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DIOFLAV
500 mg film-coated tablets
Bioflavonoids (micronised purified flavonoid fraction)
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 instructed by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your pharmacist.
If you have any undesirable effects, talk to your doctor or pharmacist. This includes any possible undesirable effects not listed in this leaflet. See Section 4.
If you do not feel better, or feel worse after 6 weeks of treatment for venous insufficiency, or after 7 days of a haemorrhoidal crisis, you must see a doctor.
1. WHAT DIOFLAV IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE TAKING DIOFLAV
3. HOW TO TAKE DIOFLAV
4. POSSIBLE UNDESIRABLE EFFECTS
5. HOW TO STORE DIOFLAV
6. CONTENTS OF THE PACKET AND OTHER INFORMATION
1. WHAT DIOFLAV IS AND WHAT IT IS USED FOR

Dioflav is a venotropic and a vascular protector. It is used for:
- Treatment of symptoms and signs related to chronic venous insufficiency of the lower extremities: heavy legs and oedema, pain, tiredness.
- Symptomatic treatment of haemorrhoidal crisis.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DIOFLAV

DO NOT TAKE DIOFLAV
if you are allergic to the active substance 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.

VENOUS INSUFFICIENCY
If your condition worsens during treatment, which may be reflected by inflammation of the skin or veins, hardening of the tissue under the skin, intense pain, skin ulcers or atypical symptoms, such as sudden swelling of one or both legs, see your doctor immediately.

Treatment with Dioflav is more beneficial when accompanied by a balanced lifestyle:
avoid exposure to sunlight and avoid standing for any significant length of time;
maintain an appropriate weight;
in some patients, wearing special stockings can improve circulation.

Dioflav will not help reduce swelling in your legs if it is caused by heart, kidney or liver disease.

HAEMORRHOIDAL CRISIS
If you have a haemorrhoidal crisis, you can only take Dioflav for a limited period of 15 days. If the symptoms do not go away within this period, see your doctor.

If your condition worsens during treatment, i.e. if you notice increased bleeding from your anus (rectum) or blood in your stool, or if you are in doubt about haemorrhoid-related bleeding, see your doctor.

Treatment with Dioflav is not a substitute for specific treatment for other anal conditions.

CHILDREN AND ADOLESCENTS
Use in children and adolescents is not recommended.

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

DIOFLAV WITH FOOD AND DRINK
You should take Dioflav with meals.

PREGNANCY AND BREASTFEEDING
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

PREGNANCY
As a precautionary measure, it is preferable to avoid the use of Dioflav during pregnancy.

BREASTFEEDING
Breastfeeding is not recommended during treatment, due to insufficient data on the excretion of the product into breast milk.

DRIVING AND OPERATING MACHINERY
Dioflav does not appear to interfere with the ability to drive or use machines. If you experience dizziness, do not drive or use machines.

3. HOW TO TAKE DIOFLAV

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Talk to your doctor, pharmacist or nurse if you have any questions.

Posology
VENOUS INSUFFICIENCY:
The recommended dose is 2 film-coated tablet per day.
You need to take this medicine for at least 4 to 5 weeks before improvements can be expected. If the symptoms worsen or do not improve after 6 weeks of treatment, see your doctor.
IN THE EVENT OF A HAEMORRHOIDAL CRISIS:
- in the first 4 days: 2 tablet 3 times daily,
- in the next 3 days: 2 tablet 2 times daily; then return to maintenance dose: 2 tablet per day.

If the symptoms do not improve or worsen after 7 days of treatment, see your doctor.

ROUTE OF ADMINISTRATION
Dioflav should be taken with meals.
Swallow the tablet with some liquid.

IF YOU TAKE MORE DIOFLAV THAN YOU SHOULD
If you take more Dioflav than you should, contact your doctor or pharmacist immediately. Experience of overdoses with bioflavonoids is limited, but reported symptoms include diarrhoea, nausea, abdominal pain, pruritus and rash.

IF YOU FORGET TO TAKE DIOFLAV
Take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. POSSIBLE UNDESIRABLE EFFECTS

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

In order of decreasing frequency, undesirable effects may include:

NERVOUS SYSTEM DISORDERS:
• Rare: dizziness, headache, malaise.

GASTROINTESTINAL DISORDERS:
• Common: diarrhoea, dyspepsia, nausea, vomiting.
• Uncommon: colitis.
• Not known: abdominal pain.

SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
• Rare: rash, pruritus, urticaria.
• Not known: isolated swelling of the face, lips, eyelids.
Very rare: Quincke’s disease.

REPORTING UNDESIRABLE EFFECTS
If you have any undesirable effects, including possible undesirable effects not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report undesirable effects directly to INFARMED, I.P. using the contact information indicated below. By reporting undesirable effects, you will help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably)
or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Helpline: 800222444 (free)
Email: farmacovigilancia@infarmed.pt

5. HOW TO STORE DIOFLAV
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date indicated on the outer packaging. The expiry date is the last day of the month indicated.

This medicinal product does not require any special storage conditions.

Do not dispose of any medicine in the drains or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKET AND OTHER INFORMATION

THE COMPOSITION OF DIOFLAV
- The active substances are bioflavonoids (micronised purified flavonoid fraction). Each 500 mg film-coated tablet contains:
• 90% diosmin, i.e. 450 mg per film-coated tablet,
• 10% flavonoids expressed as hesperidin, i.e. 50 mg per film-coated tablet.

- The other components are:
Core: Microcrystalline cellulose, gelatine, corn starch, magnesium stearate and talc.
Tablet coating: partially hydrolysed polyvinyl alcohol, macrogol/PEG 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and talc.

WHAT DIOFLAV LOOKS LIKE AND CONTENTS OF THE PACK
Oblong, brownish-orange film-coated tablet with a groove on each side. The groove is there to make it easier to split and swallow and not to divide into equal doses.

Dioflav is sold in packs of 10, 30, 60 and 120 film-coated tablets in blister strips.
Not all packet sizes may be marketed.

MARKETING AUTHORISATION HOLDER:
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

MANUFACTURER:
ExtractumPharma Co. Ltd.
IV körzet 6
6413 Kunfehértó
Hungary

Detailed and up-to-date information on this medicine is available by scanning the 2D code printed on the packet with a smartphone. The same information is also available at the following URL:
https://www.tolifeotc.com/dioflav

This leaflet was last revised in December 2025.