Medicines
Update of 21/11/2022
COQUELUSÉDAL® Adult
niaouli, grindelia, gelsemium
Forms and presentations
Suppository: Boxes of 10, in thermoformed blister packs.Composition
| Per suppository | |
| Niaouli, essential oil
|
40 mg |
| Grindelia, soft hydroalcoholic extract
|
40 mg |
| Gelsemium, soft hydroalcoholic extract
|
20 mg |
Indications
Adjunctive treatment of acute benign bronchial conditions.Dosage and administration
DosageReserved for adults.
1 to 2 suppositories per day.
Method of administration:
Rectal route.
The choice of the rectal route is determined only by the convenience of administration of the medicine.
- Duration of treatment:
- The use of the rectal route should be as short as possible due to the risk of local toxicity.
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.
- Due to the presence of terpene derivatives, this medicine is generally not recommended during breastfeeding.
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.
- This specialty contains terpenes (niaouli essential oil) which may cause, at excessive doses, neurological accidents of the convulsion type, in infants and children.
Follow the instructions for use: do not exceed the recommended doses; in case of a history of epilepsy, take into account the presence of terpenes.
Interactions
No interaction studies have been performed.
Fertility, pregnancy and breastfeeding
Pregnancy
There are no data or limited data on the use of niaouli essential oil, soft extracts of grindelia and gelsemium in pregnant women. Animal studies have shown reprotoxicity (see Preclinical safety).
Therefore, COQUELUSEDAL ADULTES, suppository is not recommended during pregnancy.
Breast-feeding
There are no sufficient data on the excretion of niaouli essential oil, soft extracts of grindelia and gelsemium in breast milk.
A risk to the breastfed child cannot be excluded.
COQUELUSEDAL ADULTES, suppository must not be used during breastfeeding.
Fertility
The effect of COQUELUSEDAL ADULTES, suppository on human fertility is unknown.
Adverse effects
Due to the presence of terpenes:- If the recommended doses are not respected, agitation and confusion may occur in elderly subjects.
- 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.
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
Association with an antitussive purpose (R: respiratory system).
Terpene derivatives (niaouli essential oil) may lower the epileptogenic threshold.
Preclinical safety
No conventional studies of genotoxicity, carcinogenesis, and reproductive and developmental toxicity are available with niaouli essential oil, or with grindelia and gelsemium extracts included in the composition of COQUELUSEDAL ADULTES, suppository. Published studies in rats report embryotoxic and fetotoxic effects of certain substances contained in niaouli essential oil.
Storage conditions
- Shelf life
- 3 years.
Store at a temperature not exceeding 25 °C.
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400938396546 (2008, RCP rév 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.
