Sedafiton®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEDAFITON®

Composition:

Active substances:

1 ml of drops contains:
Tincture of crushed hawthorn fruits (Crataegi fructus) (1:10) (extraction solvent – 70% ethanol) 0.275 ml,
Tincture of valerian root (Valerianae radix) (1:5) (extraction solvent – 70% ethanol) 0.295 ml,
Tincture of motherwort herb (Leonuri herba) (1:5) (extraction solvent – 70% ethanol) 0.43 ml.

Pharmaceutical form. Oral drops.

Main physicochemical properties: A liquid ranging in color from yellowish-brown to reddish-brown, with a characteristic odor of valerian. Formation of sediment during storage is possible.

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. The effect of the medicinal product is determined by the properties of the components contained in its composition. Biologically active substances from valerian roots and hawthorn herb (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. Biologically active substances from hawthorn fruits (flavonoids, choline, acetylcholine, phytosterols, triterpenic acids) are capable of enhancing circulation in coronary and cerebral vessels, increasing myocardial contractility (mild positive inotropic effect) and reducing its excitability (negative bathmotropic effect). Biologically active substances from hawthorn fruits promote increased myocardial tolerance to hypoxia, reduce peripheral vascular resistance, improve cardiac endurance during physical exertion, and exert antiarrhythmic, antihypertensive, and hypocholesterolemic effects.

The medicinal product has the ability to enhance the effect of other sedative and hypnotic agents.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Mild forms of neurotic disorders accompanied by irritability, anxiety, feelings of fear, depression, fatigue, inattention, increased nervous excitability; mild forms of sleep disorders associated with excitation; headaches caused by nervous tension; mild forms of dysmenorrhea. Use as part of combination therapy for climacteric syndrome.

Neurocirculatory dystonia with tachycardia, cardialgia, and arterial hypertension; stage I arterial hypertension. Use as part of combination therapy and for prevention of chronic ischemic heart disease, atherosclerosis, arterial hypertension, and early stages of chronic heart failure.

Persistent mental stress.

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; pregnancy or breastfeeding period; peptic ulcer of the stomach and duodenum; liver cirrhosis; history of alcoholism; concomitant use of alcohol-containing preparations.

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 medicinal product enhances the activity of cardiac glycosides (digoxin), as well as the effects of spasmolytics, tranquilizers, neuroleptics, sedatives, and hypnotics. The medicinal product should not be used concomitantly with antiarrhythmic agents of the III generation, or with other agents that may decrease or increase heart rate.

The medicinal product may potentiate the pharmacological effects of analgesics, cardiac, and antihypertensive medicinal products, and also enhances the effects of alcohol.

Concomitant intake with alkaloid salts is not recommended due to the possibility of forming adverse complexes. The medicinal product should not be used together with cisapride.

Special precautions for use.

During the period of using the medicinal product SEDAFITON®, oral drops, alcohol consumption should be avoided. The medicinal product should not be taken during meals to avoid interaction with food components.

The medicinal product contains ethanol! Prolonged use is not recommended.

Use during pregnancy or breastfeeding. Use is contraindicated.

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.

Dosage and Administration.

Administer the medicinal product orally. For adults, the recommended dose is 20–50 drops three times daily before meals.

For children aged 12 years and older – at a dosage of 1 drop per year of life, diluted in a small amount of water, three times daily, 10–20 minutes before meals.

If necessary, the medicinal product may be taken with a small amount of water or placed on a piece of sugar (sublingually).

The duration of treatment is determined individually for each patient, depending on the nature and severity of the pathological process, the course of the disease, tolerability of the medicinal product, and the stability of the therapeutic effect achieved.

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, chest tightness, bradycardia, decreased arterial blood pressure, reduced visual and auditory acuity, palpitations, mental agitation.

Treatment: immediate discontinuation of the medicinal product and prompt emergency measures (gastric lavage, administration of activated charcoal and desensitizing agents). Symptomatic therapy helps rapidly eliminate clinical signs of overdose.

Adverse reactions.

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

Central nervous system effects: dizziness, drowsiness, general weakness, depression, suppression of emotional responses.

Cardiovascular system effects: possible tachycardia or bradycardia, decreased arterial pressure, significant slowing of heart rate.

Gastrointestinal effects: nausea, vomiting, spasmodic abdominal pain, dyspepsia.

General disorders: fatigue, decreased mental and physical performance, edema.

In case of any adverse effects, it is necessary to consult a physician regarding further use of the medicinal product!

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 50 ml in glass and polymer bottles with dropper caps, polymer caps with tamper-evident seal, 1 bottle per carton.

Dispensing category. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's name and address of manufacturing site.

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

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

Ukraine, 02100, Kyiv, Verkhovnoyi Rady Avenue, 7, floor 3, room 18.