NOTICE
ANSM - Last updated: 04/05/2017
Description of the Medicine
FLUVERMAL 2 PER CENT, oral suspension
flubendazole
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Please read this leaflet carefully before you start taking this medication because it contains important information for you.
You should always take this medication by strictly following the information provided in this leaflet or by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should contact your doctor if you feel uncomfortable or feel less well.
What is in this leaflet?
1. What is FLUVERMAL 2 PERCENT, oral suspension and in which cases is it used?
2. What information should I take before taking FLUVERMAL 2 PER CENT, oral suspension?
3. How to take FLUVERMAL 2 PER CENT, oral suspension?
4. What are the possible undesirable effects?
5. How to store FLUVERMAL 2 PER CENT, oral suspension?
6. Contents of the package and other information.
1. WHAT IS FLUVERMAL 2 PER CENT, oral suspension AND WHAT USE IS IT USED FOR?
Pharmacotherapeutic group: ANTHELMINTHICS - ATC code: P02CA05.
FLUVERMAL is used for the treatment of infestations by certain parasitic worms of the digestive tract: pinworm, ascaris, whipworm, hookworm.
2. BEFORE YOU TAKE FLUVERMAL 2 PER CENT, drinkable suspension?
Do not take FLUVERMAL 2 Percent, drinkable suspension:
AT· if you are allergic to flubendazole or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
This medicinal product contains sodium methyl parahydroxybenzoate (E219) and may cause allergic reactions.
The use of this medication is advised in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (heterosexual diseases). Rarity).
Talk to your doctor or pharmacist before taking FLUVERMAL 2 Percent, oral suspension.
children
Do not use in children under one year of age without medical advice.
Other medicines and FLUVERMAL 2 PER CENT, oral suspension
Inform your doctor or pharmacist if you are taking, have recently taken or could take any other medicines.
FLUVERMAL 2 PER CENT, drinkable suspension with food and beverages
Not applicable.
Pregnancy and breast feeding
As a precaution, unless your doctor tells you otherwise, it is best to avoid taking flubendazole during pregnancy or breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Driving and using machines
This medication may cause dizziness in some people. If this is your case, you should not drive vehicles or use machines.
FLUVERMAL 2 PERCENT, oral suspension contains sucrose and sodium methyl parahydroxybenzoate (E219).
3. HOW TO TAKE FLUVERMAL 2 PER CENT, oral suspension?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is the same for both children and adults. It depends on the infesting worm:
AT· Oxyure: 1 measuring spoon in single grip. The catch will be renewed 15 to 20 days later in order to completely eliminate any infestation.
Rigorous hygiene measures (nail cleaning, etc ...) and clothing must accompany the treatment to eliminate the risk of re-infestation.
AT· Ascaris, trichocephalus, ankylostomiasis: 1 measuring spoon morning and evening for 3 days.
FLUVERMAL is available as a tablet and oral suspension.
Administration mode
Oral use.
Neither purge nor meal pre-requisites are needed. There is no need to predict a particular diet during treatment.
Shake the oral suspension well before use. To take FLUVERMAL 2 PER CENT, oral suspension, use the measuring spoon.
Instructions for opening the vial :
The bottle has a child-resistant cap and should be opened as follows: press the cap, while turning it counterclockwise.
Use in children
Do not use in children under one year of age without medical advice.
If you take more FLUVERMAL 2 PER CENT, drinkable suspension than you should have "
If you have accidentally taken too much FLUVERMAL, consult your doctor immediately as a safety precaution.
If you forget to take FLUVERMAL 2 PER CENT, oral suspension
Do not take a double dose to make up for a forgotten dose.
If you stop taking FLUVERMAL 2 PER CENT, drinkable suspension
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
Frequent (less than 1 in 10 patients):
Abdominal pain, diarrhea;
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Uncommon (less than 1 in 100 patients):
Nausea, vomiting;
Dizziness.
Rare (less than 1 in 1000 patients):
Allergic reactions such as urticaria, skin rash, swelling of the face and neck (Angioedema), discomfort.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting undesirable effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE FLUVERMAL 2 PER CENT, oral suspension?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the vial. The redemption date refers to the last day of that month.
Do not store beyond 3 months after first opening the bottle.
Do not throw any medicines into the sewer or the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What FLUVERMAL contains 2 PER CENT, oral suspension
AT· The active substance is:
Flubendazole ................................................. .................................................. .................... 2 g
For 100 ml.
AT· The other components are:
Sucrose, carbomer (carbopol 974P), sodium lauryl sulphate, sodium methyl parahydroxybenzoate (E 219), banana flour *, sodium hydroxide (qs pH = 6.1-6.5), purified water e.
* Banana Argan : acetaldehyde, amyl butyrate, benzyl propionate, citral, diethyl malonate, eugenol, furfuryl acetate, heliotropin, isoamyl acetate, acetate isobutyl, maltol, 2-octynoate, gamma-nonalactone, phenyl alcohol, propylene glycol, vanillin.
What is FLUVERMAL 2 PER CENT, drinkable suspension and contents of the outer packaging
This medication is in the form of a drinkable suspension. 30 ml bottle with 5 ml measuring spoon.
Holder of the marketing authorization
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Operator of the marketing authorization
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
JANSSEN PHARMACEUTICA NV
TURNHOUTSEWEG 30
2340 BEERSE
BELGIUM
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
Other
Detailed information on this medicinal product can be found on the website of the ANSM (France).