SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated: May 30, 2024

1. NAME OF THE MEDICINAL PRODUCT

BEPANTHEN 5%, ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dexpanthenol: 5.0 g

Per 100 g of ointment.

Excipients with known effects: lanolin (wool fat), stearyl alcohol and cetyl alcohol.

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Skin irritation, particularly diaper rash (redness of the buttocks) in infants.

4.2 Dosage and method of administration

Dosage

Apply one or more times daily, massaging gently.

Method of administration

For cutaneous use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Infected or weeping skin conditions.

4.4 Special warnings and precautions for use

• Avoid contact with the eyes.
• This medicinal product contains lanolin (wool fat), stearyl alcohol and cetyl alcohol. It may cause local skin reactions, such as contact dermatitis.

4.5 Interaction with other medicinal products and other forms of interaction

The data currently available do not suggest the existence of any clinically significant interactions.

4.6 Fertility, pregnancy and breastfeeding

Use with caution in women who are pregnant or breastfeeding due to the lack of usable clinical data. If applied to the breasts during breastfeeding, clean the skin before each feeding.

4.7 Effects on the ability to drive and use machines

BEPANTHEN 5% Ointment has no or negligible influence on the ability to drive or operate machinery.

4.8 Undesirable effects

Rare allergic skin reactions.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product.

Healthcare professionals should report any suspected adverse reactions through the French national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers.

Website: www.signalement-sante.gouv.fr

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: SKIN PROTECTANT

ATC code: D03AX (D: Dermatologicals).

Dexpanthenol is a component of coenzyme A.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Protegin X*, petroleum jelly, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin and purified water.

*Composition of Protegin X: light liquid paraffin, petroleum jelly, microcrystalline wax (THG), glyceryl monooleate and wool-fat alcohols.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C (77°F).

6.5 Nature and contents of the outer packaging

Aluminum tubes containing 3.5 g, 30 g, 80 g or 100 g.

Not all package sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
FRANCE

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 338 300 7 6: 3.5 g in an aluminum tube
• 34009 359 399 2 0: 30 g in an aluminum tube
• 34009 359 400 0 1: 80 g in an aluminum tube
• 34009 359 401 7 9: 100 g in an aluminum tube
• 34009 391 999 1 7: 2 × 100 g aluminum tubes
• 34009 301 230 7 2: One 100 g aluminum tube plus one 30 g aluminum tube
• 34009 302 611 7 0: 3 × 100 g aluminum tubes

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

[To be completed at a later date by the marketing authorization holder.]

10. DATE OF REVISION OF THE TEXT

[To be completed at a later date by the marketing authorization holder.]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Medicinal product not subject to medical prescription.