Patient Information Leaflet

Biotin Polpharma, 5 mg, tablets
Biotinum
Please read the entire leaflet carefully 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
your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further 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

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

1. What Biotin Polpharma 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 vitamin B group.
Biotin Polpharma is used in the treatment of biotin deficiency presenting with symptoms such as hair loss, impaired growth of hair and nails, excessive brittleness of hair and nails, inflammatory skin conditions around the eyes, nose, mouth, and ears, and for prevention of its consequences, after other causes have been excluded by a physician.
Biotin supports keratin formation and the differentiation of epidermal cells, as well as hair and nail cells.

2. Important information before using Biotin Polpharma

When not to use Biotin Polpharma
Do not use this medicine 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 to use Biotin Polpharma, discuss this with a doctor or pharmacist.

Effect on laboratory tests
Biotin Polpharma contains 5 mg of biotin in each tablet. If the patient is due to undergo laboratory tests, they must inform the doctor or laboratory staff that they have recently taken Biotin Polpharma, as biotin may interfere with the results of such tests.
Depending on the test, results may be falsely elevated or falsely low due to biotin. The doctor may recommend discontinuing Biotin Polpharma before laboratory testing. It is also important to remember 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 Biotin Polpharma 3 days before a scheduled laboratory test, unless the laboratory provides different recommendations.

Children and adolescents
Biotin Polpharma may be used in children and adolescents only upon medical advice. The doctor will determine the optimal dosage and duration of treatment.

Biotin Polpharma and other medicines
Inform the 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) reduce biotin blood levels. Valproic acid decreases the activity of biotinidase (an enzyme involved in biotin metabolism).

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

Alcohol reduces biotin blood levels.

Steroid hormones may accelerate biotin breakdown in tissues.

Antibiotics may reduce biotin concentration or activity by disrupting intestinal microflora 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 biotin deficiency and reduced treatment efficacy.

Biotin Polpharma with food, drink, and alcohol
During treatment, do not consume raw egg white, 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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

Breastfeeding
The amount of biotin in Biotin Polpharma 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, Biotin Polpharma 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.

Biotin Polpharma contains monohydrate lactose and sodium

Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

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

3. How to use Biotin Polpharma

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 usually observed after approximately 4 weeks of treatment.
Children and adolescents
This medicine may be used in children and adolescents only on the advice of a physician. The physician will determine the appropriate dosage and duration of treatment.
Method of administration
Oral administration.
The tablet should be taken with sufficient amount of water (e.g. ½ glass).
Use of a higher than recommended dose of Biotin Polpharma
There are no reports of biotin overdose in humans.
Missed dose of Biotin Polpharma
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning 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 frequently than in 1 out of 10,000 people):
allergic reactions (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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
Phone: +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.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Biotin Polpharma

No special storage conditions are required for this medicinal product.
Keep the medicine in a place inaccessible and out of sight 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 following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Biotin Polpharma contains

The active substance is biotin. Each tablet contains 5 mg of biotin.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K 30, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

What Biotin Polpharma looks like and contents of the pack
Biotin Polpharma is a round, white or almost white, biconvex tablet with a diameter of 5.8–6.2 mm.
Biotin Polpharma is available in PVC/Aluminium blisters.
Pack size – a cardboard box containing 10, 20, 30, 60, 90 or 120 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01