Instructions for Sedaphyton forte capsules blister No. 48
Composition
active ingredients: 1 capsule contains: valerian rhizomes with roots thick extract (Valerianae radix cum radicibus) (1:2.5) (extractant – ethanol 40%) 0.1 g, motherwort herb thick extract (Leonuri herba) (1:3.0) (extractant – ethanol 40%) 0.06 g, hawthorn fruit thick extract (Crataegi fructus) (1:1.7) (extractant – ethanol 70%) 0.06 g;
Excipients: heavy magnesium carbonate, potato starch, povidone, talc, magnesium stearate.
Dosage form
Capsules.
Main physicochemical properties: hard cylindrical gelatin capsules with brown body and cap. Capsule contents – mass from greenish-gray, gray or brownish-gray to grayish-green or grayish-brown.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics.
The effect of the drug is due to the properties of the components that make up its composition. Biologically active substances of valerian and motherwort extracts (essential oils, saponins, alkaloids, tannins) have a beneficial effect on the functional activity of the central and autonomic nervous system, exhibiting mainly sedative, anxiolytic and antispasmodic effects; regulate cardiac activity, reduce blood pressure and heart rate; suppress feelings of fear, mental stress, improve falling asleep and sleep structure. The pharmacological properties of hawthorn extract are due to the presence of flavonoids, choline, acetylcholine, phytosterols, triterpenic acids. Hawthorn extract is able to enhance blood circulation in the coronary and cerebral vessels, increase myocardial contractility (slight positive inotropic effect) and reduce its excitability (negative bathmotropic effect). Biologically active substances of hawthorn extract contribute to increasing myocardial tolerance to hypoxia, reduce peripheral vascular resistance and improve cardiac endurance to physical exertion, have antiarrhythmic, hypotensive, hypocholesterolemic effects (reduce cholesterol and triglyceride levels in the blood).
The drug has the ability to enhance the effects of other sedatives and hypnotics.
Pharmacokinetics.
Not investigated.
Indication
Mild forms of neurotic disorders accompanied by irritability, anxiety, feelings of fear, depression, increased fatigue, inattention, increased nervous excitability; mild forms of sleep disorders associated with excitement; attacks of headaches, migraines caused by nervous tension; mild forms of dysmenorrhea, climacteric syndrome; neurocirculatory dystonia with tachycardia, cardialgia and arterial hypertension; arterial hypertension of stage I; as part of complex therapy and prevention of chronic ischemic heart disease, atherosclerosis, arterial hypertension, supraventricular and ventricular arrhythmias, initial stages of chronic heart failure; dermatoses accompanied by itching of the skin (urticaria, atopic dermatitis, eczema); constant mental stress (manager's syndrome).
Contraindication
Increased individual sensitivity to the components of the drug, severe arterial hypotension, severe bradycardia, depression and other diseases accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
If the patient is taking any other medications, it is imperative to inform the doctor.
The drug enhances the activity of cardiac glycosides (digoxin), as well as the effects of antispasmodics, hypnotics and sedatives. The drug 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.
Taking it with alkaloid salts is not recommended due to the possibility of forming negative complexes. The drug should not be used together with cisapride.
Use during pregnancy or breastfeeding
The drug is not recommended for use due to insufficient data on safety during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of administration and doses
A single dose for adults and children over 12 years of age is 1 capsule 2-3 times a day. For mild forms of insomnia - 1 capsule 1 hour before bedtime.
The maximum daily dose of the drug is 3 capsules.
The course of treatment depends on the form and severity of the disease, the nature of concomitant therapy, the achieved treatment effect and is determined individually.
Children: Do not use in children under 12 years of age.
Overdose
Symptoms: headache, dizziness, increased fatigue, lethargy, depression, weakness, decreased performance and concentration, drowsiness, abdominal pain, nausea, hand tremor, dilated pupils, feeling of tightness in the chest, bradycardia, decreased blood pressure, decreased visual and hearing acuity, increased heartbeat, mental agitation.
Treatment: immediate discontinuation of the drug and timely emergency measures (gastric lavage, administration of activated charcoal and desensitizing therapy) and symptomatic treatment contribute to the rapid elimination of clinical manifestations of overdose.
Side effects
General disorders: feeling of fatigue, decreased mental and physical performance, edema.
Allergic reactions. In patients with individual hypersensitivity to the components of the drug, allergic reactions may develop, including symptoms such as rash, itching, hyperemia and edema of the skin, urticaria.
From the nervous system: dizziness, drowsiness, general weakness, depression, suppression of emotional reactions were observed.
On the part of the cardiovascular system: tachycardia or bradycardia, decreased blood pressure, significant slowing of the heart rate are possible.
Gastrointestinal: nausea, vomiting, abdominal cramps, dyspepsia.
If any negative effects occur, you should definitely consult a doctor regarding further use of the drug!
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
6 capsules in a blister; 2 or 4 or 8 blisters in a pack; 30 capsules in a container, 1 container in a pack.
Vacation category
Without a prescription.
Producer
PJSC "FITOPHARM" (responsible for batch release, not including batch control/testing).
Location of the manufacturer and address of its place of business.
Ukraine, 08303, Kyiv region, Boryspil city, Chumatska st., 17.
Applicant
PJSC "FITOPHARM".
Location of the applicant.
Ukraine, 02092, Kyiv city, Almaty street, building 12.
In case of adverse reactions or questions regarding the safety, quality and effectiveness of the use of the medicinal product, please contact the Pharmacovigilance Department of PJSC "FITOFARM" by phone +38 (044) 390 52 96 or go to the link https://fitofarm.ua in the "Pharmacology" section and choose a convenient method.
