Biotin 5 mg Tablets – 60 Tablets

Description
Biotin 5 mg tablets, developed by Bayer Laboratories, are designed to support adults experiencing hair loss (diffuse alopecia) and hair fragility. Each tablet provides 5 mg of biotin (Vitamin H or Vitamin B8), an essential nutrient that supports keratin synthesis, a crucial component of healthy hair.

Composition
Each tablet contains:

• Active Ingredient: Biotin (Vitamin H) – 5 mg
• Notable Excipient: Lactose monohydrate
• Additional Excipients: Corn starch, talc, stearic acid, and magnesium stearate

Dosage and Administration

• Recommended Dosage: 3 tablets per day, taken with a glass of water for 6 weeks.
• Instructions: Swallow the tablets whole without chewing or crushing.

Important Precautions

• Lactose: Contains lactose monohydrate; not suitable for individuals with lactose or galactose intolerance, or glucose malabsorption syndrome.
• Age: For adults and adolescents over 15 years only.

Packaging

• Box of 60 tablets, packaged in blister packs, providing a 20-day supply.
  

Please read the following full disclosure before purchasing or taking this product. 

Product Summary

ANSM – Updated on: 06/06/2019

1. Product Name
BIOTINE BAYER 5 mg, tablet

2. Qualitative and Quantitative Composition

• Biotin (Vitamin H): 5 mg per tablet
• Notable excipient: lactose

For a complete list of excipients, see section 6.1.

3. Pharmaceutical Form
Tablet

4. Clinical Data

4.1. Therapeutic Indications
Adjunctive treatment for diffuse alopecia (hair loss).

4.2. Dosage and Administration

• Dosage: 3 tablets per day for 6 weeks.
• Administration Method: Swallow with a glass of water. Oral use only.

4.3. Contraindications
Hypersensitivity to the active ingredient or any excipients listed in section 6.1.

4.4. Special Warnings and Precautions

• Lactose intolerance: Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (rare hereditary conditions) should not take this medication.
• Interference with Laboratory Tests: Biotin may interfere with laboratory tests based on biotin/streptavidin interaction, potentially causing false high or low results, depending on the test. This risk is higher in children and patients with renal insufficiency and increases with higher doses. When interpreting lab results, consider biotin interference, especially if results are inconsistent with the clinical presentation (e.g., false indications of Graves' disease in thyroid tests or false-negative troponin results in myocardial infarction patients). If interference is suspected, use alternative tests unaffected by biotin. Notify laboratory staff if biotin is being used when ordering tests.

4.5. Interactions with Other Medicines
No interaction studies have been conducted.

4.6. Fertility, Pregnancy, and Breastfeeding

• Pregnancy: There is no reliable data on teratogenic effects in animals. Clinically, no malformative or fetotoxic effects have been observed, but available pregnancy data are insufficient to rule out risk. As a precaution, it is preferable to avoid using this medication during pregnancy.
• Breastfeeding: In the absence of data, it is preferable to avoid using this medication during breastfeeding.

4.7. Effects on Driving and Using Machines
BIOTINE BAYER 5 mg tablets have no or negligible effect on the ability to drive or operate machinery.

4.8. Adverse Reactions
Allergic-type hypersensitivity reactions, mainly skin reactions (urticaria, angioedema, rash, itching), have been reported.

Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions post-authorization is important for continuous monitoring of the benefit-risk ratio. Healthcare professionals should report any suspected adverse reactions via the national reporting system: ANSM and Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose
No specific overdose risk with biotin has been reported.

5. Pharmacological Properties

5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: VITAMIN H (Dermatology).

6. Pharmaceutical Data

6.1. List of Excipients
Lactose monohydrate, corn starch, talc, stearic acid, magnesium stearate.

6.2. Incompatibilities
None known.

6.3. Shelf Life
5 years.

6.4. Special Storage Precautions
No special storage conditions required.

6.5. Packaging

• 20 tablets in blister packs (PVC/Aluminum) of 10 tablets each.
• 60 tablets in blister packs (PVC/Aluminum) of 10 tablets each.

6.6. Disposal Precautions
No specific disposal requirements.

7. Marketing Authorization Holder
BAYER HEALTHCARE SAS
220, AVENUE DE LA RECHERCHE
59120 LOOS

8. Marketing Authorization Number(s)

• 34009 369 091 06: 20 tablets in blister packs (PVC/Aluminum)
• 34009 369 092 74: 60 tablets in blister packs (PVC/Aluminum)

Prescription and Supply Conditions
Non-prescription medication.