NOTICE
ANSM - Last updated: 04/05/2017
Name of the medicinal product
FLUVERMAL, tablet
flubendazole
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might 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 mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is FLUVERMAL, tablet and in which cases it is used?
2. What should I know before taking FLUVERMAL tablets?
3. How to take FLUVERMAL, tablet?
4. What are the possible side effects?
5. How to store FLUVERMAL, tablet?
6. Package contents and other information.
1. WHAT FLUVERMAL, tablet AND WHAT IT IS 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. WHAT INFORMATION MUST BE KNOWN BEFORE TAKING FLUVERMAL, tablet?
Do not take FLUVERMAL tablets:
· if you are allergic to flubendazole or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Talk to your doctor or pharmacist before taking FLUVERMAL tablets.
children
The use of FLUVERMAL 2% oral suspension should be considered in some patients, especially young children who are not able to swallow the tablet at 100 mg.
Do not use in children under one year of age without medical advice.
Other medicines and FLUVERMAL, tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FLUVERMAL, tablet with food and drink
Not applicable.
Pregnancy and breast feeding
For caution, unless your doctor has advised otherwise, it is best to avoid taking flubendazole during pregnancy or lactation.
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 medicine.
Driving and using machines
This medicine may cause dizziness in some people. If this is your case, you should not drive or use machines.
FLUVERMAL, tablet contains sucrose.
3. HOW TO TAKE FLUVERMAL, tablet?
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 in doubt.
Dosage
The recommended dose is the same for both children and adults. It depends on the infesting worm:
· Oxyure: 1 tablet in single dose. The catch will be renewed 15 to 20 days later to completely eliminate any infestation.
Rigorous hygiene measures (nail cleaning, etc ...) and clothing must accompany the treatment to eliminate the risk of reinfestation.
· Ascaris, trichocephalus, hookworm infection: 1 tablet morning and evening for 3 days.
FLUVERMAL is available as a tablet and oral suspension.
Administration mode
Oral use.
The tablets can be taken with a little water or can be crunched during meals.
Neither purging nor fasting are necessary. There is no need to plan for a particular diet during treatment.
Use in children
The use of FLUVERMAL 2% oral suspension should be considered in some patients, especially young children who are not able to swallow the tablet at 100 mg.
Do not use in children under one year of age without medical advice.
If you take more FLUVERMAL, tablet 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, tablet
Do not take a double dose to make up for the tablet you have forgotten to take.
If you stop taking FLUVERMAL, tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Common (less than 1 in 10 patients):
Abdominal pain, diarrhea;
Headache.
Uncommon (less than 1 in 100 patients):
Nausea, vomiting;
Dizziness.
Rare (less than 1 in 1000 patients):
Allergic reactions such as urticaria, rash, swelling of the face and neck (angioedema), itching.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE FLUVERMAL, tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What FLUVERMAL contains, tablet
· The active substance is:
Flubendazole ................................................. .................................................. .............. 100 mg
Per tablet.
· The other components are:
Microcrystalline cellulose, potato starch, pregelatinized starch, sucrose, sodium laurilsulfate, talc, magnesium stearate.
What is FLUVERMAL, tablet and contents of the pack
This medicine comes in tablet form. Box of 6.
Marketing Authorization Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing Authorization Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
JANSSEN-CILAG
DOMAIN OF MAIGREMONT
27100 VAL DE REUIL
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which 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).