Biotinum Apteo Med

Package Leaflet: Information for the Patient

Biotinum APTEO MED, 10 mg, Tablets

Biotinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 weeks, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Biotinum APTEO MED and what is it used for
• 2. Important information before using Biotinum APTEO MED
• 3. How to use Biotinum APTEO MED
• 4. Possible side effects
• 5. How to store Biotinum APTEO MED
• 6. Package contents and other information

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

This medicine belongs to the group of vitamin products. The biotin it contains is a water-soluble vitamin, classified as a vitamin B.
Biotinum APTEO MED is used to treat biotin deficiency with symptoms such as:
hair loss, hair and nail growth disorders, skin inflammation localized 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 using Biotinum APTEO MED

When not to use Biotinum APTEO MED

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 Biotinum APTEO MED, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
Biotinum APTEO MED contains 10 mg of biotin in each tablet. If the patient is to undergo laboratory tests, they must inform their 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, the results may be falsely elevated or falsely low due to biotin. The doctor may recommend stopping the use of Biotinum APTEO MED before undergoing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin products or dietary supplements used to improve the condition of hair, skin, and nails, may also contain biotin and affect the results of laboratory tests. If the patient is taking such products, they should inform their doctor or laboratory staff.
It is recommended to discontinue the use of Biotinum APTEO MED for 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. The doctor will determine the optimal dosage and duration of treatment.

Biotinum APTEO MED and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin levels in the blood. Valproic acid lowers the activity of biotinidase (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 levels in the blood.
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 the case of biotin deficiency or the use of its preparations, raw egg white should not be consumed.
Smoking accelerates biotin processing, which may cause its deficiency and reduced treatment effectiveness.

Biotinum APTEO MED with food, drink, and alcohol

While taking the medicine, the patient should not consume raw egg white at the same time, as it may inhibit biotin absorption. Alcohol causes a decrease in biotin levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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, so the medicine should not be used during this period.
Breastfeeding
The amount of biotin in Biotinum APTEO MED significantly exceeds the recommended daily intake for breastfeeding women. Biotin passes into breast milk, but it has not been found to affect the breastfed infant. The medicine should not be used during breastfeeding.

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.

Biotinum APTEO MED contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Biotinum APTEO MED

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose:
Adults: from 5 mg to 10 mg per day.
The usual recommended dose is 5 mg per day (half a tablet) or, in severe cases, 10 mg per day (one tablet).
The 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 use.
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 duration of treatment.
Method of administration
Oral use.
The tablet should be taken with a sufficient amount of water (e.g., ½ glass).

Using a higher dose of Biotinum APTEO MED than recommended

There are no reports of biotin overdose in humans.

Missing a dose of Biotinum APTEO MED

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 any side effects occur, including any side effects not listed in this package leaflet, the patient should inform their 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Biotinum APTEO MED

Store in the original packaging to protect from light.
There are no special recommendations for the storage temperature of the medicine.
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 stated on the packaging after "EXP" means the last day of the given month.
The entry on the packaging after "Lot" means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Biotinum APTEO MED contains

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

What Biotinum APTEO MED looks like and what the package contains

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.
The packaging - a cardboard box contains 30, 60, 90, or 120 tablets.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
phone: 607 696 231
email: infodn@synoptispharma.pl

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of the last update of the package leaflet: