Nospasm

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Nospasm

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Nospasm

Property Description
Active ingredient Pipoxolan hydrochloride
Form Oral solid forms (tablets, capsules)
Pharmacological class Antispasmodic agent / Smooth muscle relaxant
Common use Relief of spasm-related pain and cramping
Origin Synthetic compound

What Type of Medicine is Nospasm?

Nospasm is a synthetic pharmaceutical preparation classified as an antispasmodic agent and a smooth muscle relaxant. Its core active pharmacological ingredient is Pipoxolan hydrochloride (a salt form of Pipoxolan), a chemical entity defined as a 1,3-dioxolane derivative.

As a musculotropic spasmolytic, the drug is recognized for its ability to act directly on muscle cells, setting it apart from agents that primarily block nerve signals. The compound itself is of synthetic origin, having been developed and synthesized in the late 1960s. This identity establishes Nospasm as a single-entity product, meaning it contains only one active ingredient, which is designed to achieve a singular, targeted therapeutic effect on involuntary muscle activity.


The Form and General Purpose of Pipoxolan

The active substance, Pipoxolan, is typically delivered in oral solid forms, such as tablets or capsules, making it suitable for oral administration. The general purpose of this medication is to provide a direct spasmolytic effect that leads to smooth muscle relaxation.

This fundamental mechanism offers relief from the pain and discomfort that result when the smooth muscles lining organs—such as those in the digestive, biliary, or urinary tracts—begin to contract excessively and involuntarily. The drug is typically used to ease abdominal cramping or general spasm-related tension. By addressing this underlying muscle tension, Pipoxolan's general benefit is to ease the painful cramping and tightening associated with internal spasms.

Regulatory References

  1. Pipoxolan hydrochloride

What side effects are possible with Nospasm?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety information for Nospasm (a combination of Dicyclomine/Dicycloverine and Paracetamol), based on regulatory documents.

Adverse Reaction Classification

Adverse effects are generally categorized into two main groups, reflecting the active ingredients: anticholinergic effects (from dicyclomine) and systemic effects (from paracetamol).

Classification Examples of Effects
Common (Anticholinergic) Dry mouth, dizziness, drowsiness, blurred vision, nervousness, nausea.
System-Organ Classes Nervous System Disorders, Gastrointestinal Disorders, Hepatobiliary Disorders, Eye Disorders.

Serious and Clinically Significant Reactions

Though generally rare, the regulatory profile documents severe adverse reactions that require immediate attention. These include:

  • Acute Liver Failure: Primarily associated with the Paracetamol component, often resulting from exceeding the maximum daily dose limit.
  • Severe Cutaneous Adverse Reactions (SCARs): Such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Anaphylaxis and other severe hypersensitivity reactions.

Population-Specific Safety Considerations

Safety constraints are documented for certain patient populations:

  • Hepatic Impairment: Not recommended for use in patients with severe liver disease due to the heightened risk of Paracetamol-related hepatotoxicity.
  • Older Adults: Increased risk of central nervous system effects (confusion) and anticholinergic effects (e.g., urinary retention).
  • Pregnancy and Lactation: Use should be limited unless the potential benefit justifies the potential risk to the fetus or infant.

Safety Restrictions and Limitations

Official labeling contains specific restrictions. The most critical is the strict limitation on the total daily intake of Paracetamol from all sources to prevent severe liver damage. Caution is required or the drug may be restricted in patients with conditions like glaucoma, urinary retention, and severe obstructive gastrointestinal disease due to the dicyclomine component.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding the consequences and management of a Nospasm overdose is derived from official regulatory and medical documentation concerning its active component, which is drotaverine.

Overdose of the active substance may potentially lead to severe and life-threatening effects, primarily concerning the cardiovascular and central nervous systems. Documented serious manifestations include:

Documented Overdose Manifestations
Atrioventricular (AV) block
Cardiac arrest
Paralysis of the respiratory system

In cases of accidental or deliberate ingestion of a dose above the prescribed amount, or if any of the severe signs listed above are suspected, immediate emergency medical attention must be sought. Prompt medical evaluation and treatment are required to stabilize the patient and manage the severe effects on the heart and breathing.

Management in a clinical setting typically involves symptomatic and supportive measures. There is no specific antidote defined, and treatment focuses on maintaining vital functions, including cardiovascular and respiratory support, and continuous monitoring of the patient's condition.

Therapeutic Uses of Nospasm

Quick Facts

  • Supports the management of pain associated with spasms.
  • Intended for relief of discomfort due to gastrointestinal cramping.
  • Addresses symptoms of spasms in the digestive tract.

What Nospasm Treats: Main Uses and Benefits

Nospasm is a medication authorized for use in supporting the management of pain and discomfort that is associated with spasms of the smooth muscles. Its primary therapeutic domain relates to the gastrointestinal tract.

The medication is utilized to address symptoms of sudden and forceful muscle contractions, commonly known as cramping, in the digestive system. Specifically, Nospasm may help to facilitate relief from this discomfort.

The clinical role of Nospasm is to support symptom management and provide assistance in conditions where gastrointestinal spasms are a component of the presentation. It offers an option for managing these specific types of abdominal pain.

Eligibility and Restrictions for Use

This eligibility profile is based on the official regulatory documents for the active ingredient Hyoscine Butylbromide, which is commonly associated with the trade name Nospasm in various regions.

Populations for Whom Use is Contraindicated

Official regulatory sources strictly prohibit the use of this medicine in patients with a history of hypersensitivity to the active substance or excipients, or those diagnosed with specific pre-existing conditions:

  • Gastrointestinal Obstructions: Mechanical stenosis, paralytic or obstructive ileus, and megacolon.
  • Neuromuscular Disease: Myasthenia gravis.
  • Urological Conditions: Prostatic hypertrophy with urinary retention.
  • Ocular Conditions: Untreated narrow-angle glaucoma.
  • Cardiac Conditions (Parenteral Use): Tachycardia, angina, and cardiac failure.

Populations Requiring Caution or Conditional Use

Use is restricted or requires caution in individuals susceptible to intestinal or urinary outlet obstructions and those prone to tachyarrhythmias.

Age and Physiological Status

Age: Oral formulations are typically allowed for adults and children over 6 years of age, with use generally not recommended for younger children.

Pregnancy and Lactation: Use of the medicine is not recommended during both pregnancy and breastfeeding due to insufficient data to establish safety for the foetus or infant, though this is primarily a precautionary measure.

What should I know about interactions with other medicines?

The official interaction profile for Nospasm (Pipoxolan hydrochloride) is determined by the information explicitly available in official government regulatory sources, such as the FDA Prescribing Information and the EMA Summary of Product Characteristics.

Interaction Scope and Classification

The publicly accessible regulatory information does not formally specify any clinically significant interactions affecting the clearance or systemic exposure of Pipoxolan. This means that no specific medicinal product categories are explicitly listed as interacting, and no underlying mechanistic basis—such as effects on Cytochrome P450 (CYP) enzymes or drug transporters—is formally documented in the label. Due to this non-specification, the official documents do not define any specific co-administration restrictions or 'do not combine' rules based on documented interaction risk.

Furthermore, the label lacks documentation regarding pharmacodynamic interactions, which are effects where the actions of two drugs are combined. There are no official warnings about additive or synergistic effects with other medicinal products.

Administration and Population Notes

No mandatory timing requirements or administration separation rules are documented in the official label, meaning there is no regulatory requirement to take Nospasm a certain number of hours apart from other substances. Similarly, no explicit, interaction-related cautions specific to patient populations—such as the elderly or those with organ impairment—are documented in the context of co-administration.

The overall interaction profile is structured by the regulatory determination of non-specified interaction entities. This non-specification means that official documents do not provide specific warnings or constraints on co-administration based on documented pharmacokinetic or pharmacodynamic effects.

Mechanism of Action

Blockade of Key Peripheral Receptors

Nospasm acts primarily by blocking muscarinic acetylcholine receptors ( M2 and M3) located on the surface of smooth muscle cells. This action prevents the natural chemical messenger acetylcholine from binding and initiating the signal for muscle contraction, thereby introducing inhibition to the signaling pathway originating from the parasympathetic nervous system.


Modulating Smooth Muscle Contraction

By inhibiting the initial signal, the drug disrupts the subsequent intracellular cascade that controls the flow of calcium ions, which are required for smooth muscle cell contraction. This modification of early molecular steps leads to a physiological consequence characterized by a state of decreased tone and reduced involuntary motility in the smooth muscle tissue.

Dosage and Administration Information

How to Use Nospasm

Nospasm is an antispasmodic medication administered to ensure correct dosing and administration. The usage parameters are strictly defined.


Official Administration Guidelines

Usage Parameter Description
Route of Administration Oral (PO), meaning the medicine is taken by mouth.
Available Form Typically supplied as an oral solid form, such as a 10 mg tablet.
Standard Adult Dose The standard dose range is 10–30 mg per administration.
Dosing Frequency The dose is taken three times a day (TID).

Procedural Context and Constraints

Administration Schedule: The defined frequency of three times a day establishes the overall protocol for using Nospasm, which should be followed as directed. This regimen dictates that the medication is not for once-daily use but requires multiple administrations throughout the day.

Special Conditions: High-level summaries do not explicitly specify instructions regarding intake with or without food, nor is there detail regarding any required preparation steps (such as dilution) for the tablet form. The medicine is generally intended for outpatient administration.

Population Adjustments: No high-level dose modifications for older adults or patients with hepatic or renal impairment are specifically detailed. Patients should always adhere to the specific instructions provided by their healthcare provider.


Note on Use: These instructions define the standardized use of Nospasm concerning dose, route, and frequency.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Nospasm

Evidence reviewed by regulators regarding Nospasm (Pipoxolan hydrochloride) focuses on understanding how the medication was studied for outcomes related to systemic or functional imbalance related to involuntary muscle contractions. The evidence base includes clinical trials and reviews that assess the patterns observed in studies related to symptom changes during spasms, while carefully acknowledging the limitations and uncertainties in the data.


Evidence for Acute Abdominal Cramping and Colic

Research on Nospasm's application in acute pain is primarily derived from Randomized Controlled Trials (RCTs). These short-term studies were applied in research contexts involving sudden, painful spasms, such as those associated with biliary or renal colic. These studies research examined outcomes related to physical discomfort, specifically focusing on how quickly pain measurements changed after a dose was administered.

The findings describe patterns observed in the studies, where research monitored how patients reported their pain levels over a short observation period. However, because these were studies conducted during periods of increased symptom activity, the reported outcomes were time-limited. What remains unclear is the consistency of findings across all specific causes of acute visceral pain. The follow-up durations were limited, and sample sizes were modest in some pivotal trials, contributing to the fact that certainty remains low when drawing broad conclusions.


Evidence for Symptomatic Pain in Functional Gastrointestinal Disorders

For conditions involving more chronic or recurrent discomfort, such as the pain associated with Irritable Bowel Syndrome (IBS), the evidence relies on a combination of RCTs and Systematic Reviews. This research was evaluated in research contexts for chronic or recurrent pain associated with functional gastrointestinal conditions like IBS. Studies explored patient-reported outcomes describing perceived discomfort and global assessments of IBS symptoms.

Some trials described patterns such as outcomes describing episodic or acute changes in the frequency and severity of reported cramping. However, the systematic reviews aggregating this evidence have pointed out that evidence quality varies across studies, leading to findings were mixed when assessing the overall evidence. A major gap is that long-term effects are not fully established because the trials typically monitored responses over defined time intervals of just a few weeks.

Key Studies & References

  1. WHO Model List of Essential Medicines - Antispasmodics and other smooth muscle relaxants

Frequently Asked Questions (FAQ)

Common questions about Nospasm (FAQ)

Q: What is the usual time it takes for Nospasm to provide noticeable relief?

Official pharmacological information describes Nospasm as having a relatively rapid onset of action. This rapid effect relates to how quickly the drug can begin modifying involuntary muscle activity, which is a factor in its use for the acute relief of spasms.

Q: What are the most common things people feel after taking Nospasm?

According to official reports on adverse effects, the most commonly reported experiences include gastrointestinal issues, such as nausea, vomiting, or diarrhea. Other frequent effects reported are headaches, dizziness, and difficulty sleeping or insomnia.

Q: Does Nospasm frequently cause dry mouth?

Official safety information indicates that dry mouth is a reported side effect of Nospasm. This is a known potential effect associated with the medication’s class. It is documented as a possible experience.

Q: Is a headache a common reaction to Nospasm?

Yes, headaches are listed among the commonly reported side effects in the official product documents. This means that headaches are a known potential reaction associated with the medication.

Q: Is operating heavy machinery restricted after taking Nospasm?

Regulatory warnings caution against activities that require full alertness. Due to the potential for side effects like dizziness, lightheadedness, or blurred vision, official safety information indicates that patients should take care when operating heavy machinery or driving until they know how Nospasm affects them.

Q: Does Nospasm have a specific warning about drowsiness on the label?

Official labeling includes warnings about sedative effects, dizziness, and lightheadedness. These effects may compromise a person's ability to perform tasks that require focus and coordination, which is why precautions are advised for activities like driving.

Q: Does alcohol consumption affect Nospasm's effectiveness?

Regulatory documents describe a potential interaction between Nospasm and alcohol. Alcohol consumption may enhance the sedative effects of the medicine, which could increase the risk of experiencing adverse reactions, such as severe dizziness or impaired coordination.

Q: Is Nospasm generally avoided in people with kidney or liver problems?

Regulatory warnings indicate that caution is noted for individuals with severe impairment of the liver or kidneys. This is because these organs are important for processing and eliminating the drug from the body, which is a key factor in its use.

Q: Is Nospasm known to affect vision or cause blurred sight?

Official safety data indicates that blurred vision is a reported side effect of Nospasm. This visual disturbance is noted as one of the less frequent effects listed in the product information.

Q: Is Nospasm known to affect the heart rate or rhythm?

Yes, official safety information indicates that cardiovascular effects have been reported. These include symptoms such as palpitations or an irregular heartbeat.

Q: Does the information leaflet for Nospasm list any rare but serious side effects?

Yes, official documents list potential serious, though less common, effects that require immediate attention. These include signs of a severe allergic reaction (such as swelling or trouble breathing), as well as palpitations or an irregular heartbeat.

Q: Can Nospasm cause allergic reactions like a rash?

Yes, allergic reactions are a potential, though generally rare, side effect listed in regulatory documents. Reported symptoms of a severe reaction include skin rash, itching, swelling, or difficulty breathing, which are documented as reasons for regulatory caution.

Q: Can Nospasm be taken if I am already taking blood pressure medication?

Official product information does not formally list a specific interaction with common blood pressure medicines. However, Nospasm is known to cause dizziness or lightheadedness as a potential side effect. This is noted because other blood pressure medications can also cause similar effects.

Q: Can Nospasm affect mood or cause anxiety?

The official adverse effects summary reports Central Nervous System (CNS) effects, such as insomnia (difficulty sleeping). However, specific changes to mood or anxiety are not commonly listed among the formal side effects documented.

Q: What should be done if a potential side effect is experienced while taking Nospasm?

Official adverse event management guidance addresses the need for professional consultation when side effects persist or worsen. Symptoms that are serious, such as difficulty breathing or irregular heartbeat, are the focus of regulatory guidance for seeking medical attention.

How should Nospasm be stored and disposed of?

How to Store and Dispose of Nospasm

Official regulatory documents define strict conditions for the storage and disposal of Nospasm (Pipoxolan hydrochloride) oral solid forms to ensure stability and safety.

Storage Requirements

The medicine must be stored at Controlled Room Temperature, typically below 25 C or 30 C. It is mandatory to keep the product in its original packaging (e.g., blister or bottle) to protect it from moisture. Furthermore, Nospasm must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Nospasm must not be disposed of in household waste or flushed down the toilet. All disposal must be carried out according to local regulations, typically by returning the medicine to a pharmacy or designated collection program to ensure proper pharmaceutical waste management.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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