ESBERIVEN 100 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESBERIVEN 100 mg/ml oral solution

Troxerutin

Read the package leaflet carefully before starting to take this medicine because it contains important information for you

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is Esberiven and what is it used for.
2. What you need to know before taking Esberiven.
3. How to take Esberiven.
4. Possible side effects.
5. Storage of Esberiven.
6. Contents of the pack and further information.

1. What is Esberiven and what is it used for

Esberiven belongs to the group of capillary protective medicines.

It is indicated for the short-term treatment (for two to three months) of edema and symptoms related to chronic venous insufficiency, such as: feeling of heavy, painful, and swollen legs.

2. What you need to know before taking Esberiven

Do not take Esberiven

• If you are allergic to troxerutin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Be particularly careful with Esberiven.

• If you have or have had gastric or duodenal ulcers, severe bleeding, or a decrease in the number of platelets (blood cells involved in blood coagulation processes).

Talk to your doctor or pharmacist before taking Esberiven.

Using Esberiven with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

No interactions with other medicines are known.

Using Esberiven with food

No interactions with food are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is no adequate experience regarding the safety of Esberiven in pregnancy. Its use in pregnant women will be done, always weighing the benefit and the possible risk of its administration.

Breastfeeding

Troxerutin does not pass into breast milk in significant amounts. No harmful effects have been reported for the breastfed child.

Driving and using machines

It does not affect the ability to drive and use machines.

Esberiven 100 mg/ml oral solution contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take Esberiven

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medicine is administered orally.

Adults:

The recommended dose is 10 milliliters per day, in one 10 ml dose or in two 5 ml doses.

This medicine can be taken mixed with a little cold milk with or without sugar, fruit juice or soft drink, or sugared water.

If you take more Esberiven than you should

Nausea or vomiting and stomach pain may occur. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esberiven

Do not take a double dose to make up for forgotten doses.

If you stop taking Esberiven

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Esberiven can cause side effects, although not everybody gets them.

The side effects of Esberiven are generally infrequent, mild, and transient.

The adverse reactions that have been observed are:

Gastrointestinal disorders:abdominal discomfort, dyspepsia (heavy digestion, heartburn, and acidity), nausea.

Disorders of the skin and subcutaneous tissue:skin rash.

Nervous system disorders:headache.

If you experience side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

5. Storage of Esberiven

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Esberiven 100 mg/ml oral solution

• The active ingredient is troxerutin. Each 10 ml of the oral solution contains 1 g of troxerutin as the active ingredient.
• The other ingredients are: propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate (E202), sodium saccharin, caramel flavor, and purified water.

Appearance of the product and pack contents

Esberiven is an oral solution, transparent, and intense yellow in color, presented in a topaz glass bottle with a polypropylene/polyethylene high-density (PP/HDPE) cap with a child-proof closure, containing 200 ml of solution accompanied by a dosing cup.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this package leaflet:December 2004

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/