Valeodicramen (Drops) Instructions for Use

Marketing Authorization Holder

Voronezh Pharmacy State Unitary Enterprise of Voronezh Region (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Valeodicramen

Oral drops: 25 ml dropper bottle.

Dosage Form, Packaging, and Composition

25 ml – dropper bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Sedative

Pharmacological Action

The drug is a combination product that has a sedative as well as a spasmolytic effect. Its pharmacological activity is due to its constituent herbal components and diphenhydramine.

Hawthorn tincture has a moderate cardiotonic, spasmolytic, and sedative effect.

Valerian tincture, due to the ester of borneol and isovaleric acid and free valeric acid, has a moderately pronounced sedative and spasmolytic (on the smooth muscles of the gastrointestinal tract organs) effect. It facilitates the onset of natural sleep. The sedative effect develops slowly but is quite stable. It also has a choleretic effect and increases the secretion of the glands of the gastrointestinal tract.

Peppermint tincture has a moderate spasmolytic effect on the organs of the gastrointestinal tract and a mild sedative effect, and possesses choleretic properties.

Motherwort tincture has a sedative, moderate cardiotonic (slows the rhythm and increases the strength of heart contractions) effect, and possesses moderate hypotensive properties.

Diphenhydramine is a first-generation H1-histamine receptor blocker, and has antiallergic, sedative, and hypnotic effects. The effect on the central nervous system is due to the blockade of H3-histamine receptors in the brain and the inhibition of cholinergic structures.

Pharmacokinetics

The effect of the drug is the combined effect of its components, so conducting pharmacokinetic studies is not possible.

Indications

As a sedative for neuroses, vegetative-vascular dystonia with a tendency to increase blood pressure and a sensation of palpitations.

ICD codes

Dosage Regimen

Administer orally to adults only.

Dilute 30-40 drops in a small amount of water prior to administration.

Take 3-4 times a day, 30 minutes before meals.

The standard treatment course is 10-15 days.

Do not exceed the recommended dosage or duration of use.

Conduct repeated courses only on the recommendation of a physician.

Maintain an interval of 1-1.5 months between treatment courses.

Discontinue use and consult a physician if no improvement is observed.

Adverse Reactions

Allergic reactions, rarely – dyspepsia, with prolonged use – dryness of the oral mucosa.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

Hypersensitivity to the components of the drug, tendency to arterial hypotension, acute and chronic heart failure, decreased heart rate (less than 55 beats/min), epilepsy, alcoholism, traumatic brain injury, brain diseases, impaired renal and/or liver function, age under 18 years (efficacy and safety of use have not been established).

Use in Pregnancy and Lactation

No special clinical studies have been conducted on the use of the drug during pregnancy and breastfeeding, so its use during the above conditions is not recommended.

Use in Hepatic Impairment

Contraindicated: impaired liver function.

Use in Renal Impairment

Contraindicated: impaired renal function.

Pediatric Use

Contraindicated: age under 18 years (efficacy and safety of use have not been established).

Special Precautions

During treatment, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. The ethanol content in the preparation is at least 67%.

The content of absolute ethanol in a single dose (30-40 drops) is from 0.72 to 0.96 g, and in the maximum daily dose (160 drops) is 3.84 g.

Overdose

Symptoms: depression or excitation (especially in children with accidental ingestion) of the functions of the central nervous system, depression, dilated pupils, dry mouth, slowed gastrointestinal motility.

Treatment: there is no specific antidote. Gastric lavage. Supportive measures include monitoring blood pressure, if necessary, using drugs that increase blood pressure, oxygen, intravenous administration of plasma-substituting fluids. Epinephrine (Adrenaline) and analeptics should not be used.

Drug Interactions

When prescribed simultaneously with drugs that depress the activity of the central nervous system (sedatives, hypnotics, tranquilizers, neuroleptics), mutual enhancement of effects is possible. Monoamine oxidase inhibitors (MAOIs) enhance the anticholinergic activity of diphenhydramine.

Storage Conditions

In a place protected from light at a temperature of 15 to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life. 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.