ELUDRILPERIO 0,20 % Mouthwash, PET bottle/200ml

VIDAL
Medicines
Update of the 18/12/2025

ELUDRILPERIO^® 0,20 %, mouthwash solution
chlorhexidine

Forms and presentations

Mouthwash solution at 0,20 % (clear; red): 
Bottle of 200 ml with 10 ml dosing cup.
Bottle of 1 L with 10 ml dosing cup (model reserved for professional use).

Composition

	for 100 ml
Chlorhexidine digluconate	0,200 g
(in the form of chlorhexidine digluconate solution: 1,065 g)

Excipients: glycerol, propylene glycol, carmine red A (E124), macrogolglycerol hydroxystearate, mint anise flavouring^*, benzyl alcohol, acesulfame potassium, purified water.
^*  Composition of mint anise flavouring: flavouring substances, natural flavouring substances, natural flavouring preparations, including pulegone, menthofuran, estragole, thujone, methyl eugenol, safrole, linalool; propylene glycol.

Excipients with known effect: benzyl alcohol (0,650 g/100 ml), carmine red A (E124) (0,003 g/100 ml), propylene glycol (2,031 g/100 ml), macrogolglycerol hydroxystearate (1,5 g).

Allergen contained in the flavouring: linalool. The amount of mint anise flavouring is 0,3 g/100 ml.

Indications

Adjunctive local treatment of periodontal conditions linked to bacterial plaque development (gingivitis and/or periodontitis), as well as during pre- and post-operative care in odontostomatology.
This medicine is indicated in adults, adolescents and children aged over 6 years.

Dosage and administration

Dosage

Perform the mouthwash with 10 ml of Eludrilpério solution, twice a day.

The usual duration of treatment is 7 days.

The need to continue treatment beyond one week must be evaluated by a physician or a dental surgeon.

If symptoms persist beyond 5 days, the need to continue treatment must be evaluated by the physician or the dental surgeon.

Paediatric population:

This medicine is contraindicated in children under 6 years (see Contraindications).

Method of administration:

Local use as a mouthwash.

Do not swallow.

Brush teeth before each use and rinse the mouth thoroughly with water before using Eludrilpério.

The solution is ready to use and must be used undiluted and neat.

Pour the solution into the measuring cup. Carry out the mouthwash for 1 minute, then spit out. Do not rinse the mouth after carrying out the mouthwash

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
  
• In children under 6 years.
  

Warnings and precautions

Local use as a mouthwash.

Do not swallow the solution.

Do not get Eludrilpério in the eyes, nose and ears. If the mouthwash comes into contact with the eyes, nose and ears, rinse immediately and abundantly with water.

If symptoms persist beyond 5 days and/or associated fever occurs, the advice of a doctor or dentist must be sought.

This medicine may cause severe generalised allergic reactions due to the presence of chlorhexidine, which may occur a few minutes after exposure (see Undesirable effects).

Prolonged use may cause staining of the tongue, teeth, dental prostheses or filling materials. This staining is reversible and can be avoided on teeth and filling materials by brushing teeth daily before using the mouthwash, or by using a dental solution for removable (dental) prostheses.

Continuous use could lead to an imbalance of the normal microbial flora of the oral cavity, with a risk of bacterial and fungal spread (candidiasis).

This medicine contains:

• 0,065 g of benzyl alcohol per 10 ml dose. Benzyl alcohol may cause allergic reactions. It must be taken into account in pregnant or breastfeeding women or in patients with liver or kidney disease, as a large quantity of benzyl alcohol may accumulate and cause metabolic acidosis.
  
• 0,203 g of propylene glycol per 10 ml dose.
  
• carmine red A (E124) which may cause allergic reactions.
  
• macrogolglycerol hydroxystearate which may cause stomach upset and diarrhoea.
  
• a flavouring containing linalool which may cause allergic reactions.
  

Precautions for use

This specialty contains terpene derivatives as excipients, which may lower the epileptogenic threshold if ingested (see Overdose).

This must be taken into account in cases of a history of epilepsy.

Interactions

Chlorhexidine is incompatible with anionic agents generally present in conventional toothpastes. Therefore, a thorough rinsing of the mouth with water, after brushing the teeth with a toothpaste, must be carried out before using this medicine. An interval must be respected between the use of the 2 products.

Fertility, pregnancy and breastfeeding

Pregnancy:

There are no data or limited data (fewer than 300 pregnancies) on the use of chlorhexidine in pregnant women.

Animal studies have not shown direct or indirect harmful effects (under normal conditions of use) on reproduction (see Preclinical safety).

As a precautionary measure, it is preferable to avoid using Eludrilpério during pregnancy.

Breastfeeding:

It is not known whether chlorhexidine is excreted in breast milk.

Eludrilpério 0,20 % contains terpene derivatives as excipients. Data on the kinetics of excretion into milk are limited.

A risk to newborns / infants cannot be excluded.

Eludrilpério must not be used during breastfeeding.

Fertility:

Chlorhexidine has no effect on fertility

Driving and using machines

No studies on the ability to drive vehicles and use machines have been performed with Eludrilpério.

Adverse effects

Undesirable effects are classified below by system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), and frequency not known (cannot be estimated from the available data).

System organ class	MedDRA classification (preferred terms) (Frequency not known)
Immune system disorders	- Anaphylactic shock, anaphylactic reaction* - Hypersensitivity to chlorhexidine or to any of the constituents of the solution
Nervous system disorders	- Dysgeusia - Burning sensation of the mucous membranes These effects may appear at the start of treatment and generally decrease with continued treatment.
Gastrointestinal disorders	- Brown discoloration of the tongue, reversible on discontinuation of treatment (see Warnings and Precautions for Use) - Brown discoloration of the teeth, dental prostheses or filling materials, reversible on discontinuation of treatment (see Warnings and Precautions for Use) - Swelling of the parotid glands, reversible on discontinuation of treatment - Oral desquamation: if this occurs, diluting the mouthwash solution with more than 50 % water will often allow continued use of the mouthwash

^*  Risk of generalised allergy to chlorhexidine, which may lead to anaphylactic shock that could be fatal if medical care is not provided immediately. It may manifest as difficulty breathing, facial swelling, or severe skin rash.

If the patient has an allergic reaction to chlorhexidine, they must immediately stop using this product and consult a doctor.

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.

Overdose

Overdose is not expected under the normal conditions of use of this mouthwash solution.

Pharmacodynamics

Pharmacotherapeutic class: Anti-infectives and antiseptics for local oral treatment, ATC code: A01AB03.

Chlorhexidine is a broad-spectrum bactericidal antiseptic belonging to the bisdiguanide family.

Its bactericidal activity is exerted on Gram-positive germs and, to a lesser degree, on Gram-negative germs. It has fungicidal activity on Candida albicans.

The antiseptic activity of Eludrilpério has been demonstrated in vitro, in particular on pathogenic germs of the oral flora (Streptococcus mutans, Fusobacterium nucleatum).

Through its antiseptic activity, the Eludrilpério solution helps reduce dental plaque and consequently gingival inflammation.

Pharmacokinetics

Preclinical safety

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicity and local tolerance, genotoxicity, carcinogenesis, and reproductive and developmental functions did not reveal any particular risk for humans.

In non-clinical oral studies, effects at repeated doses were observed only at doses considered sufficiently higher than the maximum dose in humans, which indicates little relevance for clinical use after topical application.

Preclinical data conducted with Eludrilpério showed good local tolerance in the oral mucosa after repeated administration, as well as good general tolerance.

Storage conditions

Shelf life 3 years.

Store at a temperature not exceeding 30 °C.

After opening:

• Bottle of 200 ml: 26 days.
  
• Bottle of 1 L: 3 months.
  

HANDLING/DISPOSAL INSTRUCTIONS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)	3400922257204 (2012, SmPC rev 20.11.2025) bottle 200 ml.
	3400930089835 (2017, SmPC rev 20.11.2025) bottle 1 L.

Price:	2,44 euros (bottle of 200 ml).
Bottle of 200 ml: Reimbursed by social security at 15 %. Collect.
Bottle of 1 L: Collect.

PIERRE FABRE MÉDICAMENT Division PIERRE FABRE MEDICAL CARE
Parc industriel de la Chartreuse. 81100 Castres
Medical info:
Pharmacovigilance: Tel: 01 49 10 96 18 (direct line)
Customer Service:
Tel: 0811 022 022
Fax: 0811 021 012
https://www.pierre-fabre.com