BUCCOBET 0,1 mg Cpr à sucer Plq/50

VIDAL
Medicines
Update of 12/05/2025

BUCCOBET^®
betamethasone

Forms and presentations

Sucking tablet at 0,1 mg (white):  Box of 50, under thermoformed blister packs.

Composition

	per tablet
Betamethasone	0,1 mg
(i.e. as betamethasone valerate: 0,122 mg/tab)

Excipients: lactose monohydrate, gum arabic, magnesium stearate.
Excipient with known effect: lactose.

Indications

Local treatment of inflammations of the oral mucosa and oropharynx.

Dosage and administration

5 to 10 tablets per day, spreading out the doses.

Suck the tablets slowly without chewing or swallowing them, until completely dissolved.

Contraindications

This medicine is contraindicated in the following situations:

• Child under 6 years.
  
• Hypersensitivity to any of the components.
  
• Oral lesions of viral origin.
  

Warnings and precautions

Precautions for use

A pheochromocytoma crisis, which may be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids must not be administered to patients in whom a pheochromocytoma is suspected or confirmed until an appropriate benefit/risk assessment has been made.

Given local use and normal conditions of use, systemic passage of betamethasone valerate, if any, is low. Adverse effects linked to systemic corticosteroid therapy are unlikely.

Local anti-inflammatory treatment must not replace an etiological investigation and possible specific treatment, in particular antibacterial or antifungal.

If symptoms persist beyond 10 days and/or if associated fever occurs, the management should be reassessed.

Interactions

At the recommended doses, betamethasone for topical use is not likely to cause medically significant drug interactions.

Fertility, pregnancy and breastfeeding

Pregnancy:

In humans, epidemiological studies have not detected any malformation risk associated with corticosteroid use during the first trimester, although transplacental passage does occur.

During chronic diseases requiring treatment throughout pregnancy, a slight intrauterine growth retardation is possible. Neonatal adrenal insufficiency has been exceptionally observed after high-dose corticosteroid therapy. It seems justified to observe a period of clinical (weight, urine output) and biological monitoring of the newborn.

Consequently, this medicine may be prescribed during pregnancy if needed.

Breastfeeding:

Corticosteroids pass into breast milk and should be avoided during breastfeeding.

Adverse effects

Risk of oropharyngeal candidiasis, which resolves with local antifungal treatment.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Pharmacodynamics

Pharmacotherapeutic class: Corticosteroids for local oral treatment. ATC code: A01AC.

Betamethasone valerate: synthetic glucocorticoid.

Storage conditions

Store at a temperature below 25 °C.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)

3400937414708 (1968/96, SmPC rev 02.12.2021).

Not reimbursed by Social Security.

Marketing authorisation holder: SCA Pharma.

DB PHARMA Laboratories
1 bis, avenue du Cdt-Rivière
La Varenne-St-Hilaire
94210 Saint-Maur-des-Fossés
Tel: 01 48 83 25 14. Fax: 01 48 83 27 57
http://www.db-pharma.com