Label: information for the user

Variliv Troxerutina 1 g powder for oral solution

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, 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 label. See section 4.

-You should consult a doctor if you worsen or do not improve after 2 weeks.

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

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

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

Do not take Variliv Troxerutina

• If you are allergic to troxerutina 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 Variliv Troxerutina if:

• You have edema in the lower extremities due to a heart, kidney, or liver disease.
• You are under 18 years old.

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 taken recently, or may need to take any other medication.

Taking Variliv Troxerutina with food and drinks

The taking of 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

According to general safety recommendations, Variliv Troxerutina should not be used during the first 3 months of pregnancy.

Driving and operating machines

You may experience fatigue and dizziness when taking Variliv Troxerutina, although this is rare. If this happens, do not drive or operate machines.

Variliv Troxerutina contains sodium

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

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

Adults:

The recommended dose is 1 tablet 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 must consult your doctor.

At the doctor's discretion, treatment may be continued with the same daily dose (1 tablet) for 2-3months.

Use in children and adolescents

This medication is for adults, children cannot take it unless your doctor considers itnecessary.

How to take

Dissolve the contents of the tablet 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Variliv Troxerutina

Do not take a double dose to compensate for the 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.

If any of these symptoms are experienced, which may be signs of an allergic/anaphylactic reaction, discontinue 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 bumps.

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 Adverse Effects

If any type of adverse effect is experienced, consult a doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. Adverse effects can also be reported directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.Reporting adverse effects can contribute to providing more information on the safety of this medication.

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

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

This medication does notrequire special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Variliv Troxerutina

• The active principle is troxerutina. Each sachet contains 1000 mg of troxerutina.
• The other components are: mannitol (E-421), sodium saccharin (E-954) and orange aroma (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 contents of the packaging

Variliv Troxerutina 1 g granulated for oral solution are single-dose sachets of a metal-composite printed with a coating on one side / extruded polyethylene / aluminum / heat-sealable resin containing a fine yellow powder with an orange aroma.

Variliv Troxerutina is presented in packaging containing 14 or 30 sachets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:February 2021.

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