Patient Information Leaflet

ZEFLAVON 500 mg film-coated tablets

micronized flavonoids, as diosmin and other flavonoids expressed as hesperidin
Please read all of this leaflet carefully before 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 instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 6 weeks of treatment for chronic venous disease or after 7 days of treatment for an acute hemorrhoidal attack.

Contents of this leaflet:

What Zeflavon is and what it is used for
What you need to know before taking Zeflavon
How to take Zeflavon
Possible side effects
How to store Zeflavon
Contents of the pack and other information

1. What Zeflavon is and what it is used for

Zeflavon is a vasoprotective agent. It increases venous tone and strengthens the resistance of small blood vessels.
Zeflavon is indicated in adults:

for the treatment of symptoms related to chronic venous insufficiency of the lower limbs: leg heaviness, leg swelling, pain, nocturnal leg cramps (pain occurring in the legs during the night);
for the treatment of functional symptoms associated with acute haemorrhoidal crisis, such as pain, bleeding, and swelling in the anal region.

2. What you need to know before taking Zeflavon

Do not take Zeflavon:

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Zeflavon. Chronic venous disease: In case of venous insufficiency, treatment should be combined with a healthy lifestyle to achieve the best results. Avoid exposure to sunlight and heat, prolonged standing, and being overweight. Walking and wearing special compression stockings improve circulation. If your condition worsens during treatment, with symptoms such as inflammation of the skin or veins, hardening of the subcutaneous tissue, severe pain, skin ulcers, or atypical symptoms such as sudden swelling of one or both legs, speak to your doctor immediately. Zeflavon does not help reduce swelling of the lower limbs if this is caused by heart, kidney, or liver diseases.

Acute hemorrhoidal disease:
If you are experiencing an acute hemorrhoid attack, you may take Zeflavon for a limited period of 7 days only. If symptoms of the acute hemorrhoidal attack do not disappear within 7 days, consult your doctor.
If your condition worsens during treatment—for example, if you notice increased rectal bleeding, blood in the stool, or have doubts about hemorrhoidal bleeding—consult your doctor.
Treatment with Zeflavon does not replace specific treatment for other anal disorders.
If you have any questions, ask your doctor or pharmacist.
Children and adolescents
Zeflavon is not recommended for use in children and adolescents.
Other medicines and Zeflavon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a general precaution, it is preferable to avoid using this medicine during pregnancy and breastfeeding. Due to the lack of data on excretion in breast milk, the use of this medicine is not recommended during breastfeeding.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines.

3. How to take Zeflavon

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Chronic venous insufficiency:
The recommended dose for adults is two tablets daily for 2 months, one tablet at noon and one tablet in the evening, taken during meals. The treatment may be continued for another 2 months if justified by the persistence of symptoms.
You should speak to your doctor or pharmacist if you do not feel better or if you feel worse after 6 weeks of taking Zeflavon for the treatment of chronic venous disease symptoms. If further Zeflavon is needed, the duration of treatment will be determined by your doctor.
Acute hemorrhoidal attack:
During the first 4 days of treatment, the recommended dose for adults is 3 tablets twice daily (6 tablets per day). During the following 3 days, the dose is 2 tablets twice daily (4 tablets per day).
Take these tablets during meals.
If you are taking Zeflavon to treat symptoms of an acute hemorrhoidal condition, consult your doctor or pharmacist if you do not feel better or if you feel worse after 7 days.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
If you take more Zeflavon than you should
If you have taken more Zeflavon than you should, contact your doctor or pharmacist.
Experience with overdosage of micronized flavonoids is limited. Adverse events in case of overdose may include diarrhea, nausea, abdominal pain, pruritus, and skin rash.
If you forget to take Zeflavon
Do not take a double dose to make up for the missed dose.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common: may affect up to 1 in 10 people
Nausea, vomiting, diarrhoea, dyspepsia.
Uncommon: may affect up to 1 in 100 people
Inflammation of the colon.
Rare: may affect up to 1 in 1,000 people
Headache, dizziness, malaise, rash, itching, urticaria.
Not known: frequency cannot be estimated from the available data

Isolated facial, lip or eyelid oedema associated with allergic symptoms. Angioedema (Quincke's oedema) may exceptionally develop (rapid swelling of the face, lips, mouth, tongue or pharynx, which may be accompanied by breathing difficulties).
Abdominal pain.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse reactions directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Zeflavon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zeflavon contains

The active substances are micronized flavonoids, consisting of diosmin and other flavonoids expressed as hesperidin. Each film-coated tablet contains 500 mg of micronized flavonoids, including 450 mg of diosmin and 50 mg of other flavonoids expressed as hesperidin.
Other components are:
Core: microcrystalline cellulose (type 102), gelatin, corn starch, talc, magnesium stearate.
Coating: partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Zeflavon and the contents of the pack
Orange-brown, oblong, film-coated tablets with a score line on both sides, measuring 18.2 ± 0.3 mm in length and 8.2 ± 0.3 mm in width.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and does not serve to divide the tablet into equal doses.
Pack sizes: 30, 60, 90, 120 or 180 film-coated tablets in PVC/Al blisters, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Viale L. Bodio 37/b
20158 Milan
Italy
EXTRACTUMPHARMA CO LTD.
IV körzet 6 6413 Kunfehértó
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Hungary, Bulgaria, Italy, Romania: Zeflavon
Latvia, Lithuania, Estonia: Hesio