PATIENT INFORMATION LEAFLET

ESBERIVEN 100 mg/ml oral solution

Troxerutina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Esberivenbelongs to the group of capillary-protecting medications.

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

Do not take Esberiven

• If you are allergic to troxerutina or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with Esberiven.

• If you have or have had a stomach or duodenal ulcer, severe bleeding, or a decrease in the number of platelets (blood cells involved in blood clotting)

Consult your doctor or pharmacist before starting to take Esberiven.

Use of Esberiven with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

No interactions with other medications are known.

Use of 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

No appropriate experience is available regarding the safety of Esberiven during pregnancy. Its use in pregnant women will always be weighed against the relationship between the benefits provided and the possible risk of its administration.

Breastfeeding

Troxerutina does not pass into breast milk in significant amounts. No adverse effects have been described for the breastfeeding infant.

Driving and operating machinery

No effect on the ability to drive and operate machinery.

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 sensation of choking) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication is administered orally.

Adults:

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

This medication can be taken mixed with a little cold milk with or without sugar, fruit juice, or sugar-sweetened soda 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Esberiven

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Esberiven

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

Like all medications, Esberiven can produce adverse effects, although not all people will experience them.

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

The adverse reactions that have been observed are:

Gastrointestinal Disorders:abdominal discomfort, dyspepsia (heavy digestion, burning, and acidity), nausea.

Dermatological and Subcutaneous Tissue Disorders:cutaneous eruption.

Nervous System Disorders:headache.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.This will help protect the environment.

Composition of E sberiven 100 mg/ml oral solution

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

Appearance of the product and content of the container

E sberiven is an oral solution, transparent and of intense yellow color that is presented in a glass vial topaz, with a polypropylene/polycarbonate high-density (PP/HDPE) cap with a child-resistant closure, that contains 200 ml of solution accompanied by a dosing cup.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: December 2004

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /