DIOFLAV 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dioflav500 mg film-coated tablets

diosmin

Read this package leaflet carefully before you start taking this medicine, because 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, 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 Dioflav and what is it used for
2. What you need to know before taking Dioflav
3. How to take Dioflav
4. Possible side effects
5. Storage of Dioflav
6. Contents of the pack and further information

1. What is Dioflav and what is it used for

Dioflav 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 Dioflav

Do not takeDioflav

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dioflav.

Do not use for a prolonged period without medical supervision.

Children and adolescents

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

Other medicines and Dioflav

Inform 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 might 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 diosmin during pregnancy, adequately assessing the potential benefit 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 Dioflav.

Dioflavcontains lactose and sodium

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

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

3. How to take Dioflav

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 more Dioflavthan 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 takeDioflav:

It is important to take this medicine every day. However, if you forget to take one or more doses of Dioflav, 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 (may affect up to 1 in 10 people): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Uncommon (may affect up to 1 in 100 people): colitis.
• Rare (may affect up to 1 in 1,000 people): nervous system disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).
• Frequency not known (cannot be estimated from the 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 of 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 national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dioflav

Keep out of 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 "EXP". 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 any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dioflav:

The active substance is diosmin (500 mg per tablet).

The other components are:

• Core of the tablet: microcrystalline cellulose (E-460), gelatin, sodium starch glycolate, talc, and magnesium stearate.
• Coating of the tablet: lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and contents of the pack:

Film-coated tablets, biconvex, oblong, salmon-colored, and marked with "D500" on one side.

Each pack contains 30 or 60 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Polígono industrial Areta

31620 Huarte-Pamplona (Navarra)-Spain

This package leaflet was approved inDecember 2023

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