Instructions for Valerian film-coated tablets 30 mg blister No. 30
Composition
active ingredient: valerian dry extract (valerianae radix);
1 tablet contains valerian dry extract (valerianae radix) (5-8:1) (extractant: water-alcohol solution) 30 mg;
Excipients: microcrystalline cellulose, lactose monohydrate, copovidone, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, polyethylene glycol (macrogol) 3350, titanium dioxide (E 171), talc, sunset yellow FCF (E 110), iron oxide yellow (E 172), ponceau 4 R (E 124).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets with a diameter of 7 mm, coated, pale orange in color, with a characteristic odor of valerian.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M09.
Pharmacological properties
Pharmacodynamics
The drug reduces the excitability of the central nervous system. The effect is due to the content of essential oil, most of which is an ester of borneol alcohol and isovaleric acid. Valepotriates and alkaloids - valerine and chotinine - also have sedative properties. The sedative effect manifests itself slowly, but quite steadily.
Valerian acid and valepotriates have a weak antispasmodic effect.
Indication
Increased nervous excitability, insomnia; as part of combination therapy for mild functional disorders of the cardiovascular system.
Contraindication
Increased individual sensitivity to valerian or other components of the drug. Depression and other conditions accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
Valerian preparations may enhance the effects of alcohol, sedatives, hypnotics, analgesics, antispasmodics, and anxiolytics.
Application features
While using the drug, you should refrain from drinking alcoholic beverages.
Patients who have severe liver dysfunction or have had severe liver disease in the past should be cautious when taking the drug.
There may be a specific sensitivity to the smell of valerian.
This medicinal product contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains azo dyes: sunset yellow FCF (E 110) and ponceau 4R (E 124), which may cause allergic reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Use during pregnancy or breastfeeding
The drug is not recommended for use due to insufficient data on safety during pregnancy or breastfeeding.
Method of administration and doses
The drug is taken orally after meals. The recommended dose for adults and children over 12 years of age is 30-60 mg (1-2 tablets) 3-4 times a day. Swallow the tablets without chewing, drinking plenty of liquid.
The duration of treatment is determined depending on the therapeutic effect and tolerability of the drug.
Children
Use for the treatment of children over 12 years of age. The appropriateness of prescribing the drug to children over 6 years of age is determined by the doctor in each individual case.
Overdose
Symptoms: headache, dizziness, drowsiness, lethargy, general weakness, hand tremors, dilated pupils, feeling of tightness in the chest, abdominal pain, nausea, decreased hearing and vision, tachycardia.
Treatment: stop using the drug, wash the stomach, take activated charcoal. Therapy is symptomatic.
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.
On the part of the digestive tract: nausea.
Immune system: hypersensitivity reactions, including rash, itching, hyperemia.
Expiration date
2 years.
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, 3 blisters in a cardboard box. 20 tablets in a blister, 5 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
JSC "Sopharma".
Location of the manufacturer and its business address
2800, Sandanski, Industrial Zone, Bulgaria.
