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What is in this leaflet
1. What DAFLON 500 mg, film-coated tablet is and what it is used for
2. What you need to know before you take DAFLON 500 mg. film-coated tablets
3. How to take DAFLON 500 mg, film-coated tablet
4. Possible side effects
5. How to store DAFLON 500 mg, film-coated tablet
6. Contents of the pack and other information

1. WHAT DAFLON 500 mg, film-coated tablet IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: VASOPROTECTIVES / CAPILLARY STABILIZING AGENTS/ BIOFLAVONOIDS (C05CA53: Cardiovascular system)

This medicine is a Veno tonic (it increases venous tone) and a vasculoprotector (it increases resistance in small blood vessels).

It is recommended for the treatment of venous circulation disorders (heavy legs, pain, restless legs) and the treatment of functional symptoms related to acute hemorrhoidal attack.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFLON 500 mg, film-coated tablet

Do not take DAFLON 500 mg, film-coated tablet:
• if you are allergic to micronized purified flavonoic fraction or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Acute haemorrhoidal attack:
If the hemorrhoid symptoms do not disappear within 15 days, talk to your doctor.
venous circulation disorders;
The most effective way of giving this treatment is in combination with a healthy lifestyle.
• Avoid exposure to the sun, heat, excessive standing and being overweight.
• Walking and. if appropriate, wearing special support stocking stimulate blood circulation.
Do not hesitate to ask your doctor or your pharmacist tor ad’Jice before taking DAFLON 500 mg, film-coated tablets.

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

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

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

Breast feeding
In the absence of data in breast-feeding women, it is preferable to avoid breast-feeding while taking this treatment.

3. HOW TO TAKE DAFLON 500 mg, film-coated tablet
Always take this medicine exactly as your doctor or Pharmacist has told
you. Check with your doctor or pharmacist. lf you are not sure.

venous circulation disorders:
the recommended dose is 2 tablet daily, i.e. one at midday and one in the evening at meal times.

Acute haemorrhoidal attack:
the recommended dose is 6 tablets daily for 4 days, then 4 tablets daily for the next 3 days at mealtimes.

If you take more DAFLON 500 mg, film-coated tablets than you should:
Contact your doctor or pharmacist immediately.
The experience of overdoses with DAFLON Is limited but reported symptoms Include diarrhea, nausea, abdominal pain, pruritus and rash.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DAFLON 500 mg, film-coated tablet can cause side
effects, although not everyone gets them. The frequency of the possible
side effects listed below is defined using the following system:
• very common (affects more than 1 in 1 O users)
• common (affects between 1 and 10 in 100 users)
• uncommon (affects between 1 and 10 in 1,000 users)
• rare (affects between 1 and 10 in 10,000 users)
• very rare (affects fewer than 1 in 1 0, 000 users)
• not known (cannot be estimated from the available data) They may
include: Common: diarrhea, dyspepsia (difficult digestion), nausea,
vomiting.

Uncommon: colitis(inflammation of the large intestine).

Rare: dizziness, headaches, discomfort, rash (sudden redness in patches),
pruritus (skin reactions such as itching) and urticaria (allergic reaction in
the form of small red spots).

Not known (cannot be estimated from the available data): abdominal pain,
isolated oedema (swelling) of the face, lips and eyelids.

Exceptionally: angioneurotic oedema (swelling of the face, lips, mouth,
tongue or throat which could cause breathing difficulties)


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 national reporting system. By reporting side effects You can help provide more information on this medicine.

5. HOW TO STORE DAFLON SOO mg, film-coated tablet .
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 box. the expiry date refers to the last day of that month.

Store below 30°G.

Do not throw away medicines waste.

Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION .
What DAFLON 500 mg, film-coated tablet contains
• The active substance is:
Micronised purified flavonoid fraction ……….. . 500.000 mg
Corresponding to:
Diosmin: 90 per cent ……………….450.000 mg
Flavonoids expressed as hesperidin
10 per cent………………………………. 50.000 mg .
Mean humidity ………………………………………… . 20.000 mg
For one film-coated tablet

The other ingredients are:
Sodium starch glycolate, microcrystalline cellulose, gelatine, magnesium stearate, talc.. . .

Film-coating: titanium dioxide (E 171), glycerol, sodium laurylsulphate, macrogol 6000, Hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), magnesium stearate.

What DAFL0N 500 mg, film-coated tablet look like and contents of the
pack
10,30 or 60 film-coated tablets in blister {PVC-Aluminum}.
Not all pack sizes may be available.


*~ ~ SERVIER Les Laboratoires Servier – France

Pharmacotherapeutic group: VASOPROTECTIVES / CAPILLARY STABILIZING AGENTS/ BIOFLAVONOIDS (C05CA53:

Cardiovascular system) This medicine is a v~n?tonic (it increases venous tone) and a vasculoprotector (1t increases resistance in small blood vessels).

It is recommended for the treatment of venous circulation disorders (heavy legs, pain, restless legs) and the treatment of functional symptoms related to acute haemorrhoidal attack.

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