Medicines
Update of 18/01/2021
COQUELUSÉDAL® Children
grindelia, gelsemium
Forms and presentations
Suppository: Boxes of 10, in thermoformed blister packs.Composition
| per suppository | |
| Grindelia (Grindelia robusta Nutt.) (soft extract of flowering tops of)
|
20 mg |
| (drug/extract ratio: 4 : 1) | |
| Gelsemium (Gelsemium sempervirens (L) Ait.) (soft extract of underground part of)
|
10 mg |
| (drug/extract ratio: 10 : 1) | |
Extraction solvent: ethanol 70% v/v (grindelia); ethanol 60% v/v (gelsemium).
Excipient with known effect: propylene glycol.
Indications
Traditional herbal medicinal product used for the symptomatic treatment of mild acute bronchial conditions.Its use is restricted to the specified indications on the exclusive basis of long-standing use.
Coquelusedal Children, suppository is indicated in children and adolescents from 30 months to 15 years.
Dosage and administration
Dosage
Paediatric population
- Children and adolescents from 30 months to 15 years: 1 to 2 suppository(ies) per day.
- Children under 30 months: this medicine is not indicated in children under 30 months.
Method of administration
Rectal route.
Duration of treatment
5 days.
If symptoms persist beyond 5 days of treatment, a doctor or pharmacist must be consulted.
Contraindications
- Hypersensitivity to the active substances, to other plants of the Asteraceae family or to any of the excipients mentioned in the section Composition.
- Due to the route of administration, recent history of ano-rectal lesions.
Warnings and precautions
If symptoms persist or worsen while using this medicine, or if dyspnoea, purulent expectoration or fever occurs, a doctor must be consulted.
In case of chronic bronchial and lung disease, a doctor must be consulted before using Coquelusédal Enfants, suppository.
This medicine contains 15 mg of propylene glycol per dose.
Interactions
No interaction studies have been performed.
Fertility, pregnancy and breastfeeding
Pregnancy:The safety of use in pregnant women has not been demonstrated. In the absence of sufficient data, this medicine is not recommended during pregnancy.
Breastfeeding:
The safety of use in breastfeeding women has not been demonstrated. In the absence of sufficient data, this medicine is not recommended during breastfeeding.
Fertility:No data on fertility are available.
Driving and using machines
The effects on the ability to drive vehicles and use machines have not been studied.Adverse effects
Local effects (irritation of the anus or rectum), related to the route of administration, may be observed. They are all the more frequent and intense the longer the duration of use, and the higher the frequency of administration and the dose.
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: www.signalement-sante.gouv.fr.
Overdose
No cases of overdose have been reported.
Preclinical safety
No genotoxicity, carcinogenicity or reproductive function studies have been carried out with the soft extracts of grindelia and gelsemium included in the composition of the specialty Coquelusédal Enfants, suppository.
Storage conditions
- Shelf life
- 3 years.
Store at a temperature not exceeding 30 °C.
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements for disposal.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400930194072 (2019, SmPC rev 15.06.2020). |
| Not reimbursed by Social Security. |
ÉLERTÉ
181-183, rue André-Karman
93300 Aubervilliers. Tel: 01 48 34 75 03
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.