BIOTYLEK

Package leaflet: information for the patient

BIOTYLEK, 5 mg, tablets
Biotinum
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

This medicine belongs to the group of vitamin preparations. The active ingredient, biotin, is a water-soluble vitamin belonging to the B-complex group of vitamins.
BIOTYLEK is used in the treatment of biotin deficiency, which may manifest as hair loss, impaired growth of hair and nails, excessive brittleness of hair and nails, inflammatory skin conditions around the eyes, nose, mouth, and groin, as well as for prevention of consequences of biotin deficiency, after exclusion of other causes by a physician.
Biotin supports keratin formation and differentiation of epidermal, hair, and nail cells, thereby improving their condition.

2. Important information before taking BIOTYLEK

When not to take BIOTYLEK:

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

Warnings and precautions
Before starting treatment with BIOTYLEK, discuss it with your doctor or pharmacist.

Effect on laboratory tests
BIOTYLEK contains 5 mg of biotin per tablet. If you are scheduled for laboratory tests, you must inform your doctor or laboratory personnel that you have recently taken BIOTYLEK, because biotin may interfere with test results. Depending on the test, results may be falsely elevated or falsely low due to biotin. Your doctor may recommend discontinuing BIOTYLEK before laboratory testing. You should also be aware that other products you may be taking, such as multivitamin preparations or dietary supplements used to improve hair, skin, and nails, may also contain biotin and may affect laboratory test results. If you are taking such products, you should inform your doctor or laboratory personnel.

Children and adolescents
BIOTYLEK should be used in children and adolescents only under medical supervision.

BIOTYLEK with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) may reduce biotin blood levels.
• Steroid hormones may accelerate biotin breakdown in tissues.
• Avidin, a basic glycoprotein found in raw egg white, binds to biotin, inactivating it and preventing its absorption. In cases of biotin deficiency or when taking biotin supplements, raw egg white should not be consumed.
• Valproic acid reduces the activity of enzymes involved in biotin metabolism.
• Antibiotics may reduce biotin concentration or efficacy by disrupting intestinal flora.

BIOTYLEK with food, drink, and alcohol
Do not consume raw egg white while taking this medicine, as it may inhibit biotin absorption.
Alcohol reduces biotin blood levels.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy
The amount of biotin in BIOTYLEK significantly exceeds the recommended daily intake for pregnant women; therefore, this medicine should not be used during pregnancy.

Breastfeeding
The amount of biotin in BIOTYLEK significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk; however, no adverse effects on breastfed infants have been reported. Nevertheless, this medicine should not be used during breastfeeding.

Driving and operating machinery
BIOTYLEK has no effect or negligible effect on the ability to drive and operate machinery.

BIOTYLEK contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

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

3. How to use BIOTYLEK

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
The recommended dose is 5 mg to 10 mg of biotin per day.
If 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 approximately 4 weeks of treatment.
For patients who have difficulty swallowing, the tablet may be crushed and dissolved in a small
amount of water.
Warning: the medicine should be taken regularly.
Use in children and adolescents
BIOTYLEK may be used in children and adolescents only on medical advice.
The doctor will determine the optimal dosing regimen.
Taking more BIOTYLEK than recommended
There are no reports of biotin overdose in humans.
Missed dose of BIOTYLEK
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Frequency unknown (cannot be estimated from the available data)

• gastrointestinal disorders,
• urticaria.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store BIOTYLEK

No special storage temperature requirements for this medicinal product.
Store in the original packaging to protect from light.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What BIOTYLEK contains

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

What BIOTYLEK looks like and contents of the pack
BIOTYLEK is white, round, biconvex tablets with bevelled edges, approximately 6.1 mm x 3.2 mm in size.
One pack contains 15, 30, 45 or 60 tablets in blister packs within a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel. 22 742 00 22
e-mail: [email protected]