Source: Marketing Authorisation Holder Revision Year: 2019 Publisher: Les Laboratoires Servier France.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
The administration of this product for the symptomatic treatment of acute haemorrhoids does not preclude treatment for other anal conditions.
If symptoms do not subside promptly, a proctological examination should be performed and the treatment should be reviewed.
No interaction studies have been performed. No clinically relevant drug interaction has been reported to date from post marketing experience on the product.
There are no or limited amount of data from the use of Micronised Purified Flavonoid Fraction in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Daflon during pregnancy.
It is unknown whether the active substance/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Daflon therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Reproductive toxicity studies showed no effect on fertility in male and female rats (see section 5.3).
No specific studies on the effects of flavonoid fraction on the ability to drive and use machines have been performed. However, on the basis of the overall safety profile of flavonoid fraction, DAFLON has nor or negligible influence on these abilities.
The following adverse effects or events have been reported and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data).
Rare effects: dizziness, headache, malaise
Common effects: diarrhoea, dyspepsia, nausea, vomiting
Uncommon effects: colitis
Not known: abdominal pain
Rare effects: rash, pruritus, urticaria
Not known: isolated face, lip, eyelid oedema. Exceptionally Quincke’s oedema
If you experience any undesirable effect, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also declare the undesirable effects directly via the national declaration system. By reporting side effects, you can help provide more information on the safety of this medicine.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
