DAFLON 500 MG FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Daflon 500 mg film-coated tablets

Purified and micronized flavonoid fraction

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 1 or 2 weeks, depending on the indication.

Contents of the Leaflet

1. What is Daflon and what is it used for
2. What you need to know before taking Daflon
3. How to take Daflon
4. Possible side effects
   1. Storage of Daflon

1. Package contents and additional information

1. What is Daflon and what is it used for

Daflon is a venotonic medicine: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).

Daflon is indicated, in adults, for the relief of symptoms related to mild venous insufficiency of the lower limbs, such as pain, feeling of heaviness, tightness, tingling, and itching in legs with varices or swollen legs.

It is indicated for the relief of symptoms related to hemorrhoids, such as pain or inflammation in the anal area in adults.

You should consult a doctor if your symptoms worsen or do not improve after 2 weeks of treatment in case of venous insufficiency, or after 1 week of treatment in case of hemorrhoids.

2. What you need to know before taking Daflon

Do not take Daflon:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daflon.

Do not use for a prolonged period without medical supervision.

Children and adolescents

Daflon is not intended for use in children and adolescents (under 18 years of age).

Other medicines and Daflon

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including those obtained without a prescription.

No interactions with food or other medicines are known, but you should never take another medicine on your own initiative without your doctor's recommendation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using 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

No effects on the ability to drive and use machines have been described with Daflon.

Daflon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Daflon

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your pharmacist.

Adults:

Venous insufficiency:

The recommended dose is 2 tablets a day, divided into two doses, one tablet at midday and another at night, with meals.

Relief of symptoms usually occurs within the first 2 weeks of treatment. If you do not feel relief after 2 weeks or if your symptoms worsen, you should consult your doctor.

On medical indication, treatment can be continued with the same daily dose (2 tablets a day) for up to 2-3 months.

Hemorrhoids:

The recommended dose is:

For the first 4 days: 2 tablets, 3 times a day.

For the next 3 days: 2 tablets, 2 times a day.

After this, treatment can be continued with a dose of 2 tablets a day.

If your symptoms do not improve or worsen within the first week of treatment, you should consult your doctor.

If you take more Daflon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

There is limited experience with Daflon overdose, but reported symptoms include diarrhea, nausea, abdominal pain, pruritus, and skin rash.

If you forget to take Daflon

It is important to take this medicine every day. However, if you forget to take one or more doses of Daflon, take another as soon as you remember and then continue with the treatment. Do not take a double dose to make up for the missed doses.

4. Possible side effects

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

These side effects include:

• Frequent (less than 1 in 10 but more than 1 in 100): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Uncommon (less than 1 in 100 but more than 1 in 1,000): colitis.
• Rare (less than 1 in 1,000 but more than 1 in 10,000): nervous system disorders (dizziness, headache, malaise) and skin reactions (skin rash, pruritus, urticaria).
• Frequency not known: abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that can cause difficulty breathing).

These side effects have been reported without the need to interrupt treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Daflon

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Daflon

• The active substance is purified and micronized flavonoid fraction (500 mg per tablet), containing: Diosmin 450 mg and Flavonoids expressed as Hesperidin 50 mg.
• The other components are: sodium carboxymethyl starch type A (potato), microcrystalline cellulose, gelatin, magnesium stearate, talc, sodium lauryl sulfate, polyethylene glycol 6000, dry salmon coating premix*.

*The dry salmon coating premix is composed of: titanium dioxide (E 171), glycerol, hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), polyethylene glycol 6000, and magnesium stearate.

Appearance of the product and package contents

Daflon tablets are film-coated, salmon-colored, and oval-shaped.

Daflon is available in blister packs in packages containing 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIOS SERVIER, S.L.

Avda. de los Madroños 33

28043 Madrid

Spain

Manufacturer:

LABORATORIOS SERVIER, S.L.

Avda. de los Madroños 33

28043 Madrid

Spain

or

LES LABORATOIRES SERVIER INDUSTRIE

905 Route de Saran

45520 Gidy

France

Date of the last revision of this leaflet:June 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.