BIOTYNOX

Package leaflet: Information for the patient

Biotynox, 5 mg, tablets
Biotynox Forte, 10 mg, tablets
Biotinum
Please read the entire 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 patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

Table of contents

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

1. What Biotynox/Biotynox Forte 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.
Biotynox and Biotynox Forte are used in the treatment of biotin deficiency presenting with symptoms such as:

• hair loss,
• impaired growth of hair and nails,
• inflammatory skin conditions around the eyes, nose, mouth, ears, and genital area, after exclusion of other causes by a doctor.

Biotin supports keratin formation and the differentiation of epidermal, hair, and nail cells, thereby improving their condition.
If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

2. Important information before using Biotynox/Biotynox Forte

When not to use Biotynox/Biotynox Forte
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 treatment with Biotynox/Biotynox Forte, discuss it with your doctor or pharmacist.

Children and adolescents
Due to limited experience, use in children under 12 years of age is not recommended. In adolescents aged 12–18 years, the medicine should be used only under medical supervision. The doctor will determine the optimal dosage and duration of treatment.

Biotynox/Biotynox Forte and other medicines
You must inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) reduce biotin blood levels. Valproic acid decreases the activity of enzymes involved in biotin metabolism. High doses of pantothenic acid and lipoic acid reduce the effectiveness of biotin; therefore, these medicines should not be used simultaneously with biotin.

Alcohol reduces biotin blood levels.

Steroid hormones may accelerate biotin breakdown in tissues.

Antibiotics may reduce biotin content or activity by disrupting intestinal microflora function.

Avidin, a protein present in raw egg white, binds to biotin, inactivating it and preventing its absorption. In cases of biotin deficiency or when taking biotin supplements, consumption of raw egg white should be avoided. Avidin is inactivated during cooking.

Cigarette smoking accelerates biotin metabolism in women, which may lead to deficiency and reduced treatment efficacy.

Effect on laboratory tests
It has been shown that biotin doses exceeding 10 mg/day may interfere with the results of certain laboratory tests (e.g. measurement of certain hormones, especially thyroid hormones). Therefore, biotin should be discontinued several days before scheduled laboratory tests, and the doctor should be informed about biotin intake.

Biotynox/Biotynox Forte with food, drink, and alcohol
During treatment, raw egg white should not be consumed, as it may inhibit biotin absorption.

Alcohol reduces biotin blood levels.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

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

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

Driving and operating machinery
The properties of biotin and the nature of reported adverse effects indicate that the medicine does not adversely affect the ability to drive or operate machinery.

Biotynox/Biotynox Forte contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Biotynox/Biotynox Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a physician or pharmacist. In case of doubt, consult a doctor or pharmacist.
Dosage
The recommended dose is 5 mg to 10 mg per day.
If treatment is initiated by a physician, they may recommend a different dosing regimen.
Oral administration. Take before meals with a glass of water.
The duration of treatment depends on the nature and course of the disease. Improvement of symptoms is usually observed after approximately 4 weeks of use.
Use in children and adolescents
This medicine may be used in children and adolescents only upon medical advice.
The physician will determine the optimal dosage and duration of treatment.
Use of a higher than recommended dose of Biotynox/Biotynox Forte
There are no reports of biotin overdose in humans.
Missed dose of Biotynox/Biotynox Forte
Do not take a double dose to make up for a missed dose.
Discontinuation of Biotynox/Biotynox Forte
If you have any further questions 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 everyone will experience them.
The following adverse reactions may occur during use of the medicine:
Very rare (in 1 to 10 people per 10,000):

• urticaria, allergic reactions

Frequency unknown (cannot be estimated from available data):

• headache
• rash

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

5. How to store Biotynox/Biotynox Forte

No special storage instructions are required for this medicinal product.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Biotynox/Biotynox Forte contains

• The active substance is biotin.

Biotynox
One tablet contains 5 mg of biotin.
Biotynox Forte
One tablet contains 10 mg of biotin.

• The other ingredients are: microcrystalline cellulose, lactose monohydrate, crospovidone type A, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

What Biotynox/Biotynox Forte looks like and contents of the pack
Biotynox, 5 mg:
White or almost white, round, biconvex tablets with a diameter of 7.1 mm ± 0.3 mm.
Biotynox Forte, 10 mg:
White or almost white, round, biconvex tablets with a score line on one side, with a diameter of 9.1 mm ± 0.3 mm.
The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not ensure equal dosing.
The tablets are packed in blisters made of PVC/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium, placed together with the patient leaflet in a cardboard box.
Pack contents:
Biotynox
30, 60, 90 or 120 tablets
Biotynox Forte
30, 60, 90 or 120 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]