Biotina Olimp Max

Leaflet attached to the packaging: patient information

Biotin OLIMP MAX, 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 weeks, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Biotin OLIMP MAX and what is it used for
• 2. Important information before taking Biotin OLIMP MAX
• 3. How to take Biotin OLIMP MAX
• 4. Possible side effects
• 5. How to store Biotin OLIMP MAX
• 6. Package contents and other information

1. What is Biotin OLIMP MAX and what is it used for

This medicine belongs to the group of vitamin preparations. The biotin it contains is a water-soluble vitamin, classified as a vitamin B.
Biotin OLIMP MAX is used to treat biotin deficiency with symptoms such as hair loss, nail and hair growth disorders, and excessive brittleness, skin inflammation localized around the eyes, nose, mouth, and genital area, as well as to prevent the consequences of biotin deficiency, after excluding other causes by a doctor.

2. Important information before taking Biotin OLIMP MAX

When not to take Biotin OLIMP MAX

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 Biotin OLIMP MAX, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
Biotin OLIMP MAX contains 10 mg of biotin in one tablet. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory staff that they have recently taken Biotin OLIMP MAX, as biotin may interfere with the results of such tests. Depending on the test, the results may be falsely elevated or falsely low due to biotin.
The doctor may recommend stopping the use of Biotin OLIMP MAX before undergoing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin preparations or dietary supplements used to improve 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 staff. To minimize the effect of biotin on laboratory test results, Biotin OLIMP MAX should be discontinued 3 days before the planned test, unless the laboratory provides other recommendations in this regard.

Children and adolescents

In children and adolescents, the medicine can only be used after a doctor's recommendation. The doctor will determine the optimal dosage and duration of treatment.

Biotin OLIMP MAX and other medicines

The patient should tell 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) reduce biotin levels in the blood.
• Alcohol reduces biotin levels in the blood.
• Steroid hormones may accelerate biotin breakdown in tissues.
• Avidin, a basic glycoprotein found in egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In the case of biotin deficiency or when taking its preparations, raw egg white should not be consumed.
• Valproic acid reduces the activity of enzymes that metabolize biotin.
• Antibiotics may reduce the level or effectiveness of biotin by disrupting the intestinal microflora.
• Pantothenic acid in high doses and lipoic acid may reduce the effectiveness of biotin.
• Smoking increases biotin catabolism, which may cause its deficiency and reduced treatment effectiveness.

Biotin OLIMP MAX with food, drinks, and alcohol

While taking the medicine, the patient should not consume raw egg white at the same time, as this may inhibit biotin absorption.
Alcohol reduces biotin levels in the blood.

Pregnancy and breastfeeding

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 Biotin OLIMP MAX significantly exceeds the recommended daily intake for pregnant women, so the medicine should not be used in this period.
Breastfeeding
The amount of biotin in Biotin OLIMP MAX significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but it has not been found to affect the breastfed infant. The medicine should not be used in breastfeeding women.

Driving and using machines

Biotin OLIMP MAX has no influence or negligible influence on the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodiumper tablet, which means the medicine is considered "sodium-free".

3. How to take Biotin OLIMP MAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
The recommended dose is from 5 mg (achieving a dose of 5 mg is possible with another available medicine) to 10 mg of biotin per day.
If a doctor decides to start treatment, they may recommend a different regimen for taking the medicine.
The duration of treatment depends on the nature and course of the disease. Improvement of symptoms is usually observed after about 4 weeks of use.
In case of difficulty swallowing, the tablet can be crushed and dissolved in a small amount of water.
The medicine should be taken regularly.

Use in children and adolescents

In children and adolescents, the medicine can only be used after a doctor's recommendation.
The doctor will determine the optimal dosage and duration of treatment.

Taking a higher dose of Biotin OLIMP MAX than recommended

There are no reports of biotin overdose in humans.

Missing a dose of Biotin OLIMP MAX

A double dose should not be taken to make up for a missed dose.
If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Biotin OLIMP MAX can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with the medicine:
Very rare(occurring in less than 1 in 10,000 people)

• urticaria, allergic reactions. Frequency not known(cannot be estimated from the available data)
• headache,
• rash.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 help to gather more information on the safety of the medicine.

5. How to store Biotin OLIMP MAX

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Biotin OLIMP MAX contains

• The active substance of the medicine is biotin. Each tablet contains 10 mg of biotin.
• The other ingredients are: siliconized microcrystalline cellulose, microcrystalline cellulose, sodium carmellose, magnesium stearate, anhydrous colloidal silica.

What Biotin OLIMP MAX looks like and what the package contains

Biotin OLIMP MAX is a white, round, biconvex tablet with a dividing line on both sides, 8 mm in diameter, packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
One package of the medicine contains 30, 60, or 90 tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
Phone: +48 146803200
{logo of the marketing authorization holder}

Date of the last update of the leaflet: