Daflon 500 mg comprimidos recubiertos con pelÍcula

Prospect: information for the patient

Daflon 500 mg coated tablets

Purified and micronized flavonoic fraction

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

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• Consult your pharmacist if you need advice or more information.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 1 or 2 weeks, depending on the indication.

1.What is Daflon and for what it is used

2.What you need to knowbefore starting to takeDaflon

3.How to take Daflon

4.Possible adverse effects

1. Storage ofDaflon

6.Contents of the package and additional information

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

Daflon is indicated, in adults, for the relief of symptoms related to mild lower limb venous insufficiency, such as pain, heaviness, tightness, tingling, and itching in legs with varicose veins 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.

Consult a doctor if 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.

Do not take Daflon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daflon.

Do not use for an extended period without medical supervision.

Children and adolescents

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

Other medications and Daflon

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

No interactions with food or other medications are known; however, never take another medication 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a precaution, it is preferable to avoid using Daflon during pregnancy.

Breastfeeding

It is not recommended to breastfeed during treatment due to the lack of data on the excretion of the medication in breast milk.

Driving and operating machines

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

Daflon contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your pharmacist.

Adults:

Chronic Venous Insufficiency:

The recommended dose is 2 tablets per day, taken in two doses, one tablet at midday and one 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 symptoms worsen, consult your doctor.

At the doctor's discretion, treatment may be continued with the same daily dose (2 tablets per day) for 2-3 months.

Hemorrhoids:

The recommended dose is:

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

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

After this, treatment may be continued with a daily dose of 2 tablets.

If symptoms do not improve or worsen in the first week of treatment, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Daflon

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

These adverse effects include:

• Frequent (less than 1 in 10 but more than 1 in 100): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Less Frequent (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, discomfort) and skin reactions (skin rash, pruritus, urticaria).
• Unknown frequency: abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, angioedema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that may cause difficulty breathing).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.

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

This medication should not be used after the expiration date indicated on the packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Daflon

• The active principle is purified and micronized flavonoic fraction (500 mg per tablet), containing: Diosmina 450 mg and Flavonoids expressed in Hesperidina 50 mg.
• The other components are: carboxymethylcellulose sodium type A (from potato), microcrystalline cellulose, gelatin, magnesium stearate, talc, sodium lauryl sulfate, polyethylene glycol 6000, dry salmon pre-mix for coating*.

*The dry salmon pre-mix 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 content of the packaging

Daflon tablets are coated with a salmon-colored film and oval shape.

Daflon is available in blisters in packaging that contains 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 Madrid

Spain

Responsible for manufacturing:

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 Madrid

Spain

or

Les Laboratoires Servier Industrie

905 Route de Saran

45520 Gidy

France

Last review date of this leaflet:June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.