Gastrokap (Drops) Instructions for Use

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

ATC Code

A03AX (Other drugs for functional gastrointestinal disorders)

Active Substances

Valerian (BP British Pharmacopoeia)

Belladonna (Ph.Eur. European Pharmacopoeia)

Absinthium (BP British Pharmacopoeia)

Dosage Form

Gastrokap

Oral drops: bottle 25 ml

Dosage Form, Packaging, and Composition

25 ml – dark glass dropper bottle (1) – cardboard packs.
25 ml – dark glass bottles (36) – cardboard boxes.
25 ml – dark glass dropper bottles (36) – cardboard boxes.
25 ml – dark glass dropper bottles (49) – cardboard boxes.
25 ml – dark glass dropper bottles (64) – cardboard boxes.
25 ml – dark glass bottles (49) – cardboard boxes.
25 ml – dark glass bottles (64) – cardboard boxes.
25 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with sedative and antispasmodic action

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

It has an antispasmodic and also a moderate sedative effect.

Belladonna leaf has an m-cholinolytic and antispasmodic effect. It prevents the stimulating action of acetylcholine; reduces the secretion of salivary, gastric, bronchial, lacrimal, sweat glands, and the pancreas. It reduces the tone of the muscles of the gastrointestinal tract, bile ducts, and gallbladder; causes tachycardia, improves atrioventricular conduction. It dilates the pupils, impedes the outflow of intraocular fluid, increases intraocular pressure, and causes paralysis of accommodation.

Valerian rhizome with roots has a sedative and antispasmodic effect. It facilitates the onset of natural sleep. The sedative effect develops slowly but is quite stable. It has a choleretic effect, increases the secretion of the gastrointestinal mucosa, slows the heart rate, and dilates the coronary vessels. The effect on cardiac activity is mediated through neuroregulatory mechanisms and a direct influence on the automatism and conduction system of the heart.

Absinthium herb has a choleretic effect, increases appetite, and stimulates acid production.

Indications

The drug is used as an antispasmodic agent for diseases of the gastrointestinal tract accompanied by smooth muscle spasms (including chronic hypo- and anacid gastritis, chronic colitis, biliary dyskinesia).

ICD codes

Dosage Regimen

Administer orally.

Dilute the dose in a small amount of water before administration.

For adults, the single dose is 15 to 25 drops.

Administer up to 3 times per day as needed for symptom relief.

Do not exceed the maximum daily dose of 75 drops.

Limit the total duration of continuous daily use to 1.5 to 2 months.

Avoid prolonged use without medical supervision.

Consult a physician if symptoms persist or worsen.

Adverse Reactions

Allergic reactions are possible. With prolonged use, the following may occur: dryness of the skin and oral mucosa, dilated pupils, heartburn, gastralgia, diarrhea, drowsiness, decreased performance, paresis of accommodation, depression.

Contraindications

Hypersensitivity to the components of the drug, glaucoma, hyperacid gastritis, gastric and duodenal ulcer in the acute stage, childhood and adolescence (under 18 years of age), prostatic hypertrophy with impaired urine outflow.

With caution. Alcoholism, craniocerebral trauma, brain diseases, liver diseases.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible if the expected benefit to the mother outweighs the potential risk to the fetus and child. It is necessary to consult a doctor.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated under 18 years of age.

Special Precautions

The drug should not be taken daily for more than 1.5-2 months. During treatment, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

The content of ethyl alcohol in the drug is at least 60%. A single dose of the drug (15-25 drops) contains up to 0.23 g of absolute ethyl alcohol. The maximum daily dose of the drug (75 drops) contains up to 0.7 g of absolute ethyl alcohol.

Overdose

In case of overdose, the following side effects may be intensified: dryness of the skin and oral mucosa, dilated pupils, heartburn, gastralgia, diarrhea, drowsiness, decreased performance, tremor, headache, dizziness, convulsions.

Treatment is symptomatic.

Drug Interactions

It enhances the effect of hypnotics and sedatives, and antispasmodics.

Storage Conditions

Store the drug in a place protected from light, at a temperature of 12 to 15°C (59°F). Keep out of the reach of children.

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.