1. WHAT IS ESBERIVEN FORT, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
VASCULOPROTECTOR / DRUG ACTING ON THE CAPILLARIES
Therapeutic indications
This medicine is a venotonic(it increases the tone of the veins) and a vasculoprotector(it increases the resistance of blood vessels).
This medicine is recommended for venous circulation disorders and hemorrhoidal crisis.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ESBERIVEN FORT, coated tablet
List of information needed before taking the medicine
Not applicable.
Contraindications
Do not take ESBERIVEN FORT, coated tablet:
This medicine is generally not recommended during breastfeeding.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE
Precautions for use; special warnings
Be careful with ESBERIVEN FORT, coated tablet:
Special warnings
Due to the presence of lactose, this medicine should not be used in patients with glucose-galactose malabsorption syndrome or lactase deficiency(rare metabolic diseases).
Due to the presence of sucrose, this medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Precautions for use
Haemorrhoidal crisis: if haemorrhoidal problems do not subside within 15 days, it is essential to consult your doctor.
Disorders of the venous circulation: this treatment has all its effectiveness when it is associated with a good hygiene of life.
Avoid exposure to the sun, heat, prolonged standing and excess weight. Walking and possibly wearing adapted stockings help blood circulation.
NEVER LEAVE WITHIN THE REACH OF CHILDREN
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
Pregnancy
This medicine should not be used during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
Breastfeeding
Due to the passage of coumarin into breast milk, this medicine is not recommended during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: lactose, sucrose.
3. HOW TO TAKE ESBERIVEN FORT, coated tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
1 tablet twice daily.
Do not exceed 2 tablets per day.
IN ALL CASES, STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION.
Method of administration
Take by mouth.
Frequency of administration
1 tablet in the morning and 1 tablet in the evening.
Duration of treatment
DO NOT EXCEED THE EXPIRY DATE INDICATED ON THE PACKAGING.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ESBERIVEN FORT, coated tablet is likely to have side effects, although not everyone is subject to them.
nausea, vomiting,
pruritus,
headache,
exceptional liverdamage.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE ESBERIVEN FORT, coated tablet
Keep out of the reach and sight of children.
Expiry date
Do not use ESBERIVEN FORT, coated tablets after the expiry date stated on the box.
Storage conditions
Store at a temperature not exceeding 25°C
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ESBERIVEN FORT, coated tablet contain?
The active ingredients are
Rutoside .......................................................................................................................................... 250 mg
Dry aqueous extract of sweet clover .............................................................................................................. 30 mg
Enriched with coumarin titrated to .................................................................................................................. 5 mg
For one coated tablet.
Other components are:
Lactose monohydrate*, microcrystalline cellulose*, sodium carboxymethyl starch, magnesium stearate, calcium sulfate dihydrate, sucrose, gum arabic, sodium carmellose, titanium dioxide, white opalux (Titanium dioxide, sucrose, sodium benzoate, purified water), carnauba wax.
*Corresponding to Cellactose
Pharmaceutical form and content
What is ESBERIVEN FORT, coated tablet and what does it contain?
This medicine is presented as a coated tablet.
Box of 20, 30 or 60 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
AMDIPHARM LIMITED
TEMPLE CHAMBERS
3, BURLINGTON ROAD
DUBLIN 4
IRELAND
Français
English
