NOTICE
ANSM - Updated on: 16/06/2017
Name of the medicinal product
COQUELUSEDAL INFANTS, suppository
Grindélia (soft hydro-alcoholic extract of), Gelsémium (soft hydro-alcoholic extract of)
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you see no improvement or if your child feels worse.
What is in this leaflet?
1. What is COQUELUSEDAL NOURISHING, suppository and in which cases is it used?
2. What information should be known before using COQUELUSEDAL INFANTS, suppository?
3. How to use COQUELUSEDAL INFANTS, suppository?
4. What are the possible side effects?
5. How to preserve COQUELUSEDAL INFANTS, suppository?
6. Package contents and other information.
1. WHAT IS COQUELUSEDAL INFANT, suppository AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: Association with antitussive aim (R. Respiratory system)
This medication is used as an adjunct to acute benign bronchitis in infants up to 30 months of age.
Warning :
If symptoms persist consult doctor.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE USING COQUELUSEDAL INFANTS, suppository?
Do not use COQUELUSEDAL INFANTS, suppository:
· if your child is allergic to the active ingredients or to any of the other ingredients of this medication mentioned in section 6.
· if your child has a recent history of anal or rectal lesions (contra-indication related to the route of administration).
Warnings and Precautions
In case of fever, greasy or purulent sputum, or in case of chronic bronchial and lung disease, seek the advice of your doctor.
Talk to your doctor or pharmacist before using COQUELUSEDAL INFANTS, suppository .
children
Not applicable.
Other medicines and COQUELUSEDAL INFANTS, suppository
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
COQUELUSEDAL INFANTS, suppository with food and drink
Not applicable.
Pregnancy and breast feeding
Not applicable.
Driving and using machines
Not applicable.
COQUELUSEDAL INFANTS, suppository contains propylene glycol.
3. HOW TO USE COQUELUSEDAL INFANTS, suppository?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
1 to 2 suppositories per day.
Duration of treatment
The duration of treatment should be as short as possible due to the risks of local toxicity.
Administration mode
Rectal route. For infants up to 30 months.
If you used more COQUELUSEDAL INFANTS, suppository than you should have
The suppository form makes this eventuality unlikely.
If you forget to use COQUELUSEDAL INFANTS, suppository
Do not take a double dose to make up for the missed dose.
If you stop using COQUELUSEDAL INFANTS, suppository
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
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.
Due to the presence of propylene glycol, there is a risk of skin irritation.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE COQUELUSEDAL INFANTS, suppository?
Keep this medicine out of the reach and sight of children.
Store at a temperature not exceeding 25 ° C.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What Contains COQUELUSEDAL INFANTS, suppository
· The active substance (s) is (are):
Grindélia (soft hydro-alcoholic extract from) ......................................... 10.0 mg
Gelsemium (Soft Hydroalcoholic Extract of) ......................................... ................................ 5.0 mg
For a suppository.
· The other components are: Propylene glycol, solid hemisynthetic glycerides
What is COQUELUSEDAL INFANTS, suppository and contents of the pack
This medication is in the form of a suppository.
Box of 6, 10 or 12 suppositories
Marketing Authorization Holder
ELERT LABORATORIES
181 - 183 rue André Karman
93300 Aubervilliers
Marketing Authorization Operator
ELERT LABORATORIES
181 - 183 rue André Karman
93300 Aubervilliers
Maker
ELERT LABORATORIES
181 - 183 rue André Karman
93300 Aubervilliers
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).