Fitosed

FITOSED® capsules

Instruction manual

For medical use of the drug

Structure:

Active ingredients: 1 capsule contains a mixture of medicinal plant materials “Fitosed®”: crataegi fructus (hawthorn fruit) - 30 mg, leonuri cardiacae herba (motherwort herb) - 60 mg, lupuli strobili (hop cones) - 60 mg, aveni fructus (oats fruits) - 75 mg, melissae officinalis herba (Melissa officinalis) - 45 mg, coriandri fructus (coriander fruits) - 15 mg, meliloti herba (melilot grass) - 15 mg.

Dosage form.

Capsules

Basic physical and chemical properties: hard gelatin capsules of green color. The contents of the capsules is a powder of plant origin, light brown with a yellowish brown tint.

Pharmacotherapeutic group.

Sleeping pills and sedatives. ATX code n05c m.

Pharmacological properties.

Pharmacodynamics

The drug has a sedative effect due to the components that make up its composition.

The active substances of hawthorn fruit (flavonoids, organic acids, etc.) reduce the excitability of the central nervous system, help improve coronary and cerebral circulation, normalize heart rate, and eliminate dizziness.

The complex of biologically active substances of motherwort herb (alkaloids, glycosides, etc.), in addition to a pronounced sedative effect, has a hypotensive effect, reduces the heart rate.

Hop cones contain essential oil, resins, flavonoids and other similar substances that cause a sedative effect.

Indole alkaloid avenine, B vitamins and other substances contained in the fruits of oats have a positive effect on the nervous system and have a pronounced calming effect.

Melissa officinalis herb has an antidepressant, calming, tonic effect.

Coriander fruits have a sedative effect with increased nervous excitability.

Melilotus grass has a sedative effect.

Pharmacokinetics

The sedative effect of the drug occurs from the first day of use. The maximum therapeutic effect occurs in 1–1.5 hours and lasts 2–4 hours.

Clinical characteristics.

Indications.

As a sedative for: neuroses of various etiologies; mild neurasthenia, which is accompanied by irritability, anxiety, fear, fatigue, distraction; nervous excitement; sleep disorders or insomnia (mild forms); hypertensive and cardiac neurocirculatory dystonia; asthenic syndrome (hypersthenic form).

Contraindications

Fitosed® is contraindicated in case of hypersensitivity to any component of the drug, severe arterial hypotension and bradycardia, with decreased blood coagulation and internal bleeding, with depression and other diseases accompanied by inhibition of the central nervous system.

Interaction with other drugs and other types of interactions.

The drug enhances the effect of sleeping pills and other drugs that inhibit the central nervous system.

With the simultaneous administration of the drug Fitosed^® with cardiac glycosides, the effect of the latter is enhanced.

The drug can slightly potentiate the effect of direct and indirect anticoagulants.

It is not recommended to take the drug simultaneously with alkaloids in connection with the possibility of the formation of negative complexes.

It should not be used with third-generation antiarrhythmic drugs.

The drug can potentiate the pharmacological effects of analgesic, antihypertensive drugs, and also enhances the effect of alcohol.

Features of the application.

To prevent the occurrence of side effects during use, one should strictly adhere to the recommendations set forth in the section "method of administration and dosage".

Use during pregnancy or lactation.

It is contraindicated to use the drug during pregnancy and lactation.

The ability to influence the speed of reactions when driving vehicles or other mechanisms.

The drug is not prescribed for drivers and persons working with mechanisms and devices that require increased attention and rapid motor reactions.

Dosage and administration.

Assign inside adults and children from 12 years old 1-2 capsules 3 times a day 30 minutes after eating; the drug should be washed down with at least 100 ml of liquid. the course of treatment is 4 weeks. if necessary, it can be repeated after 10-15 days. during the year, the course of treatment is recommended to be repeated 2-3 times.

Children.

Do not prescribe to children under 12 years of age.

Overdose.

When using doses higher than recommended, drowsiness, dizziness, headache, fatigue, abdominal pain, tremor of the hands, dilated pupils, chest tightness, and bradycardia may occur. in some cases, a decrease in blood pressure, the occurrence of dyspeptic symptoms (nausea, vomiting, heartburn) is possible. symptomatic therapy.

Adverse Reactions

From the cardiovascular system: very rarely, a noticeable decrease in blood pressure is possible; bradycardia.

From the central nervous system: dizziness, drowsiness (when taking high doses of the drug), fatigue, headache; in connection with the pronounced sedative effect of motherwort - a decrease in mental and physical disability.

From the gastrointestinal tract: nausea, vomiting, epigastric pain, heartburn.

Allergic reactions: with increased sensitivity to the components of the drug, the occurrence of urticaria, itching, small-dot and spotty red rashes may occur.

Shelf life.

2 years.

Do not use after the expiration date indicated on the package.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 os.

Keep out of the reach of children.

Packaging.

10 capsules in a blister.

2 blisters in a pack of cardboard.

Vacation category.

Over the counter.

Manufacturer.

Pao "chemical farm" red star ".

The location of the manufacturer and the address of the place of business.

Ukraine, 61010, Kharkov, st. Gordienkovo, 1.

FITOSED® tincture

Instruction manual

For medical use of the drug

Structure:

Active ingredients: 100 ml of the preparation contains tinctures from a mixture of medicinal plant materials “Fitosed®” (1:10) (extractant - ethanol 40%): crataegi fructus (hawthorn fruit) - 1 g; leonuri cardiacae herba (motherwort herb) - 2 g; lupuli strobili (hop cones) - 2 g; aveni fructus (oat fruit) - 2.5 g; melissae officinalis herba (Melissa officinalis) - 1.5 g; coriandri fructus (coriander fruits) - 0.5 g; meliloti herba (melilot grass) - 0.5 g;

excipients: none, except for the extractant.

Dosage form.

Tincture.

Basic physical and chemical properties: a clear liquid from brown-green to brown-red in color, with a pleasant specific smell. During storage, precipitation is allowed.

Pharmacotherapeutic group.

Sleeping pills and sedatives. ATX code n05c m.

Pharmacological properties.

The drug has a sedative effect due to the components that make up its composition.

The active substances of hawthorn fruit (flavonoids, organic acids, tannins) reduce the excitability of the central nervous system, help improve coronary and cerebral circulation, normalize heart rhythm, and eliminate dizziness.

The complex of biologically active substances of motherwort herb (alkaloids, glycosides, rutin, saponins), in addition to a pronounced sedative effect, has a hypotensive effect, reduces the heart rate.

Hop cones contain essential oil, resins, flavonoids, which cause a sedative effect.

Indole alkaloid avenine, B vitamins contained in oat fruits have a positive effect on the nervous system and have a pronounced calming effect.

Melissa officinalis herb has an antidepressant, calming, tonic effect.

Coriander fruits have a sedative effect with increased nervous excitability.

Sweet clover grass has a sedative effect.

The sedative effect of the drug occurs from the first day of use. The maximum therapeutic effect occurs in 1–1.5 hours and lasts 2–4 hours.

Clinical characteristics.

Indications.

As a sedative for neurosis of various etiologies; mild neurasthenia, which is accompanied by irritability, anxiety, fear, fatigue, distraction; nervous excitement; insomnia; hypertensive and cardiac neurocirculatory dystonia; asthenic syndrome (hypersthenic form).

Contraindications

Fitosed® is contraindicated in case of hypersensitivity to any component of the drug, severe arterial hypotension and bradycardia, with reduced blood coagulation and internal bleeding, with depression and other diseases that are accompanied by inhibition of the central nervous system.

Interaction with other drugs and other types of interactions.

The drug enhances the effect of sleeping pills and other drugs that inhibit the central nervous system.

With the simultaneous administration of Fitosed^® with cardiac glycosides, the effect of the latter is enhanced.

The drug can slightly potentiate the effect of direct and indirect anticoagulants.

It is not recommended to take the drug simultaneously with alkaloids in connection with the possibility of the formation of negative complexes.

It should not be used with third-generation antiarrhythmic drugs.

The drug can potentiate the pharmacological effects of analgesic, antihypertensive drugs, and also enhances the effect of alcohol.

Features of the application.

Shake well before use.

Use during pregnancy or lactation.

The use of the drug during pregnancy or lactation is contraindicated.

The ability to influence the speed of reactions when driving vehicles or other mechanisms.

The drug should not be prescribed to drivers and persons working with mechanisms and devices requiring increased attention and rapid motor reactions.

Dosage and administration.

Assign 1 teaspoon (5 ml) in a small amount of water 3-4 times a day, 1 time before bedtime, for adults and children over 12 years old. the course of treatment is from 10 to 30 days. if necessary, the course of treatment can be repeated after 10-15 days (after consultation with a doctor).

Children.

Do not administer to children under 12 years of age.

Overdose.

When using doses exceeding the recommended doses, drowsiness, dizziness, headache, fatigue, abdominal pain, hand tremor, dilated pupils, chest tightness, and bradycardia may occur. in some cases, a decrease in blood pressure and the occurrence of dyspeptic phenomena (nausea, vomiting, heartburn) are possible. symptomatic therapy.

Adverse Reactions

From the cardiovascular system: lowering blood pressure, bradycardia.

From the central nervous system: dizziness, drowsiness (when taking high doses of the drug), headache, fatigue; in connection with the pronounced sedative effect of motherwort - a decrease in mental and physical disability.

From the digestive tract: nausea, vomiting, pain in the epigastric region, heartburn.

Allergic reactions, including urticaria, itching, rashes, flushing of the skin, edema.

Shelf life.

2 years.

Do not use after the expiration date indicated on the package.

Storage conditions.

Keep out of the reach of children.

Store in the original packaging at a temperature not exceeding 25 ⁰WITH.

Packaging.

100 ml in a bottle or jar in a pack of cardboard.

Vacation category.

Over the counter.

Manufacturer / Applicant.

Pao "chemical farm" red star ".

Location of the manufacturer and address of the place of business / location of the applicant and / or representative of the applicant.

61010, Ukraine, Kharkov, st. Gordienkovo, 1.