Instructions for use Dioflan film-coated tablets 500 mg blister No. 60
Composition
active ingredients: diosmin, hesperidin;
1 tablet contains purified micronized flavonoid fraction – 500 mg, which contains diosmin – 450 mg, hesperidin* – 50 mg;
* – the name “hesperidin” refers to a mixture of flavonoids: isorhoifolin, hesperidin, linarin, diosmetin;
excipients: microcrystalline cellulose; sodium starch glycolate (type A); hypromellose; talc; sodium lauryl sulfate; magnesium stearate; coating mixture "Opaglos 2 Orange" No. 97A23967 contains: sodium carboxymethylcellulose, maltodextrin, dextrose monohydrate, titanium dioxide (E 171), purified stearic acid, talc, iron oxide yellow (E 172), iron oxide red (E 172), sunset yellow FCF (E 110).
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, pale pink in color, oval in shape, with a biconvex surface, with a score on one side of the tablet and the inscription "KMP" on the other side. A beige core is visible when broken.
Pharmacotherapeutic group
Capillary stabilizing agents. Bioflavonoids. Diosmin, combinations. ATX code C05C A53.
Pharmacological properties
Pharmacodynamics.
"Dioflan®" has a venotonic and angioprotective effect, increases venous tone, reduces venous distensibility and venostasis, improves microcirculation, reduces capillary permeability and increases their resistance, improves lymphatic drainage, increasing lymphatic outflow. The drug also reduces the interaction of leukocytes and endothelium, leukocyte adhesion in post-capillary venules. This reduces the damaging effect of inflammatory mediators on the walls of veins and leaflets of vein valves.
Pharmacokinetics.
The elimination half-life is 11 hours. The active substance is excreted mainly through the intestines. An average of 14% of the administered dose is excreted in the urine.
Indication
Symptomatic treatment of venolymphatic insufficiency (heaviness in the legs, pain, swelling).
Symptomatic treatment of hemorrhoids.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted. There are no data on cases of interaction.
Application features
The use of this medicinal product for acute hemorrhoids does not replace specific treatment and does not interfere with the treatment of other proctological diseases. If the symptoms do not disappear quickly during a short course of treatment, a proctological examination should be performed and the therapy reviewed.
For venous circulation disorders, more effective treatment is provided by combining therapy with adherence to the following lifestyle recommendations:
- avoid prolonged exposure to the sun, prolonged standing, and excess body weight;
- walk and in some cases wear special stockings to improve blood circulation.
Use during pregnancy or breastfeeding
Pregnant women should use the drug with caution. Consult a doctor before use.
Studies have not found teratogenic effects of diosmin and hesperidin, and no side effects have been reported.
Due to the lack of data on the penetration of the drug into breast milk, the use of the drug during breastfeeding should be avoided. Reproductive toxicity studies have shown no effect of diosmin and hesperidin on the fertility of rats.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and work with various mechanisms. In case of signs of side effects of the drug (see the section "Adverse reactions"), caution should be exercised.
Method of administration and doses
For oral use.
Assign to adults.
Treatment of venolymphatic insufficiency (symptoms: swelling, pain, heaviness in the legs, night cramps, trophic ulcers, lymphedema).
The recommended dose is 2 tablets per day: 1 tablet in the afternoon and 1 tablet in the evening, with meals. After a week of use, you can take 2 tablets per day once during meals.
Treatment of chronic hemorrhoids. 2 tablets per day (in two divided doses) with meals. After a week of use, 2 tablets per day can be used once during meals.
Treatment of acute hemorrhoids. 6 tablets per day for 4 days, then 4 tablets per day for the next 3 days. Take with meals. Divide the daily number of tablets into 2-3 doses.
Treatment course. The duration of treatment depends on the indication for use and the course of the disease. The average duration of treatment is 2-3 months.
Children.
There are no data on the use of the drug in children.
Overdose
No cases of overdose have been reported.
Adverse reactions
Neurological disorders: dizziness, headache, malaise.
Skin and subcutaneous tissue disorders: rash, itching, urticaria, isolated swelling of the face, lips, eyelids, angioedema.
The presence of yellow FCF (E 110) in the composition of the drug may cause allergic reactions.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25ºС, out of the reach of children.
Packaging
10 tablets in a blister, 3 or 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and its business address
01032, Ukraine, Kyiv, Saksaganskoho St., 139.
