Esberiven 100 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESBERIVEN 100 mg/ml oral solution
Troxerutin
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet; 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.
Contents of the leaflet:
- What Esberiven is and what it is used for.
- What you need to know before taking Esberiven.
- How to take Esberiven.
- Possible side effects.
- How to store Esberiven.
- Contents of the pack and other information.
1. What Esberiven is and what it is used for
Esberiven belongs to a group of medicines known as capillary protectives.
It is indicated for short-term relief (for two to three months) of oedema and symptoms related to chronic venous insufficiency, such as a 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 to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with Esberiven:
- If you currently have or have previously had gastric or duodenal ulcer, severe bleeding, or a reduced platelet count (blood cells involved in blood clotting processes).
Consult your doctor or pharmacist before starting to take Esberiven.
Taking Esberiven with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
No interactions with other medicines are known.
Taking Esberiven with food
No interactions with food are known.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is no adequate experience regarding the safety of Esberiven during pregnancy. Its use in pregnant women should only occur after careful assessment of the benefit-risk balance.
Breast-feeding
Troxerutin does not pass into breast milk in significant amounts. Harmful effects in the breastfed infant have not been reported.
Driving and using machines
Esberiven does not affect the ability to drive or operate machinery.
Esberiven 100 mg/ml oral solution contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)
These may cause allergic reactions (possibly delayed) and, very rarely, bronchospasm (sudden sensation of suffocation), as this medicine contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
3. How to take Esberiven
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered orally.
Adults:
The recommended dose is 10 milliliters per day, taken either as a single 10 ml dose or as two doses of 5 ml each.
This medicine may be taken mixed with a little cold milk with or without sugar, fruit juice or soft drink, or sugar-sweetened water.
If you take more Esberiven than you should
Nausea, vomiting, and stomach pain may occur. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.
If you stop using Esberiven
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Esberiven may cause adverse effects, although not everyone experiences them.
The adverse effects of Esberiven are generally uncommon, mild, and transient.
The adverse reactions observed are:
Gastrointestinal disorders: abdominal discomfort, dyspepsia (indigestion, heartburn, and acid reflux), nausea.
Skin and subcutaneous tissue disorders: skin rash.
Nervous system disorders: headache.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Esberiven 100 mg/ml oral solution
- The active substance is troxerutin. Each 10 ml of oral solution contains 1 g of troxerutin as the active substance.
- The other components are: propylene glycol, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), potassium sorbate (E202), sodium saccharin, caramel flavour, and purified water.
Appearance of the product and contents of the container
Esberiven is an oral solution, transparent and intense yellow in colour, supplied in a 200 ml amber glass bottle with a child-resistant closure (Child-Proof) made of polypropylene/high-density polyethylene (PP/HDPE), and accompanied by a dosing glass.
Marketing Authorization Holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer
Faes Farma, S.A.
Scientific and Technological Park of Bizkaia
Ibaizabal Bidea, Building 901
48160 Derio (Bizkaia)
Spain
Date of the most recent review of this leaflet: December 2004
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/