Instructions for Sedistress tablets blister pack No. 30
Composition
active ingredients: dry passionflower extract, ethyl ester of α-bromisovaleric acid;
1 tablet contains: dry extract of passionflower (Passiflorae herba) (3-7/1), extractant – methanol 70% (v/v) – 300 mg, contains not less than 4% of the total flavonoids in terms of vitexin; ethyl ester of α-bromoisovaleric acid 10.2 mg;
Excipients: peppermint oil; β-cyclodextrin; glycine; mannitol; crospovidone; citric acid monohydrate; aspartame; colloidal anhydrous silicon dioxide; magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round, flat-cylindrical tablets with a score, from light brown to dark brown with inclusions. The tablets have a specific odor.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics.
Sedistress is a sedative and hypnotic drug, the effect of which is determined by the components that make up its composition.
Passionflower extract causes sedative and hypnotic effects.
Ethyl ester of α-bromizovaleric acid has a reflex sedative and antispasmodic effect, caused by a decrease in reflex excitability in the central nervous system and an increase in inhibition phenomena in the neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of central vasomotor centers and a direct antispasmodic effect on vascular smooth muscle.
Pharmacokinetics.
Not studied.
Indication
As a sedative for various types of neuroses, for somatoform disorders (vegetative-vascular dystonia), for stress. In the complex therapy of hypertension, Meniere's disease, climacteric disorders, premenstrual syndrome, migraine attacks. The drug is indicated in psychologically difficult situations to stabilize the emotional background, reduce anxiety, reduce irritability, maintain psychological balance.
As a sleeping pill for sleep disorders (insomnia) of various origins.
Contraindication
– Hypersensitivity to the components of the drug;
– severe liver and/or kidney dysfunction;
– severe heart failure;
– arterial hypotension, bradycardia.
Interaction with other medicinal products and other types of interactions
Centrally acting drugs enhance the effect of the drug. The drug enhances the effect of local anesthetics, analgesics, and hypnotics.
Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.
Application features
Patients with cardiovascular diseases should consult a doctor before using the drug.
When using the drug, a slight change in tongue color is possible, which is caused by the physicochemical properties of dry passionflower extract.
While using the drug, you should refrain from drinking alcoholic beverages.
Simultaneous intake of stimulating drinks (coffee, tea), emotional and visual stress is not recommended.
The drug contains aspartame, which is transformed into phenylalanine in the body, so it should not be used by patients with phenylketonuria.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
You should refrain from driving or working with complex mechanisms.
Method of administration and doses
The recommended dose is 1-2 tablets per day orally. The tablets should be taken before meals with liquid. For sleep disorders, take 2 tablets 30 minutes before bedtime orally.
The duration of treatment is determined by the doctor individually.
Children
The efficacy and safety of the drug in children under 12 years of age have not been established, therefore its use in this category of patients is not recommended.
Overdose
Overdose is possible with frequent or long-term use of the drug, which is associated with the cumulation of its components.
Possible manifestations of hypersensitivity, requiring desensitization therapy.
Symptoms: lethargy, drowsiness, dizziness, nausea, vomiting, as well as episodes of unstable ventricular tachycardia.
Treatment: symptomatic therapy.
Adverse reactions
In some cases, the following side effects may occur:
from the digestive tract: discomfort in the stomach and intestines, nausea, vomiting;
from the nervous system: drowsiness, mild dizziness, decreased concentration;
from the immune system: allergic reactions (rash, itching, hyperemia, skin edema), vasculitis;
Cardiovascular system: tachycardia, bradycardia, ventricular tachycardia.
These manifestations are eliminated by reducing the dose.
If you experience any unwanted symptoms, you should consult a doctor.
Expiration date
1 year 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging, out of the reach of children, at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister. 1, 3 and 6 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
"Pharma Start" LLC.
Location of the manufacturer and its business address
Ukraine, 03124, Kyiv, I. Lepse Blvd., 8.
