Package leaflet: Information for the user

Biotinum APTEO MED, 10 mg, tablets
Biotinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as
directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible side effects 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 consult your doctor.

Leaflet contents

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

1. What Biotinum APTEO MED is and what it is used for

This medicine belongs to the group of vitamin products. The active ingredient, biotin, is a water-soluble vitamin belonging to the vitamin B group.
Biotinum APTEO MED is used in the treatment of biotin deficiency associated with symptoms such as:
hair loss, disturbances in the 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 Biotinum APTEO MED

When not to use Biotinum APTEO MED
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 treatment with Biotinum APTEO MED, discuss this with your doctor or
pharmacist.

Effect on laboratory tests
Biotinum APTEO MED 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 Biotinum APTEO MED, 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 Biotinum APTEO MED before laboratory testing. It should also be noted
that other products the patient may be taking, such as multivitamins or dietary supplements used
to improve the condition of 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 Biotinum APTEO MED for 3 days before a scheduled test,
unless the laboratory provides different instructions.

Children and adolescents
This medicine should be used in children and adolescents only on medical advice. The doctor will
determine the optimal dosage and duration of treatment.

Biotinum APTEO MED 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.

Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) may 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 this has not been confirmed in clinical studies.

Alcohol reduces biotin blood levels.

Steroid hormones may accelerate biotin breakdown in tissues.

Antibiotics may reduce biotin levels or effectiveness by disrupting intestinal microflora.

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.

Biotinum APTEO MED 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 her doctor or pharmacist before using this medicine.

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

Breastfeeding
The amount of biotin in Biotinum APTEO MED significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into human milk, but no adverse effects on breastfed infants have been observed. Nevertheless, this 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.

Biotinum APTEO MED contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Biotinum APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose:
Adults : 5 mg to 10 mg per day.
The usual recommended dose is 5 mg per day (half a tablet) or, in cases of severe symptoms,
10 mg per day (one whole tablet).
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 use.
Children and adolescents
This medicine should be used in children and adolescents only on medical advice. The physician will determine the optimal dosage and duration of treatment.
Method of administration
For oral use.
The tablet should be taken with an adequate amount of water (e.g. ½ glass).
Use of a higher than recommended dose of Biotinum APTEO MED
There are no reports of biotin overdose in humans.
Missed dose of Biotinum APTEO MED
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 doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Very rare (less than 1 in 10,000 people):

allergic reactions (urticaria)
gastrointestinal disorders

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 Biotinum APTEO MED

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 no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Biotinum APTEO MED 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 Biotinum APTEO MED looks like and contents of the pack
Biotinum APTEO MED 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.
Biotinum APTEO MED is available in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters.
Packaging – a cardboard box containing 30, 60, 90 or 120 tablets.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel. 607 696 231
email: [email protected]
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice