Venosmil 200 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VENOSMIL 200 mg hard capsules

Hydrosmine

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 2 weeks.

Leaflet contents:

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

1. What Venosmil capsules are and what they are used for

Venosmil is a venotonic medicinal product: it increases venous tone and capillary resistance (small blood vessels).

Venosmil is indicated in adults for the relief of symptoms related to mild venous insufficiency of the lower limbs, such as pain, sensation of heaviness, tightness, tingling, and itching in legs with varicose veins or swollen legs.

You should consult a doctor if your condition worsens or does not improve after 2 weeks.

2. What you need to know before taking Venosmil capsules

Do not take Venosmil

• if you are allergic to hidrosmin 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 Venosmil capsules.

• Do not use for prolonged periods without medical supervision.

Children and adolescents

Venosmil must not be used in children and adolescents unless specifically instructed by your doctor.

Taking Venosmil 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. Nevertheless, you should never take another medicine on your own initiative without your doctor's recommendation.

Taking Venosmil with food

No interactions with food are known.

Pregnancy and breastfeeding

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

There are no clinical data on Venosmil regarding the use of hidrosmin in pregnant women. As a precautionary measure, the use of Venosmil during pregnancy is not recommended, unless in the physician’s judgment the potential benefits outweigh the possible risks.

There are no clinical data on the use of hidrosmin in breastfeeding women. It is unknown whether hidrosmin is excreted in breast milk; therefore, its use during breastfeeding is not recommended.

Driving and using machines

The influence of Venosmil on the ability to drive and use machines is none or negligible.

3. How to take Venosmil capsules

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For oral use only.

If symptoms do not improve within 2 weeks, you must stop treatment and consult your doctor.

Under medical advice, treatment may continue with the same daily dose for up to 2–3 months.

Adults

The recommended dose of Venosmil is 1 capsule of 200 mg three times daily, usually taken with main meals.

Children and adolescents

This medicine should not be used in children and adolescents unless specifically instructed by your doctor.

Instructions for correct administration

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 Venosmil than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Venosmil

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 a forgotten dose.

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 may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported during the period of use of Venosmil capsules, for which the frequency could not be precisely determined:

• hypersensitivity (allergic) reactions to the active substance (diosmin) or to any of the excipients (see section 2 “What you need to know before taking Venosmil”)
• 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 Venosmil capsules

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Venosmil after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Package contents and other information

Composition of Venosmil capsules

• The active substance is hidrosmina. Each capsule contains 200 mg of hidrosmina.
• The other components (excipients) are magnesium stearate and gelatin capsule composed of: gelatin, erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171) and water.

Appearance of the medicine and contents of the pack

Venosmil capsules are presented in aluminum-PVC blisters containing 60 or 90 hard gelatin capsules, orange in colour, 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.

Scientific and Technological Park of Bizkaia

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

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

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