NOTICE
ANSM - Updated: 18/08/2017
Name of the drug
DIARALIA, tablet
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 DIARALIA, tablet and in what cases is it used?
2. What information do you need to know before taking DIARALIA, tablet?
3. How to take DIARALIA, tablet?
4. What are the possible side effects?
5. How to store DIARALIA, tablet?
6. Contents of the package and other information.
1. WHAT DIARALIA, tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic group: homeopathic medicine.
DIARALIA, tablet is a homeopathic medicine traditionally used in the short-term treatment of acute passing diarrhea in adults and children over 6 years.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DIARALIA, tablet?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take DIARALIA, tablet:
· In children under 6 years of age due to the risk of miscarriage related to the pharmaceutical form.
Warnings and precautions
This medicine should not be used in case of vomiting, high fever, blood in the stool.
Any major diarrhea is at risk of dehydration requiring proper rehydration.
If the diarrhea persists beyond 3 days, a medical consultation is required.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
children
Not applicable.
Other medicines and DIARALIA, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DIARALIA, tablet with food and drinks
This medicine is to be taken away from meals.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
DIARALIA tablet contains sucrose and lactose monohydrate.
3. HOW TO TAKE DIARALIA, tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
1 tablet to suck, 4 to 6 times a day for a treatment of 3 days maximum.
Stop treatment when the symptoms disappear.
Administration mode
Oral way.
Tablet to suck.
If you take more DIARALIA, tablet than you should
Immediately consult your doctor or pharmacist.
If you forget to take DIARALIA, tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking DIARALIA, tablet
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 DIARALIA, tablet?
Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
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 .
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 DIARALIA contains, tablet
· The active substances are:
Arsenicum album 9 CH .............................................. .................................................. ............. 1 mg
China rubra 5 CH .............................................. .................................................. ...................... 1 mg
Podophyllum peltatum 9 CH .............................................. .................................................. ..... 1 mg
For a 300 mg tablet
· The other ingredients are: sucrose, lactose monohydrate and magnesium stearate.
What DIARALIA, tablet looks like and contents of the pack
DIARALIA comes in tablet form. It is packaged in a box containing 40 tablets.
Marketing Authorization Holder
Boiron
2 avenue west Lyon
69510 MESSIMY
LA FRANCE
Operator of the marketing authorization
Boiron
2 avenue west Lyon
69510 MESSIMY
LA FRANCE
Maker
Boiron
2 avenue west Lyon
69510 MESSIMY
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).