Biotifem max

Package leaflet: Information for the patient

Biotifem MAX, 10 mg, tablets
Biotinum
Please read the entire leaflet carefully before taking the 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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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, contact your doctor.

Table of contents of the leaflet

1. What Biotifem MAX is and what it is 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 Biotifem MAX 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 MAX 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 prevention of consequences of biotin deficiency after exclusion of other causes by a physician.
Biotin supports keratin formation and epidermal, hair, and nail cell differentiation, thereby improving their condition.
If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

2. 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, discuss this with a doctor or pharmacist.
Effect on laboratory tests
Biotifem MAX contains 10 mg of biotin per tablet. If the patient is due to undergo laboratory tests, they must inform the doctor or laboratory staff that they have recently taken Biotifem MAX, because 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 instruct 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 the doctor or laboratory staff.
Children and adolescents
Biotifem MAX should be used in children and adolescents only under medical advice.
This medicine contains 288.50 mg of isomalt per tablet. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Biotifem MAX with other medicines
Tell the 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) 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 MAX with food, drink or alcohol
During treatment with this medicine, raw egg white should not be consumed simultaneously, as it may inhibit the absorption of biotin.
Alcohol reduces the concentration of biotin in the blood.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The amount of biotin contained in Biotifem MAX significantly exceeds the recommended daily intake for pregnant women; therefore, this medicine should not be used during pregnancy.
Breastfeeding
The amount of biotin contained in Biotifem MAX 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 MAX does not affect the ability to drive or operate machinery.

3. How to take Biotifem MAX

This medicine should always be taken according to the instructions given by the doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 5 mg to 10 mg 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 the doctor to rule out other causes.
Use in children and adolescents
This medicine should be used in children and adolescents only on medical advice.
The doctor will determine the optimal dosing regimen.
Elderly patients
Dosage as in younger adults.
Patients with renal or hepatic impairment
No special dosage recommendations are required.
Taking more Biotifem MAX than recommended
Cases of biotin overdose have not been reported.
Missing a dose of Biotifem MAX
Do not take a double dose to make up for a missed tablet.
Stopping Biotifem MAX
To correct biotin deficiency, Biotifem MAX should be taken as recommended.
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 experiences them.
Gastrointestinal disorders and urticaria may occur in individual cases.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. 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 helps to provide more information on the safe use of the medicine.

5. How to store Biotifem MAX

Keep this medicine out of sight and reach of children.
No special storage conditions for this medicine.
Do not use this medicine 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 stated month.
Medicines should 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 packaging and other information

What Biotifem MAX contains

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

What Biotifem MAX looks like and contents of the pack
The tablets are white or almost white, round, biconvex, with an embossed "10" on one side,
approximately 8.5 mm in diameter.
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 or 90 tablets.
Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o.,
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka