NOTICE
ANSM - Updated: 11/07/2017
Name of the drug
FAMENPAX, orodispersible 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.
What does this booklet contain ?
1. What is FAMENPAX, orodispersible tablet and when is it used?
2. What information do you need to know before taking FAMENPAX, orodispersible tablet?
3. How to take FAMENPAX, orodispersible tablet?
4. What are the possible side effects?
5. How to store FAMENPAX, orodispersible tablet?
6. Contents of the package and other information.
1. WHAT IS FAMENPAX, orodispersible tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class - ATC code:
Not applicable.
FAMENPAX, orodispersible tablet is a homeopathic medicine traditionally used in nausea and vomiting of pregnancy or motion sickness.
2. BEFORE YOU TAKE FAMENPAX, orodispersible tablet?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Never use FAMENPAX, orodispersible tablet:
· In children under 18 months.
· 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
Talk to your doctor or pharmacist before taking FAMENPAX, orodispersible tablet .
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 FAMENPAX, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
FAMENPAX, orodispersible tablet with food and drinks
This medicine is to be taken away from meals.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
FAMENPAX, orodispersible tablet contains lactose.
3. HOW TO TAKE FAMENPAX, orodispersible tablet?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Medication reserved for adults and children over 18 months.
1 tablet every 10 minutes the first hour, space according to improvement not exceeding 10 tablets per day.
Administration mode
In adults and children over 6 years: let the tablet melt under the tongue, preferably outside of meals.
In children from 18 months to 6 years: dissolve the tablet in a little water before its administration, because of the risk of false route.
Sublingual route.
If you take more FAMENPAX, orodispersible tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take FAMENPAX, orodispersible tablet:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking FAMENPAX, orodispersible 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 FAMENPAX, orodispersible tablet?
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 blister or carton. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 30 ° C.
Do not use this medicine if you notice any visible signs of deterioration.
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 FAMENPAX, orodispersible tablet
· The active substances are:
Cocculus indicus 8 DH .............................................. .................................................. ........ 5 mg
Tabacum 8 DH ............................................... .................................................. ................... 5 mg
Argentum nitricum 6 DH .............................................. .................................................. ...... 5 mg
Sepia officinalis 6 DH .............................................. .................................................. .......... 5 mg
Borax 4 DH ............................................... .................................................. ....................... 5 mg
Nux vomica 4 DH .............................................. .................................................. ................ 5 mg
for a 250 mg tablet
· The other ingredients are: lactose, mannitol, croscarmellose sodium, magnesium stearate.
What FAMENPAX orodispersible tablet looks like and contents of the pack
FAMENPAX, orodispersible tablet is a 250 mg orodispersible tablet presented in blister packs.
Box of 20, 30 or 40 tablets packaged in 2, 3 or 4 packs of 20 tablets (PVC / PVDC / Aluminum).
Marketing Authorization Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
LA FRANCE
Operator of the marketing authorization
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
LA FRANCE
Maker
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
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).