Spasmocystenal (Drops) Instructions for Use

Marketing Authorization Holder

Euromed, LLC (Russia)

Manufactured By

Peoples’ Friendship University of Russia (Russia)

ATC Code

G04BC (Drugs for the treatment of nephrourolithiasis)

Active Substances

Belladonna (Ph.Eur. European Pharmacopoeia)

Rubia tinctorum (Group Grouping name)

Dosage Form

Spasmocystenal

Oral drops: bottle 10 ml

Dosage Form, Packaging, and Composition

Oral drops as a clear orange liquid, with a characteristic odor.

Excipients : salicylic acid – 0.020 g, magnesium salicylate – 0.140 g, anise fruit oil – 1.475 g, bitter fennel herb oil – 1.475 g, eucalyptus leaf oil – 2.800 g, ethanol (absolute ethyl alcohol) – 0.750 g, linoleic acid – 0.700 g, linolenic acid – 0.700 g, castor oil (ricinus oil) – up to 10 ml.

10 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with diuretic, spasmolytic, and anti-inflammatory action

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

A herbal medicinal product that has spasmolytic, moderate diuretic, anti-inflammatory, and analgesic effects.

The drug reduces pain, relaxes the smooth muscles of the ureters and facilitates the passage of small calculi; it contributes to shifting the urine pH to the acidic side and disintegrating urinary calculi containing calcium and magnesium phosphates.

Indications

Renal colic in urolithiasis, spasms of the urinary tract.

ICD codes

Dosage Regimen

Administer orally.

The specific regimen is determined by the clinical indication.

For renal colic, take 20 drops as a single dose.

For urinary tract spasms, take 10 drops three times daily.

Place the drops onto a piece of sugar before oral administration.

During therapy, maintain a daily fluid intake of 1.5-2 liters, unless contraindicated.

Do not exceed the recommended dosage.

Discontinue use and consult a physician if symptoms persist or worsen.

This product contains ethyl alcohol; exercise caution in patients with brain diseases or a history of alcoholism.

Adverse Reactions

Possible allergic reactions, decreased secretion of the salivary glands and respiratory tract glands, mydriasis, increased intraocular pressure, accommodation disturbance, photophobia, tachycardia, urinary retention, headache, constipation, when taken in high doses – hyperthermia, blockade of sweat gland secretion, anxiety, convulsions, loss of consciousness.

Contraindications

Hypersensitivity to the active substances included in the drug used, acute and chronic glomerulonephritis, renal failure, pyelonephritis, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, benign prostatic hyperplasia, pregnancy, breastfeeding period, age under 18 years; hypersensitivity to salicylates (including bronchial asthma induced by the intake of salicylates and NSAIDs; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs, including COX-2 inhibitors (including in history).

With caution

Liver diseases, alcoholism, traumatic brain injury, brain diseases (because the drug used may contain ethyl alcohol).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

In the absence of contraindications from the cardiovascular and urinary systems, patients are recommended to consume at least 1.5-2 liters of fluid per day during treatment.

Effect on the ability to drive vehicles and mechanisms

During treatment, one should refrain from performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Drug Interactions

Simultaneous administration of the drug with other medicinal products should be avoided.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.