Leaflet: information for the user

Venolep 200 mg hard capsules

Hidrosmina

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

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

Venolepis used in adults for short-term (for 2-3 months) relief of edema and related symptoms of chronic venous insufficiency (pain, heaviness of legs, swelling, etc.).

Do not take Venolep

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venolep.

Do not use for an extended period without medical supervision.

Children and adolescents

Do not use in children and adolescents unless your doctor advises it.

Other medications and Venolep

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Venolep with food

No food interactions are known.

Pregnancy and breastfeeding

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

Driving and operating machines

The influence of Venolep on the ability to drive and operate machines is negligible or insignificant.

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

Oral administration only.

Adults

The recommended dose ofVenolepis 1 capsule of 200 mg 3 times a day, usually coinciding with the main meals.

Instructions for Correct Administration of the Preparation

Once removed from the blister pack, the capsule should be swallowed directly. It can be accompanied by water or another beverage 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. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Venolep

Take the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with the next capsules at your usual time.

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of Venolep, the following adverse effects have occurred whose frequency has not been determined with exactness:

• Reactions of hypersensitivity (allergic) to the active ingredient or to any of its excipients (see section 2 “What you need to know before starting to take Venolep”).
• Dizziness
• Headache
• Abdominal 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 about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Venolep after the expiration date that appears on the packaging after 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 medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Venosmil capsules

• The active principle is hydrosmina.Each capsule contains 200 mg of hydrosmina.
• The other components (excipients) aremagnesium stearateandgelatin capsule composed of: gelatin, erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171) and water.

Appearance of the product and contents of the packaging

Venosmil capsules are presented in aluminum-PVC blisters with 60 or 90 hard gelatin orange-colored capsules containing a fine yellow powder.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:January 2025

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/