Composition
Active Ingredient:
Valerian Medicinal Rhizome with Roots Extract-20,000 mg (Valerian Thick Extract)
Auxiliary substances:
magnesium hydroxycarbonate-50,500 mg
potato starch-26,690 mg
talc – 2,580 mg
gelatin-0.230 mg
Shell composition:
OPADRY® COMPLETE FILM COATING SYSTEM
20F230009 YELLOW
[hypromellose (hydroxypropylmethylcellulose)Â – 5,000 mg, talc – 2,350 mg,titanium dioxide – 1,280 mg, macrogol (polyethylene glycol) – 0,500 mg hyprolose (hydroxypropyl cellulose) – 0,500 mg, dye quinoline yellow (E 104) – 0,345 mg, dye sunset yellow (E 110) – 0,013 mg, dye iron oxide yellow (E 172) – 0.012 mg]
OPADRY® II COMPLETE FILM COATING SYSTEM
85FI9250 CLEAR
[polyvinyl alcohol – 0.523 accordingly mg, talc – 0,300 mg, macrogol (polyethylene glycol) -0,147 mg Polysorbate 80 – 0.030 mg].Pharmacological action
Pharmacotherapeutic group: sedative of plant origin.
ATX code: N05CM09
Pharmacological properties
Pharmacodynamics
The active ingredient of the drug is an ester of borneol and isovaleric acid. It has a moderate sedative effect, which occurs slowly, but is quite stable. Facilitates the onset of unnatural sleep. In addition, it has an antispasmodic effect on the smooth muscle of the gastrointestinal tract.
Indications
· Increased nervous excitability·
* insomnia (violation of falling asleep);
· as part of complex therapy ‒ functional disorders of the cardiovascular system;
· spasms of the gastrointestinal tract.
Use during pregnancy and lactation
Pregnancy
The use of the drug is contraindicated in the first trimester of pregnancy. The use of the drug in the second and third trimesters is possible if the expected benefit to the mother exceeds the potential risk to the fetus.
Before using the drug Valerian extract, if you are pregnant or think that you might be pregnant, or are planning to become pregnant, you should consult your doctor.
Breast-feeding period
The use of the drug during breastfeeding is possible if the expected benefit to the mother exceeds the potential risk to the child.
Contraindications
· Hypersensitivity to the components
of the drug; * congenital fructose intolerance· *
glucose-galactose malabsorption syndrome
· * sucrose/isomaltase deficiency
· * lactase deficiency, lactose intolerance·
* pregnancy (I trimester);
· children under 12 years of age.
Use caution
for chronic enterocolitis.
Side effects
Lethargy; drowsiness; muscle weakness; depression; decreased performance; with prolonged use ‒ constipation.
In some cases, allergic reactions may develop.
It is important to report the development of adverse reactions in order to ensure continuous monitoring of the benefit-risk ratio of the drug. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor. Health professionals report adverse drug reactions through national adverse reaction reporting systems.
Interaction
Increases the effect of sleeping pills and sedatives, as well as antispasmodics.
If you are using the above or other medications (including over-the-counter medications), please consult your doctor before using Valerian Extract.
How to take, course of use and dosage
Inside.
Adults and children over 12 years of age: 1-2 tablets 3 times a day after meals. The duration of therapy is 2-4 weeks. A second course is possible as prescribed by a doctor.
Overdose
Symptoms: overdose may increase side effects such as lethargy, drowsiness, muscle weakness, depression, and decreased performance.
Treatment: symptomatic.
Description
Round biconvex tablets covered with a yellow film coating.
On the cross-section, the core is brown in color, light and dark inclusions are allowed.
Special instructions
Content of bread units (XE):
* in a single dose (1 tablet) ‒ 0.005 XE;
· in the maximum daily dose (6 tablets) – 0.03 XE.
Do not take the drug without consulting a doctor for more than 4 weeks
With prolonged use in large doses, it is possible to reduce psychomotor reactions, which should be taken into account when driving vehicles, working with mechanisms.
Influence on the ability to drive vehicles and mechanisms
During the period of use of the drug, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Storage conditions
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf
life is 5 years.
Do not use after the expiration date.
Active ingredient
Valerian Officinalis Rhizome with Roots Extract
Dosage form
Tablets
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