Package leaflet: Information for the patient

Biotifem, 5 mg, tablets
Biotinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken 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 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, consult your doctor.

Table of contents

What Biotifem is and what it is used for
What you need to know before taking Biotifem
How to take Biotifem
Possible side effects
How to store Biotifem
Contents of the pack and other information

1. What Biotifem is and what it is used for

This medicine belongs to the group of vitamin preparations. The active ingredient, biotin, is a water-soluble vitamin belonging to the vitamin B group.
Biotifem is used in the treatment of biotin deficiency associated with symptoms such as hair loss, impaired growth of nails and hair, excessive brittleness of hair and nails, inflammatory skin conditions around the eyes, nose, mouth, and groin, and for the prevention of consequences of biotin deficiency, after exclusion of other causes by a physician.
Biotin supports keratin formation and the differentiation of epidermal cells, as well as hair and nail cells, thereby improving their condition.
If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

2. Important information before taking Biotifem

When not to take Biotifem:

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, discuss this with your doctor or pharmacist.
Effect on laboratory tests
Biotifem contains 5 mg of biotin per tablet. If the patient is due to have laboratory tests,
they must inform the doctor or laboratory staff that they have recently taken Biotifem,
because biotin may interfere with test results. Depending on the test, results may be
falsely elevated or falsely low due to biotin. The doctor may instruct the patient to stop
taking Biotifem before undergoing laboratory tests. It should also be noted 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
Biotifem should be used in children and adolescents only under medical supervision.
This medicine contains 293.50 mg of isomalt per tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Biotifem with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) and alcohol
may reduce blood levels of biotin.
Steroid hormones may accelerate the breakdown of biotin in tissues.
Valproic acid inhibits the breakdown of biotin (by reducing the activity of enzymes that degrade biotin).
Antibiotics may reduce the concentration and effectiveness of biotin (by affecting intestinal microflora).
Biotifem with food, drink or alcohol
During treatment with this medicine, raw egg white should not be consumed simultaneously,
as this may inhibit the absorption of biotin.
Alcohol reduces blood levels of biotin.
Pregnancy, breastfeeding and fertility
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 in Biotifem significantly exceeds the recommended daily intake for
pregnant women; therefore, this medicine should not be used during pregnancy.
Breastfeeding
The amount of biotin in Biotifem significantly exceeds the recommended daily intake for
breastfeeding women; therefore, this medicine should not be used during breastfeeding.
Fertility
Biotin is one of several vitamins used in the treatment of infertility.
Driving and operating machinery
Biotifem has no influence on the ability to drive or operate machinery.

3. How to take Biotifem

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of
doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 5 mg to 10 mg, i.e. 1 or 2 tablets per day.
The duration of treatment depends on the type and course of the disease. Symptoms usually improve after approximately 4 weeks
of treatment.
If there is no improvement after 4 weeks, the patient should contact their doctor to
exclude other possible causes.
Use in children and adolescents
This medicine should be used in children and adolescents only upon medical advice.
The doctor will determine the optimal dosing regimen.
Elderly patients
Dosage is the same as in younger adults.
Patients with renal or hepatic impairment
No special dosage recommendations are required.
Taking more Biotifem than recommended
Cases of biotin overdose have not been reported.
Missing a dose of Biotifem
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Biotifem
To correct biotin deficiency, Biotifem should be taken regularly as recommended and for a prolonged period.
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 disturbances and urticaria may occur in individual cases.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
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 helps to provide more information on the safety of the medicine.

5. How to store Biotifem

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. 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 Biotifem contains

The active substance is biotin. Each tablet contains 5 mg of biotin.
The other ingredients (excipients) are: isomalt and magnesium stearate.

What Biotifem looks like and contents of the pack
The tablets are white or almost white, round, biconvex,
with a diameter of approx. 8.5 mm.
The immediate packaging consists of PVC/PVDC/Aluminium blisters. The blisters and the package leaflet are packed in a cardboard box. The pack contains 30, 60, 90 or 120 tablets.
Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o., ul. Podstoczysko 30
07-300 Ostrów Mazowiecka