Daflon 500 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Daflon 500 mg film-coated tablets
Purified and micronized flavonoid fraction
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 1 or 2 weeks, depending on the indication.
Contents of the leaflet
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What Daflon is and what it is used for
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What you need to know before taking Daflon
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How to take Daflon
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Possible side effects
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How to store Daflon
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Contents of the pack and other information
1. What Daflon is and what it is used for
Daflon is a venotonic medication: it increases venous tone and capillary resistance (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, heaviness, tightness, tingling, and itching in legs with varicose veins or swollen legs.
It is also indicated for the relief of symptoms associated with haemorrhoids, such as pain or inflammation in the anal area in adults.
You should consult a doctor if your condition worsens or does not improve after 2 weeks of treatment in the case of venous insufficiency, or after 1 week of treatment in the case of haemorrhoids.
2. What you need to know before starting Daflon
Do not take Daflon:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Daflon.
Do not use for prolonged periods 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
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
No interactions with food or other medicines are known. However, you should never take another medicine on your own initiative without first consulting your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 use of machines
No effects on the ability to drive or use machines have been reported with Daflon.
Daflon contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially "sodium-free".
3. How to take Daflon
Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your pharmacist.
Adults:
Venous insufficiency:
The recommended dose is 2 tablets daily, divided into two doses: one tablet at midday and one at night, taken with meals.
Symptom relief usually occurs within the first 2 weeks of treatment. If you do not experience relief within 2 weeks or if symptoms worsen, you should consult your doctor.
As directed by your doctor, treatment may continue with the same daily dose (2 tablets daily) for up to 2–3 months.
Haemorrhoids:
The recommended dose is:
For the first 4 days: 2 tablets, 3 times a day.
For the following 3 days: 2 tablets, 2 times a day.
After this, treatment may continue with a dose of 2 tablets daily.
If symptoms do not improve or worsen during 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, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
Experience with Daflon overdose is limited, 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 the missed dose as soon as you remember, and then continue with your regular schedule. Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can cause 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).
- 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 (rash, pruritus, urticaria).
- Frequency not known: abdominal pain, isolated swelling of the face, lips and eyelids (edema). Very rarely, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat, which may cause difficulty breathing).
These adverse effects have been reported without the need to discontinue treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Daflon
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to a SIGRE Point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other 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 (from potato), microcrystalline cellulose, gelatin, magnesium stearate, talc, sodium lauryl sulfate, polyethylene glycol 6000, salmon-coloured coating dry premix*.
*The salmon-coloured coating dry premix consists 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 contents of the container
Daflon tablets are salmon-coloured, oval-shaped, film-coated tablets.
Daflon is available in blisters in packs containing 30, 36 or 60 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratorios Servier, S.L.
Glorieta Mar Caribe, 1
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 most recent revision of this leaflet: June 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.