Valerian extract film-coated tablets 20 mg No. 50

Instructions Valerian extract film-coated tablets 20 mg No. 50

Composition

active ingredient: 1 tablet contains valerian extract thick (valerianae extractum spissum) extractant ethanol (40%) calculated on dry matter 20 mg;

excipients: lactose monohydrate, heavy magnesium carbonate, croscarmellose sodium, stearic acid, castor oil, talc;

coating: heavy magnesium carbonate, sugar, hypromellose, talc, povidone, titanium dioxide (E 171), colloidal anhydrous silica, beeswax, paraffin, sunflower oil, tartrazine (E 102).

Dosage form

Film-coated tablets.

Main physicochemical properties: film-coated tablets, yellow in color, with a biconvex surface. Three layers are visible on cross section.

Pharmacotherapeutic group

Hypnotics and sedatives. ATX code N05C M09.

Pharmacological properties

Pharmacodynamics

The drug reduces the excitability of the central nervous system. The action 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 stably. Valerian acid and valepotriates have a weak antispasmodic effect.

Pharmacokinetics

Data is missing.

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.

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 sugar, which must be taken into account by patients with diabetes.

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.

The medicine contains the azo dye tartrazine (E 102), 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

Adults and children over 12 years of age should take 2-4 tablets 3 times a day.

Children over 6 years of age should take 1-2 tablets 3 times a day.

The appropriateness of prescribing to children aged 6 years and older is determined by the doctor in each individual case.

The tablets should be taken without chewing and washed down with liquid.

The duration of treatment is determined by the doctor individually.

Children

Use for the treatment of children over 12 years of age. The appropriateness of prescribing 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;

from the digestive tract: nausea;

On the part of the immune system: allergic reactions, including rash, itching, hyperemia, skin edema.

Expiration date

3 years.

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, 5 blisters in a pack.

Vacation category

Without a prescription.

Producer

PJSC "Halychpharm".

Location of the manufacturer and its business address

Ukraine, 79024, Lviv, Opryshkivska St., 6/8.