Biotebal max
Poland
Table of Contents
Package leaflet: Information for the patient
BIOTEBAL MAX, 10 mg, tablets
Biotinum
Please read carefully the entire leaflet before using 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
the physician or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any 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, you should contact your doctor.
Table of contents of the leaflet
- What BIOTEBAL MAX is and what it is used for
- Important information before taking BIOTEBAL MAX
- How to take BIOTEBAL MAX
- Possible side effects
- How to store BIOTEBAL MAX
- Contents of the pack and other information
1. What BIOTEBAL MAX is and what it is used for
BIOTEBAL MAX contains biotin in the form of d-biotin, the only biologically active isomer of biotin (d-Biotin isomer). Biotin is also known as vitamin H, a water-soluble vitamin belonging to the vitamin B group.
BIOTEBAL MAX 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 the prevention of its consequences, after exclusion of other causes by a physician.
Biotin supports keratin formation processes and the differentiation of epidermal cells, as well as hair and nail cells.
2. Important information before using BIOTEBAL MAX
When not to use BIOTEBAL MAX
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 to use BIOTEBAL MAX, discuss this with your doctor or pharmacist.
Effect on laboratory tests
BIOTEBAL MAX contains 10 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 BIOTEBAL MAX, 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 BIOTEBAL MAX 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 their doctor or laboratory staff.
It is recommended to discontinue BIOTEBAL MAX for 3 days before a scheduled test, unless the laboratory provides different recommendations in this regard.
Children and adolescents
BIOTEBAL MAX should be used in children and adolescents only on medical advice. The doctor will determine the optimal dosage and duration of treatment.
BIOTEBAL 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) reduce blood levels of biotin. 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 reduce the effectiveness of biotin; however, clinical studies have not confirmed this.
Alcohol reduces the concentration of biotin in the blood.
Steroid hormones may accelerate the breakdown of biotin in tissues.
Antibiotics may reduce the concentration or potency of biotin by disrupting intestinal microflora function.
Avidin, a basic glycoprotein found in raw egg white, has the ability to 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 in smokers.
BIOTEBAL MAX with food, drink, and alcohol
During treatment with this medicine, raw egg white should not be consumed simultaneously, as it may inhibit biotin absorption.
Alcohol reduces the concentration of biotin in the blood.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The amount of biotin contained in BIOTEBAL MAX greatly exceeds the recommended daily intake for pregnant women; therefore, the medicine should not be used during pregnancy.
Breastfeeding
The amount of biotin contained in BIOTEBAL MAX greatly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but no adverse effects on the breastfed infant have been observed. However, 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.
BIOTEBAL MAX contains lactose monohydrate and sodium
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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 BIOTEBAL MAX
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 once daily.
The usual recommended dose is 5 mg (available on the market) once daily, or, in cases of severe symptoms, 10 mg once daily.
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 treatment.
Children and adolescents
BIOTEBAL MAX may be used in children and adolescents only upon physician's recommendation. The physician will determine the optimal 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 BIOTEBAL MAX
There are no reports of biotin overdose in humans.
Missed dose of BIOTEBAL MAX
Do not take a double dose to make up for a missed dose.
If you have any further questions 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 they do not occur in everyone.
Frequency of adverse reactions
Very rare (less than 1 in 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 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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store BIOTEBAL MAX
No special storage instructions are required for this medicinal product.
The medicine should be stored out of 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 following the abbreviation EXP indicates the expiry date, and the marking following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What BIOTEBAL MAX contains
- The active substance is biotin. Each tablet contains 10 mg of biotin.
- The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone K 30, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
What BIOTEBAL MAX looks like and contents of the pack
BIOTEBAL MAX is a round, white or almost white, biconvex tablet with the imprint "10" on one side, with a diameter of 7.8–8.2 mm.
BIOTEBAL MAX is available in PVC/Aluminum blisters.
Packaging – 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