Valocormid

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALOCORMID (VALOCORMID)

Composition:

Active substances: valerian tincture of rhizomes with roots, lily-of-the-valley tincture of herb, belladonna leaf tincture, sodium bromide, racemic menthol;

25 ml of the preparation contain: tincture of valerian rhizomes with roots (Valerianae rhizoma cum radicibus) (1:5) (extraction solvent – 70% ethanol) 8.33 ml; lily-of-the-valley herb tincture (Convallariae herba) (1:10) (extraction solvent – 70% ethanol) 8.33 ml; belladonna leaf tincture (Belladonnae folium) (1:10) (extraction solvent – 40% ethanol) 4.17 ml; sodium bromide 3330 mg; racemic menthol 208 mg;

Excipient: purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: transparent reddish-brown liquid with the odor of valerian and menthol. Formation of a precipitate may occur during storage.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

A combined herbal preparation exerting sedative and spasmolytic effects. The specific action of the drug is determined by the substances contained in its composition. Valerianic acid exerts a calming effect on the central nervous system. Belladonna tincture blocks M-cholinergic receptors of smooth muscles of internal organs, thus producing a spasmolytic effect. Lily of the valley tincture enhances myocardial contractility and increases stroke and minute blood volume. Sodium bromide enhances inhibitory processes in the cerebral cortex and restores the balance between excitation and inhibition in conditions of increased excitability. Menthol, by stimulating the oral mucosa, reflexively dilates coronary vessels.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Cardiovascular neuroses accompanied by bradycardia.

Contraindications.

Hypersensitivity to the components of the drug. Glaucoma, severe cardiac disorders, prostate hyperplasia, kidney diseases, hyperthermic syndrome, thyrotoxicosis, acute hemorrhage, severe liver and kidney diseases, heart failure with impaired diastolic function (acute myocardial infarction, atrioventricular block, extrasystole, sinoatrial node weakness syndrome, unstable angina, acute myocarditis, hypertrophic obstructive cardiomyopathy, isolated mitral stenosis), glycoside intoxication.

Interaction with other medicinal products and other types of interactions.

Potentiates the effects of sedatives, hypnotics, and spasmolytics; may enhance the effects of alcohol, antihypertensives, and anxiolytics. Concomitant use with adrenaline hydrochloride and other adrenomimetics may lead to rhythm disturbances. Interaction with amantadine, antiarrhythmic cholinolytics (including quinidine), tricyclic antidepressants, and glutethimide may enhance anticholinergic effects. Combination with haloperidol, organic nitrates, and glucocorticoids may lead to increased intraocular pressure. Possible reduction of pilocarpine hydrochloride effect during glaucoma treatment. Antacids, ascorbic acid, and attapulgite may reduce the drug's effect.

Special precautions for use.

When using the drug, consumption of alcoholic beverages should be avoided. The drug should be used with caution in patients with Down syndrome, cerebral palsy, brain injury, reflux esophagitis, hiatal hernia associated with reflux esophagitis, inflammatory bowel diseases including nonspecific ulcerative colitis and Crohn's disease, in patients with megacolon, xerostomia (dry mouth), elderly and/or debilitated patients, patients with chronic lung diseases without irreversible obstruction, autonomic neuropathy, chronic alcoholism, and during cytostatic therapy. Use of the drug may cause increased body temperature, difficulty swallowing, and sore throat.

Valerian may produce moderate depressant effects; therefore, concomitant use of the drug with synthetic sedatives is not recommended due to potentiation of the effect.

In cases of pronounced atherosclerosis of cerebral vessels, the drug may be used only under medical supervision.

Specific sensitivity to the smell of valerian may occur.

Recommended doses of the drug should not be exceeded.

The drug contains ethanol! Prolonged use of the drug is not recommended.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The drug may affect reaction speed; therefore, during treatment, driving vehicles and working with potentially hazardous machinery should be avoided.

Dosage and Administration.

Administer orally to adults, 10–20 drops 2–3 times daily before meals.

The duration of use depends on the nature, course of the disease, and the therapeutic effect achieved.

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if any adverse reactions occur.

Children. Do not use in children due to lack of experience with use.

Overdose.

Symptoms: dry mouth, thirst, abdominal pain, nausea, vomiting, headache, dizziness, drowsiness/excitation, irritability, weakness, visual disturbances, palpitations, hyperthermia.

Treatment: symptomatic.

Adverse reactions.

In case of individual hypersensitivity to the drug, the following adverse reactions are possible:

From the immune system: skin allergic manifestations – rashes, itching, hyperemia, swelling, dryness of the skin and mucous membranes;

Psychiatric disorders: depression of emotional responses, mental depression or mental excitement, photophobia;

From the central nervous system: drowsiness, headache, decreased hearing and visual acuity, reduced mental and physical performance, muscle weakness, dilated pupils;

From the cardiovascular system: rarely – bradycardia, atrioventricular conduction disturbances;

From the gastrointestinal tract: thirst, taste disturbances, dysphagia, suppression of digestion, decreased intestinal motility, nausea, vomiting, diarrhea;

From the respiratory system: reduced bronchial secretion and tone.

With prolonged use – headache, decreased hearing and visual acuity, hallucinations, suppression of digestion.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

25 mL in bottles;

25 mL in a bottle; 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4 Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.