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Daflon 1000mg is a medicine that helps improve the health of veins and small blood vessels. It's often used to treat symptoms related to a condition called a hemorrhoidal crisis, which is often associated with painful and uncomfortable piles (hemorrhoids).
Its main ingredient is something called a Flavonoid fraction, at a strength of 1000 mg. It also contains other ingredients like sodium carboxymethyl starch, microcrystalline cellulose, gelatin, magnesium stearate, and talc. It's coated with things like titanium dioxide, glycerol, sodium lauryl sulfate, and a few others.
Every box contains 18 tablets.
If you have a hemorrhoidal crisis, the suggested amount to take is 3 tablets a day for the first 4 days, and then 2 tablets a day for the next 3 days, and you should take them when you're eating a meal.
If your symptoms don't get better after 15 days, you should talk to your doctor.
You shouldn't take Daflon 1000mg if you're allergic to the flavonoid fraction or any of the other ingredients in the medicine. Also, always tell your doctor or pharmacist about any other medicines you're currently taking. If you're pregnant or breastfeeding, you should ask your doctor if it's safe to take Daflon 1000 mg.
Also, you can use Daflon 1000 tablets together with Rectoquotane cream, which is another treatment for hemorrhoids.
Please read the following full disclosure.
PRODUCT CHARACTERISTICS SUMMARY
ANSM - Updated on: 04/12/2021
- NAME OF THE MEDICATION
DAFLON 1000 mg, film-coated tablet
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Micronized purified flavonoid fraction.............................................................................. 1000 mg
Corresponding to:
Diosmin 90 percent.......................................................................................................... 900 mg
Flavonoids expressed as hesperidin 10 percent................................................................. 100 mg
Average moisture.................................................................................................................. 40 mg
For a film-coated tablet.
For the full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Film-coated tablet.
The break bar is there only to facilitate the taking of the tablet, it does not divide it into equal doses.
- CLINICAL DATA
4.1. Therapeutic indications
Treatment of functional signs related to the hemorrhoidal crisis.
4.2. Dosage and method of administration
Dosage
3 tablets per day for the first 4 days, then 2 tablets per day for 3 days.
Pediatric population
The safety and effectiveness of DAFLON 1000 mg in children and adolescents under 18 years of age have not been established.
Mode of administration
Oral route.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1
4.4. Special warnings and precautions for use
The administration of this product does not exempt from the specific treatment of other anal diseases. The treatment should be short-term. If symptoms do not quickly subside, a proctological examination should be performed and the treatment should be reviewed.
Excipients
DAFLON 1000 mg contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
4.5. Interactions with other medicines and other forms of interaction
No interaction study has been conducted. No clinically relevant drug interaction has been reported to date since the product was launched.
4.6. Fertility, pregnancy and breastfeeding
Pregnancy
There are no data or there are limited data on the use of the micronized purified flavonoid fraction in pregnant women.
Studies carried out in animals have not revealed any reproductive toxicity (see section 5.3).
As a precaution, it is preferable to avoid the use of DAFLON during pregnancy.
Breastfeeding
It is not known whether the micronized purified flavonoid fraction/metabolites are excreted in breast milk.
A risk to newborns/infants cannot be excluded.
A decision must be made to either stop breastfeeding or to stop/abstain from treatment with DAFLON taking into account the benefit of breastfeeding for the child compared to the benefit of treatment for the woman.
Fertility
Reproductive toxicity studies have not shown any effect on the fertility of male and female rats (see section 5.3).
4.7. Effects on the ability to drive and use machines
No specific study of the effects of the flavonoid fraction on the ability to drive vehicles and use machines has been conducted. However, given the overall safety profile of the flavonoid fraction, DAFLON has no or negligible effect on the ability to drive vehicles and use machines.
4.8. Undesirable effects
The following adverse effects have been reported and are classified according to their frequency.
Very common (≥ 1/10); common (≥ 1/100, <1/10); infrequent (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000); unknown (cannot be estimated from the available data).
Nervous system disorders
Rare: dizziness, headaches, malaise.
Gastrointestinal disorders
Common: diarrhea, dyspepsia, nausea, vomiting.
Infrequent: colitis.
Unknown frequency: abdominal pain.
Skin and subcutaneous tissue disorders
Rare: rash, itching, hives
Unknown frequency: isolated edema of the face, eyelids, lips. Exceptionally, Quincke's edema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
Symptoms
Data on overdosing with DAFLON are limited. The most frequently reported adverse reactions in case of overdose were gastrointestinal effects (such as diarrhea, nausea, abdominal pain) and skin effects (such as itching, rash).
Management
In case of overdose, symptomatic treatment should be instituted.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: VASCULOPROTECTORS / MEDICINES ACTING ON CAPILLARIES / BIOFLAVONOIDS, ATC code: C05CA53.
Pharmacodynamic effects
DAFLON has a dual action on the venous return system:
· at the level of the veins and venules, it increases the parietal tonicity and exerts an antistase action,
· at the level of the microcirculation, it increases the capillary resistance and normalizes capillary permeability.
5.2. Pharmacokinetic properties
In humans, after oral administration of the drug with carbon 14 marked diosmin:
· excretion is mainly fecal and urinary excretion is on average 14 percent of the amount administered,
· the half-life of elimination is 11 hours,
· the product is highly metabolized, this metabolism is evidenced by the presence of different phenolic acids in the urine.
5.3. Preclinical safety data
Non-clinical data from conventional studies of repeated-dose toxicity, genotoxicity, and reproductive function have not revealed any particular risk to humans.
- PHARMACEUTICAL INFORMATION
6.1. List of excipients
Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, magnesium stearate, talc, purified water.
Film coating: titanium dioxide (E 171), glycerol, sodium lauryl sulfate, macrogol 6000, hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), magnesium stearate.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special storage precautions
This medicine does not require any special storage precautions.
6.5. Nature and contents of outer packaging
18, 30, 36 or 40 film-coated tablets in blisters (PVC/Aluminium).
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
- MARKETING AUTHORIZATION HOLDER
LES LABORATOIRES SERVIER
50 RUE CARNOT
92284 SURESNES CEDEX
FRANCE
- MARKETING AUTHORIZATION NUMBER(S)
· CIP 34009 300 745 6 5: 18 film-coated tablets in blisters (PVC/Aluminium).
· CIP 34009 550 265 6 3: 30 film-coated tablets in blisters (PVC/Aluminium).
· CIP 34009 550 265 8 7: 36 film-coated tablets in blisters (PVC/Aluminium).
· CIP 34009 550 265 9 4: 40 film-coated tablets in blisters (PVC/Aluminium).
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
[To be completed later by the holder]
- DATE OF REVISION OF THE TEXT
[To be completed later by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND DISPENSING CONDITIONS
Medicine not subject to medical prescription.
