Dioflav 500 mg film-coated tablets
Diosmin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

What is in this leaflet

1. What Dioflav is and what it is 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, sensation of heaviness, tightness, tingling and itching in legs with varicose veins or swollen legs.

You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of treatment.

2. What you need to know before you take Dioflav

Do not take Dioflav

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

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Dioflav.

Do not use for prolonged periods without medical supervision.

 

Children and adolescents

Dioflav is not indicated for use in children and adolescents (under 18 years of age).

 

Other medicines and Dioflav

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are no known interactions with food or other medicines. In any case, you should never take another medicine on your own initiative without your doctor’s recommendation.

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no known harmful effects on humans. Extreme caution should be exercised in the use of diosmin during pregnancy, adequately assessing the potential benefit of this medicine during this period.

Breast-feeding

As it is not known whether Dioflav is excreted in human milk, its use is not recommended during breast-feeding.

 

Driving and using machines

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

 

Dioflav contains lactose and sodium

If you have been told by your doctor that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Dioflav

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The recommended dose is 2 tablets daily, one taken at midday and one in the evening, with meals.

If the symptoms do not improve or get worse in the first 2 weeks of treatment, you should talk to your doctor.

On your doctor’s advice, treatment can be continued at the same daily dose (2 tablets daily) for up to 2–3 months.

 

If you take more Dioflav than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: +34 91 562 04 20, indicating the medication and the amount taken.

 

If you forget to take Dioflav:

It is important to take this medicine every day. However, if you miss one or more doses of Dioflav, take another dose as soon as you remember and then continue with the prescribed treatment.

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

If you have any further questions on 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:

  • Common (may affect up to 1 in 10 people): gastrointestinal disorders (diarrhoea, 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, itching, hives).
  • Not known (frequency cannot be estimated from the available data): abdominal pain, isolated oedema of the face, lips and eyelids (swelling). Very rarely, Quincke’s oedema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat that may cause difficulty breathing).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dioflav

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

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Dispose of containers and medicines that you do not need at the SIGRE Point in the pharmacy. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dioflav contains

The active substance is diosmin 500 mg per tablet.

The other ingredients are:

  • Tablet core: microcrystalline cellulose (E-460), gelatine, carboxymethyl potato 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).

 

What Dioflav looks like and contents of the pack

Biconvex, oblong, salmon-coloured, film-coated tablets, marked with “D500” on one side.

Each pack contains 30 or 60 tablets.

Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

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 (Navarre)-Spain

 

This leaflet was last revised in: December 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es/

Detailed and updated information on this product is available by scanning the QR code included in the outer carton with a smartphone. The same information is also available from the following URL: https://www.pensapharma.es/info/Dioflav-500mg-comprimidos and the following website: https://cima.aemps.es/cima/dochtml/p/76986/P_76986.html