VARILIV DIOSMIN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Variliv Diosmina500 mg film-coated tablets

Diosmina

Read this package leaflet 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 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 it worsens or does not improve after 2 weeks.

Contents of the Package Leaflet

1. What is Variliv Diosmina and what is it used for
2. What you need to know before taking Variliv Diosmina
3. How to take Variliv Diosmina
4. Possible side effects
5. Storage of Variliv Diosmina
6. Package contents and additional information

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

Diosmina is a venotonic medicine: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).

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.

You should consult a doctor if it worsens or does not improve after 2 weeks of treatment.

2. What you need to know before taking Variliv Diosmina

Do not takeVariliv Diosmina:

If you are allergic to diosmina, other flavonoids, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Variliv Diosmina.

Do not use for a prolonged period without medical control.

Children and adolescents

Variliv Diosmina is not indicated in children and adolescents (under 18 years).

Taking Variliv Diosmina with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. No interactions with food or other medicines are known; in any case, never take another medicine on your own initiative without your doctor's recommendation.

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 medicine.

Pregnancy

No harmful effects have been reported in humans. Caution should be exercised when using diosmina during pregnancy, weighing the potential benefits of this medicine during pregnancy.

Breastfeeding

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

Driving and using machines

No effects on the ability to drive and use machines have been reported with Variliv Diosmina.

Variliv Diosmina contains lactose.

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

3. How to take Variliv Diosmina

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults:

The recommended dose is 2 tablets a day, divided into two doses, one tablet at noon and another at night, with meals.

If symptoms do not improve or worsen in the first 2 weeks of treatment, you should consult a doctor.

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

If you take moreVariliv Diosmina than you should

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

If you forget to takeVariliv Diosmina

It is important to take this medicine every day. However, if you forget to take one or more doses of Variliv Diosmina, take another 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 other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects include:

• Frequent (less than 1 in 10 but more than 1 in 100): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Uncommon (less than 1 in 100 but more than 1 in 1,000): colitis.
• Rare (less than 1 in 1,000 but more than 1 in 10,000): nervous system disorders (dizziness, headache, discomfort) and skin reactions (rash, pruritus, urticaria).
• Frequency not known: abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that can cause difficulty breathing).

These side effects have been reported without the need to interrupt treatment.

Reporting of side effects

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

5. Storage of Variliv Diosmina

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

Store in the original packaging to protect it from light.

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

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

6. Package contents and additional information

Composition ofVariliv Diosmina

The active ingredient is diosmina (500 mg per tablet).

The other ingredients are:

Tablet core: microcrystalline cellulose (E-460), gelatin, sodium potato carboxymethyl starch, talc, and magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and package contents

Film-coated tablets, biconvex, oblong, salmon-colored, and marked with the code "D500".

Each package contains 30 and 60 tablets.

Only some package 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: June 2018

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