NOTICE
ANSM - Last updated: 10/02/2012
Name of the medicinal product
COQUELUSEDAL CHILDREN, suppository
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS COQUELUSEDAL CHILDREN, suppository AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE COQUELUSEDAL CHILDREN, suppository?
3. HOW TO USE COQUELUSEDAL CHILDREN, suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE COQUELUSEDAL CHILDREN, suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS COQUELUSEDAL CHILDREN, suppository AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Association with antitussive aim
(R. Respiratory system)
Therapeutic indications
This medication is used as adjunctive therapy for benign acute bronchial conditions in children over 30 months to 15 years of age.
The duration of treatment is limited to 3 days.
2. BEFORE YOU USE COQUELUSEDAL CHILDREN, suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use COQUELUSEDAL CHILDREN, suppository in the following cases:
· Allergy to one of the constituents.
· Children under 30 months.
· Children with a history of epilepsy or febrile convulsions.
· Children with a recent history of anorectal injury.
Due to the presence of terpene derivatives, this medication is GENERALLY NOT RECOMMENDED, unless otherwise advised by your doctor, during breast-feeding.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with COQUELUSEDAL CHILDREN, suppository:
Special warnings
This specialty contains niaouli which can lead to excessive neurological convulsions in infants and children.
· Do not prolong treatment time beyond 3 days due to:
o the risk of accumulation of the terpene derivative (niaouli) in the body including the brain, and in particular the risk of neurological disorders,
o of the risk of burning irritations in the rectum.
· Do not exceed recommended doses due to increased risk of adverse events and disorders associated with overdosage.
· Terpene derivatives being flammable, do not approach this specialty of a flame.
In case of fever, greasy or purulent sputum, or in case of chronic bronchial and lung disease, seek advice from your doctor.
Observe the dosage and duration of use mentioned in this leaflet .
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use
If you have a history of seizures, seek advice from your doctor.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
Do not use with other products (medicines or cosmetics) containing terpene derivatives (eg camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine) irrespective of the route of administration (oral, rectal, cutaneous or pulmonary). |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Do not use this medication while pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE COQUELUSEDAL CHILDREN, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for children over 30 months to 15 years.
1 to 2 suppositories per day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
· It may not be suitable for another case.
· Do not advise another person.
Administration mode
Rectal route.
The choice of the rectal route is determined only by the convenience of administration of the drug.
Frequency of Administration
1 to 2 suppositories per day.
Duration of the treatment
The duration of the treatment is limited to 3 days.
The use of the rectal route should be as short as possible, due to the risks of local toxicity.
Symptoms and Instructions for Overdose
If you used more COQUELUSEDAL CHILDREN, suppository you should:
Due to the presence niaouli and in case of non-respect of recommended doses: risk of convulsions in the child and the infant.
Consult your doctor.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all drugs, COQUELUSEDAL CHILDREN, suppository is likely to have undesirable effects, although not everyone is subject to it.
Local effects (irritation of the anus or rectum), related to the route of administration, can be observed. They are all the more frequent and intense as the duration of use is prolonged, the rhythm of administration and the dosage high.
· If the recommended dose is not observed, there is a risk of convulsions in the infant.
DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE COQUELUSEDAL CHILDREN, suppository?
Keep out of the reach and sight of children.
Expiration date
Do not use COQUELUSEDAL CHILDREN, suppository after the expiry date stated on the carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is COQUELUSEDAL ENFANTS, suppository?
The active substances are:
Niaouli essential oil .............................................. .................................................. 20 mg
Soft hydro-alcoholic extract of grindelia ........................................... .................................................. 20 mg
Soft hydro-alcoholic extract of gelsémium ........................................... ............................................... 10 mg
For a suppository.
The other components are:
Propylene glycol, solid hemi-synthetic glycerides (type Witepsol WS55).
Pharmaceutical form and content
What is COQUELUSEDAL CHILDREN, suppository and contents of the outer packaging?
This medication is in the form of a suppository.
Box of 6, 8, 10 or 12.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181-183, ANDRE KARMAN STREET
BP 101
93303 AUBERVILLIERS CEDEX
exploiting
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181-183, ANDRE KARMAN STREET
93303 AUBERVILLIERS CEDEX
Maker
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181-183, ANDRE KARMAN STREET
93303 AUBERVILLIERS CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.