NOTICE
ANSM - Last updated: 13/02/2008
Description of the Medicine
COQUELUSEDAL ADULTS, suppository
© framed
Please read this leaflet carefully before using this medication. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
AT· Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
AT· If symptoms worsen or persist, consult your doctor.
AT· If you notice any side effects not listed in this leaflet, or if you notice any of the side effects listed as severe, please inform your doctor or pharmacist.
Summary sheet
In this notice :
1. WHAT IS COQUELUSEDAL ADULTS, suppository AND IN WHAT CASES IS IT USED?
2. WHAT ARE THE INFORMATION TO BE KNOWED BEFORE USING COQUELUSEDAL ADULTS, suppository?
3. HOW TO USE COQUELUSEDAL ADULTS, suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ADULTS, suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS COQUELUSEDAL ADULTS, suppository AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Association with antitussive aim
(R. Respiratory system)
Therapeutic Indications
This medication is used as an adjunct to acute bronchial disorders in adults.
2. WHAT ARE THE INFORMATION TO BE KNOWED BEFORE USING COQUELUSEDAL ADULTS, suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use COQUELUSEDAL ADULTS, suppository if:
AT· recent lesions of the anus or rectum (contra-indication related to the route of administration).
Due to the presence of terpenic derivatives, this medication is GENERALLY NOT RECOMMENDED unless your doctor advises you when breast-feeding.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment precautions; special warnings
Take special care with COQUELUSEDAL ADULTS, suppository:
Special warnings
In case of fever, greasy or purulent sputum, or in case of chronic bronchial and lung disease, seek advice from your doctor.
This specialty contains terpenes (essential oil of niaouli) which can lead, in excessive doses, neurological accidents in the type of convulsions, in the infant and in the child.
Observe the dosage and duration of use mentioned in this leaflet.
In case of convulsions, seek advice from your doctor.
Employment Precautions
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, speak to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
During breast-feeding, the intake of this medication is discouraged due to the passage of its constituents into breast milk.
Ask your doctor or pharmacist for advice before taking any medication.
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 ADULTS, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
Reserved for adults
1 to 2 suppositories per day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
AT· It may not be suitable for another case.
AT· 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 treatment
The use of the rectal route should be as short as possible (a few days), due to the risks of local toxicity.
Symptoms and Instructions for Overdose
If you used more than COQUELUSEDAL ADULTS, suppository you should have:
The suppository form makes this possibility unlikely.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medications, COQUELUSEDAL ADULTS, 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, may be observed. They are all the more frequent and intense as the duration of use is prolonged, the rhythm of administration and the high dosage.
AT· If the recommended dose is not observed, there is a risk of agitation and confusion in the elderly due to the presence of terpenic derivatives.
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 certain undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE ADULTS, suppository?
Keep out of the reach and sight of children.
Date of filing
Do not use COQUELUSEDAL ADULTS, suppository after the date of birth mentioned on the carton.
Storage conditions
Keep at a temperature not exceeding 25 ° C.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away at the sewer or with household garbage. Ask your pharmacist what to do with unused medications. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains COQUELUSEDAL ADULTS, suppository?
The active substances are:
Niaouli essential oil .............................................. .................................................. .................. 40 mg
Soft hydro-alcoholic extract of grindelia ......................................... .................................................. .. 40 mg
Soft hydro-alcoholic gel extract ......................................... ................................................. 20 mg
For a suppository.
The other components are:
Propylene glycol, solid synthetic solid glycerides (type Witepsol WS55).
Pharmaceutical form and content
What is COQUELUSEDAL ADULTS, suppository and contents of the outer packaging?
This medication is presented as 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 Therapeutic Realizations ELERTE
181-183, Andrà © Karman Street
BP 101
93303 Aubervilliers Cedex
exploiting
Laboratories ELERTE
181-183, Andrà © Karman Street
93303 AUBERVILLIERS CEDEX
Maker
Laboratory of Therapeutic Realizations ELERTE
181-183, Andrà © Karman Street
93303 AUBERVILLIERS CEDEX
Names of medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicinal product can be found on the website of AFssaps (France).
Information for health professionals
Not applicable.
Other
Not applicable.