Sedistress

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEDISTRESS (SEDISTRESS)

Composition:

Active substances: dry extract of passionflower, ethyl ether of α-bromoisovaleric acid;

One tablet contains: dry extract of passionflower (Passiflorae herba) – 300 mg; ethyl ether of α-bromoisovaleric acid – 10.2 mg;

Excipients: peppermint oil; β-cyclodextrin; glycine; mannitol (E 421); crospovidone; citric acid monohydrate; aspartame (E 951); colloidal anhydrous silicon dioxide; magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets from light brown to dark brown in color with specks, flat surface, round-shaped, beveled edge, with a score line on one side. A weak specific odor may be present.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code: N05CM.

Pharmacological properties.

Pharmacodynamics.

Sedictres is a sedative and hypnotic medicinal product, whose action is determined by the components contained in its composition.

Passiflora extract provides sedative and hypnotic effects.

Ethyl ether of α-bromoisovaleric acid exerts reflex sedative and spasmolytic effects, caused by reduction of reflex excitability in the central parts of the nervous system and enhancement of inhibition phenomena in neurons of the cerebral cortex and subcortical structures of the brain, as well as by decreasing the activity of central vasomotor centers and direct spasmolytic action on smooth muscle of blood vessels.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

As a sedative in various types of neuroses, somatoform disorders (vegetative-vascular dystonia), and stress conditions. In complex therapy of hypertension, Ménière's disease, climacteric disorders, premenstrual syndrome, and migraine attacks. The medicinal product is indicated in psychologically challenging situations for stabilization of emotional state, reduction of anxiety levels, decrease of irritability, and maintenance of psychological balance.

As a hypnotic agent in sleep disorders (insomnia) of various origins.

Contraindications.

• Hypersensitivity to the components of the medicinal product;
• severe impairment of liver and/or kidney function;
• severe heart failure;
• arterial hypotension, bradycardia;
• pregnancy and breastfeeding period.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with medicinal products that depress the central nervous system, such as barbiturates and tranquilizers, the sedative and hypnotic effects of Sedistress are enhanced. The drug enhances the effects of local anesthetics, analgesics, and hypnotics.

Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.

Alcoholic beverages must not be consumed during treatment with Sedistress.

Special precautions for use

Use with caution in patients with severe organic diseases of the gastrointestinal tract.

Patients with cardiovascular diseases should consult a physician before using the medicinal product.

Elderly patients should start treatment with the minimum dose.

Prolonged use is not recommended due to the risk of bromine accumulation in the body and development of bromine poisoning.

When using the drug, a slight change in tongue color may occur, caused by the physicochemical properties of the dry extract of Passiflora.

Concurrent intake of stimulant beverages (coffee, tea) as well as emotional and visual stress is not recommended.

The medicinal product contains aspartame, which is metabolized in the body to phenylalanine; therefore, it should not be used by patients with phenylketonuria.

Use during pregnancy or breastfeeding. Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Patients should refrain from driving or operating complex machinery.

Method of Administration and Dosage.

The recommended dose is 1–2 tablets per day taken orally. Tablets should be taken before meals with liquid. For sleep disorders – 2 tablets once, 30 minutes before bedtime, taken orally.

The duration of treatment is determined individually by a physician.

Children.

The efficacy and safety of the medicinal product in children under 12 years of age have not been established; therefore, its use in this patient category is not recommended.

Overdose.

There is no data regarding overdose with this medicinal product. An increase in adverse reactions may be expected. Overdose is possible with frequent or prolonged use of the drug due to accumulation of its components. Manifestations of hypersensitivity may occur, requiring desensitizing therapy.

Treatment: discontinue the drug, gastric lavage. Symptomatic therapy.

Side effects.

In individual cases, the following adverse reactions may occur (frequency unknown):

Gastrointestinal tract: dyspeptic disorders, including discomfort in the stomach and intestinal area, nausea, vomiting, heartburn, bitter taste in the mouth;

Nervous system: drowsiness, mild dizziness, decreased attention concentration;

Immune system: allergic reactions (rash, itching, hyperemia, skin swelling, including Quincke's edema), vasculitis;

Cardiovascular system: transient arterial hypotension, tachycardia, bradycardia, ventricular tachycardia.

Prolonged use of medicinal products containing bromine may lead to bromine poisoning, characterized by the following symptoms: central nervous system depression, depressive mood, apathy, confusion, ataxia, purpura, rhinitis, conjunctivitis, lacrimation, acne. These symptoms resolve after dose reduction or discontinuation of the medicinal product.

If any adverse symptoms occur, consult a physician.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Keep in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

10 tablets per blister. 1, 3, or 6 blisters per cardboard box.

Supply category. Over-the-counter.

Manufacturer.

LLC "Pharma Start".

Manufacturer's address and location of business activity.

8, Vatslava Havela Boulevard, Kyiv, 03124, Ukraine.

If you experience any adverse effects or have questions regarding the safety of using this medicinal product, please contact the Pharmacovigilance Department of LLC "ASINO UKRAINE" at the following address: 8, Vatslava Havela Boulevard, Kyiv, 03124, Ukraine; tel./fax: +38 044 281 2333.