VARILIV DIOSMIN 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Variliv Diosmina Forte 1,000 mg film-coated tablets

Diosmin

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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 weeks.

Contents of the Package Leaflet

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

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

Variliv Diosmina Forte is a venotonic medication: 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 of the legs with varices or swollen legs.

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

2. What you need to know before taking Variliv Diosmina Forte

Do not take Variliv Diosmina Forte

If you are allergic to diosmin, other flavonoids, 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 Diosmina Forte.

Do not use for prolonged periods without medical supervision.

Children and Adolescents

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

Other Medications and Variliv Diosmina Forte

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. No interactions with food or other medications are known; however, you should never take another medication 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 medication.

Pregnancy

As a precautionary measure, it is preferable to avoid using Variliv Diosmina Forte during pregnancy.

Breastfeeding

Breastfeeding is not recommended during treatment due to the lack of data on the excretion of the medication in breast milk.

Driving and Using Machines

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

Variliv Diosmina Forte contains lactose.

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

Variliv Diosmina Forte contains sodium.

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

3. How to take Variliv Diosmina Forte

Follow the administration instructions for the medication 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 1 tablet per day, preferably in the morning. The tablets should be taken with water to facilitate swallowing.

The tablet can be divided into equal doses.

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

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

On the doctor's indication, treatment can be continued with the same daily dose (1 tablet per day) for up to 2-3 months.

If you take more Variliv Diosmina Forte 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 medication and the amount ingested.

There is limited experience with overdose of Variliv Diosmina Forte, but reported symptoms include diarrhea, nausea, abdominal pain, pruritus, and skin rash.

If you forget to take Variliv Diosmina Forte

It is important to take this medication every day. However, if you forget to take one or more doses, take another as soon as you remember and then continue with the treatment.

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

4. Possible Side Effects

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

These side effects include:

• Frequent (may affect up to 1 in 10 patients): gastrointestinal disorders (diarrhea, indigestion, nausea, and vomiting).
• Uncommon (may affect up to 1 in 100 patients): colitis.
• Rare (may affect up to 1 in 1,000 patients): nervous system disorders (dizziness, headache, and malaise) and skin reactions (skin rash, pruritus, and urticaria).
• Frequency not known (cannot be estimated from available data): 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).

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: https://www.notificaram.es/ By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Variliv Diosmina Forte

Keep this medication out of sight and reach of children.

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

This medication does not require any special storage temperature.

Keep in the original packaging to protect it from light.

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

6. Package Contents and Additional Information

Composition of Variliv Diosmina Forte

• The active ingredient is diosmin (1,000 mg per tablet).

• The other components are:

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

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E-171), 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, scored, salmon-colored, and marked with the code "D1000" on one face.

The tablets are packaged in single-dose PVC-PVDC/Aluminum blisters. Each package contains 30 tablets.

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:January 2022

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/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86537/P_86537.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86537/P_86537.html