Package Insert: Information for the User

VENOSMIL 200 mg Hard Capsules

Hidrosmina

Read this package insert carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 weeks.

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

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

Consult a doctor if symptoms worsen or do not improve after 2 weeks.

Do not take Venosmil

• if you are allergicto hydrosamine 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 Venosmil capsules.

• 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.

Taking Venosmil with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

No interactions with other medications are known, butdo not take another medication 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

No clinical data are available on the use of hydrosamine in pregnant women. As a precaution, the use of Venosmil during pregnancy is not recommended, unless your doctor considers that the potential benefits of its administration outweigh the possible risks.

No clinical data are available on the use of hydrosamine in breastfeeding women. It is unknown whether hydrosamine is excreted in breast milk, so its use during breastfeeding is not recommended.

Driving and operating machinery

The influence of Venosmil on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Oral administration only.

If symptoms do not improve in 2 weeks, discontinue treatment and visit your doctor.

At the doctor's discretion, treatment can be continued with the same daily dose for 2-3 months.

Adults

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

Children and Adolescents

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

Instructions for Correct Administration of the Preparation

Once extracted from the blister, the capsule should be taken directly. It can be accompanied by water or another beverage to facilitate swallowing.

If Taking More Venosmil than Prescribed

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or visit a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Venosmil

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 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 will experience them.

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

• hypersensitivity reactions (allergic) to the active ingredient (hydrosmina) or to any of the excipients (see section 2 “What you need to know before starting to take Venosmil”)
• dizziness
• headache
• stomach pain
• nausea
• eruption
• itching

Reporting 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 prospectus. 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 out of sight and reach of children.

No special storage conditions are required.

Do not use Venosmil after the expiration date shown 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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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) are magnesium stearate and gelatin 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.

Marketing authorization holder

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 /