FLEBOSTASIN RETARD 50 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information Leaflet

Flebostasin Retard 50 mg prolonged-release hard capsules

Escin

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Flebostasin Retard and what is it used for
2. What you need to know before taking Flebostasin Retard
3. How to take Flebostasin Retard
4. Possible side effects
5. Storage of Flebostasin Retard
6. Package contents and additional information

1. What is Flebostasin Retard and what is it used for

Flebostasin Retard is a medicine that belongs to the group of capillary protectors.

Flebostasin Retard is indicated for the short-term relief (for two to three months) of edema and symptoms related to chronic venous insufficiency.

2. What you need to know before taking Flebostasin Retard

Do not take Flebostasin Retard

If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flebostasin Retard.

If you have any disease, you should inform your doctor.

Children and adolescents

It should not be administered to children.

Taking Flebostasin Retard with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Pregnancy and breastfeeding

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.

Since there is no adequate experience regarding the safety of Flebostasin Retard during pregnancy and breastfeeding, its use should be avoided in these situations.

Driving and using machines:

No effects have been described that affect the ability to drive and use machines.

3. How to take Flebostasin Retard

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

Your doctor will indicate the duration of your treatment with Flebostasin Retard.

The recommended dose is 1 capsule in the morning and 1 capsule in the evening. Take the capsules whole, without chewing, with a little liquid, and preferably before meals.

If you think the effect of Flebostasin Retard is too strong or too weak, inform your doctor or pharmacist.

If you take more Flebostasin Retard than you should

If you take more capsules than you should or if a child accidentally ingests one or more capsules, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine packaging with you.

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 Flebostasin Retard

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to make up for the missed doses.

If you stop taking Flebostasin Retard

Do not stop treatment without consulting your doctor, as there is a possibility that the treatment may lose its effect.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

During treatment, you may experience stomach heaviness or mild abdominal discomfort. Skin alterations such as itching, redness, and rash may also occur, although rarely.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flebostasin Retard

Keep out of sight and reach of children.

Store below 25°C.

Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiration date stated on the packaging after the abbreviation "CAD". The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Flebostasin Retard

The active substance is escin. Each Flebostasin Retard capsule contains 50 mg of escin (corresponding to 300 mg of aesculus hippocastanum extract).

• The other components are vinylpyrrolidone-vinyl acetate copolymer, talc, dextrin, ammonio methacrylate copolymer (Type B), ammonio methacrylate copolymer (Type A), and triethyl citrate.
• Capsule components:

Gelatin, sodium lauryl sulfate, black iron oxide (E-172), red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), indigo carmine (E-132), and quinoline yellow (E-104).

Appearance and packaging of the product

Flebostasin Retard is presented in the form of prolonged-release hard capsules. The cap of the capsule is opaque brown and the body is transparent green.

Each package contains 60 prolonged-release hard capsules.

Marketing authorization holder:

Glenwood GmbH

Pharmazeutische Erzeugnisse

Arabellastr.17

81925 Munich

Germany

Manufacturer:

SWISS CAPS GmbH

Grassingerstrasse 9

83043 Bad Aibling

Germany

Or

FARMASIERRA, S.A.

Carretera. Irún, Km. 26,200

28700 San Sebastián de los Reyes (Madrid)

Date of the last revision of this leaflet: September 2019.

Other sources of information

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/