ANSM - Updated: 14/09/2017
Name of the drug
ZENALIA, sublingual tablet
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 15 days.
What does this booklet contain ?
1. What is ZENALIA, sublingual tablet and when is it used?
2. What information do you need to know before taking ZENALIA, sublingual tablet?
3. How to take ZENALIA, sublingual tablet?
4. What are the possible side effects?
5. How to store ZENALIA, sublingual tablet?
6. Contents of the package and other information.
1. WHAT ZENALIA, sublingual tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Homeopathic medicine.
Zénalia, sublingual tablet is a homeopathic medicine traditionally used in cases of stage fright, apprehension, anxiety (tremors, diarrhea, restless sleep, emotional palpitations).
2. WHAT INFORMATION SHOULD BE KNOWN BEFORE TAKING ZENALIA, sublingual 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 ZENALIA, sublingual tablet:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
This medication is contraindicated in children under 6 years of age due to the risk of misinformation related to the pharmaceutical form.
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).
Other medicines and ZENALIA, sublingual tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ZENALIA, sublingual tablet with food and drinks
Take tablets 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
ZENALIA, sublingual tablet contains sucrose and lactose
3. HOW TO TAKE ZENALIA, sublingual tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
From the first symptoms of stage fright, 1 tablet morning and evening.
Melt the tablet under your tongue, away from meals.
Duration of treatment
The treatment will not exceed 15 days.
If you take more ZENALIA, sublingual tablet than you should
Immediately consult your doctor or pharmacist.
If you forget to take ZENALIA, sublingual tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking ZENALIA, sublingual tablet
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 ZENALIA, sublingual 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 ZENALIA contains, sublingual tablet
· The active substances are:
Gelsemium sempervirens 9 CH .............................................. .................................................. 1 mg
Ignatia amara 9 CH .............................................. .................................................. ................... 1 mg
Kalium phosphoricum 15 CH .............................................. .................................................. ..... 1 mg
For a 300 mg tablet
· The other ingredients are: sucrose, lactose monohydrate and magnesium stearate
What ZENALIA, sublingual tablet looks like and contents of the pack
ZENALIA comes in the form of sublingual tablets. It is packaged in a box containing 30 tablets.
Marketing Authorization Holder
2 Avenue West Lyonnais
Operator of the marketing authorization
2 Avenue West Lyonnais
2 Avenue West Lyonnais
Names of the drug in the member states of the European Economic Area
The last date this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).