Flebostasin retard 50 mg cÁpsulas duras de liberaciÓn prolongada

Prospect: information for the patient

Flebostasin Retard 50 mg prolonged-release hard capsules

Escina

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Flebostasin Retard

3.How to take Flebostasin Retard

4.Possible adverse effects

5.Storage of Flebostasin Retard

6.Contents of the pack and additional information

Flebostasin Retardis a medication that belongs to the group of capillary protectors.

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

Do not take Flebostasin Retard

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

Warnings and precautions

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

If you have any medical condition, you must inform your doctor.

Children and adolescents

Flebostasin Retard should not be administered to children.

Taking Flebostasin Retard with other medications

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

Pregnancy and breastfeeding

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

Due to the lack of appropriate experience regarding the safety of Flebostasin Retard during pregnancy and breastfeeding, its use should be avoided in these situations.

Driving and operating machinery:

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

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

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

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

If you estimate that the action 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 take or if a child accidentally ingests one or more capsules, contact your doctor immediately or go to the nearest hospital emergency center and bring the medication packaging with you.

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 Flebostasin Retard

If you forgot to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Flebostasin Retard

Do not suspend treatment beforehand, as there is a possibility that the treatment may no longer be effective.

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

During treatment, you may experience stomach heaviness or mild abdominal discomfort. You may also experience, although rarely, skin changes such as itching, redness, and skin rash.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Store below 25°C.

Store in the original packaging to protect it from humidity.

Do not usethis medicationafter the expiration date that appears on the packaging after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Flebostasin Retard

The active principle is escin. Each capsule of Flebostasin Retard contains 50 mg of escin

(corresponding to 300 mg of Aesculus hippocastanum extract).

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

-Components of the capsule:

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

Appearance of the product and content of the packaging

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

Each package contains 60 hard, prolonged-release capsules.

Holder of the marketing authorization:

Glenwood GmbH

Pharmaceutical Products

Arabellastr.17

81925 Munich

Germany

Responsible for manufacturing:

SWISS CAPS GmbH

Grassingerstrasse 9

83043 Bad Aibling

Germany

O

FARMASIERRA, S.A.

Carretera. Irún, Km. 26,200

28700 San Sebastián de los Reyes (Madrid)

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

Other sources of information

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