Venoruton diosmin 500 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venoruton diosmin 500 mg film-coated tablets

Diosmin

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 doctor or 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 1 or 2 weeks, depending on the indication.

Leaflet contents:

1. What Venoruton diosmin is and what it is used for.
2. What you need to know before taking Venoruton diosmin.
3. How to take Venoruton diosmin.
4. Possible adverse effects.
5. Storage of Venoruton diosmin.

Pack contents and additional information.

1. What Venoruton diosmin is and what it is used for

Venoruton diosmin is a venotonic medication: it increases venous tone and capillary resistance (small blood vessels).

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

It is also indicated for the relief of symptoms related to hemorrhoids, such as pain or inflammation in the anal area in adults.

You should consult a doctor if your condition worsens or does not improve after 2 weeks of treatment in the case of venous insufficiency, or after 1 week of treatment in the case of hemorrhoids.

2. What you need to know before starting to take Venoruton diosmina

Do not take Venoruton diosmina

• if you are allergic to the active substance 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 Venoruton diosmina.

Do not use for prolonged periods without medical supervision.

Children and adolescents

Venoruton diosmina is not intended for use in children and adolescents (under 18 years of age).

Other medicines and Venoruton diosmin

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 food or other medicines are known. However, you should never take another medicine on your own initiative without it being recommended by your doctor.

Use of Venoruton diosmin with food, beverages, and alcohol

No interactions of this medication with food, beverages, or alcohol are known.

Pregnancy, lactation and fertility

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 is no known harmful effect in humans. Caution should be exercised when using diosmin during pregnancy, with careful assessment of the potential benefit of this medication.

It is not known whether the medicine passes into breast milk; therefore, its use during breastfeeding is not recommended.

Driving and use of machinery

No effects of diosmin on the ability to drive or operate machinery have been reported.

3. How to use Venoruton diosmin

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

Adults

Venous insufficiency:

The recommended dose for adults is 2 tablets per day, divided into two doses—one tablet at midday and one in the evening—with meals.

Symptom relief usually occurs within the first 2 weeks of treatment. If you do not experience relief within 2 weeks or if symptoms worsen, you should consult your doctor.

Under medical advice, treatment may continue at the same daily dose (2 tablets daily) for up to 2 to 3 months.

Hemorrhoids:

The recommended dose is:

For the first 4 days: 2 tablets, 3 times a day.

For the following 3 days: 2 tablets, 2 times a day.

After this, treatment may continue with a dose of 2 tablets per day.

If symptoms do not improve or worsen during the first week of treatment, you should consult your doctor.

Use in children and adolescents

The safety and efficacy of diosmin in children and adolescents have not been established.

If you take more Venoruton diosmin than you should

Cases of overdose with diosmin have not been reported.

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 medication and the amount ingested.

If you forget to take Venoruton diosmin

It is important to take this medicine every day. However, if you forget to take one or more doses of Venoruton diosmin, take the next dose as soon as you remember, and then continue with the prescribed treatment. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Venoruton diosmina may cause adverse effects, although not everyone will experience them.

The frequencies of adverse effects are listed below according to the following definitions:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people

Common: gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
Uncommon: colitis
Rare: nervous system disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).
Frequency not known: abdominal pain, isolated swelling of the face, lips, and eyelids (edema). Exceptionally, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat, which may cause difficulty breathing).

These adverse effects have been reported without the need to discontinue treatment.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venoruton Diosmin

No special storage conditions are required.

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

Do not use this medicine 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 or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venoruton diosmina

• The active substance is diosmin (500 mg per tablet).
• The other components are: microcrystalline cellulose (E460i), gelatin, sodium starch glycolate (potato starch), talc (E553b), magnesium stearate, sodium lauryl sulfate, and Opadry orange (hydroxypropylmethylcellulose (E464), glycerol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), polyethylene glycol 6000, magnesium stearate).

Appearance of the medicine and contents of the pack

Venoruton diosmina are orange-colored, oblong, film-coated tablets, scored on one side. The tablets are presented in blister packs contained in cartons of 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Laboratori Fundació Dau

C/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

Date of the most recent revision of this leaflet: November 2024

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