DAFLON Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
DAFLON 500 mg, film-coated tablet.
2. Qualitative and quantitative composition
Micronised purified flavonoid fraction: 500 mg Corresponding to: Diosmin: 90 per cent: 450 mg Flavonoids expressed as hesperidin: 10 per cent: 50 mg Mean humidity: 20 mg For one film-coated tablet. For ...
3. Pharmaceutical form
Film-coated tablet.
4.1. Therapeutic indications
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, early morning restless legs), Treatment of functional symptoms related to acute hemorrhoidal attack.
4.2. Posology and method of administration
<b>Usual dosage:</b> 2 tablets daily in two divided doses, midday and evening at meal times. <b>Acute hemorrhoidal attack:</b> 6 tablets per day for the first 4 days, then 4 tablets per day for 3 days. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
4.4. Special warnings and precautions for use
Acute hemorrhoidal attack 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, ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No clinically relevant drug interaction has been reported to date from post marketing experience on the product.
4.6. Fertility, pregnancy and breastfeeding
Pregnancy 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 ...
4.7. Effects on ability to drive and use machines
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 ...
4.8. Undesirable effects
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 ...
4.9. Overdose
Symptoms There is limited experience with Daflon overdose. The most frequently reported adverse events in overdose cases were gastrointestinal events (such as diarrhoea, nausea, abdominal pain) and skin ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> VASCULOPROTECTIVE / CAPILLARY STABILIZING AGENTS / BIOFLAVONOIDS <b>ATC Code:</b> C05CA53: cardiovascular system Pharmacology It is active upon the return vascular system ...
5.2. Pharmacokinetic properties
In man, following oral administration of the substance containing <sup>14</sup>C Diosmin: Excretion is mainly faecal; a mean of 14% of the dose administered is excreted in the urine The elimination half-life ...
5.3. Preclinical safety data
Non-clinical data from conventional studies of repeated toxicity administration, genotoxicity and reproductive function toxicity studies do not show any specific risk for humans.
6.1. List of excipients
Sodium starch glycolate, microcrystalline cellulose, gelatine, magnesium stearate, talc, titanium. <u>Film-coating:</u> dioxide (E 171), glycerol, sodium lauryl sulphate, macrogol 6000, hypromellose, yellow ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Below 30°C.
6.5. Nature and contents of container
15 or 30 tablets in blister packs (PVC-Aluminium). Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Les Laboratoires Servier France.
10. Date of revision of the text
January 2019
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