+ Product Information
COMPOSITION
Each film-coated tablet contains:
Purified Diosmin …………………….. 500 mg
DOSAGE FORM
Film-coated tablet.
White to off-white tablets with intact edges and surfaces.
PACKAGING
Box of 1 blister, 3 blisters, or 5 blisters.
Each blister contains 10 tablets.
INDICATIONS
- Indicated in adults for the treatment of signs and symptoms of chronic venous insufficiency such as leg pain, heaviness in the legs, leg fatigue, restlessness in the legs, nocturnal cramps, edema, and trophic disorders of the lower limbs.
- Used for the treatment of symptoms associated with acute hemorrhoidal attacks.
DOSAGE AND ADMINISTRATION
Chronic venous disease
- 2 tablets per day, either as two divided doses or as a single daily dose.
- Minimum treatment duration: 4 to 5 weeks.
Acute hemorrhoidal disease
- First 4 days: 6 tablets per day.
- Next 3 days: 4 tablets per day.
- Maintenance dose: 2 tablets per day.
Pediatric population
Due to insufficient data, diosmin is not recommended for use in children and adolescents.
Special populations
No dosage studies have been conducted in patients with renal and/or hepatic impairment or in the elderly. Based on available data, no specific risks have been identified in these populations.
Method of administration
Oral use.
The product should be taken with food.
CONTRAINDICATIONS
Hypersensitivity to diosmin or to any of the excipients.
DRUG INTERACTIONS
No interaction studies have been performed.
No interactions between diosmin and other medicinal products have been reported during post-marketing use.
ADVERSE EFFECTS
Common:
- Gastrointestinal disorders: diarrhea, dyspepsia, nausea, vomiting.
Uncommon:
- Gastrointestinal: colitis.
Rare:
- Nervous system: headache, malaise, dizziness.
- Skin: pruritus, rash, urticaria.
STORAGE CONDITIONS
Store in a dry place, protected from light, at temperatures below 30°C.
SHELF LIFE
36 months from the date of manufacture.
