Bepanthene Hair Tablets – 60 Tablets

Indications
Bepanthene 100 mg tablets are designed as a supportive treatment for adults experiencing diffuse hair loss (alopecia). The active ingredient, dexpanthenol, is a component of coenzyme A, which contributes to the synthesis of vitamin B5 and supports hair health.

Who It’s For

• Adults Only
• Pregnancy and Breastfeeding: Not recommended

Form: Tablets

Dosage
For adults, the recommended dose is 3 tablets daily, taken with a large glass of water, for a duration of 6 weeks.

Precautions

• Allergy Alert: Do not use if you are allergic to dexpanthenol or any of the other listed ingredients, including lactose.
• Lactose Intolerance: Not suitable for individuals with galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.
• Pregnancy and Breastfeeding: Avoid using during pregnancy or breastfeeding and consult your doctor if you are on other treatments.

Packaging
Each box contains 60 tablets.

Please read the following full disclosure before purchasing or using these tablets.

Product Summary

ANSM – Updated on: 30/05/2024

1. Product Name
BEPANTHENE 100 mg, tablet

2. Qualitative and Quantitative Composition

• Dexpanthenol (Vitamin B5): 100 mg per tablet
• Notable excipients: Each tablet contains 300 mg of lactose

For a full 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
For adults only

• Dosage: 3 tablets per day for 6 weeks.

4.3. Contraindications
Hypersensitivity to any of the ingredients.

4.4. Special Warnings and Precautions
Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary disorders) should not take this medication.

4.5. Interactions with Other Medicines
None known.

4.6. Fertility, Pregnancy, and Breastfeeding

Pregnancy

• There are no reliable teratogenicity data in animals.
• No specific malformative or fetotoxic effects have been observed in humans, but insufficient data exist. As a precaution, it is preferable to avoid this medication during pregnancy.

Breastfeeding

• In the absence of data, it is preferable to avoid use during breastfeeding.

4.7. Effects on Driving and Using Machines
No effects on the ability to drive or operate machinery have been observed.

4.8. Adverse Reactions
Very rare cases of skin reactions such as urticaria or erythema have been reported.

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

4.9. Overdose
No cases of overdose have been reported.

5. Pharmacological Properties

5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: VITAMIN B5, ATC code: A11HA30 (D: dermatology).

6. Pharmaceutical Data

6.1. List of Excipients
Hydrated colloidal silica, gum arabic, lactose monohydrate, corn starch, stearic acid, magnesium stearate.

6.2. Incompatibilities
None known.

6.3. Shelf Life
3 years.

6.4. Special Storage Precautions
Store at a temperature below 25°C.

6.5. Packaging
Available in:

• 20 tablets in blister packs (PVC/PE/PVDC/Aluminum)
• 60 tablets in blister packs (PVC/PE/PVDC/Aluminum)

6.6. Disposal Precautions
No specific requirements.

7. Marketing Authorization Holder
BAYER HEALTHCARE SAS
1 rue Claude Bernard
59000 Lille

8. Marketing Authorization Number(s)

• 3400930107140: 20 tablets in blister packs (PVC/PE/PVDC/Aluminum)
• 3400932949243: 60 tablets in blister packs (PVC/PE/PVDC/Aluminum)

Prescription and Supply Conditions
Non-prescription medication.