Fluvermal, deworming tablets is an over-the-counter medication containing Flubendazole for the treatment of infestations caused by certain intestinal parasitic worms: pinworms, roundworms, whipworms, hookworms, etc.
For warnings, precautions and contraindications, please consult the Fluvermal package insert.
Fluvermal tablets are a deworming medication indicated for the treatment of infestations by certain parasitic worms of the digestive tract : pinworms, roundworms, whipworms and hookworms .
Contamination by intestinal pinworms (Enterobius vermicularis) occurs through ingestion of eggs released into the external environment. The eggs hatch under the effect of digestive juices, releasing pinworm larvae that evolve in the small intestine, where they undergo 5 moults in 2 to 4 weeks, becoming adults in the caecoappendicular region. Only the gravid female passes through the anal sphincter. The intestinal Oxyure worm attaches itself by its mouth to the anal mucosa and lays an average of 10,000 eggs before dying, with a high risk of contamination.
Fluvermal Oxyurose tablet is an over-the-counter Flubendazole-based medicine used to treat infestations by certain parasitic worms of the digestive tract in adults and children: pinworms, roundworms, whipworms and hookworms.
Being the best of hosts is often a pleasure... but it's not always the case! If I tell you: hosting intestinal worms or other parasites of the same family, it doesn't exactly sound like a dream. And yet, these unpleasant organisms sometimes insidiously find their way into our bodies, settling in comfortably and living there like princes. Intestinal worms depend on other organisms, like our own, to live. This is where they draw the energy and nutrients they need to survive and multiply.
Fluvermal dosage is identical for children and adults. It depends on the infesting worm:
FLUVERMAL is available as a tablet, and Fluvermal syrup as a drinkable suspension.
In all cases, follow your doctor's prescription.
Administration of Fluvermal :
Oral route.
Tablets may be taken with a little water or crunched during meals.
No purging or fasting is required. No special diet is required during treatment.
If you have taken more FLUVERMAL, tablet than you should have :
If you have accidentally taken too much FLUVERMAL, consult your doctor immediately, for safety reasons.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains sucrose. Its use is not recommended in patients with sucrose intolerance (a rare hereditary disease).
Other medications :
If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist.
Pregnancy and breast-feeding:
As a precaution, unless otherwise advised by your doctor, it is preferable to avoid taking flubendazole during pregnancy or while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine without a prescription.
The active substance is:
Flubendazole: 100 mg for 1 tablet
The other components are: Microcrystalline cellulose, potato starch, pregelatinized starch, sucrose, sodium lauryl sulfate, talc, magnesium stearate.
Notable excipient: sucrose.
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
Talk to your doctor or pharmacist before taking FLUVERMAL, tablet.
If symptoms persist, consult a physician.
If you are pregnant or breastfeeding, if you think you may be pregnant or intend to become pregnant, or if you are a woman of childbearing age, you should consult your doctor or pharmacist before taking this medicine. Flubendazole should only be given to pregnant or breast-feeding women if prescribed by a doctor.
For internal use only. Store in a clean, dry place away from heat, light and moisture. Keep out of reach of children. Pregnant and breast-feeding women: seek advice from a health professional.
Fluvermal deworming Oxyure Ascaris comes in a box of 6 tablets.
Summary of product characteristics for Fluvermal (ANSM)
Fluvermal over-the-counter medication is not like any other product. Read the Fluvermal package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
To destroy and expel intestinal worms or parasites, substances called dewormings or antihelmintics are used.
For pinworms, a deworming treatment is required. This can be obtained without a prescription, and is available in tablet or drinkable suspension form, more suitable for young children. These drugs only act on adult worms. Treatment must therefore be repeated after 2 or 3 weeks, to avoid re-infestation by eggs that have hatched in the meantime. We recommend treating the whole family.
Pharmacovigilance Report an adverse drug reaction(s)
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
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).
anthelmintic
flubendazole
. Presentations . Composition . Indications . Contraindications . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FLUVERMAL: tablet (white); box of 6.
Refunded at 65%. - price: 2,25 euro (s).
FLUVERMAL: oral suspension (banana flavoring); 30 ml bottle.
Refunded at 65%. - price: 2.54 euro (s).
Laboratory
| p cp | pc to c | |
| flubendazole | 100 mg | 100 mg |
| Sucrose | 1.4 g |
Usual dosage: