Biotifem Max

Package Leaflet: Information for the Patient

Biotifem MAX, 10 mg, Tablets

Biotin

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This 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 the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Biotifem MAX and what is it used for
• 2. Important information before taking Biotifem MAX
• 3. How to take Biotifem MAX
• 4. Possible side effects
• 5. How to store Biotifem MAX
• 6. Contents of the pack and other information

1. What is Biotifem MAX and what is it used for

This medicine belongs to the group of vitamin preparations. The biotin it contains is a water-soluble vitamin, classified as one of the B vitamins.
Biotifem MAX is used to treat biotin deficiencies with symptoms such as hair loss, nail and hair growth disorders, and excessive brittleness, skin inflammation around the eyes, nose, mouth, and genital area, as well as to prevent the consequences of deficiencies, after other causes have been ruled out by a doctor.
Biotin supports the processes of keratin formation and differentiation of skin, hair, and nail cells, improving their condition.
If there is no improvement after 4 weeks or the patient feels worse, they should consult their doctor.

2. Important information before taking Biotifem MAX

When not to take Biotifem 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 take Biotifem MAX, the patient should discuss it with their doctor or pharmacist.
Effect on laboratory tests
Biotifem MAX contains 10 mg of biotin per tablet. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory personnel that they have recently taken Biotifem MAX, 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 order the patient to stop taking Biotifem MAX before undergoing laboratory tests. It should also be remembered that other products being taken, 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 personnel.
Children and adolescents
This medicine can be used in children and adolescents only if prescribed by a doctor.
This medicine contains 288.50 mg of isomalt in each tablet. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Biotifem MAX 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) and alcohol cause a decrease in biotin blood levels.
Steroid hormones may accelerate biotin breakdown in tissues.
Valproic acid inhibits biotin breakdown (by reducing the activity of biotin-degrading enzymes).
Antibiotics may decrease biotin levels and potency (by affecting gut microflora).

Biotifem MAX with food, drink, or alcohol

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

Pregnancy, breastfeeding, and fertility

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 Biotifem MAX far exceeds the recommended daily intake for pregnant women, so the medicine should not be used in pregnant women.
Breastfeeding
The amount of biotin in Biotifem MAX far exceeds the recommended daily intake for breastfeeding women, so the medicine should not be used in breastfeeding women.
Fertility
Biotin is one of the many vitamins used to treat infertility.

Driving and using machines

Biotifem MAX does not affect the ability to drive and use machines.

3. How to take Biotifem MAX

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Adults
The recommended dose is from 5 mg to 10 mg per day.
The duration of treatment depends on the type and course of the disease. Symptoms subside after about 4 weeks of taking the medicine.
If there is no improvement after 4 weeks, the patient should contact their doctor to rule out other causes.
Use in children and adolescents
This medicine can be used in children and adolescents only if prescribed by a doctor.
The doctor will determine the optimal dosing regimen.
Elderly patients
Dosing is the same as for younger adults.
Patients with renal or hepatic impairment
There are no special dosing recommendations.

Taking more than the recommended dose of Biotifem MAX

No cases of biotin overdose have been reported.

Missing a dose of Biotifem MAX

A double dose should not be taken to make up for a missed tablet.

Stopping treatment with Biotifem MAX

To supplement biotin deficiency, Biotifem MAX should be taken as directed.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Biotifem MAX can cause side effects, although not everybody gets them.
In individual cases, gastrointestinal disorders and hives may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Biotifem MAX

The medicine should be stored out of sight and reach of children.
There are no special storage recommendations.
The medicine should not be used after the expiry date stated on the carton and blister pack after:
Expiry date (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Biotifem MAX contains

• The active substance is biotin. Each tablet contains 10 mg of biotin.
• The other ingredients are: isomalt and magnesium stearate.

What Biotifem MAX looks like and contents of the pack

The tablets are white or almost white, round, flat on both sides, with the imprint "10" on one side, with a diameter of about 8.5 mm.
The immediate packaging consists of PVC/PVDC/Aluminum blisters. The blisters and the patient leaflet are packed in a cardboard box. The pack contains 30, 60, or 90 tablets.

Marketing authorization holder and manufacturer

Natur Produkt Pharma Sp. z o.o.,
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka

Date of last revision of the leaflet: