NOTICE
ANSM - Updated on: 07/11/2017
Drug Name
FAMENPAX, orodispersible tablet
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What is in this leaflet?
1. What is FAMENPAX, orodispersible tablet, and what is it used for?
2. What should you know before taking FAMENPAX, orodispersible tablet?
3. How should you take FAMENPAX, orodispersible tablet?
4. What are the possible side effects?
5. How should FAMENPAX, orodispersible tablet, be stored?
6. Package contents and other information.
1. WHAT IS FAMENPAX, ORAL DISPERSIBLE TABLET, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code:
Not applicable.
FAMENPAX, orodispersible tablet is a homeopathic medicine traditionally used for nausea and vomiting associated with pregnancy or motion sickness.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING FAMENPAX, orodispersible tablet?
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Never use FAMENPAX, orodispersible tablet:
· In children under 18 months of age.
· If you are allergic to the active ingredients or any of the other ingredients in this medicine listed in Section 6.
Warnings and Precautions
Consult your doctor or pharmacist before taking FAMENPAX , orodispersible tablet.
The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary diseases).
Children
Not applicable.
Other Medications 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 beverages
This medicine should be taken between meals.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medication.
Driving and operating machinery
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 you have any questions.
Dosage
This medicine is intended for adults and children over 18 months of age.
1 tablet every 10 minutes for the first hour, then space out doses as symptoms improve, without exceeding 10 tablets per day.
Administration
For adults and children over 6 years of age: let the tablet dissolve under the tongue, preferably between meals.
For children 18 months to 6 years of age: dissolve the tablet in a small amount of water before administration, due to the risk of choking.
Sublingual route.
If you have taken more FAMENPAX orodispersible tablets than you should have:
Consult your doctor or pharmacist immediately.
If you miss a dose of FAMENPAX, orodispersible tablet:
Do not take a double dose to make up for the dose you missed.
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 side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD FAMENPAX, orodispersible tablet, BE STORED?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the blister pack or on the box. The expiration date refers to the last day of that 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 down the drain or with household trash. Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What FAMENPAX, orodispersible tablet contains
· The active ingredients 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
per 250 mg tablet
· The other ingredients are: lactose, mannitol, croscarmellose sodium, magnesium stearate.
What FAMENPAX is, the orodispersible tablet, and contents of the outer packaging
FAMENPAX, orodispersible tablet is a 250 mg orodispersible tablet supplied in blister packs.
Box of 20, 30, or 40 tablets packaged in 2, 3, or 4 blister packs of 20 tablets (PVC/PVDC/Aluminum).
Marketing Authorization Holder
LABORATOIRES LEHNING
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Marketing Authorization Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Manufacturer
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information on this medicine is available on the ANSM (France) website.