DIOFLAV

500 mg film-coated tablets

Micronised flavonoids (diosmin and hesperidin)

Read all of this leaflet carefully before you start taking this medicine, as 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.

IN THIS LEAFLET:

1. What Dioflav is and what it is used for

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2. What you need to know before taking Dioflav

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3. How to take Dioflav

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4. Possible undesirable effects

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5. How to store Dioflav

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6. Contents of the pack and other information

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1. WHAT DIOFLAV IS AND WHAT IT IS USED FOR

Diosmin belongs to a group of substances called bioflavonoids and it is used for capillary stability. Dioflav contains active substances that affect venous activity and protect the veins. They improve venous tonicity and capillary resistance. Dioflav reduces oedema and has anti-inflammatory effects.
Dioflav is recommended to adults for the treatment of signs and symptoms of venous insufficiency, such as pain, a feeling of heaviness, tired legs, swollen legs, night cramps, oedema and trophic changes. It is also recommended for the treatment of symptoms of haemorrhoidal crisis, such as pain, bleeding and swelling in the anal region.
If you are taking Dioflav for venous insufficiency and you do not feel better or feel worse after 6 weeks of treatment, you must see a doctor. If you are taking Dioflav for a haemorrhoidal crisis and you do not feel better or feel worse after 7 days of treatment, you must see a doctor.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DIOFLAV

DO NOT TAKE DIOFLAV
• If you are allergic to diosmin, hesperidin 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 demonstrated 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
No interactions have been reported between diosmin or hesperidin and other medicines, but tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

DIOFLAV WITH FOOD
Take Dioflav with meals.

PREGNANCY AND BREASTFEEDING
The safety of taking Dioflav during pregnancy or breastfeeding has not been fully established. Its use during these periods is therefore not recommended. 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.

DRIVING AND USING MACHINES
The effects of Dioflav on driving and using machines are non-existent or negligible

3. HOW TO TAKE DIOFLAV

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

Dosage

Venous insufficiency
The recommended daily dose is 2 tablets, which can be taken in a single dose or in two separate doses.
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.
You can self-medicate without seeing a doctor for a period of 3 months. However, you can continue to take Dioflav for a longer period if your doctor decides that no other specific treatment is necessary.

Haemorrhoidal crisis
In the first 4 days of treatment, the recommended daily dose is 6 tablets (3 tablets twice a day).
In the following 3 days, the recommended daily dose is 4 tablets (2 tablets twice a day).
After this, the recommended maintenance dose is 2 tablets a day (1 tablet twice a day).
If the symptoms do not improve or worsen after 7 days of treatment, see your doctor. You can self-medicate with Dioflav for 15 days; if the symptoms do not go away in this period, 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 have taken more tablets than you should, talk to your doctor or pharmacist. No cases of overdose with Dioflav have been reported to date.

If you forget to take Dioflav
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 or pharmacist.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, this medicine can cause undesirable effects, although not everybody has them. The undesirable effects reported with diosmin + hesperidin include:

Common (can affect up to 1 in 10 people):
• Diarrhoea, indigestion, nausea, vomiting.

Uncommon (may affect up to 1 in 100 people):
• Colitis (inflammation of the colon).

Rare (may affect up to 1 in 1,000 people):
• Headache, malaise, vertigo (a spinning sensation);
• Skin rash, itching, hives.

Unknown (the frequency cannot be calculated from the available data):
• Abdominal pain;
• Oedema (swelling of the face, lips and eyelids), exceptionally angioedema (rapid swelling of tissue, such as the face, lips, tongue or throat, which may make it difficult to breathe).

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 can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably)
or through the following contacts:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Phone: +351 21 798 73 73
Medicines Helpline: 800222444 (free)
E-mail: 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 PACK AND OTHER INFORMATION

The composition of Dioflav
Its active substances are micronised flavonoids - diosmin and hesperidin. Each film-coated tablet contains 450 mg of diosmin and 50 mg of hesperidin.
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 and 60 film-coated tablets in blister strips. Not all pack sizes may be marketed.

Marketing Authorisation Holder
toLife - Produtos Farmacêuticos, 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 included with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/dioflav.

This leaflet was last revised in April 2021.