NOXON

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOXON (NOKSON)

Composition:

Active substance: valerian extract;

1 tablet contains valerian dry aqueous-ethanolic extract (Valeriana officinalis L., radix), (4–8/1), extractant ethanol-water 30–70% (v/v), calculated to anhydrous substance – 450 mg;

Excipients: microcrystalline cellulose, silicon dioxide colloidal anhydrous (aerosil); sodium croscarmellose; talc; magnesium stearate;

coating mixture containing: hydroxypropylmethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, stearic acid, talc, titanium dioxide (E 171), yellow iron oxide (E 172), quinoline yellow (E 104), indigocarmine (E 132).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: film-coated tablets, green in color, elongated shape, biconvex surface, with a score line on one side.

Pharmacotherapeutic group. Hypnotics and sedatives.

ATC code N05CM09.

Pharmacological Properties

The drug exerts a sedative effect, restores the macrostructure of sleep, and stabilizes autonomic functions.

This is a plant-derived agent. Its action is due to the complex ester of borneol and isovaleric acid, valeritrates, and alkaloids (valerine, chatenine). The drug improves the efficiency and quality of sleep. Valeric acid and valeritrates exert a mild spasmolytic effect. In addition, the complex of biologically active substances of Valeriana officinalis has choleretic properties, enhances secretory activity of the gastrointestinal mucosa, slows heart rate, and dilates coronary vessels. Regulation of cardiac activity occurs via neurohumoral mechanisms and direct influence on the heart's automaticity and conduction system. Therapeutic effects become apparent with systematic and prolonged course treatment. The drug reduces spontaneous and increased excitability of the central nervous system and exerts a moderate anticonvulsant effect. It does not produce local irritant effects.

Clinical characteristics

Indications. Insomnia, increased nervous excitability.

Contraindications. Hypersensitivity to valerian or to other components of the medicinal product. Depression and other conditions associated with suppression of central nervous system activity. Arterial hypotension, cholelithiasis, somnolence.

Interaction with other medicinal products and other forms of interaction. Valerian preparations may enhance the effects of hypnotics, tranquilizers, sedatives, anxiolytics, analgesics, spasmolytics, centrally-acting antihypertensives, neuroleptics, ethyl alcohol, nootropics, anesthetics, and curare-like muscle relaxants.

Concomitant use with synthetic sedative drugs is not recommended.

Concurrent alcohol consumption should also be avoided.

Special precautions.

Do not exceed the recommended doses of the drug.

Caution should be exercised in patients with a history of severe hepatic impairment or those who have previously experienced severe liver disease.

Specific sensitivity to the odor of valerian may occur.

Use during pregnancy or breastfeeding. The use of the drug is not recommended due to insufficient safety data during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. Patients should refrain from driving or operating potentially hazardous machinery while taking this drug.

Dosage and Administration

. The medicinal product should be taken orally. Tablets should be swallowed whole, without chewing, with liquid.

To relieve nervous tension, Nokson is administered at a dose of 1 tablet 1–2 times daily.

As a remedy for insomnia, Nokson is administered at a dose of 1 tablet 30–60 minutes before bedtime. If necessary, an additional tablet may be taken earlier in the evening.

The drug should be used long-term, for at least 2–4 weeks. If there is no improvement in the patient's condition, or if the condition worsens after 2 weeks of treatment, medical advice must be sought. The duration of treatment is determined individually by a physician.

Children. The drug is not intended for use in children.

Overdose.

Symptoms: headache, dizziness, drowsiness, lethargy, general weakness, hand tremor, dilated pupils, chest tightness, abdominal pain, nausea, decreased hearing and visual acuity, tachycardia.

Treatment: discontinue the drug, perform gastric lavage, administer activated charcoal. Symptomatic therapy.

Side effects.

Central and peripheral nervous system: headache, dizziness, lethargy, drowsiness, depression of emotional responses, depression, general weakness, decreased mental and physical performance, reduced attention span; in individual cases – mental excitement, anxiety, insomnia.

Cardiovascular system: arterial hypotension, chest tightness, palpitations, chest pain, cardiac arrhythmias (including bradycardia, tachycardia).

Gastrointestinal tract: nausea, diarrhea, spasms and abdominal pain; with prolonged use, possible suppression of digestive processes, constipation.

Hepatobiliary system: possible signs of hepatotoxicity.

Immune system: in cases of individual hypersensitivity to the drug components, possible skin rashes, itching, urticaria, hyperemia, swelling, shortness of breath.

Adverse reactions occur very rarely, are reversible, and usually develop during prolonged use or significant exceeding of the recommended doses.

If any adverse events occur, the patient must consult a physician.

Shelf life: 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 film-coated tablets in a blister; 2 blisters per pack.

Availability category: Over-the-counter.

Manufacturer: JSC "Kyivmedpreparat".

Manufacturer's address and place of business activity.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.