Biotinox

Package Leaflet: Information for the Patient

Biotynox, 5 mg, Tablets

Biotynox Forte, 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 for the patient or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

• 1. What is Biotynox/Biotynox Forte and what is it 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 is Biotynox/Biotynox Forte and what is it used for

The medicine belongs to a group of vitamin preparations. Biotin contained in it is a water-soluble vitamin, classified as a vitamin B.

Biotynox and Biotynox Forte are used to treat biotin deficiency with symptoms such as:

• hair loss,
• disorders of hair and nail growth,
• skin inflammation localized around the eyes, nose, mouth, ears, and genital area, 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.

If after 4 weeks there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Biotynox/Biotynox Forte

When not to take Biotynox/Biotynox Forte

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

Warnings and precautions

Before starting to take Biotynox/Biotynox Forte, discuss it with your doctor or pharmacist.

Children and adolescents

Due to limited experience, it is not recommended to use in children under 12 years of age. In adolescents between 12 and 18 years of age, the medicine can be used only under the supervision of a doctor. The doctor will determine the optimal dosage and duration of treatment.

Biotynox/Biotynox Forte with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin blood levels. Valproic acid lowers the activity of biotin-metabolizing enzymes.

Pantothenic acid in high doses and lipoic acid reduce the effectiveness of biotin; these medicines should not be taken at the same time as biotin.

Alcohol causes a decrease in biotin blood levels.

Steroid hormones may accelerate biotin breakdown in tissues.

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

Avidin, found in raw egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In the case of biotin deficiency or the use of its preparations, raw egg white should not be consumed. During cooking, avidin is inactivated.

Smoking accelerates biotin processing in women, which may cause its deficiency and reduced treatment effectiveness.

Effect on laboratory tests

It has been shown that biotin in doses above 10 mg/day may interfere with the results of some laboratory tests (determination of certain hormones, especially thyroid hormones). Therefore, biotin should be discontinued a few days before scheduled laboratory tests and the doctor should be informed about biotin intake.

Biotynox/Biotynox Forte with food, drink, and alcohol

While taking the medicine, do not consume raw egg white at the same time, as it may inhibit biotin absorption.

Alcohol causes a decrease in biotin blood levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

The amount of biotin in Biotynox/Biotynox Forte far exceeds the recommended daily intake for breastfeeding women. Biotin passes into breast milk, but it has not been found to affect the infant. The medicine should not be used in breastfeeding women.

Driving and using machines

The properties of biotin and the type of reported side effects indicate that the medicine does not adversely affect the performance of these activities.

Biotynox/Biotynox Forte contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the 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 take Biotynox/Biotynox Forte

Take this medicine always exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Dosage

The recommended dose is from 5 mg to 10 mg per day.

In situations where the start of treatment is decided by a doctor, they may recommend a different intake schedule.

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 observed after about 4 weeks of treatment.

Use in children and adolescents

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

The doctor will determine the optimal dosage and duration of treatment.

Taking a higher dose of Biotynox/Biotynox Forte than recommended

There are no reports of biotin overdose in humans.

Missing a dose of Biotynox/Biotynox Forte

Do not take a double dose to make up for a missed dose.

Stopping treatment with Biotynox/Biotynox Forte

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with the medicine:

Very rare(affects 1 to 10 people in 10,000):

• urticaria, allergic reactions

Frequency not known(cannot be estimated from the available data):

• headache
• rash

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your 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

Jerozolimskie Avenue 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 allow for more information to be collected on the safety of the medicine.

5. How to store Biotynox/Biotynox Forte

There are no special precautions for storage.

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 that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.

The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, together with the patient leaflet in a cardboard box.

The pack contains:

Biotynox

30, 60, 90, or 120 tablets

Biotynox Forte

30, 60, 90, or 120 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.

Wałbrzyska Street 13

60-198 Poznań

tel.: +48 61 66 51 500

fax: +48 61 66 51 505

biofarm@biofarm.pl

Date of last revision of the leaflet: 22.08.2024