Medicines
Update of 21/11/2022
COQUELUSÉDAL® Infant
grindelia, gelsemium
Forms and presentations
Infant suppository: Box of 10, under thermoformed blisters.Composition
| suppos | |
| Grindelia, soft hydroalcoholic extract
|
10 mg |
| Gelsemium, soft hydroalcoholic extract
|
5 mg |
Indications
Adjunctive treatment of acute benign bronchial conditions.Dosage and administration
Dosage- Paediatric population:
- Reserved for infants up to 30 months.
- 1 to 2 suppositories per day.
Method of administration:
Rectal route.
Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section Composition.
- Due to the route of administration, recent history of ano-rectal lesions.
Warnings and precautions
If greasy and purulent expectoration appears, or in case of fever or chronic bronchial and lung disease, the therapeutic approach should be re-evaluated.
Fertility, pregnancy and breastfeeding
COQUELUSEDAL INFANT suppository is intended for infants. However, in case of use in pregnant women or breastfeeding women, the following information should be noted:
Pregnancy
There is no data on the use of soft extracts of grindelia and gelsemium in pregnant women. Studies performed in animals are insufficient to conclude on reproductive toxicity (see Preclinical safety).
Therefore, COQUELUSEDAL INFANT suppository is not recommended during pregnancy.
Breast-feeding
COQUELUSEDAL INFANT suppository may be used during breastfeeding.
Fertility
The effect of COQUELUSEDAL NOURRISSONS, suppository, on human fertility is unknown.
Adverse effects
Due to the route of administration:
Risk of local toxicity, which is more frequent and intense the longer the duration of treatment, and the higher the frequency of administration and dosage.
Due to the presence of propylene glycol, risk of skin irritation.
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
The suppository form makes this eventuality practically unfeasible.
Pharmacodynamics
Pharmacotherapeutic class: respiratory system (antitussive combination), ATC code: R05.
Preclinical safety
No conventional studies of genotoxicity, carcinogenesis, and toxicity for reproduction and development are available with the extracts of grindelia and gelsemium included in the composition of COQUELUSEDAL NOURRISSONS, suppository.
Storage conditions
- Shelf life
- 3 years.
Store at a temperature not exceeding 25 °C
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements for disposal.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400937560467 (2006, SmPC rev 09.08.2022). |
| 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.