Package leaflet: information for the patient

OeparolMed Biotin, 10 mg, tablets
Biotinum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions 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

What OeparolMed Biotin is and what it is used for
Important information before taking OeparolMed Biotin
How to take OeparolMed Biotin
Possible side effects
How to store OeparolMed Biotin
Contents of the pack and other information

1. What OeparolMed Biotin 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 B vitamin group.
OeparolMed Biotin is 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, and ears, after exclusion of other causes by a doctor.
Biotin supports keratin formation and the differentiation of epidermal, hair, and nail cells.

2. Important information before using OeparolMed Biotyna

When not to use OeparolMed Biotyna
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 OeparolMed Biotyna, discuss this with your doctor or
pharmacist.

Effect on laboratory tests
OeparolMed Biotyna contains 10 mg of biotin in each tablet. If the patient is due to undergo
laboratory testing, they must inform the doctor or laboratory staff that they have recently
taken OeparolMed Biotyna, 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 OeparolMed Biotyna before laboratory testing. It should also be noted 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 the doctor or laboratory staff.
It is recommended to discontinue OeparolMed Biotyna 3 days before a scheduled test, unless the laboratory provides different instructions.

Children and adolescents
OeparolMed Biotyna should be used in children and adolescents only on medical advice.

OeparolMed Biotyna with 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.

Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) may reduce biotin blood levels. Valproic acid reduces the activity of biotinidase (an enzyme involved in biotin metabolism).

Preclinical studies have shown that pantothenic acid in high doses and lipoic acid may reduce the effectiveness of biotin; however, clinical studies have not confirmed this.

Alcohol reduces biotin blood levels.

Steroid hormones may accelerate biotin breakdown in tissues.

Antibiotics may reduce biotin levels or its effectiveness by disrupting intestinal flora function.

Avidin, a basic glycoprotein found in raw egg white, can bind 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.

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

OeparolMed Biotyna with food, drink, and alcohol
During treatment, do not consume raw egg white simultaneously, as it may inhibit biotin absorption. Alcohol reduces biotin blood levels.

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

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

Breastfeeding
The amount of biotin in OeparolMed Biotyna significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but no adverse effects on breastfed infants 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.

OeparolMed Biotyna contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use OeparolMed Biotyna

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Recommended dose:
Adults: 5 mg to 10 mg per day.
The usual recommended dose is 5 mg per day, or 10 mg per day in cases of severe symptoms.
The duration of treatment depends on the patient's condition and the course of the disease. Improvement of symptoms is typically observed after approximately 4 weeks of use.
Children and adolescents
OeparolMed Biotyna may be used in children and adolescents only on a physician's advice. The physician will determine the optimal dosage and duration of treatment.
Method of administration
Oral use.
The tablet should be taken with a sufficient amount of water (e.g. ½ glass).
Use of a higher than recommended dose of OeparolMed Biotyna
There are no reports of biotin overdose in humans.
Missed dose of OeparolMed Biotyna
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 everyone will experience them.
Very rare (less than 1 in 10,000 people):
allergic reactions (urticaria)
gastrointestinal disturbances
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store OeparolMed Biotyna

Keep in the original packaging to protect from light.
No special temperature storage requirements 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 packaging after "EXP".
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What OeparolMed Biotyna contains

The active substance is biotin. Each tablet contains 10 mg of biotin.
The other ingredients are: microcrystalline cellulose, type 102, monohydrate lactose, povidone K 30, crospovidone, type B, magnesium stearate.

What OeparolMed Biotyna looks like and contents of the pack
OeparolMed Biotyna is a round, flat, white or almost white tablet with a diameter of 7 mm,
with a score line on one side to facilitate division.
The tablet can be divided into equal doses.
OeparolMed Biotyna is available in PVC/PVDC/Aluminium or PVC/PE/PVDC/Aluminium blisters.
Packaging – cardboard box containing 30, 60, 90 or 120 tablets.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice