Flebostasin Retard 50 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Flebostasin Retard 50 mg prolonged-release hard capsules

Aescin

Read the entire 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 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Flebostasin Retard is a medicine belonging to the group of capillary protectives.

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 starting to take Flebostasin Retard

Do not take Flebostasin Retard

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

Warnings and precautions

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

If you suffer from any medical condition, you must inform your doctor.

Children and adolescents

This medicine must not be given to children.

Taking Flebostasin Retard with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

Because there is insufficient 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 affecting the ability to drive or operate machinery have been reported.

3. How to take Flebostasin Retard

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

If you think that 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 prescribed or if a child accidentally swallows one or more capsules, contact your doctor immediately or go to the nearest hospital emergency department, and bring the medicine package with you.

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, stating the name of the medicine and the amount taken.

If you forget to take Flebostasin Retard

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

If you stop taking Flebostasin Retard

Do not stop treatment prematurely, as the treatment may cease to be effective.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 expiry date stated on the container after the abbreviation “EXP”. The expiration date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Flebostasin Retard

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

• The other components are vinylpyrrolidone-vinyl acetate copolymer, talc, dextrin, ammonium methacrylate copolymer (Type B), ammonium 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), indigotine (E-132), and quinoline yellow (E-104).

Appearance of the product and contents of the pack

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

Each pack 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)
Spain

Date of the most recent review of this leaflet: September 2019.

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/