VARILIV TROXERUTINE 1 g ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Variliv Troxerutina 1 g Granules for Oral Solution

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.

• 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.
• You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.

Contents of the Package Leaflet

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

1. What Variliv Troxerutina is and what it is used for

The active ingredient of Variliv Troxerutina is troxerutina, which belongs to the group of medications known as Vasoprotectores, which protect blood vessels (systemic vasoprotectores).

It is indicated, in adults, for the relief of symptoms of mild venous insufficiency of the legs, such as:

• pain, feeling of heaviness and tightness
• tingling and itching in legs with varices
• swollen legs.

2. What you need to know before taking Variliv Troxerutina

Do not take Variliv Troxerutina

• If you are allergic to troxerutina 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 Variliv Troxerutina if:

• you have edema in the lower limbs due to heart, kidney, or liver disease
• in children under 18 years of age.

Children and adolescents

Variliv Troxerutina is not recommended for use in children.

Taking Variliv Troxerutina with other medications

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

Taking Variliv Troxerutina with food and drinks

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

Pregnancy and breastfeeding

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, Variliv Troxerutina should not be used during the first 3 months of pregnancy.

Driving and using machines

You may experience fatigue and dizziness when using Variliv Troxerutina, although this is rare. If this occurs, do not drive or use machines.

Variliv Troxerutina contains sodium

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

3. How to take Variliv Troxerutina

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

Adults:

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 your symptoms worsen, you should consult your doctor.

On the advice of your doctor, treatment can be continued with the same daily dose (1 sachet) for up to 2-3 months.

Use in children and adolescents

This medication is for adults; children should not take it unless their doctor considers it necessary.

How to take

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

If you take more Variliv Troxerutina than you should

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

If you forget to take Variliv Troxerutina

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

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

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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Variliv Troxerutina

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Variliv Troxerutina

• The active ingredient is troxerutina. Each sachet contains 1000 mg of troxerutina.
• The other ingredients are: mannitol (E-421), sodium saccharin (E-954), and orange flavor (flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)).

Appearance of the product and pack contents

Variliv Troxerutina 1 g granules for oral solution are single-dose sachets of a complex printed metal composite consisting of a coating on one side / extruded polyethylene / aluminum / thermosetting resin containing a fine yellow powder with an orange flavor.

Variliv Troxerutina is available in packs containing 14 or 30 sachets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)-Spain

Date of the last revision of this package leaflet:February 2021.

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