Biotifem

Package Leaflet: Information for the Patient

Biotifem, 5 mg, Tablets

Biotin

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by the Doctor or Pharmacist.

• This Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, the Pharmacist Should be Consulted.
• If the Patient Experiences any Side Effects, Including those Not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If There is no Improvement or the Patient Feels Worse after 4 Weeks, the Doctor Should be Consulted.

Table of Contents of the Leaflet

• 1. What is Biotifem and What is it Used For
• 2. Important Information Before Taking Biotifem
• 3. How to Take Biotifem
• 4. Possible Side Effects
• 5. How to Store Biotifem
• 6. Contents of the Pack and Other Information

1. What is Biotifem and What is it Used For

This Medication Belongs to the Group of Vitamin Preparations. The Biotin it Contains is a Water-Soluble Vitamin, Classified as a Vitamin B.

Biotifem is Used to Treat Biotin Deficiencies with Symptoms such as Hair Loss, Nail and Hair Growth Disorders, and their Excessive Fragility, Skin Inflammations 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 the Doctor.

Biotin Supports the Processes of Keratin Formation and Differentiation of Skin, Hair, and Nail Cells, Improving their Condition.

If There is no Improvement or the Patient Feels Worse after 4 Weeks, the Doctor Should be Consulted.

2. Important Information Before Taking Biotifem

When Not to Take Biotifem:

• If the Patient is Allergic to Biotin or any Other Ingredient of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Biotifem, the Doctor or Pharmacist Should be Consulted.

Effect on Laboratory Tests

Biotifem Contains 5 mg of Biotin per Tablet. If the Patient is to Undergo Laboratory Tests, they Must Inform the Doctor or Laboratory Personnel that they Have Recently Taken Biotifem, as Biotin May Interfere with the Test Results. Depending on the Test, the Results May be Falsely Elevated or Falsely Low Due to Biotin. The Doctor May Order the Discontinuation of Biotifem Before Performing Laboratory Tests. It Should also be Noted that Other Products, 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 Personnel.

Children and Adolescents

In Children and Adolescents, the Medication Should Only be Used After a Doctor's Recommendation.

This Medication Contains 293.50 mg of Isomalt in Each Tablet. If the Patient has Previously been Diagnosed with Intolerance to Certain Sugars, they Should Consult a Doctor Before Taking the Medication.

Biotifem and Other Medications

The Doctor or Pharmacist Should be Informed of all Medications the Patient is Currently Taking or Has Recently Taken, as Well as any Medications the Patient Plans to Take.

Antiepileptic Medications (Phenytoin, Carbamazepine, Phenobarbital, Primidone) and Alcohol May Decrease Biotin Levels in the Blood.

Steroid Hormones May Accelerate the Breakdown of Biotin in Tissues.

Valproic Acid Inhibits the Breakdown of Biotin (by Reducing the Activity of Biotin-Breaking Enzymes).

Antibiotics May Decrease the Level and Effectiveness of Biotin (by Affecting the Gut Microflora).

Biotifem with Food, Drink, or Alcohol

During Treatment with Biotifem, the Patient Should not Consume Raw Egg White at the Same Time, as it May Inhibit Biotin Absorption.

Alcohol May Decrease Biotin Levels in the Blood.

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 a Doctor or Pharmacist Before Taking this Medication.

Pregnancy

The Amount of Biotin in Biotifem Significantly Exceeds the Recommended Daily Intake for Pregnant Women, so the Medication Should not be Used in Pregnant Women.

Breastfeeding

The Amount of Biotin in Biotifem Significantly Exceeds the Recommended Daily Intake for Breastfeeding Women, so the Medication Should not be Used in Breastfeeding Women.

Fertility

Biotin is one of the Many Vitamins Used to Treat Infertility.

Driving and Operating Machinery

Biotifem Does not Affect the Ability to Drive and Operate Machinery.

3. How to Take Biotifem

This Medication Should Always be Taken as Advised by the Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.

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 Subside after About 4 Weeks of Treatment.

If There is no Improvement after 4 Weeks, the Patient Should Consult a Doctor to Rule Out Other Causes.

Use in Children and Adolescents

In Children and Adolescents, the Medication Should Only be Used After a Doctor's Recommendation.

The Doctor Will Determine the Optimal Dosing Schedule.

Elderly Patients

Dosing is the Same as for Younger Adults.

Patients with Renal or Hepatic Impairment

No Special Dosage Recommendations.

Overdose of Biotifem

No Cases of Biotin Overdose Have Been Reported.

Missed Dose of Biotifem

A Double Dose Should not be Taken to Make up for a Missed Tablet.

Discontinuation of Biotifem

To Supplement Biotin Deficiency, Biotifem Should be Taken as Advised and for a Long Time.

In Case of Further Doubts About the Use of this Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Biotifem can Cause Side Effects, although not Everybody Gets them.

In Rare Cases, Gastrointestinal Disorders and Hives May Occur.

Reporting Side Effects

If any Side Effects Occur, Including those Not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. 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 Helps to Gather More Information on the Safety of the Medication.

5. How to Store Biotifem

The Medication Should be Stored Out of Sight and Reach of Children.

Store in a Temperature Below 30°C.

Do not Use this Medication After the Expiry Date Stated on the Carton and Blister Pack:

Expiry Date (EXP). The Expiry Date is the Last Day of the Specified Month.

Medications Should not be Disposed of via Wastewater or Household Waste. The Pharmacist Should be Asked how to Dispose of Unused Medications. This 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 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 about 8.5 mm.

The Immediate Packaging Consists of PVC/PVDC/Aluminum Blisters. The Blisters and the Leaflet are Packed in a Cardboard Box. The Pack Contains 30, 60, 90, or 120 Tablets.

Marketing Authorization Holder and Manufacturer

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

Date of the Last Update of the Leaflet: