NOTICE
ANSM - Updated: 30/06/2017
Name of the drug
CAMILIA, oral solution in single dose container
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
What does this booklet contain ?
1. What is CAMILIA oral solution in a single-dose container and when is it used?
2. What information do you need to know before taking CAMILIA, oral solution in a single-dose container?
3. How to take CAMILIA, oral solution in single-dose container?
4. What are the possible side effects?
5. How to store CAMILIA, oral solution in single-dose container?
6. Contents of the package and other information.
1. WHAT IS CAMILIA, oral solution in a single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Homeopathic medicine.
CAMILIA, oral solution in single-dose container is a homeopathic medicine traditionally used in disorders attributed to teething in infants.
2. BEFORE YOU TAKE CAMILIA, oral solution in a single-dose container
Do not take CAMILIA, oral solution in single-dose container:
· if you are allergic to active substances.
Warnings and precautions
DO NOT INSTILLATE IN THE EYE OR IN THE EAR.
DO NOT INJECT.
children
Not applicable.
Other medicines and CAMILIA, oral solution in single-dose container
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines.
CAMILIA, oral solution in single-dose container with food and drink
Not applicable.
Pregnancy and breast feeding
Not applicable.
Driving and using machines
Not applicable.
CAMILIA oral solution in a single-dose container contains
Not applicable.
3. HOW TO TAKE CAMILIA, oral solution in single-dose container?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
3 to 6 single doses per 24 hours for 3 to 8 days.
If symptoms persist for more than 3 days, check with a health care professional for signs of teething.
Oral way.
· Wash hands before using single doses.
· Do not keep a single-dose container after opening. The single-dose container should be discarded after each use.
1. Open the aluminum bag
2. Detach a single dose container from the bar
3. Open the single-dose container by turning the tip
4. Put the child in a sitting position. Pour the contents of the single-dose container by squeezing lightly into the child's mouth.
5. Carefully close the pouch containing the other single-dose containers by folding the open side.
In order to administer an always sterile solution, use a new single-dose container for each use.
If you have given more CAMILIA, oral solution in a single-dose container than you should
Immediately consult your doctor or pharmacist.
If you forget to give CAMILIA, oral solution in single-dose container
Do not give a double dose to make up for the single dose you forgot to give.
If you stop giving CAMILIA, oral solution in single-dose container
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE CAMILIA, oral solution in single-dose container?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month .
Before opening the sachet: no special precautions for storage.
After opening the sachet: keep unused single-dose containers in the sachet.
After opening the single-dose container:
· The product should be used immediately.
· Discard the single-dose container after use.
· Do not keep it for later use.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What CAMILIA contains, oral solution in single-dose container
· The active substances are:
Chamomilla vulgaris 9 CH .............................................. .................................................. ... 333.3 mg
Phytolacca will decant 5 CH .............................................. .................................................. 333.3 mg
Rheum 5 CH ............................................... .................................................. ..................... 333.3 mg
For a single dose container of 1 ml.
· The other component is:
Purified water
What CAMILIA oral solution in single-dose container looks like and contents of the pack
This medicine is in the form of oral solution in 1 ml single dose containers. Box of 10 single-dose containers or box of 30 single-dose containers.
Marketing Authorization Holder
Boiron
2 avenue de l'Ouest Lyonnais
69510 MESSIMY
LA FRANCE
Operator of the marketing authorization
Boiron
2 avenue de l'Ouest Lyonnais
69510 MESSIMY
LA FRANCE
Maker
Boiron
ZAC of the Frenes
1 rue Edouard Buffard
77144 MONTEVRAIN
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).