Instructions for Fitosed capsules blister No. 20
Composition
Active ingredients: 1 capsule contains a mixture of medicinal plant raw materials “Phytosed®”: сrataegi fructus (hawthorn fruits) – 30 mg, leonuri cardiacae herba (dog nettle herb) – 60 mg, lupuli strobili (hop cones) – 60 mg, aveni fructus (oat fruits) – 75 mg, melissae officinalis herba (melissa herb) – 45 mg, coriandri fructus (coriander fruits) – 15 mg, meliloti herba (sweet clover herb) – 15 mg.
Dosage form
capsules.
Main physicochemical properties: hard gelatin capsules of green color. The contents of the capsules are a powder of plant origin, light brown with a yellow-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 ingredients of hawthorn fruits (flavonoids, organic acids, etc.) 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 nettle herb (alkaloids, glycosides, etc.), in addition to a pronounced sedative effect, has a hypotensive effect and reduces the heart rate.
Hop cones contain essential oil, resins, flavonoids, and other similar substances that cause a sedative effect.
The indole alkaloid avenin, B vitamins, and other substances contained in oat fruits have a positive effect on the nervous system and have a pronounced calming effect.
Lemon balm herb has antidepressant, calming, and tonic effects.
Coriander fruits have a sedative effect on increased nervous excitability.
The herb burkun has a sedative effect.
Pharmacokinetics.
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; sleep disorders or insomnia (mild forms); 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, decreased 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.
Should not be used together with third-generation antiarrhythmics.
The drug may potentiate the pharmacological effects of analgesic and antihypertensive drugs, and also enhances the effects of alcohol.
Application features
To prevent side effects during use, you should strictly follow the recommendations set out in the "Method of administration and dosage" section.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy and breastfeeding is contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug is not prescribed to drivers and persons who work with mechanisms and devices that require increased attention and quick motor reactions.
Method of administration and doses
Administer orally to adults and children over 12 years of age, 1–2 capsules 3 times a day 30 minutes after meals; 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. It is recommended to repeat the course of treatment 2–3 times during the year.
Children.
Not prescribed for children under 12 years of age.
Overdose
When using doses of the drug that exceed 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 dyspeptic phenomena (nausea, vomiting, heartburn) may occur. Therapy is symptomatic.
Side effects
From the cardiovascular system: very rarely, a significant decrease in blood pressure is possible; bradycardia.
Gastrointestinal: nausea, vomiting, epigastric pain, heartburn.
Allergic reactions: with hypersensitivity to the components of the drug, urticaria, itching, small-dotted and spotted red rashes may occur.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister.
2 blisters in a cardboard pack.
Leave category.
Without a prescription.
Vacation category
Without a prescription.
Producer
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Address
Ukraine, 61010, Kharkiv, 1 Hordienkivska St.
