Venolep 200 mg hard capsules

Spain
Brand name Venolep 200 mg hard capsules
Form capsules, hard
Active substance / Dosage
HYDROSMINE · 200 mg
Prescription type Prescription Only Medicine
Registration number 57089
Manufacturer Faes Farma S.A.

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venolep 200 mg Hard Capsules

Hydroxyethylrutosides

Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, as 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. See section 4.

Contents of this leaflet

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

1. What Venolep is and what it is used for

Venolep is a venotonic medicine: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).

Venolep is used in adults for the short-term relief (for 2-3 months) of edema and symptoms related to chronic venous insufficiency (pain, leg heaviness, swelling, etc.).

2. What you need to know before starting to take Venolep

Do not take Venolep

  • If you are allergic to diosmin 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 Venolep.

Do not use for prolonged periods without medical supervision.

Children and adolescents

Should not be used in children and adolescents unless specifically instructed by a doctor.

Other medicines and Venolep

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

Taking Venolep with food

No interactions with food are known.

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.

Driving and using machines

The effect of Venolep on the ability to drive and use machines is none or negligible.

3. How to take Venolep

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

For oral use only.

Adults

The recommended dose of Venolep is 1 capsule of 200 mg taken 3 times a day, usually taken with main meals.

Instructions for proper administration of the preparation

Once removed from the blister pack, the capsule should be swallowed whole. It may be taken with water or another drink to facilitate swallowing.

If you take more Venolep than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, 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 Venolep

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.

Do not take a double dose to make up for forgotten doses.

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 experiences them.

The following adverse effects have been reported during the period of use of Venolep, although their frequency cannot be precisely determined:

  • Hypersensitivity (allergic) reactions to the active substance or to any of the excipients (see section 2 “What you need to know before taking Venolep”).
  • Dizziness
  • Headache
  • Stomach pain
  • Nausea
  • Rash
  • Itching

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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venolep

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Venolep after the expiry date stated on the packaging after EXP. The expiry 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 you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venolep

  • The active substance is diosmin. Each capsule contains 200 mg.
  • The other components are: magnesium stearate and gelatin capsule composed of: gelatin, erythrosine (E-127), quinoline yellow (E-104), titanium dioxide (E-171), and water.

Appearance of the product and contents of the pack

Venolep is presented in aluminum-PVC blisters containing 60 hard gelatin capsules of orange color, containing a fine yellow powder.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent revision of this leaflet: January 2025

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