Sedaviton®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEDAFITON®

Composition:

Active substances: 1 tablet contains: valerian rhizomes with roots extract, dry (Valerianae radix cum radicibus) (1:2.5) (extractant – ethanol 40%) 0.05 g, motherwort herb extract, dry (Leonuri herba) (1:3.0) (extractant – ethanol 40%) 0.03 g, hawthorn fruit extract, dry (Crataegi fructus) (1:1.7) (extractant – ethanol 70%) 0.03 g;

Excipients: magnesium carbonate heavy, potato starch, povidone, talc, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are whole, regular circular cylinders, with convex upper and lower surfaces, ranging in color from greenish-gray, gray, brownish-gray to grayish-green, grayish-brown, with light and dark multicolored speckles.

Pharmacotherapeutic group.

Hypnotics and sedatives. ATC code N05CM.

Pharmacological Properties.

Pharmacodynamics. The effect of the drug is determined by the properties of the components included in its composition. Biologically active substances of valerian and cramp bark extracts (essential oils, saponins, alkaloids, tannins) exert a beneficial effect on the functional activity of the central and autonomic nervous systems, predominantly exhibiting sedative, anxiolytic, and spasmolytic actions; they regulate cardiac activity, reduce arterial pressure and heart rate; suppress feelings of fear and mental tension, and improve sleep onset and sleep structure. The pharmacological properties of hawthorn extract are due to the presence of flavonoids, choline, acetylcholine, phytosterols, and triterpenic acids. Hawthorn extract is capable of enhancing blood flow in coronary and cerebral vessels, increasing myocardial contractility (a mild positive inotropic effect), and reducing myocardial excitability (a negative bathmotropic effect). Biologically active substances of hawthorn extract promote increased myocardial tolerance to hypoxia, reduce peripheral vascular resistance, improve cardiac endurance during physical exertion, and exert antiarrhythmic, hypotensive, and hypocholesterolemic effects (lower blood levels of cholesterol and triglycerides).

The drug has the ability to enhance the effects of other sedatives and hypnotics.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Mild forms of neurotic disorders accompanied by irritability, anxiety, fear, depression, fatigue, inattention, increased nervous excitability; mild forms of sleep disorders associated with excitement; headaches and migraine attacks caused by nervous tension; mild forms of dysmenorrhea, climacteric syndrome; neurocirculatory dystonia with tachycardia, cardialgia, and arterial hypertension; stage I arterial hypertension; as part of complex therapy and prevention of chronic ischemic heart disease, atherosclerosis, arterial hypertension, supraventricular and ventricular arrhythmias, early stages of chronic heart failure; dermatoses accompanied by skin itching (urticaria, atopic dermatitis, eczema); persistent mental stress (manager’s syndrome).

Contraindications.

Increased individual sensitivity to the components of the drug, pronounced arterial hypotension, pronounced bradycardia, depression and other diseases accompanied by suppression of central nervous system activity.

Interaction with other medicinal products and other types of interactions.

If the patient is taking any other medicinal products, it is mandatory to inform the physician.

The drug enhances the activity of cardiac glycosides (digoxin) and the effects of spasmolytics, hypnotics, and sedatives. The drug should not be used concomitantly with antiarrhythmic agents of the III generation.

The drug may potentiate the pharmacological effects of analgesics and antihypertensive drugs, as well as enhance the effect of alcohol.

Concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes. The drug should not be used together with cisapride.

Special precautions for use.

Use during pregnancy or breastfeeding. The use of this medicinal product is not recommended during pregnancy or breastfeeding due to insufficient safety data.

Ability to affect reaction speed when driving or operating machinery. When using this medicinal product, avoid driving or operating potentially hazardous machinery.

Method of Administration and Dosage.

The single dose for adults and children aged 12 years and older is 1–2 tablets 2–3 times daily. In mild forms of insomnia – 1–2 tablets 1 hour before bedtime.

The maximum daily dose is 6 tablets.

The duration of treatment depends on the form and severity of the disease, the nature of concomitant therapy, and the therapeutic effect achieved, and is determined individually.

Children. Do not use in children under 12 years of age.

Overdose.

Symptoms: headache, dizziness, increased fatigue, lethargy, depression, weakness, reduced work capacity and concentration, drowsiness, abdominal pain, nausea, hand tremor, pupil dilation, sensation of chest tightness, bradycardia, decreased arterial pressure, reduced visual and hearing acuity, palpitations, mental excitement.

Treatment: immediate discontinuation of the drug, timely implementation of emergency measures (gastric lavage, administration of activated charcoal, and desensitizing therapy), and symptomatic treatment promote rapid elimination of clinical signs of overdose.

Side effects.

General disorders: feeling of fatigue, decreased mental and physical performance, swelling.

Allergic reactions: in patients with individual hypersensitivity to the components of the medicine, allergic reactions may occur, including symptoms such as rash, itching, skin hyperemia, and swelling.

From the nervous system: dizziness, drowsiness, general weakness, depression, suppression of emotional responses.

From the cardiovascular system: possible tachycardia or bradycardia, decreased blood pressure, significant slowing of heart rate.

From the gastrointestinal tract: nausea, vomiting, abdominal spasms, dyspepsia.

If any adverse effects occur, it is essential to consult a physician regarding further use of the medicine!

Reporting of adverse reactions after drug registration is highly important. It allows continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 12 tablets per blister; 2 or 4 or 8 blisters per carton.

Dispensing category. Over-the-counter.

Manufacturer: JSC «FITOFARM».

Manufacturer's address and location of its business activity:

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder: JSC «FITOFARM».

Address of the Marketing Authorization Holder:

7 Boulevard of the Supreme Council, Building 7, Floor 3, Premises 18, Kyiv, 02100, Ukraine.

If you experience any adverse reactions or have questions regarding the safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC «FITOFARM» at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the «Pharmacovigilance» section, and choose a convenient method of communication.

INSTRUCTION

for medical use of the medicinal product

SEDAFITON®

Composition:

Active substances: 1 tablet contains:
valerian rhizomes with roots extract, thick (Valerianae radix cum radicibus) (1:2.5) (extraction solvent – ethanol 40%) – 0.05 g,
motherwort herb extract, thick (Leonuri herba) (1:3.0) (extraction solvent – ethanol 40%) – 0.03 g,
hawthorn fruit extract, thick (Crataegi fructus) (1:1.7) (extraction solvent – ethanol 70%) – 0.03 g.

Excipients: magnesium carbonate heavy, potato starch, povidone, talc, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are whole, regular round cylinders, with convex upper and lower surfaces, ranging in color from greenish-gray, gray, brownish-gray to grayish-green, grayish-brown, with light and dark multicolored specks.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. The effect of the drug is determined by the properties of the components included in its composition. Biologically active substances of valerian and cramp bark extracts (essential oils, saponins, alkaloids, tannins) favorably affect the functional activity of the central and autonomic nervous systems, predominantly exhibiting sedative, anxiolytic, and spasmolytic effects; they regulate cardiac activity, reduce arterial pressure and heart rate; suppress feelings of fear and mental tension, and improve sleep onset and sleep structure. The pharmacological properties of hawthorn extract are due to the presence of flavonoids, choline, acetylcholine, phytosterols, and triterpenic acids. Hawthorn extract is capable of enhancing blood flow in coronary and cerebral vessels, increasing myocardial contractility (mild positive inotropic effect), and reducing its excitability (negative bathmotropic effect). Biologically active substances of hawthorn extract promote increased myocardial tolerance to hypoxia, reduce peripheral vascular resistance, improve cardiac endurance during physical exertion, and exert antiarrhythmic, hypotensive, and hypocholesterolemic effects (lower blood cholesterol and triglyceride levels).

The drug has the ability to enhance the effects of other sedative and hypnotic agents.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Mild forms of neurotic disorders accompanied by irritability, anxiety, fear, depression, increased fatigue, inattention, and heightened nervous excitability; mild forms of sleep disorders associated with excitement; headaches and migraine attacks caused by nervous tension; mild forms of dysmenorrhea, climacteric syndrome; neurocirculatory dystonia with tachycardia, cardialgia, and arterial hypertension; stage I arterial hypertension; as part of complex therapy and prevention of chronic ischemic heart disease, atherosclerosis, arterial hypertension, supraventricular and ventricular arrhythmias, and initial stages of chronic heart failure; dermatoses accompanied by skin itching (urticaria, atopic dermatitis, eczema); persistent mental stress (manager syndrome).

Contraindications.

Hypersensitivity to the components of the drug, pronounced arterial hypotension, pronounced bradycardia, depression, and other conditions accompanied by suppression of central nervous system activity.

Interaction with other medicinal products and other types of interactions.

If the patient is taking any other medicinal products, it is essential to inform the physician.

The drug enhances the activity of cardiac glycosides (digoxin) and potentiates the effects of spasmolytics, hypnotics, and sedatives. The drug should not be used concomitantly with class III antiarrhythmic agents.

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

Concomitant use with alkaloid salts is not recommended due to the possibility of formation of adverse complexes. The drug should not be used together with cisapride.

Special precautions for use.

Use during pregnancy or breastfeeding. The use of this medicinal product during pregnancy or breastfeeding is not recommended due to insufficient safety data.

Ability to affect reaction speed when driving or operating machinery. When using this medicinal product, driving vehicles and operating potentially hazardous machinery should be avoided.

Method of Administration and Dosage

The single dose for adults and children aged 12 years and older is 1–2 tablets 2–3 times daily. In mild cases of insomnia, take 1–2 tablets 1 hour before bedtime.

The maximum daily dose is 6 tablets.

The duration of treatment depends on the form and severity of the disease, the nature of concomitant therapy, and the therapeutic effect achieved, and is determined individually.

Children. Do not use in children under 12 years of age.

Overdose.

Symptoms: headache, dizziness, increased fatigue, lethargy, depression, weakness, reduced work capacity and concentration, drowsiness, abdominal pain, nausea, hand tremor, pupil dilation, sensation of chest tightness, bradycardia, decreased arterial pressure, reduced visual and hearing acuity, palpitations, mental excitement.

Treatment: immediate discontinuation of the drug; timely measures of emergency care (gastric lavage, administration of activated charcoal, and desensitizing therapy) as well as symptomatic treatment promote rapid elimination of clinical signs of overdose.

Side effects.

General disorders: feeling of fatigue, reduced mental and physical performance, edema.

Allergic reactions. In patients with individual hypersensitivity to the components of the drug, allergic reactions may occur, including symptoms such as rash, itching, hyperemia and skin swelling, urticaria.

From the nervous system: dizziness, drowsiness, general weakness, depression, suppression of emotional responses.

From the cardiovascular system: possible tachycardia or bradycardia, decreased blood pressure, significant slowing of heart rate.

From the gastrointestinal tract: nausea, vomiting, abdominal spasms, dyspepsia.

If any adverse effects occur, it is mandatory to consult a physician regarding further use of the drug!

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging. 12 tablets per blister; 2, 4, or 8 blisters per carton.

Dispensing category. Over-the-counter.

Manufacturer. JSC «FITOFARM» (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of operations.

17 Chumatska St., Boryspil, Kyiv region, Ukraine, 08303.

Marketing authorization holder. JSC «FITOFARM».

Address of the marketing authorization holder.

7, Verkhovnoi Rady Ave., Kyiv, Ukraine, 02100, 3rd floor, room 18.

If you experience any adverse reactions or have questions regarding the safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC «FITOFARM» at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the "Pharmacovigilance" section, and choose your preferred method of communication.