QUAIT® SOOTHING

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KVAJT® SEDATIVE (QUIET SEDATIVE)

Composition:

Active substances: dry aqueous-ethanolic extract of valerian (Valeriana officinalis L.), dry extract of lemon balm leaves (Melissa officinalis L.), dry extract of passionflower herb (Passiflora incarnata L.);

One tablet contains: dry aqueous-ethanolic extract of valerian (Valeriana officinalis L.) (DER: (3–6:1), extraction solvent: ethanol 70%) – 125 mg; dry extract of lemon balm leaves (Melissa officinalis L.) (DER: (4–6:1), extraction solvent: methanol 30%) – 112.5 mg; dry extract of passionflower herb (Passiflora incarnata L.) (DER: (3–6:1), extraction solvent: ethanol 70%) – 80 mg;

Excipients: lactose monohydrate; microcrystalline cellulose; sodium croscarmellose; colloidal anhydrous silicon dioxide; 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, yellow sunset FCF (E 110)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: oval-shaped, biconvex tablets with or without a score line, coated with a dark green film coating.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

QUAIT® Calming is a herbal medicinal product with sedative effects. The pharmacologically active components of the product are natural extracts from medicinal plants valerian, lemon balm, and passionflower, which exert a calming effect in cases of stress-induced anxiety and tension, and also facilitate sleep onset.

Pharmacokinetics.

No studies available.

Clinical characteristics.

Indications.

Anxiety and insomnia due to nervous tension.

Contraindications.

Hypersensitivity to melissa, valerian, passionflower, or to any of the excipients.

Depression and other conditions associated with central nervous system depression.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with other hypnotics, analgesics, spasmolytics, sedative medicinal products, and alcohol, mutual enhancement of effect is possible.

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

No clinical interaction has been observed with drugs metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1.

If taking or using other medicinal products, inform your doctor.

Special precautions for use.

Do not exceed the recommended doses of the medicinal product.

Alcoholic beverages should be avoided during treatment with this medicine.

Use with caution in patients with severe organic gastrointestinal disorders, severe liver diseases, or a history of severe hepatic dysfunction. The drug may be administered in cases of pronounced cerebral vascular atherosclerosis only under medical supervision.

This medicinal product is contraindicated in patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. The product contains the dye "Quinoline Yellow FCF" (E 110), which may cause allergic reactions.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

"QUITE® calming" contains lactose — if the patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the medicinal product "QUITE® calming" during pregnancy or breastfeeding; therefore, the product should not be used during these periods.

Ability to influence reaction speed when driving or operating machinery.

"QUITE® calming" may affect reaction speed even when used as directed, particularly when combined with alcohol. Therefore, potentially hazardous activities requiring heightened attention, such as driving or operating machinery, should be avoided.

Method of Administration and Dosage

Adults and children aged 12 years and older

For the treatment of anxiety states: take 2 tablets up to 3 times daily.

For the treatment of insomnia due to nervous tension: take 2 tablets 30 minutes to 1 hour before bedtime. If necessary, an additional 2 tablets may be taken earlier in the evening.

Method of Administration

The tablets should be taken with liquid.

The duration of treatment with the medicinal product "KVAIT® calming" should be determined by a physician. If symptoms persist for more than two weeks or worsen, treatment must be discontinued and medical advice should be sought.

If a dose of the medicinal product "KVAIT® calming" is missed, do not double the dose — continue taking as per the above recommendations.

Children

The product is intended for children aged 12 years and older.

Overdose

Administration of valerian root in doses exceeding 20 g (18 tablets) at one time has led to the following symptoms: weakness, abdominal cramps, chest tightness, feeling of emptiness in the head, hand tremors, and dilated pupils. These symptoms resolve within 24 hours.

Headache, dizziness, drowsiness, lethargy, reduced visual and auditory acuity, and tachycardia may also occur. In case of significant overdose, medical advice should be sought. Treatment: discontinue the use of the drug; if necessary, perform gastric lavage, administer activated charcoal, and provide symptomatic therapy.

Cases of withdrawal syndrome (delirium) have been reported after prolonged use of very high doses of valerian extract over several years (approximately 30 g per day).

Side effects.

Central and peripheral nervous system: dizziness, drowsiness, suppression of emotional responses, depression, general weakness, decreased mental and physical performance.

Gastrointestinal tract: nausea, vomiting.

Immune system: allergic reactions, including rash, itching, hyperemia, skin swelling.

If the first signs of an allergic reaction occur, the use of the medicinal product should be discontinued, and it must not be taken again.

After taking passionflower, there was 1 reported case of an allergic reaction (vasculitis), as well as nausea and tachycardia. The frequency of these events is unknown.

Reporting of suspected adverse reactions.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are advised to report any suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

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

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 tablets per blister. 2 or 4 blisters per carton.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.