Biotin olimp max

Package leaflet: Information for the patient

Biotyna OLIMP MAX, 10 mg, tablets
Biotinum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as
advised by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or additional information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks, or if your condition worsens, consult your doctor.

Table of contents

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

1. What is Biotyna OLIMP MAX and what is it 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.
Biotyna OLIMP MAX is indicated for the treatment of biotin deficiency associated with symptoms such as hair loss, impaired growth of nails and hair, excessive brittleness of nails and hair, inflammatory skin conditions around the eyes, nose, mouth, and groin, as well as for the prevention of consequences of biotin deficiency, after exclusion of other causes by a physician.

2. Important information before using Biotyna OLIMP MAX

When not to use Biotyna OLIMP 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 treatment with Biotyna OLIMP MAX, discuss it with your doctor or
pharmacist.

Effect on laboratory tests
Biotyna OLIMP MAX contains 10 mg of biotin per tablet. If the patient is due to undergo
laboratory testing, they must inform the doctor or laboratory personnel that they have recently
taken Biotyna OLIMP 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 Biotyna OLIMP MAX before
performing laboratory tests. It should also be remembered that other products the patient may
be taking, 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 personnel. To minimize the impact of biotin on laboratory test results, Biotyna OLIMP MAX should be discontinued 3 days before the planned test, unless the laboratory provides different instructions.

Children and adolescents
Biotyna OLIMP MAX should be used in children and adolescents only under a doctor's recommendation. The doctor will determine the optimal dosage and duration of treatment.

Biotyna OLIMP MAX and other medicines
Inform 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 blood levels of biotin.
• Alcohol decreases biotin blood concentration.
• Steroid hormones may accelerate the breakdown of biotin in tissues.
• Avidin, a basic glycoprotein found in raw egg white, binds to biotin, inactivating it and preventing its absorption. In cases 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 levels or effectiveness by disrupting intestinal flora.
• High doses of pantothenic acid and lipoic acid may reduce the effectiveness of biotin.
• Cigarette smoking increases biotin catabolism, which may lead to deficiency and reduced treatment efficacy.

Biotyna OLIMP MAX with food, drink, and alcohol
During treatment, do not consume raw egg white simultaneously, as it may inhibit biotin absorption.
Alcohol decreases biotin blood concentration.

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

Pregnancy
The amount of biotin in Biotyna OLIMP 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 Biotyna OLIMP 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, Biotyna OLIMP MAX should not be used during breastfeeding.

Driving and operating machinery
Biotyna OLIMP MAX has no effect or a negligible effect on the ability to drive and operate machinery.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Biotyna OLIMP 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 physician or pharmacist.
This medicine is for oral use.
The recommended dose is from 5 mg (achieving a 5 mg dose may require using another product available on the market) to 10 mg of biotin per day.
When 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 of symptoms is 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.
The medicine should be taken regularly.
Use in children and adolescents
In children and adolescents, this medicine should only be used on medical advice.
The physician will determine the optimal dosage and duration of treatment.
Taking more Biotyna OLIMP MAX than recommended
There are no reports of biotin overdose in humans.
Missed dose of Biotyna OLIMP 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 physician 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:
Very rare (occur in less than 1 in 10,000 people)

• Urticaria, allergic reactions. Frequency unknown (cannot be estimated from the available data)
• Headache,
• Rash.

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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 helps provide more information on the safety of the medicine.

5. How to store the medicinal product Biotyna OLIMP MAX

Keep the medicinal product out of sight and reach of children.
Store below 30°C. Keep in the original packaging to protect from light.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Biotyna OLIMP MAX contains

• The active substance is biotin. Each tablet contains 10 mg of biotin.
• Other ingredients are: silicon dioxide microcrystalline cellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.

What Biotyna OLIMP MAX looks like and contents of the pack
Biotyna OLIMP MAX is a white, round, biconvex tablet with a division line on both sides, 8 mm in diameter, packed in PVC/PVDC/Aluminium blisters placed in a cardboard box.
One pack contains 30, 60 or 90 tablets in blisters within a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
Tel.: +48 146803200
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