FITOSED®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHYTOSED® (PHYTOSED)

Composition:

Active substances: 1 capsule contains a herbal raw material mixture “Phytosed®”: crataegi fructus (hawthorn fruits) – 30 mg, leonuri cardiacae herba (motherwort herb) – 60 mg, lupuli strobili (hop cones) – 60 mg, aveni fructus (oat fruits) – 75 mg, melissae officinalis herba (lemon balm herb) – 45 mg, coriandri fructus (coriander fruits) – 15 mg, meliloti herba (sweet clover herb) – 15 mg.

Pharmaceutical form. Capsules.

Main physico-chemical properties: Hard gelatin capsules of green color. The capsule contents are a plant-derived powder, light brown with yellowish-brown tint.

Pharmacotherapeutic group.

Hypnotics and sedatives.

ATC code N05C M.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exerts a sedative effect due to the components contained in its composition.

Active substances of Crataegus fruit (flavonoids, organic acids, etc.) reduce excitability of the central nervous system, promote improvement of coronary and cerebral circulation, normalization of cardiac rhythm, and relieve dizziness.

The complex of biologically active substances in dog nettle herb (alkaloids, glycosides, etc.) exerts, in addition to pronounced sedative effect, a hypotensive action and reduces heart rate.

Hops strobiles contain essential oil, resins, flavonoids, and other similar substances responsible for the sedative effect.

The indole alkaloid avenin, B-group vitamins, and other substances contained in oats fruit exert a positive influence on the nervous system and have a pronounced calming effect.

Melissa officinalis herb exerts antidepressant, calming, and tonic effects.

Coriander fruit exerts a sedative effect in conditions of increased nervous excitability.

Valeriana officinalis herb exhibits a sedative effect.

Pharmacokinetics.

The sedative effect of the drug begins from the first day of administration. The maximum therapeutic effect occurs within 1–1.5 hours and lasts for 2–4 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Phytosed® is contraindicated in cases of hypersensitivity to any component of the drug, pronounced arterial hypotension and bradycardia, impaired blood coagulation and internal bleeding, as well as in depression and other disorders accompanied by suppression of central nervous system activity.

Interaction with other medicinal products and other types of interactions.

The drug enhances the effects of sedatives and other medicinal agents that depress the central nervous system.

Concomitant use of Phytosed® with cardiac glycosides enhances the effects of the latter.

The drug may slightly potentiate the action of direct and indirect anticoagulants.

Simultaneous intake of Phytosed® with alkaloid salts is not recommended due to the possibility of forming adverse complexes.

Should not be used together with third-generation antiarrhythmic agents.

The drug may potentiate the pharmacological effects of analgesics and antihypertensive agents, and also enhances the effects of alcohol.

Special precautions for use.

To prevent the occurrence of adverse effects, it is necessary to strictly follow the recommendations provided in the section "Dosage and administration".

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy and breastfeeding is contraindicated.

Ability to affect reaction rate when driving or operating machinery.

The drug is not intended for drivers or individuals working with machinery and equipment requiring increased attention and rapid motor reactions.

Dosage and Administration.

For oral use in adults and children aged 12 years and older: 1–2 capsules three times daily, taken 30 minutes after meals. The capsules should be taken with at least 100 ml of liquid. Treatment duration is 4 weeks. If necessary, the course may be repeated after 10–15 days. During the year, the treatment course is recommended to be repeated 2–3 times.

Children.

Not recommended for children under 12 years of age.

Overdose.

When doses exceeding the recommended amounts are used, adverse effects such as drowsiness, dizziness, headache, fatigue, abdominal pain, hand tremor, pupil dilation, chest tightness, and bradycardia may occur. In some cases, arterial hypotension and gastrointestinal symptoms (nausea, vomiting, heartburn) may develop. Symptomatic treatment is recommended.

Side effects.

Cardiovascular system: very rarely possible significant decrease in blood pressure; bradycardia.

Central nervous system: dizziness, drowsiness (when taking high doses of the drug), fatigue, headache; due to the pronounced sedative effect of black henbane – reduced mental and physical performance.

Gastrointestinal tract: nausea, vomiting, epigastric pain, heartburn.

Allergic reactions: in case of hypersensitivity to the drug components, urticaria, itching, petechial and macular rashes may occur.

Shelf life.

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 pack.

2 blisters in a cardboard box.

Availability category.

Over-the-counter.

Manufacturer.

PJSC “CHEMICAL PHARMACEUTICAL PLANT “CHERVONA ZIRKA”.

Manufacturer's address and place of business.

1 Gordienkovskaya Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.