Oeparolmed Biotina

Package Leaflet: Information for the Patient

OeparolMed Biotin, 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 this package 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What OeparolMed Biotin is and what it is used for
• 2. Important information before taking OeparolMed Biotin
• 3. How to take OeparolMed Biotin
• 4. Possible side effects
• 5. How to store OeparolMed Biotin
• 6. 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 biotin it contains is a water-soluble vitamin, classified as a vitamin B.
OeparolMed Biotin is used to treat biotin deficiency with symptoms such as: hair loss, hair and nail growth disorders, skin inflammation around the eyes, nose, mouth, and ears, after excluding other causes by a doctor.
Biotin supports the processes of keratin formation and differentiation of skin, hair, and nail cells.

2. Important information before taking OeparolMed Biotin

When not to take OeparolMed Biotin

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

Warnings and precautions

Before taking OeparolMed Biotin, discuss it with your doctor or pharmacist.
Effect on laboratory tests
OeparolMed Biotin contains 10 mg of biotin in each tablet. If you are to undergo laboratory tests, you must inform your doctor or laboratory staff that you have recently taken OeparolMed Biotin, as biotin may interfere with the results of these tests.
Depending on the test, the results may be falsely elevated or falsely low due to biotin. Your doctor may recommend stopping OeparolMed Biotin before undergoing laboratory tests. Also, remember that other products you may be taking, such as multivitamin preparations or dietary supplements for hair, skin, and nail improvement, may also contain biotin and affect laboratory test results. If you are taking such products, you should tell your doctor or laboratory staff.
It is recommended to stop taking OeparolMed Biotin 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.

OeparolMed Biotin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin blood levels. Valproic acid lowers biotinidase activity (an enzyme involved in biotin metabolism).
In preclinical studies, it has been shown that pantothenic acid in high doses and lipoic acid reduce the effectiveness of biotin, but clinical studies do not confirm this.
Alcohol causes a decrease in biotin blood levels.
Steroid hormones may accelerate biotin breakdown in tissues.
Antibiotics may decrease biotin levels or activity by disrupting the function of the intestinal microflora.
Avidin, a basic glycoprotein found in egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In case of biotin deficiency or use of its preparations, do not consume raw egg white.
Smoking accelerates biotin processing, which may cause its deficiency and reduced treatment effectiveness.

OeparolMed Biotin 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The amount of biotin in OeparolMed Biotin far exceeds the recommended daily intake for pregnant women, so the medicine should not be used in this period.
Breastfeeding
The amount of biotin in OeparolMed Biotin far exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but it has not been found to affect the breastfed baby. The medicine should not be used in breastfeeding women.

Driving and using machines

The properties of biotin and the type of side effects observed indicate that the medicine does not have a negative effect on these activities.

OeparolMed Biotin contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take OeparolMed Biotin

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Recommended dose:
Adults: 5 mg to 10 mg per day.
Usually, the recommended dose is 5 mg per day or, in cases of severe symptoms, 10 mg per day.
Treatment duration depends on the patient's condition and the course of the disease. Improvement of symptoms is usually observed after about 4 weeks of treatment.
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 treatment duration.
Method of administration
Oral administration.
Swallow the tablet with a sufficient amount of water (e.g., ½ glass).

Taking a higher dose of OeparolMed Biotin than recommended

There are no reports of biotin overdose in humans.

Missing a dose of OeparolMed Biotin

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, OeparolMed Biotin can cause side effects, although not everybody gets them.
Very rare (less than 1 in 10,000 people):
allergic reactions (hives)
gastrointestinal disorders

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 181C
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 OeparolMed Biotin

Store in the original packaging to protect from light.
No special storage temperature recommendations for the medicine.
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 specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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 OeparolMed Biotin contains

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

What OeparolMed Biotin looks like and contents of the pack

OeparolMed Biotin 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 Biotin is available in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters.
The packaging - a cardboard box contains 30, 60, 90, or 120 tablets.

Marketing authorization 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

Date of last revision of the leaflet: