INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE Flebaven®Flebaven®
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE Flebaven® Flebaven®
Registration number:
Trade name: Phlebaven®
International nonproprietary or group name: purified micronized flavonoid fraction (diosmin + flavonoids in terms of hesperidin)
Dosage form: film-coated tablets
Composition 1 film-coated tablet contains: Core: purified micronized flavonoid fraction, substance - granules 1226.00 mg [Active substance of the substance - granules: purified micronized flavonoid fraction [diosmin (90%) 900 mg + flavonoids in terms of hesperidin ( 10%). film: film-forming mixture1, red iron oxide dye (E172), yellow iron oxide dye (E172) 1 Composition of the film-forming mixture: hypromellose, titanium dioxide (E171), talc, propylene glycol
Description Oval, biconvex tablets, film-coated, orange-pink in color, scored on one side.
Pharmacotherapeutic group: venotonic and venoprotective agent
ATX code: C05CA53
Pharmacological properties Pharmacodynamics The drug is a purified micronized flavonoid fraction, consisting of diosmin and other flavonoids in terms of hesperidin. The purified micronized flavonoid fraction has venotonic and angioprotective properties. Reduces the distensibility of veins and venous stagnation, reduces capillary permeability in microcirculation and increases their resistance, improves venous hemodynamics. It affects the following venous plethysmographic parameters: venous capacity, venous distensibility, time of venous emptying. The optimal effect is achieved when taking 1000 mg per day. The drug increases venous tone by reducing the time of venous emptying. In patients with signs of severe microcirculation disorders, after using the purified micronized flavonoid fraction, an increase in capillary resistance is noted. The purified micronized flavonoid fraction is effective in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids. Pharmacokinetics The drug undergoes active metabolism, which is confirmed by the presence of phenolic acids in the urine. The drug is primarily excreted through the intestines. On average, about 14% of the dose taken is excreted by the kidneys. The half-life is 11 hours.
Indications for use The drug Flebaven® is indicated for the treatment of symptoms of chronic venous diseases (elimination and relief of symptoms). Treatment of symptoms of venous-lymphatic insufficiency: • pain; • spasms of the lower extremities; • feeling of heaviness and fullness in the legs; • “fatigue” of the legs. Treatment of manifestations of venous-lymphatic insufficiency: • swelling of the lower extremities; • trophic changes in the skin and subcutaneous tissue; • venous trophic ulcers. Symptomatic treatment of acute and chronic hemorrhoids.
Contraindications • Hypersensitivity to the active substance or to any of the excipients included in the drug. • Pregnancy and breastfeeding (limited or no experience with use). • Children under 18 years of age (no experience of use).
Use during pregnancy and breastfeeding Pregnancy Data on the use of purified micronized flavonoid fraction in pregnant women are absent or limited. As a precautionary measure, it is preferable not to use Flebaven® during pregnancy. Breastfeeding Period It is not known whether the purified micronized flavonoid fraction (metabolites) passes into human breast milk. A risk for newborns and infants cannot be excluded. It is necessary to make a decision either to stop breastfeeding or to cancel therapy with Flebaven®, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman. Effect on reproductive function Reproductive toxicity studies have shown no effect on reproductive function in rats of either sex.
Directions for use and dosage : Inside. The tablets should be swallowed with water. The recommended dose for venous-lymphatic insufficiency is 1 tablet per day, preferably in the morning, during meals. The score on the tablet is intended solely for scoring purposes to make it easier to swallow. The duration of treatment can be several months (up to 12 months). In case of recurrence of symptoms, on the recommendation of a doctor, the course of treatment can be repeated. The recommended dose for acute hemorrhoids is 3 tablets per day (1 tablet in the morning, afternoon and evening) for 4 days, then 2 tablets per day (1 tablet in the morning and evening) for the next 3 days. The recommended dose for chronic hemorrhoids is 1 tablet per day.
Side effects Side effects of the purified micronized flavonoid fraction observed during clinical studies were mild. Disorders from the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting) were predominantly observed. Classification of the incidence of side effects recommended by the World Health Organization (WHO): very common ≥ 1/10 common ≥ 1/100 to < 1/10 uncommon ≥ 1/1000 to < 1/100 rare ≥ 1/10000 to < 1/1000 very rare <1/10000 frequency unknown cannot be estimated from available data. Nervous system disorders: rarely - dizziness, headache, general malaise. Gastrointestinal disorders: often – diarrhea, dyspepsia, nausea, vomiting; uncommon – colitis; frequency unknown - abdominal pain. Disorders of the skin and subcutaneous tissues: rarely - skin rash, itching, urticaria; frequency unknown - isolated swelling of the face, lips, eyelids. In exceptional cases - angioedema. Inform your doctor if you experience any undesirable reactions and sensations, including those mentioned in these instructions, as well as changes in laboratory parameters during therapy.
Overdose Symptoms Data on cases of overdose of the drug Flebaven® are limited. The most common adverse reactions in cases of overdose were gastrointestinal disorders (diarrhea, nausea, abdominal pain) and skin reactions (itching, skin rash). Treatment Treatment for overdose should consist of eliminating clinical symptoms. In case of overdose of the drug, you should immediately consult a doctor.
Interaction with other drugs No clinical studies have been conducted to study the interactions of the purified micronized flavonoid fraction with other drugs. To date, no cases of drug interactions have been reported.
Special instructions • Before you start taking Flebaven®, it is recommended to consult your doctor. • In case of exacerbation of hemorrhoids, the use of Flebaven® does not replace the specific treatment of other diseases of the rectum and anal canal. When using the drug on your own, do not exceed the maximum periods and doses recommended for the treatment of acute hemorrhoids specified in the section “Method of administration and doses”. If symptoms persist after the recommended course of therapy, you should be examined by a proctologist, who will select further therapy. • In the presence of venous circulation disorders, the maximum effect of treatment is ensured by a combination of therapy with additional therapeutic and preventive measures and a healthy (balanced) lifestyle: it is advisable to avoid long exposure to the sun, prolonged standing, and it is also recommended to reduce excess body weight. Walking and, in some cases, wearing special stockings help improve blood circulation. Contact your doctor immediately if your condition worsens or does not improve during treatment.
Effect on the ability to drive vehicles, machinery. Clinical studies have not been conducted to study the effect of purified micronized flavonoid fraction on the ability to drive vehicles, machinery, and perform work requiring a high speed of mental and physical reactions. However, based on the available safety data, we can conclude that the drug Flebaven® does not affect (does not have a significant effect) on these processes.
Release form: Film-coated tablets, 1000 mg. 8 or 10 tablets in a blister pack made of PVC film and aluminum foil. 4.8 blister packs (8 tablets each) or 3.6 blister packs (10 tablets each) together with instructions for use are placed in a cardboard pack.
Storage conditions At a temperature not exceeding 25 °C, in the original blister packaging. Keep out of the reach of children.
Shelf life: 2 years. Do not use the drug after the expiration date.
Conditions of release Dispensed without a prescription.
Name of the legal entity in whose name the registration certificate was issued, address LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50
, 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50 Tel., fax
Name and address of the organization receiving consumer complaints LLC KRKA-RUS, 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel., fax
Phlebaven 1000 mg 32 pcs. film-coated tablets
pharmachologic effect
Angioprotective, venotonic.
Composition and release form Phlebaven 1000 mg 32 pcs. film-coated tablets
Film-coated tablets - 1 tablet:
- active substance of the core: purified micronized flavonoid fraction, granule substance - 613 mg;
- active substance granule substance (500 mg): diosmin - 450 mg (90%); other flavonoids in terms of hesperidin - 50 mg (10%);
- excipients of the granule substance: MCC - 82 mg; povidone K30 - 31 mg;
- excipients: sodium carboxymethyl starch - 27 mg; talc - 6 mg; magnesium stearate - 4 mg;
- film shell: Opadry orange 03Н32599 (hypromellose - 71.714%, titanium dioxide (E171) - 15.936%, talc - 6.972%, propylene glycol - 4.98%, iron oxide yellow (E172) - 0.332%, iron oxide red (E172) ) - 0.066%) - 18 mg.
Film-coated tablets, 500 mg. 16 tablets each in blister packs made of PVC film and aluminum foil. 2, 4 or 6 blister packs are placed in a cardboard pack.
Description of the dosage form
Capsule-shaped, biconvex tablets, film-coated, light orange-pink in color.
Appearance of tablets at the break: a rough mass from yellow to brownish-yellow in color with a film shell of a light orange-pink color.
Directions for use and doses
Inside, during meals.
The recommended dose for venous-lymphatic insufficiency is 2 tablets/day: 1 tablet. - in the middle of the day and 1 table. - In the evening.
The duration of treatment can be several months (up to 12 months). If symptoms recur, the course of treatment can be repeated (on the recommendation of a doctor).
The recommended dose for acute hemorrhoids is 6 tablets/day: 3 tablets. in the morning and 3 tablets. in the evening for 4 days, then - 4 tablets/day: 2 tablets. in the morning and 2 tablets. in the evening for the next 3 days.
Pharmacodynamics
The combination of hesperidin + diosmin has venotonic and angioprotective properties.
Reduces the distensibility of veins and venous stagnation, reduces capillary permeability in microcirculation and increases their resistance, improves venous hemodynamics. It affects the following venous plethysmographic parameters: venous capacity, venous distensibility, time of venous emptying.
The optimal effect is achieved by taking 2 tablets.
The combination of hesperidin + diosmin increases venous tone by reducing the time of venous emptying. In patients with signs of severe microcirculation disorders, there is an increase in capillary resistance.
The combination of hesperidin + diosmin is effective in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids.
Pharmacokinetics
The drug Phlebaven® is primarily excreted through the intestines. On average, about 14% of the dose taken is excreted by the kidneys.
T1/2 is 11 hours.
The drug undergoes active metabolism, which is confirmed by the presence of phenolic acids in the urine.
Indications for use Phlebaven 1000 mg 32 pcs. film-coated tablets
- treatment of symptoms of venous-lymphatic insufficiency:
- feeling of heaviness in the legs;
- pain;
- tired legs;
Contraindications
- hypersensitivity to the active or auxiliary substances included in the drug;
- breastfeeding period.
Application Phlebaven 1000 mg 32 pcs. film-coated tablets during pregnancy and breastfeeding
Experiments on animals did not reveal teratogenic effects.
To date, there have been no reports of any side effects when using the drug by pregnant women.
Due to the lack of data regarding the excretion of the drug in breast milk, women during breastfeeding are not recommended to take the drug.
special instructions
Before you start taking Flebaven®, it is recommended to consult your doctor.
In case of exacerbation of hemorrhoids, the use of Flebaven® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the periods specified in the section “Method of administration and dosage”.
If the symptoms do not disappear after the recommended course of therapy, you should be examined by a proctologist, who will select further therapy.
In the presence of venous circulation disorders, the maximum effect of treatment is ensured by combining therapy with a healthy (balanced) lifestyle: it is advisable to avoid long exposure to the sun, long periods of standing, and it is also recommended to reduce excess body weight. Walking and, in some cases, wearing special stockings help improve blood circulation.
You should immediately consult a doctor if the patient’s condition worsens or does not improve during treatment.
Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving, working with moving mechanisms). Does not affect.
Overdose
No cases of overdose have been described.
In case of overdose of Phlebaven®, you should immediately seek medical help.
Side effects Phlebaven 1000 mg 32 pcs. film-coated tablets
Classification of the frequency of side effects, recommended by WHO: very often - ≥1/10; often - from ≥1/100 to
From the side of the central nervous system: rarely - dizziness, headache, general malaise.
From the digestive system: often - diarrhea, dyspepsia, nausea, vomiting; infrequently - colitis; frequency unknown - abdominal pain.
From the skin: rarely - skin rash, itching, urticaria; frequency unknown - isolated swelling of the face, lips, eyelids. In exceptional cases - angioedema.
It is necessary to inform the doctor about the appearance of any, incl. adverse reactions and sensations not mentioned in this description, as well as changes in laboratory parameters during therapy.
Drug interactions
Not noted.
The attending physician should be informed about all medications used by the patient.
