Description:
1. NAME OF THE MEDICINAL PRODUCT
ALODONT, solution for mouthwash
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetylpyridinium chloride ........................................................................................................... 5,0000 mg
Chlorobutanol hemihydrate .......................................................................................................... 50,0000 mg
Eugenol ...................................................................................................................................... 4.0000 mg
Per 100 g of solution.
Alcoholic strength: 21 % v/v
Notable excipient: castor oil.
3. PHARMACEUTICAL FORM
Mouthwash solution.
4. CLINICAL DATA
4.1. therapeutic indications
Local adjunctive treatment of infections of the oral cavity, and post-operative care in stomatology.
4.2. Dosage and method of administration
RESERVED FOR ADULTS AND CHILDREN OVER 7 YEARS OF AGE.
Local use as a mouthwash.
Do not swallow.
In adults: 3 mouthwashes per day with pure product, keep the product in the mouth for one minute.
For children aged 7 to 12 years: 3 mouthwashes per day with product diluted at 50% with water.
4.3. Contraindications
- Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Special warnings
The indication does not justify prolonged treatment, especially as it could lead to an imbalance in the normal microbial flora of the oral cavity with a risk of bacterial or fungal spread.
This product contains terpene derivatives which may cause neurological accidents such as convulsions in infants and children in excessive doses. Respect the recommended dosage and duration of treatment.
This medicine contains castor oil and may cause skin reactions (for example: eczema).
Precautions for use
In case of persistence of symptoms beyond 5 days and/or associated fever, the course of action should be reassessed.
In case of a history of epilepsy, take into account the presence of terpene derivatives.
4.5. Interactions with other medicinal products and other forms of interaction
The simultaneous or successive use of other antiseptics should be avoided because of possible interference (antagonism, inactivation, etc.).
4.6. Pregnancy and lactation
Breast-feeding
If you are breast-feeding, it is preferable not to use this medicine because of
- the absence of kinetic data on the passage of terpene derivatives in milk,
- and their potential neurological toxicity in infants.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Due to the presence of terpene derivatives and if the recommended doses are not followed:
- risk of convulsions in children,
- possibility of agitation and confusion in elderly subjects.
Very rare: ≤ 0.01 %
Gastrointestinal disorders: Irritation of the mouth
Immune system disorders: Systemic allergic reaction
4.9. Overdose
This specialty contains terpene derivatives, as excipients, which may lower the epileptogenic threshold and cause, at excessive doses, neurological accidents in children (such as convulsions) and in elderly subjects (such as agitation and confusion). The recommended dosage and duration of treatment must be observed.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class:
STOMATOLOGY/LOCALTREATMENTWITH ANTISEPTIC EFFECT.
(A: digestive system and metabolism).
This medicinal product contains terpene derivatives which may lower the epileptogenic threshold.
5.2. Pharmacokinetic properties
Not known.
5.3. Preclinical safety data
Not provided.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Alcohol, hydrogenated polyoxyethylene castor oil 25, sodium hydroxide, citric acid monohydrate, peppermint essential oil, sodium saccharin, patent blue V (E131), purified water.
6.Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special storage precautions
Store at a temperature below 25°C.
6.5. Nature and contents of the outer packaging
- 30 ml colourless glass bottle, closed with an aluminium stopper fitted with a polexan-saranex (expanded polyethylene, vinylidene polymer, ethylene vinyl acetate) seal.
- Colourless glass bottle of 200 ml + measuring cup (polypropylene) graduated to 15 ml, closed with an aluminium stopper fitted with a pelexan-triseal type seal.
- Colourless glass bottle of 200 ml, closed with an aluminium stopper fitted with a polexan-triseal type seal.
- Colourless glass bottle of 500 ml + measuring cup (polypropylene) graduated to 15 ml, closed with a high density polyethylene stopper fitted with a polexan-triseal type seal.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
TONIPHARM
3, RUE DES QUATRE CHEMINEES
92100 BOULOGNE BILLANCOURT
8. MARKETING AUTHORISATION NUMBER(S)
- 339 028-9: 30 ml in a bottle (colourless glass).
- 316 390-3: 200 ml in a bottle (colourless glass) + measuring cup (polypropylene).
- 339 041-5: 200 ml in a bottle (colourless glass).
- 345 853-8: 500 ml in a bottle (colourless glass) + dosing cup (polypropylene).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Not applicable.
10. DATE OF UPDATE OF THE TEXT
Not applicable.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
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