Venoruton oxerutins 1 g powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venoruton oxerutins 1 g powder for oral solution

Oxerutins

Read the entire leaflet carefully before you start taking this medicine, because

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 you worsen or do not improve after 1 or 2 weeks, depending on the indication.

Leaflet contents:

1. What Venoruton oxerutins is and what it is used for
2. What you need to know before taking Venoruton oxerutins
3. How to take Venoruton oxerutins
4. Possible adverse effects
5. How to store Venoruton oxerutins
6. Contents of the pack and other information

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

The active substance of Venoruton oxerutins is oxerutins, which belongs to the group of vasoprotective medicines that protect blood vessels (systemic vasoprotectives).

It 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 legs with varicose veins or swollen legs.

It is also indicated for the relief of symptoms related to haemorrhoids, 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 haemorrhoids.

2. What you need to know before taking Venoruton oxerutins

Do not take Venoruton oxerutins:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Venoruton oxerutins
• Do not use for prolonged periods without medical supervision
• Consult your doctor before starting to take this medicine if you have swelling (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 medicines

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

Taking Venoruton oxerutins with food, drinks and alcohol

Taking this medicine with food or drinks does not affect its efficacy.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 medicine passes into breast milk; therefore, its use during breast-feeding is not recommended.

Driving and using machines

You may experience fatigue and dizziness while using Venoruton oxerutins, although this is rare. If this occurs, do not drive or operate machinery.

Venoruton oxerutins contains sucrose and sodium

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially "sodium-free".

3. How to take Venoruton

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

Adults:

Venous insufficiency:

The recommended dose is 1 sachet per day.

Symptom relief usually occurs within the first 2 weeks of treatment.

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

Under medical advice, treatment may continue 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 during the first week of treatment, you should consult your doctor.

Method of administration

To open, please separate the sachets at the perforated area. Open each individual sachet by tearing from the point indicated by the arrow; if you cannot open the sachet by hand, you may 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 Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Venoruton oxerutins

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

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

If you stop treatment with Venoruton oxerutins

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, which may be signs of an allergic/anaphylactoid 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 rash, hives, or welts.

Rare adverse 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 adverse effects: may affect up to 1 in 10,000 patients

Allergic reactions

Dizziness, headache, fatigue, skin redness.

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. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venoruton oxerutins

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, 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 oxerutins

• The active substance is oxerutins.

Each sachet contains 1 g of oxerutins.

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

Appearance of the product and contents of the pack

Pale yellow powder.

Venoruton powder for oral solution is available in packs of 14, 28 or 30 sachets made of a PET/Polyethylene/Aluminum 12 µm/Surlyn laminate.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of the most recent revision of this package leaflet: May 2025

Other sources of information

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