Package leaflet: information for the patient

DAFLON 500 mg film-coated tablets

micronized purified flavonoid fraction
Please read 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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after seven days.

Contents of this leaflet:

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

1. What Daflon is and what it is used for

Daflon is a medicine containing micronized purified flavonoid fraction, which protects
the veins and capillaries.
Daflon is indicated for the treatment of:

venous insufficiency of the lower limbs (which may manifest, for example, as swelling, heaviness, pain or cramps in the legs and feet) and haemorrhoids (veins in the anal region);
capillary fragility (easy rupture of capillaries, becoming visible on the skin and potentially causing spots and bruising);
acute haemorrhoidal attack (sudden onset of bleeding due to rupture of haemorrhoids, pain and anal itching).
Consult your doctor if you do not feel better or if you feel worse after one week of treatment.

2. What you need to know before taking Daflon

Do not take Daflon
if you are allergic to the active substances or to any of the other ingredients of this medicine
(listed in section 6);

Children and adolescents
There are no data available to support the use of this medicine in children and adolescents.

Other medicines and Daflon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
As a precautionary measure, it is preferable to avoid using Daflon during pregnancy.

Breastfeeding
Breastfeeding is not recommended during treatment due to the lack of data on the excretion of the medicine in breast milk.

Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive vehicles or operate machinery.

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

3. How to take Daflon

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Venous insufficiency (including haemorrhoids) and capillary fragility
The recommended dose is 2 tablets daily, taken with the two main meals.
Do not exceed the maximum daily dose.
Acute haemorrhoidal attack
The recommended dose is 3 tablets twice daily (6 tablets per day), taken with the two main meals during the first 4 days of treatment; for the following 3 days, the daily dose is 2 tablets twice daily (4 tablets per day).
Do not exceed the maximum daily dose.
If you take more Daflon than you should
If you have taken more Daflon than you should, contact your doctor or pharmacist immediately.
Experience with Daflon overdose is limited, but reported symptoms include diarrhoea, nausea, abdominal pain, pruritus, and rash.
If you forget to take Daflon
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions that may occur with the following frequency include:
Common (occurs in 1 to 10 patients out of 100):
diarrhoea, indigestion (dyspepsia), nausea, vomiting.
Uncommon (occurs in 1 to 10 patients out of 1,000):
colitis.
Rare (occurs in 1 to 10 patients out of 10,000):
skin redness (rash), itching, urticaria, dizziness, headache, malaise.
Not known (frequency cannot be estimated from the available data):
abdominal pain, swelling of the face, lips, eyelids (oedema), rapid swelling of the face, lips, mouth, tongue or throat which may lead to breathing difficulties (angioedema), abnormally low platelet count (thrombocytopenia).
Following the instructions contained in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at 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 Daflon

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Daflon contains
The active substance is micronized purified flavonoid fraction 500 mg, consisting of 450 mg diosmin and flavonoids expressed as 50 mg hesperidin.
The other components are: sodium carboxymethylcellulose; microcrystalline cellulose; gelatin; glycerin; hypromellose; sodium lauryl sulfate; yellow iron oxide E 172; red iron oxide E 172; titanium dioxide; macrogol 6000; magnesium stearate; talc.

Description of the appearance of Daflon and package contents
Pack sizes of 10, 15, 30, 60 or 120 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex - France

Local Representative in Italy
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy – France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland