Storage:
active substance: 1 tablet contains valerian thick extract (Valerianaeextractumspissum) 3.5:1 (extractant 40% (v/v) ethanol) in terms of dry substance – 40 mg;
excipients: lactose, monohydrate (granulac – 70); croscarmellose sodium; light magnesium carbonate; castor oil; calcium stearate; talc; coating mixture “Opaglos II Yellow” 97W22039 (sodium carmellose (sodium carboxymethyl cellulose); dextrin; glucose, monohydrate; titanium dioxide (E 171); lecithin; quinoline yellow (E 104); yellow sunset FCF (E 110)).
Pharmaceutical form. Tablets covered with a film cover.
The main physical and chemical properties: tablets covered with a film shell, from yellow to yellow with a greenish tint, round in shape, with a biconvex surface, two layers are visible on the break.
Pharmacotherapeutic group. Sleeping pills and sedatives. ATX code N05C M09.
Pharmacological properties.
The drug reduces the excitability of the central nervous system. The action is due to the content of essential oil, most of which is a compound ester of borneol alcohol and isovaleric acid. Valepotriates and alkaloids – valerine and hotinine – also have sedative properties.
Sedative effect is manifested slowly, but quite stable. Valerian acid and valepotriates have a weak antispasmodic effect.
Clinical characteristics.
Indication.
Increased nervous excitability, insomnia; as part of combined therapy – with mild functional disorders of the cardiovascular system.
Contraindication.
Hypersensitivity to valerian and/or other components of the drug; depression or other conditions accompanied by depression of the central nervous system.
Interaction with other medicinal products and other types of interactions.
Valerian preparations can enhance the effect of alcohol, sedative, hypnotic, analgesic, antispasmodic and anxiolytic drugs.
Features of application.
During the use of the drug, it is necessary to refrain from drinking alcoholic beverages.
The drug contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
The drug contains glucose, which should be taken into account by patients with diabetes.
Patients with severe liver dysfunction or a history of severe liver disease should be cautious when taking the drug.
Specific sensitivity to the smell of valerian may occur.
The drug contains azo dye sunset yellow (E 110), which can cause an allergic reaction.
Use during pregnancy or breastfeeding.
It is not recommended to use the drug due to insufficient data on the safety of use during pregnancy or breastfeeding.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of application and dosage.
Adults and children over 12 years old should take 1-2 tablets 3 times a day.
Children over 6 years old should take 1 tablet 3 times a day.
The advisability of prescribing the drug to children over 6 years of age is determined by the doctor in each individual case.
Tablets should be swallowed without chewing, washed down with liquid, after a meal.
The duration of treatment is determined by the doctor individually.
Children.
To be used for the treatment of children aged 12 and over. The advisability of prescribing the drug to children aged 6 and over is determined by the doctor individually in each individual case.
Overdose.
Symptoms: headache, dizziness, drowsiness, lethargy, general weakness, hand tremors, pupil dilation, chest tightness, abdominal pain, nausea, reduced hearing and vision, tachycardia.
Treatment: stop using the drug, wash the stomach, take activated charcoal. The therapy is symptomatic.
Adverse reactions.
From the side of the central and peripheral nervous system: dizziness, drowsiness, suppression of emotional reactions, depression, general weakness, reduced mental and physical performance;
from the digestive tract: nausea;
from the side of the immune system: allergic reactions, including rash, itching, hyperemia, swelling of the skin.
Expiry date. 2 years.
Storage conditions. Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging. 10 film-coated tablets in a blister, 5 blisters in a pack.
Release category. Without a prescription.
Producer. PJSC “Kyivmedpreparat”, Ukraine.
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