Biotinox Forte

Leaflet attached to the packaging: patient information

Biotynox, 5 mg, tablets

Biotynox Forte, 10 mg, tablets

Biotin

Read the 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 patient 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 the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks or the patient feels worse, they should contact their 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. Package contents and other information

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

The medicine belongs to the group of vitamin preparations. The 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 there is no improvement after 4 weeks or the patient feels worse, they should contact their doctor.

2. Important information before taking Biotynox/Biotynox Forte

When not to take Biotynox/Biotynox Forte

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 Biotynox/Biotynox Forte, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

Due to limited experience, it is not recommended to use Biotynox/Biotynox Forte 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 and other medicines

The patient should inform 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) cause a decrease in biotin blood levels. Valproic acid reduces 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 simultaneously with 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 the 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, the patient should not consume raw egg white, as it may inhibit biotin absorption.

Alcohol causes a decrease in biotin blood levels.

Pregnancy, breastfeeding, and fertility

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 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 have a negative effect on these activities.

Biotynox/Biotynox Forte 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 sodium per tablet, which means it is considered "sodium-free".

3. How to take Biotynox/Biotynox Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

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

In situations where the doctor decides to start treatment, they may recommend a different dosing regimen.

Oral administration. The medicine should be taken 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 about 4 weeks of treatment.

Use in children and adolescents

The medicine can be used in children and adolescents only after consultation with a doctor.

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

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Biotynox/Biotynox Forte

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Biotynox/Biotynox Forte can cause side effects, although not everybody gets them.

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

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

• urticaria, allergic reactions

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

• headache
• rash

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Biotynox/Biotynox Forte

There are no special precautions for storing the medicine.

The medicine should be stored out of sight and reach of children.

Do not use the medicine after the expiration date stated on the packaging and blister.

The expiration date is the last day of the given month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Biotynox/Biotynox Forte contains

• The active substance of the medicine is biotin.

Biotynox

One tablet contains 5 mg of biotin.

Biotynox Forte

One tablet contains 10 mg of biotin.

• 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, along with the patient leaflet, in a cardboard box.

The package 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.

ul. Wałbrzyska 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