Biotebal
Poland
Table of Contents
Package leaflet: Information for the patient
Biotebal, 5 mg, tablets
Biotinum
Please read the entire leaflet carefully 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 directed by a doctor or pharmacist.
- Keep this leaflet for future reference.
- If advice or further information is needed, consult a pharmacist.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement or if the patient feels worse, contact a doctor.
Table of contents
- What Biotebal is and what it is used for
- Important information before taking Biotebal
- How to take Biotebal
- Possible side effects
- How to store Biotebal
- Contents of the pack and other information
1. What Biotebal is and what it is used for
Biotebal belongs to the group of vitamin preparations. The active ingredient, biotin, is a water-soluble vitamin belonging to the vitamin B group.
Biotebal is indicated in biotin deficiency.
The medicine may be used in conditions resulting from biotin deficiency, such as hair loss, growth disorders of nails and hair, excessive brittleness of hair and nails, and inflammatory skin conditions around the eyes, nose, and mouth.
Biotin supports keratin formation and the differentiation of epidermal, hair, and nail cells, thereby improving their condition.
2. Important information before using Biotebal
When not to use Biotebal
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, discuss this with your doctor or pharmacist.
Biotebal and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Biotin may interfere with certain laboratory test methods and thus may distort some laboratory results. However, it does not affect the actual blood levels of hormones, factors, parameters, or drugs. Therefore, it is recommended to discontinue Biotebal 3 days before planned laboratory tests (e.g. FT4, FT3, 25(OH)D, cortisol, digoxin, TSH, hCG, troponin, PSA), unless the laboratory provides different instructions.
Also keep in mind that other products you may be taking, such as multivitamins or dietary supplements for hair, skin, and nails, may also contain biotin and affect laboratory test results.
Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) may reduce biotin blood levels.
Steroid hormones may accelerate the breakdown of biotin in tissues.
Biotebal with food, drink, and alcohol
Do not consume raw egg white while taking this medicine, as it may inhibit the absorption of biotin.
Alcohol reduces biotin blood levels.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The amount of biotin in Biotebal significantly exceeds the recommended daily intake for pregnant women; therefore, this medicine should not be used during pregnancy.
Breastfeeding
The amount of biotin in Biotebal 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, Biotebal 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 contains sorbitol (E 420)
Biotebal contains 111.50 mg of sorbitol (E 420) per tablet.
3. How to use Biotebal
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
usually 5 mg per day.
Note: the medicine should be taken regularly.
Taking more Biotebal than recommended
There are no reports of biotin overdose in humans.
If you forget to take Biotebal
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Gastrointestinal disorders and urticaria may occur in isolated cases.
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 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 enables continued monitoring of the medicine's safety.
5. How to store Biotebal
Store at a temperature not exceeding 30°C.
Keep in the original packaging to protect from moisture.
Keep the medicine 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 after the abbreviation "EXP" indicates the expiry date, and after 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 in use. This will help protect the environment.
6. Contents of the packaging and other information
What Biotebal contains
- The active substance is biotin. Each tablet contains 5 mg of biotin.
- The other ingredients are: sorbitol (E 420), magnesium stearate, colloidal silicon dioxide.
What Biotebal looks like and contents of the pack
Biotebal tablets are white, flat on both sides, with a smooth surface.
The cardboard box contains:
30, 60 or 90 tablets in blisters made of Aluminium/PVC foil.
Not all pack sizes and types may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański