Instructions for Quiet sedative film-coated tablets blister No. 20
Composition
active ingredients: dry hydroalcoholic extract of valerian (Valeriana officinalis L.), dry extract of lemon balm leaves (Melissa officinalis L.), dry extract of passionflower herb (Passiflora incarnata L.);
1 tablet contains: dry hydroalcoholic extract of valerian (Valeriana officinalis L.) (DER: (3-6:1), extractant: ethanol 70%) – 125 mg; dry extract of lemon balm leaves (Melissa officinalis L.) (DER: (4-6:1), extractant: methanol 30%) – 112.5 mg; dry extract of passionflower herb (Passiflora incarnata L.) (DER: (3-6:1), extractant: ethanol 70%) – 80 mg;
excipients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate;
film coating: Opadry 200 F 210013 green (polyvinyl alcohol, talc, polyethylene glycol (macrogol), quinoline yellow (E 104), titanium dioxide (E 171), indigo carmine (E 132), methacrylic acid copolymer, sodium bicarbonate, sunset yellow FCF (E 110)).
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped tablets with a biconvex surface, with or without a score, covered with a dark green film coating.
Pharmacotherapeutic group
Sleeping pills and sedatives. ATX code N05CM.
Pharmacological properties
Pharmacodynamics
"QUIET calming" is a herbal medicine that has a sedative effect. The pharmacologically active components of the drug are natural extracts from the medicinal plants valerian, lemon balm, and passionflower, which have a calming effect in case of anxiety and tension caused by stress, and also facilitate falling asleep.
Pharmacokinetics
There are no studies.
Indication
Anxiety and insomnia due to nervous tension.
Contraindication
Hypersensitivity to lemon balm, valerian, passionflower or any of the excipients.
Depression and other conditions accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
In case of simultaneous use with other hypnotic, analgesic, antispasmodic, sedative drugs and alcohol, mutual enhancement of the effect is possible.
Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.
No clinical interactions with drugs metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1 have been observed.
If you are taking or using other medications, you should inform your doctor.
Application features
Do not exceed the recommended doses of the drug.
While using the drug, you should refrain from drinking alcoholic beverages.
Use with caution in patients with severe organic diseases of the digestive tract, severe liver diseases and a history of severe liver dysfunction. In severe cerebral atherosclerosis, the drug can be used only under the supervision of a physician.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
Use during pregnancy or breastfeeding
There are no research data on the use of the drug "QUIET sedative" during pregnancy or breastfeeding, so the drug should not be used during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
"QUIET sedative" even when used according to instructions may alter the reaction rate when driving or operating machinery, especially when combined with alcohol. Therefore, it is advisable to refrain from potentially hazardous activities that require increased attention, such as driving or operating machinery.
Method of administration and doses
Adults and children aged 12 and over.
For the treatment of anxiety, take 2 tablets up to 3 times a day.
To treat insomnia due to nervous tension, take 2 tablets half an hour to an hour before bedtime. If necessary, you can additionally take 2 tablets earlier, during the evening.
The tablets should be taken with liquid.
The duration of use of the drug "QUIET sedative" is determined by the doctor. If the symptoms last longer than two weeks or worsen, you should stop treatment and consult a doctor.
If you miss a dose of the drug "QUIET Calming", do not double the dose - continue taking it according to the above recommendations.
Children
Applies to children aged 12 and over.
Overdose
Valerian root in doses greater than 20 g (18 tablets) has been reported in one case to cause the following symptoms: weakness, abdominal cramps, chest tightness, lightheadedness, hand tremors, and dilated pupils. These symptoms resolve within 24 hours.
Possible headache, dizziness, drowsiness, lethargy, decreased visual acuity, hearing, tachycardia. In case of significant overdose, consult a doctor. Treatment: stop using the drug, if necessary, rinse the stomach, take activated charcoal, carry out symptomatic therapy.
There have been reports of withdrawal syndrome (delirium) after taking very high doses of valerian extract for several years (approximately 30 g per day).
Adverse reactions
From the side of the central and peripheral nervous system: dizziness, drowsiness, inhibition of emotional reactions, depression, general weakness, decreased mental and physical performance.
From the digestive tract: nausea, vomiting.
On the part of the immune system: allergic reactions, including rash, itching, hyperemia, skin edema.
At the first signs of an allergic reaction, this medicine should not be taken again.
There has been 1 report of allergic reaction (vasculitis) as well as nausea and tachycardia following the intake of passionflower. Frequency unknown.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister. 2 or 4 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
