Instructions for Fitosed tincture, 100 ml jar
Composition
active ingredients: 100 ml of the drug contain tinctures from a mixture of medicinal plant raw materials “Phytosed®” (1:10) (extractant – ethanol 40%): Сrataegi fructus (hawthorn fruits) ‒ 1 g; Leonuri cardiacae herba (dog nettle herb) ‒ 2 g; Lupuli strobili (hop cones) ‒ 2 g; Aveni fructus (oat fruits) ‒ 2.5 g; Melissae officinalis herba (melissa herb) ‒ 1.5 g; Coriandri fructus (coriander fruits) ‒ 0.5 g; Meliloti herba (turmeric herb) ‒ 0.5 g;
excipients: none, except for the extractant.
Dosage form
Tincture.
Main physicochemical properties: transparent liquid from brown-green to brown-red in color, with a pleasant specific odor. 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 ingredients of hawthorn fruits (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 the herb stinging nettle (alkaloids, glycosides, rutin, saponins), in addition to a pronounced sedative effect, exhibits a hypotensive effect and reduces heart rate.
Hop cones contain essential oil, resins, and flavonoids, which cause a sedative effect.
The indole alkaloid avenin and B vitamins contained in oat fruits have a positive effect on the nervous system and have a pronounced calming effect.
Lemon balm herb has an antidepressant, calming, and tonic effect.
Coriander fruits have a sedative effect on increased nervous excitability.
The herb burkun has a sedative effect.
The sedative effect of the drug occurs from the first day of use. The maximum therapeutic effect occurs after 1-1.5 hours and lasts 2-4 hours.
Indication
As a sedative for neuroses of various etiologies; mild form of neurasthenia, accompanied by
irritability, anxiety, fear, increased fatigue, absent-mindedness; nervous excitement; insomnia; neurocirculatory dystonia of hypertensive and cardiac type; asthenic syndrome (hypersthenic form).
Contraindication
Phytosed® is contraindicated in cases of hypersensitivity to any component of the drug, severe arterial hypotension and bradycardia, reduced blood clotting and internal bleeding, depression and other diseases accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
The drug enhances the effect of sleeping pills and other drugs that depress the central nervous system.
When taking Fitosed® simultaneously with cardiac glycosides, the effect of the latter is enhanced.
The drug may slightly potentiate the effect of direct and indirect anticoagulants.
It is not recommended to take the drug simultaneously with alkaloid salts due to the possibility of forming negative complexes.
The drug should not be used together with third-generation antiarrhythmic drugs.
The drug may potentiate the pharmacological effects of analgesic and antihypertensive drugs, and also enhances the effects of alcohol.
Application features
Shake before use.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should not be prescribed to drivers and persons working with mechanisms and devices that require increased attention and quick motor reactions.
Method of administration and doses
Administer orally, adults and children over 12 years of age, 1 teaspoon (5 ml) in a small amount of water 3-4 times a day and 1 time before bedtime. The course of treatment is from 10 to 30 days. If necessary, the course of treatment can be repeated after 10-15 days (after consulting a doctor).
Children
Do not prescribe to children under 12 years of age.
Overdose
When using doses of the drug exceeding the recommended ones, drowsiness, dizziness, headache, fatigue, abdominal pain, hand tremor, pupil dilation, chest tightness, bradycardia may occur. In some cases, a decrease in blood pressure and the occurrence of dyspeptic phenomena (nausea, vomiting, heartburn) are possible. Therapy is symptomatic.
Adverse reactions
From the cardiovascular system: decreased blood pressure, bradycardia.
From the side of the central nervous system: dizziness, drowsiness (when taking high doses of the drug), headache, increased fatigue; due to the pronounced sedative effect of dog nettle - decreased mental and physical performance.
On the part of the digestive tract: nausea, vomiting, pain in the epigastric region, heartburn.
Allergic reactions, including urticaria, itching, rash, skin hyperemia, edema.
Expiration date
Do not use after the expiry date stated on the packaging.
Storage conditions
Keep out of reach of children.
Store in original packaging at a temperature not exceeding 30 0C.
Packaging
100 ml in a bottle or jar in a cardboard pack.
Vacation category
Without a prescription.
Manufacturer/Applicant
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Location of the manufacturer and its business address/location of the applicant and/or the applicant's representative
61010, Ukraine, Kharkiv, 1 Hordienkivska St.
