Gastrospasmyl (Drops) Instructions for Use

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

ATC Code

A03B (Belladonna and its derivative preparations)

Dosage Form

Gastrospasmyl

Oral drops: 25 ml bottle or dropper bottle.

Dosage Form, Packaging, and Composition

Drops for oral administration in the form of a transparent liquid of a reddish-brown color, with a characteristic odor; opalescence is possible.

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

Indications

• Symptomatic treatment of functional gastrointestinal disorders accompanied by spasms, pain, and flatulence.
• Management of irritable bowel syndrome (IBS) with predominant abdominal pain and cramping.
• As an adjunctive therapy for biliary dyskinesia and spastic conditions of the urinary tract.
• Used for mild nervous tension and sleep disturbances of a situational nature, given the sedative properties of the components.

The combination of belladonna’s anticholinergic action with the spasmolytic and carminative effects of peppermint and wormwood, plus the sedative effect of valerian, provides a comprehensive approach to managing spastic pain and associated anxiety.

Contraindications

• Hypersensitivity to belladonna alkaloids (atropine), valerian, peppermint, wormwood (Artemisia absinthium), or any other component of the preparation.
• Glaucoma (angle-closure), due to the risk of increased intraocular pressure from the anticholinergic effects of belladonna.
• Prostatic hyperplasia with significant residual urine volume or urinary retention, as anticholinergics can worsen these conditions.
• Stenosing pathologies of the gastrointestinal tract (e.g., pyloroduodenal stenosis, achalasia), paralytic ileus, or severe ulcerative colitis.
• Myasthenia gravis, as anticholinergics can exacerbate muscle weakness.
• Tachycardia and severe coronary artery disease (e.g., unstable angina, acute myocardial infarction).
• Pregnancy and breastfeeding. Safety has not been established; belladonna alkaloids can cross the placenta and are excreted in breast milk.
• Children under 12 years of age, due to the high and unpredictable sensitivity to belladonna alkaloids in this population.
• Liver failure of severe degree, as metabolism of the active components may be impaired.

Dosage Regimen

For adults and adolescents 12 years and older: The usual dose is 20-30 drops diluted in a small amount of water (approximately 30-50 ml). The dosage may be adjusted by the physician based on the severity of symptoms and individual patient response.

The frequency of administration is typically 3 times per day. It is recommended to take the drops before meals to prevent gastrointestinal spasms associated with food intake. Do not exceed the recommended daily dose without medical supervision.

Duration of treatment: The course of treatment is determined by the physician. It is generally prescribed for short-term use to relieve acute symptoms. Long-term use requires regular medical evaluation of its continued necessity and monitoring for potential adverse effects.

Shake the bottle well before use. Use the measuring dropper provided to ensure accurate dosing. If symptoms persist or worsen after a few days of use, discontinue the medication and consult your doctor.

Adverse Reactions

Adverse reactions are listed below by system organ class and frequency. Frequency is defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Nervous system disorders: Common: Drowsiness, dizziness, headache. Uncommon: Restlessness, insomnia (paradoxical reaction, especially with valerian). Not known: Confusion, especially in elderly patients.

Eye disorders: Common: Mydriasis (pupil dilation), cycloplegia (paralysis of accommodation), increased intraocular pressure. These effects are primarily associated with the belladonna component.

Cardiac disorders: Uncommon: Palpitations, tachycardia. Rare: Bradycardia (paradoxical reaction).

Gastrointestinal disorders: Common: Dry mouth, constipation. Uncommon: Nausea, vomiting, reduced gastrointestinal motility.

Renal and urinary disorders: Uncommon: Difficulty in urination, urinary retention, particularly in patients with prostatic hyperplasia.

Skin and subcutaneous tissue disorders: Uncommon: Skin rash, urticaria, pruritus, photosensitivity reactions. Not known: Angioedema.

If any of these side effects become severe or if you notice any other side effects not listed, contact your doctor or pharmacist immediately.

Drug Interactions

Central Nervous System (CNS) Depressants: The sedative effect of valerian may be potentiated when taken concurrently with other CNS depressants such as barbiturates, benzodiazepines, opioids, sedating antihistamines (e.g., diphenhydramine), antipsychotics, and alcohol. This can lead to increased drowsiness, dizziness, and impaired cognitive and motor performance. Extreme caution is advised, especially when driving or operating machinery.

Other Anticholinergic Agents: Concurrent use with other drugs possessing anticholinergic properties (e.g., tricyclic antidepressants like amitriptyline, some antihistamines, anti-Parkinson drugs, antispasmodics, and antipsychotics) may lead to an additive anticholinergic effect. This increases the risk of adverse reactions such as severe dry mouth, urinary retention, constipation, tachycardia, and blurred vision.

Drugs Affected by Gastric pH and Motility: Anticholinergics can slow gastric emptying and alter gastric pH. This may affect the absorption of other concurrently administered oral medications, potentially delaying or decreasing their absorption (e.g., ketoconazole, itraconazole) or increasing it for drugs that are absorbed in the stomach.

Monoamine Oxidase Inhibitors (MAOIs): Although the risk is considered theoretical and low with valerian compared to other sedatives, there is a potential for interaction with MAOIs, which could lead to excessive sedation or hypertension. It is recommended to avoid concomitant use or use with great caution.

Metabolism Interactions: Valerian may inhibit certain cytochrome P450 enzymes, potentially increasing the plasma concentrations of drugs metabolized by these pathways, though clinical significance is often low. Inform your doctor about all the medicines you are taking, including prescription, over-the-counter, and herbal products.

Overdose

Symptoms: Overdose with Gastrospasmyl is primarily characterized by the anticholinergic toxidrome due to the belladonna (atropine-like) content. Early signs may include intense dryness of the mouth and skin, difficulty swallowing, intense thirst, blurred vision, photophobia, and flushing. Severe overdose can lead to tachycardia, hyperthermia, restlessness, confusion, hallucinations, delirium, convulsions, respiratory depression, and circulatory collapse. Symptoms of valerian overdose, such as profound sedation, lethargy, and nausea, may also be present.

Management: There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage may be considered if performed soon after ingestion, followed by administration of activated charcoal. In severe cases with central anticholinergic syndrome, the administration of physostigmine may be considered by a physician, but its use is controversial due to its own risk of serious side effects. Catheterization may be necessary for urinary retention. Control hyperthermia with external cooling. Monitor vital signs, including ECG, and provide respiratory support if needed. In case of suspected overdose, immediately seek emergency medical attention or contact a poison control center.

Clinical-Pharmacological Group

Herbal preparation with sedative and antispasmodic action

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

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

Rx Only

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.