x 3.2 mm in size.
One pack of the medicine contains 15, 30, 45, or 60 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: [email protected]

Date of last revision of the leaflet: