ESBERIVEN FORT BOX OF 60 COATED TABLETS

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