Package Insert: Information for the User

Variliv Diosmina Forte 1,000 mg Film-Coated Tablets

Diosmina

Read this package insert carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 weeks.

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

It is indicated, in adults, for the relief of symptoms related to mild lower limb venous insufficiency, such as pain, heaviness, tightness, tingling, and itching of the legs with varicose veins or swollen legs.

Consult a doctor if symptoms worsen or do not improve after 2 weeks of treatment.

Do not take Variliv Diosmina Forte

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

Warnings and precautions

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

Do not use for an extended period without medical supervision.

Children and adolescents

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

Other medications and Variliv Diosmina Forte

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. No interactions with food or other medications are known; however, never take another medication on your own initiative without your doctor's recommendation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a precaution, it is preferable to avoid the use of Variliv Diosmina Forte during pregnancy.

Breastfeeding

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

Driving and operating machines

No effects on the ability to drive and operate 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; that is, it 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, 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, consult your doctor.

On doctor's orders, treatment can be continued with the same daily dose (1 tablet per day) for 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Variliv Diosmina Forte

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

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

These adverse effects include:

• Frequent (may affect up to 1 in 10 patients): gastrointestinal disorders (diarrhea, indigestion, nausea, and vomiting).
• Infrequent (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 discomfort) and skin reactions (skin rash, pruritus, and urticaria).
• Unknown frequency(cannot be estimated from available data): abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, angioedema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that may cause difficulty breathing).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es/By reporting adverse effects, you 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 not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 Diosmina Forte

• The active principle is diosmina (1,000 mg per tablet).

• The other components are:

Tablet core : microcrystalline cellulose (E-460), gelatin, sodium carboxymethylcellulose (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 contents of the packaging

Coated tablets with a film, biconvex, oblong, scored, salmon-colored, and marked with the code "D1000" on one side.

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

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: January 2022

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

You can access detailed and updated information on this medication by scanning the QR code included in the 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