Amylmetacresol................................................................................................................... 0.60
mg
2,4-Dichlorobenzyl alcohol............................................................................................... 1.20
mg
For one lozenge.
Notable excipients: isomalt (E953), maltitol (E965), orange yellow colouring S (E110).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Yellow-orange, round tablet.
4. CLINICAL DATA
4.1. therapeutic indications
This medicine is indicated for adults and children over 6 years of age in case of sore throat
without fever.
4.2. Dosage and method of administration
Dosage
The lowest effective dose should be used for the shortest time necessary to relieve symptoms
relief of symptoms.
Adults and children over 6 years
The dosage is 1 lozenge 3 to 6 times a day, spaced 2 to 3 hours apart.
Do not exceed 6 lozenges per 24 hours.
Children under 6 years of age
This product is contraindicated in children under 6 years of age (see section 4.3).
Method of administration
Oral administration.
Suck the lozenge slowly without chewing or swallowing. It is preferable to suck the lozenge
it is preferable to suck the tablet away from meals.
4.3. Contraindications
- · Hypersensitivity to the active substances or to any of the excipients mentioned in section
6.1.
- · Children under 6 years of age.
4.Special warnings and precautions for use
Special warnings
The indication does not justify prolonged treatment beyond 5 days, especially as it could
expose to an imbalance of the normal microbial flora of the oral cavity with a risk of
of bacterial or fungal diffusion.
Precautions for use
In case of persistence of symptoms beyond 3 days and/or associated fever, consult a physician to reassess the
doctor to reassess the appropriate course of action.
Special precautions related to excipients:
This product contains maltitol (E965) and isomalt (E953). Patients with rare hereditary
patients with rare hereditary problems of fructose intolerance should not take this medicine.
Isomalt (E953) and maltitol (E965) may have a mild laxative effect.
Take into account the caloric value of 2.3 kcal/g of isomalt (E953) or maltitol (E965).
Orange yellow S (E110) may cause allergic reactions.
4.5. Interactions with other medicinal products and other forms of interaction
The data available to date do not suggest the existence of clinically significant interactions
clinically significant interactions.
4.6. Fertility, pregnancy and lactation
Pregnancy
Studies in animals are insufficient to conclude on reproductive toxicity (see section 5.3)
(see section 5.3).
There are no or limited data available on the use of this medicinal product in pregnant women
pregnant women.
In the absence of data on this combination, the use of this medicinal product is not recommended
in the absence of data on this combination, this drug should not be used during pregnancy or in women of childbearing potential who are not using contraception.
Breastfeeding
There are insufficient data on the excretion of 2,4-dichlorobenzyl alcohol
amylmetacresol or their metabolites in breast milk.
A risk to breast-fed neonates/infants cannot be excluded.
This medicinal product should not be used during breast-feeding.
Fertility
No data on the effects on fertility in humans are available.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Adverse reactions
The adverse reactions listed below are classified by organ system class and frequency, as defined by the
in order of frequency, as defined by the MedDRA classification. The frequencies are defined as follows
very common (? 1/10), common (? 1/100, < 1/10), uncommon (? 1/1000, < 1/100), rare (? 1/1000, < 1/100), or very rare (? 1/1000, < 1/100).
1/100), rare (? 1/10000, < 1/1000), very rare (< 1/10000), undetermined (cannot be estimated based on available data)
based on available data).
Classification by
system and organ
Frequency Adverse Reactions
Immune system disorders
immune System
Not known Hypersensitivity
Reporting of Suspected Adverse Reactions
Post-marketing reporting of suspected adverse reactions is important
important. It allows continuous monitoring of the benefit/risk ratio of the medicine.
Health professionals 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 :www.signalementsante.
gouv.fr.
4.9. Overdose
Symptoms
In the unlikely event of overdose, no serious adverse effects are expected. Gastrointestinal discomfort
gastrointestinal discomfort may be experienced.
Treatment
In case of overdose, treatment should be symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: MISCELLANEOUS (ANTISEPTICS), ATC Code: R02AA20.
Association of 2 local antiseptics.
5.2. Pharmacokinetic properties
2,4-Dichlorobenzyl alcohol is metabolized in the liver to form hippuric acid
excreted in the urine.
No data are available on the metabolism and excretion of
amylmetacresol.
5.3. Preclinical safety data
No adverse effects on the course of pregnancy or fetal development have been reported in a study conducted in
no adverse effects on the course of pregnancy or fetal development were reported in a rabbit study.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Essential oil of mint, quinoline yellow (E104), saccharin sodium, tartaric acid,
orange yellow colouring S (E110), lemon essence, honey flavour, isomalt (E953), maltitol (E965).
6.Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage precautions.
6.5. Nature and contents of the outer packaging
PVC-PVDC/Aluminium leaflet.
Each box contains 6, 8, 12, 16, 24 or 36 tablets.
All presentations may not be marketed.
6.6. Special precautions for disposal and handling
No special requirements for disposal.
Any unused medication or waste material should be disposed of in accordance with applicable regulations
regulations.
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