VENORUTON OXERUTINES 1 g ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Venoruton Oxerutins 1 g Powder for Oral Solution

Oxerutins

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su médico o farmacéutico.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Should consult a doctor if it worsens or does not improve after 1 or 2 weeks, depending on the indication.

• Must consult a doctor if worsens or does not improve after 1 or 2 weeks, depending on the indication.

Contents of the Package Leaflet:

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

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

The active ingredient of Venoruton Oxerutins is oxerutins, which belongs to the group of vasoprotective medications, which protect blood vessels (systemic vasoprotectors).

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

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

Should consult a doctor if it worsens or does not improve after 2 weeks of treatment in case of venous insufficiency, or after 1 week of treatment in case of hemorrhoids.

2. What you need to know before taking Venoruton Oxerutins

Do not take Venoruton Oxerutins:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Venoruton Oxerutins
• Do not use for a prolonged period without medical control
• Consult your doctor before starting to take this medication if you have edema in the lower limbs due to heart, kidney, or liver disease

Children and adolescents

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

Taking Venoruton Oxerutins with other medications

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

Taking Venoruton Oxerutins with food, beverages, and alcohol

Taking this medication with food or beverages does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

According to generally accepted safety recommendations, Venoruton Oxerutins should not be used during the first 3 months of pregnancy.

It is not known whether the medication passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

You may experience fatigue and dizziness when using Venoruton Oxerutins, although this is rare. If this happens, do not drive or operate machinery.

Venoruton Oxerutins contains sucrose and sodium

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free”.

3. How to take Venoruton

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Adults:

Venous insufficiency:

The recommended dose is 1 sachet per day.

Relief of symptoms usually occurs within the first 2 weeks of treatment.

If you do not feel relief after 2 weeks or symptoms worsen, you should consult your doctor.

On medical indication, treatment can be continued with the same daily dose (1 sachet) for up to 2-3 months.

Hemorrhoids:

The recommended dose is 1 sachet per day. If symptoms do not improve or worsen within the first week of treatment, you should consult your doctor.

Method of administration

To open, please separate the sachets at the perforated zone. Open each sachet individually by tearing the sachet from the indicated point by the arrow; if you cannot open the sachet with your hands, you can use scissors.

Dissolve the contents of the sachet in 1 glass of water and drink immediately.

If you take more Venoruton Oxerutins than you should

In case of accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Venoruton Oxerutins

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

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

If you interrupt treatment with Venoruton Oxerutins

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of these symptoms, which may be signs of an allergic/anaphylactic reaction, stop treatment and consult a doctor immediately:

• difficulty breathing or swallowing;
• swelling of the face, lips, tongue, or throat;
• severe skin itching, with red-colored rash, hives, or bumps.

Rare side effects: may affect up to 1 in 1,000 patients

Gastrointestinal disorder, flatulence, diarrhea, abdominal pain, stomach discomfort, dyspepsia, rash, itching, or urticaria.

Very rare side effects: may affect up to 1 in 10,000 patients

Allergic reactions

Dizziness, headache, fatigue, skin redness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Venoruton Oxerutins

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Venoruton Oxerutins

• The active ingredient is oxerutins.

Each sachet contains 1 g of oxerutins

• The other components (excipients) are mannitol (E-421), sodium saccharin, orange flavor (contains sucrose and maltodextrin).

Appearance and packaging of the product

Pale yellow powder.

Venoruton powder for oral solution is presented in packs of 14, 28, or 30 sachets of PET/PE/Aluminum 12 µm/Surlyn complex.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

SmithKline Beecham, S.A.

Ctra. de Ajalvir, Km. 2,500

Alcalá de Henares, 28806

Madrid, Spain

Or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of the last revision of this package leaflet: May 2025

Other sources of information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/