BIOTYLEK MAX

Patient Information Leaflet

BIOTYLEK MAX, 10 mg, tablets
Biotinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 4 weeks, consult your doctor.

Table of Contents

1. What BIOTYLEK MAX is and what it is 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 BIOTYLEK MAX 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 vitamin B group.
BIOTYLEK MAX is used in the treatment of biotin deficiency presenting with symptoms such as hair loss, impaired growth and increased brittleness of hair and nails, inflammatory skin conditions around the eyes, nose, mouth, and groin, and for prevention of consequences of biotin deficiency, after exclusion of other causes by a physician.
Biotin supports keratin formation and the differentiation of epidermal cells, hair, and nails, thereby improving their condition.

2. Important information before using the medicine BIOTYLEK MAX

When not to use BIOTYLEK MAX:

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

Warnings and precautions
Before starting to use BIOTYLEK MAX, discuss this with your doctor or pharmacist.
Effect on laboratory tests
BIOTYLEK MAX contains 10 mg of biotin per tablet. If the patient is due to undergo laboratory testing, they must inform the doctor or laboratory staff that they have recently taken BIOTYLEK MAX, as biotin may interfere with test results. Depending on the test, results may be falsely elevated or falsely low due to biotin. The doctor may recommend discontinuing BIOTYLEK MAX prior to laboratory testing. It is also important to remember that other products the patient may be taking, such as multivitamins or dietary supplements used for improving 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 personnel.
Children and adolescents
BIOTYLEK MAX should be used in children and adolescents only under medical advice.
BIOTYLEK MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

• Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) may reduce biotin blood levels.
• Steroid hormones may accelerate the breakdown of biotin in tissues.
• Avidin, a basic glycoprotein found in raw egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In case 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 MAX with food, drink, and alcohol
During treatment, do not consume raw egg white simultaneously, as this may inhibit biotin absorption.
Alcohol consumption reduces biotin blood levels.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The amount of biotin in BIOTYLEK MAX 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 MAX significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but no adverse effects on the breastfed infant have been reported. Nevertheless, BIOTYLEK MAX should not be used during breastfeeding.
Driving and operating machinery
BIOTYLEK MAX has no effect or has a negligible effect on the ability to drive and operate machinery.
BIOTYLEK MAX contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered “sodium-free”.

3. How to use BIOTYLEK MAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
The recommended dose is 5 mg to 10 mg of biotin per day. The tablet may be divided into equal doses.
If treatment is initiated by a physician, they may recommend a different dosing regimen.
The duration of treatment depends on the nature and course of the disease. Improvement in symptoms
is usually observed after approximately 4 weeks of use.
For patients who have difficulty swallowing, the tablet may be crushed and dissolved in a small amount of water.
Warning: this medicine should be taken regularly.
Use in children and adolescents
BIOTYLEK MAX should only be used in children and adolescents upon medical advice.
The doctor will determine the optimal dosing regimen.
Taking more than the recommended dose of BIOTYLEK MAX
There are no reports of biotin overdose in humans.
Missed dose of BIOTYLEK MAX
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 everybody 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 reactions occur, including any adverse reactions 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 authorization holder.
Reporting adverse reactions enables better assessment of the benefit-risk balance of the medicine.

5. How to store BIOTYLEK MAX

There are 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. This will help protect the environment.

6. Contents of the packaging and other information

What BIOTYLEK MAX contains

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

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 to facilitate division, measuring approximately 11.1 mm x 6.3 mm x 3.6 mm.
The tablet can be divided into equal doses.
One package of the medicine contains 15, 30 or 45 tablets in blisters within a cardboard box.
Marketing Authorisation 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]