NOTICE
ANSM - Updated: 02/10/2017
Name of the drug
HOMEOAFTYL, sucking 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 5 days.
What does this booklet contain ?
1. What is HOMEOAFTYL, tablet to suck and in what cases is it used?
2. What is the information to know before taking HOMEOAFTYL, tablet to suck?
3. How to take HOMEOAFTYL, tablet to suck?
4. What are the possible side effects?
5. How to store HOMEOAFTYL, tablet to suck?
6. Contents of the package and other information.
1. WHAT IS HOMEOAFTYL, SUCTION TABLE AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Homeopathic medicine.
HOMEOAFTYL, tablet to suck is a homeopathic medicine traditionally used in the symptomatic treatment of canker sores in adults and children over 6 years.
2. BEFORE YOU TAKE HOMEOAFTYL, tablet to suck?
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 HOMEOAFTYL, tablet to suck:
Not applicable.
Warnings and precautions
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 HOMEOAFTYL, sucking tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
HOMEOAFTYL, tablet to suck with food and drinks
Not applicable.
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.
HOMEOAFTYL, sucking tablet contains sucrose and lactose monohydrate.
3. HOW TO TAKE HOMEOAFTYL, tablet to suck?
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 slowly outside meals, 4 to 5 times a day for a treatment of 5 days maximum.
Stop treatment as soon as the symptoms disappear.
Administration mode
Oral way.
Tablet to suck.
If you have the impression that the effect of HOMEOAFTYL, tablet to be sucked is too strong or too weak, consult your doctor or pharmacist.
If you take more HOMEOAFTYL, tablet to suck than you should
Consult your doctor or your pharmacist.
If you forget to take HOMEOAFTYL, tablet to suck
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking HOMEOAFTYL, tablet to suck
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 HOMEOAFTYL, tablet to suck?
Keep this medicine out of the sight and reach of children.
No special precautions of conservation.
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 contains HOMEOAFTYL, sucking tablet
· The active substances are:
Borax 5 CH ............................................... .................................................. ............................. 1 mg
Kalium bichromicum 5 CH .............................................. .................................................. ......... 1 mg
Sulfuricum acidum 5 CH .............................................. .................................................. ........... 1 mg
For a 300 mg tablet.
· The other ingredients are: sucrose, lactose monohydrate and magnesium stearate.
What is HOMEOAFTYL, tablet to suck and contents of the pack
HOMEOAFTYL comes in the form of tablets to suck. It is packaged in a box containing 60 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).