NOTICE
ANSM - Updated on: 02/08/2017
Name of the medicinal product
ESBERIVEN FORT, coated tablet
Rutoside, dry aqueous sweet clover extract, coumarin
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 ESBERIVEN FORT, coated tablet and in which cases it is used?
2. What should be known before taking ESBERIVEN FORT, coated tablet?
3. How to take ESBERIVEN FORT, coated tablet?
4. What are the possible side effects?
5. How to store ESBERIVEN FORT, coated tablet?
6. Package contents and other information.
1. WHAT IS ESBERIVEN FORT, coated tablet AND WHAT CASES IS IT USED FOR?
ESBERIVEN FORT, coated tablet, contains rutoside and dry aqueous extract of sweet clover in active substances, and is enriched with coumarin
This drug is a veinotonic (it increases the tone of the veins) and a vasculoprotectant (the resistance of the blood vessels).
This drug is recommended in adults in venous circulation disorders (heavy legs with formation of clots in the veins of the legs) and hemorrhoids (anal bleeding during passage of the stool). It helps to reduce swelling and restore normal venous function.
If you have any questions about how ESBERIVEN FORT, a coated tablet, and why you are taking this medication have been prescribed, ask your doctor.
2. BEFORE YOU TAKE ESBERIVEN FORT, coated tablet?
Do not take ESBERIVEN FORT, coated tablet:
· if you are allergic to rutoside, dry sweetened sweet clover extract or coumarin, or to any of the other ingredients of this medication (mentioned in section 6);
· if you are breastfeeding;
· if you have / have previously suffered from liver disease;
· if you are taking medicines that thin the blood or prevent coagulation (anticoagulants), as these drugs may increase the risk of bleeding.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ESBERIVEN FORT, coated tablet .
· Hemorrhoidal Hemorrhoidal Disorder: If haemorrhoids do not give up in 15 days, it is essential to consult your doctor.
· Venous circulation disorders : this treatment has all its effectiveness when combined with a healthy lifestyle.
· Avoid exposure to sunlight, heat, prolonged standing, overweight. Walking and possibly wearing adapted stockings promote blood circulation.
· During treatment with this medication, if symptoms worsen or if you develop heart or liver problems, signs of skin infection (skin inflammation), skin ulcers, vein inflammation, edema one or two legs, talk to your doctor.
Children and Youth
This medicinal product is not recommended for use in children and adolescents under 18 years of age, as no data are available.
Other drugs and ESBERIVEN FORT, coated tablet
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Tell your doctor if you are taking any of the following medications, as ESBERIVEN FORT, a coated tablet, may interact with them if taken concomitantly.
· blood thinning medications (anticoagulants),
· interferon ß (a drug that strengthens the immune system and helps reduce disease activity).
ESBERIVEN FORT, tablet coated with food, drink and alcohol
ESBERIVEN FORT, coated tablet, can be taken with or without food. Additional precautions should be taken if you drink alcohol while taking ESBERIVEN FORT, coated tablet.
Pregnancy, breast-feeding and fertility
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.
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Due to passage of coumarin in breast milk, this medication is not recommended during breast-feeding.
Driving and using machines
ESBERIVEN FORT, coated tablet, should not impair your ability to drive or use machines. However, individual responses to medications may vary. Some side effects such as dizziness have been reported. ESBERIVEN FORT, a coated tablet, may affect the ability of some patients to drive or use machines.
ESBERIVEN FORT, coated tablet contains lactose and sucrose.
If your doctor tells you that you are intolerant to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ESBERIVEN FORT, coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The recommended dose is 1 tablet coated with ESBERIVEN FORT 2 times a day.
Do not exceed 2 tablets per day.
Administration mode
Oral use.
Frequency of Administration
1 tablet in the morning and 1 tablet in the evening.
Duration of treatment
Continue to take ESBERIVEN FORT, coated tablet, as long as your doctor has prescribed it.
Use in children and adolescents
Use of this medication is not recommended in children and adolescents under 18 years of age, as there is no data available.
If you take more ESBERIVEN FORT, coated tablet than you should
Never take more tablets than your doctor has prescribed. If you accidentally take too many tablets, consult your doctor or hospital immediately. Take the medicine box with you.
Symptoms of a possible overdose may include nausea (vomiting), vomiting, general feeling of discomfort, weakness and muscle paralysis. Excessive doses can cause exacerbation of adverse effects.
If you forget to take ESBERIVEN FORT, coated tablet
Try taking ESBERIVEN FORT coated tablet exactly as prescribed. However, if you miss a dose, simply follow the usual schedule of one tablet twice a day.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking ESBERIVEN FORT, coated tablet
ESBERIVEN FORT, coated tablet, can treat your disease only if you continue to take it.
It is important to continue the treatment with ESBERIVEN FORT, coated tablet, as long as your doctor has prescribed it.
If you have any further questions on the use of this medication, talk to your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If any of the following occur, stop taking ESBERIVEN FORT, coated tablet. See your doctor immediately or go to the nearest hospital emergency room
· allergic reactions, including rash, swelling of the face, lips, tongue and / or throat that may cause difficulty in breathing or swallowing.
If you notice any of the following signs, you may require emergency medical attention:
· itching, yellow skin or eyes, dark urine or flu-like symptoms, which are the symptoms of inflammation of the liver (hepatitis);
· Rare cases of liver damage have been reported.
In addition, the following effects have also been reported
· nausea, vomiting, diarrhea;
· pruritus, rash, photosensitivity;
· headaches, dizziness, sleep disturbances;
· Loss of muscle movement, general feeling of malaise, weakness.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
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 ESBERIVEN FORT, coated 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 package.
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 ESBERIVEN FORT, Coated Tablet contains
· The active substances are:
Rutoside ................................................. .................................................. ........... 250,00000 mg
Dry aqueous sweet clover extract ............................................. ..................................... 30.00000 mg
Enriched with coumarin titrated at ............................................. .......................................... 5.00000 mg
For a coated tablet.
· Excipients with a known effect: lactose, sucrose.
{................................................. .................................................. ..........................................}
· Other excipients are lactose monohydrate *, microcrystalline cellulose *, sodium carboxymethyl starch, magnesium stearate, calcium sulphate dihydrate, sucrose, gum arabic, carmellose sodium, titanium dioxide, white opalux (titanium dioxide, sucrose, sodium benzoate, purified water), Carnauba wax
* corresponding to Cellactose
What ESBERIVEN FORT, coated tablet and contents of the pack
This medication is in the form of a coated tablet. Box of 30 or 60 tablets.
Marketing Authorization Holder
AMDIPHARM LIMITED
TEMPLE CHAMBERS
3, BURLINGTON ROAD
DUBLIN 4
IRELAND
Marketing Authorization Operator
CENTER PHARMACEUTICAL SPECIALTIES
76, AVENUE DU MIDI
63802 COURNON D'AUVERGNE
Nr. Medical Information and Pharmacovigilance: 01.47.04.80.46
Maker
ROTTENDORF PHARMA
ZI N ° 2 of PROUVY - ROUVIGNIES
1 NUNGESSER STREET
59121 PROUVY
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).