Buscopan Compositum

Treatment option:

Medically reviewed

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 Buscopan Compositum

Property	Description
Active Ingredients	Hyoscine Butylbromide and Sodium Metamizole
Type	Fixed-Dose Combination (FDC)
Pharmacological Class	Analgesic and Antispasmodic
High-Level Purpose	Addressing visceral pain associated with spasms
Origin	Synthetic

1. What is the Drug Entity: Fixed-Dose Combination and Origin

Buscopan Compositum is defined as a synthetic, fixed-dose combination (FDC) pharmaceutical preparation that simultaneously delivers two distinct active ingredients. The preparation combines the antispasmodic agent, Hyoscine Butylbromide, with the potent non-opioid analgesic, Sodium Metamizole.

This fixed-ratio medication is a product of chemical synthesis, distinguishing it from naturally derived compounds. The FDC design ensures both pharmacological actions are delivered via the same preparation, which is typically available in two forms for systemic administration: the tablet for oral intake, and a solution for injection (ampoules) for parenteral administration. This combination product is often required as a prescription-only medicine (Rx) due to the nature and efficacy of Sodium Metamizole.

2. Classification: The Dual Pharmacological Class

The medicine is classified by its complementary therapeutic actions, falling under both the Analgesic and Antispasmodic pharmacological classes. This classification reflects the composition, where Hyoscine Butylbromide functions as a quaternary ammonium derivative (anticholinergic), primarily targeting muscle spasm. As an anticholinergic, Hyoscine Butylbromide acts on gastrointestinal spasm by providing smooth muscle relaxation to ease acute discomfort.

The second component, Sodium Metamizole, belongs to the pyrazolone derivative group and provides the powerful pain-relieving effect. Compounds containing Metamizole are clinically recognized for their action in acute pain settings.

3. General Purpose: The Primary Therapeutic Goal

The primary general purpose of Buscopan Compositum is to achieve comprehensive visceral pain relief that originates from involuntary smooth muscle cramping and contraction, such as discomfort associated with the renal tract. By combining the muscle-relaxing effect with strong pain modulation, the drug is designed to address the cycle of spasm and associated pain.

This dual action distinguishes it from simple analgesics. The analgesia component alleviates discomfort, while the antispasmodic action promotes smooth muscle relaxation. Compounds like Metamizole (Sodium Metamizole) are characterized by analgesic and antipyretic properties. This synergistic approach addresses both the physical cause and the resulting discomfort.

What side effects are possible with Buscopan Compositum?

Possible Side Effects and Safety Information

The official safety profile of this fixed-dose combination, which contains Hyoscine Butylbromide and Sodium Metamizole, is defined by two primary regulatory concerns: the potential for rare, serious blood disorders, and more common anticholinergic effects.

Official Adverse Reaction Classification

Adverse reactions are classified by frequency as listed in regulatory documents. Common effects, reported in up to 1 in 10 people, include tachycardia (increased heart rate), dry mouth, constipation, dizziness, and accommodation disorders (difficulty focusing the eyes).

Less frequently, uncommon effects such as skin reactions (rash) and abnormal sweating may occur. Effects classified as Not Known (meaning frequency cannot be estimated from available data) include the most serious adverse reactions.

Serious Adverse Reactions

The regulatory labeling highlights the potential for several severe, though generally rare, adverse events, primarily associated with the Metamizole component. These include agranulocytosis (a severe reduction in white blood cells) and other blood dyscrasias like aplastic anaemia. Anaphylactic shock, a severe allergic reaction, is also documented, with potentially fatal outcomes.

Life-threatening skin reactions, specifically Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are also listed in the safety profile. For parenteral administration, the risk of severe hypotension (low blood pressure) and tachycardia is noted.

Safety-Related Restrictions and Considerations

Official documents outline specific safety restrictions. This medicine is generally contraindicated in patients with conditions that may be worsened by anticholinergic effects, such as narrow-angle glaucoma, prostatic hypertrophy with urinary retention, and pronounced tachycardia. Due to the risk of agranulocytosis, it is also contraindicated in patients with impaired bone marrow function. Use is generally restricted during the last three months of pregnancy and is not recommended during breastfeeding.

Overdose and Emergency Response

Buscopan Compositum overdose information is based on officially documented regulatory data detailing the clinical manifestations and mandated emergency response. Due to the combination of Hyoscine Butylbromide (an anticholinergic) and Sodium Metamizole (an analgesic), the overdose profile encompasses effects from both agents.

Documented Overdose Manifestations

Overdose may present with a specific symptom cluster derived from official labeling:

Anticholinergic signs: These include tachycardia (fast heartbeat), dry mouth, redness of the skin, vision disturbances, and urinary retention.
Systemic findings: Other manifestations may include nausea, vomiting, abdominal pain, dizziness, and drowsiness. Administration of very high doses is documented to potentially result in a red discoloration of the urine.

Severe Outcomes and Emergency Actions

Overdose can lead to severe or life-threatening outcomes, which require immediate medical intervention. Officially documented severe outcomes include a significant drop in blood pressure, progressing to shock, deterioration of kidney function, and neurological events such as seizures or coma. The risk of respiratory paralysis is also documented in severe cases.

When to seek immediate medical help:

Immediate medical advice or attention must be sought if an overdose is suspected or if any of the severe manifestations described above are present. Management is officially defined as symptomatic and supportive, and procedures may involve gastric lavage, administration of activated charcoal, and the use of parasympathomimetics (such as neostigmine) to address anticholinergic effects. Treating complications may require specific measures for cardiovascular issues and artificial respiration.

Therapeutic Uses of Buscopan Compositum

What Buscopan Compositum Treats: Main Uses and Benefits

Buscopan Compositum is applied for symptomatic relief in clinical settings that involve acute or unstable symptom patterns, specifically targeting pain and cramps. The medication is used in areas where additional symptomatic support is needed for managing discomfort caused by involuntary muscle activity.

It is relevant for easing symptom clusters associated with painful spasms in the gastrointestinal tract, the biliary tract, and the genitourinary system (such as the ureters and bladder). This medication is considered relevant when symptoms become momentarily overwhelming or difficult to tolerate, typically across conditions characterized by periods of heightened symptoms.

Support for Symptom Burdens

This supportive use helps address symptoms linked to organ-specific functional stress. It is often used during phases when symptoms become more noticeable, providing temporary assistance in symptom stabilization. The medication contributes to easing the overall symptom load, and supports the patient during difficult episodes by easing distress, contributing to improved comfort during symptomatic periods.

Quick Fact: Relevant for Symptoms related to heightened physiological activity

Regulatory References

BUSCOPAN® COMPOSITUM

Eligibility and Restrictions for Use

The eligibility for Buscopan Compositum ( Hyoscine Butylbromide and Sodium Metamizole) is strictly defined by official regulatory documentation, focusing on absolute contraindications and population-specific restrictions.

The medicine is contraindicated for patients with a known hypersensitivity to the active ingredients or related compounds, such as pyrazolones/pyrazidines. Absolute non-eligibility applies to patients with impaired bone marrow function, diseases of the haematopoietic system, specific eye conditions like glaucoma, neuromuscular conditions such as myasthenia gravis, and conditions causing obstruction like megacolon or mechanical stenosis in the gastrointestinal tract.

Population/Condition	Official Regulatory Status
Infants (under 12 months)	Contraindicated
Children/Adolescents (< 18 years)	Not recommended (Safety/efficacy not demonstrated)
Third Trimester Pregnancy	Contraindicated
Breastfeeding	Not recommended

Use is also prohibited in patients with acute intermittent hepatic porphyria and those with a history of analgesic-induced asthma syndrome. Conditional use applies to patients with pre-existing bronchial asthma or severe cardiovascular conditions like pronounced tachycardia or an unstable circulatory state. Caution is generally advised for individuals with existing liver or kidney impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details officially documented interaction patterns for the fixed-dose combination of Hyoscine Butylbromide and Sodium Metamizole, derived strictly from government regulatory documentation.

Formal Restrictions and Contraindications

Co-administration with other pyrazolones or pyrazolidines (e.g., Propyphenazone, Phenylbutazone) is formally contraindicated due to the risk of hypersensitivity and cross-sensitivity. For the injectable form, administration must not be given by intramuscular (IM) injection to patients on anticoagulant drugs, as this carries a risk of intramuscular haematoma; the intravenous or subcutaneous routes may be used.

Pharmacodynamic and Exposure Alterations

Pharmacodynamic intensification of the anticholinergic effect may occur when Hyoscine Butylbromide is co-administered with other anticholinergic drugs, including tri- and tetracyclic antidepressants, antipsychotics, and antihistamines. Conversely, the effect on gastrointestinal motility is officially documented to be diminished by Dopamine Antagonists such as metoclopramide.

Exposure-altering interactions for the Metamizole component include co-administration with hepatic microsomal enzyme inducers (e.g., Barbiturates), which reduce the drug’s half-life and duration of action. Furthermore, simultaneous administration with neuroleptics (Phenothiazine derivatives) may lead to severe hypothermia. Metamizole also risks compromising the anti-platelet effect of low-dose Aspirin.

Mechanism of Action

How Buscopan Compositum Works

This pharmaceutical product functions via the concerted action of two distinct components: hyoscine butylbromide and paracetamol.

Hyoscine Butylbromide: Muscarinic Receptor Antagonism

Hyoscine butylbromide acts as a quaternary ammonium antimuscarinic agent. Its primary biological target is the muscarinic acetylcholine receptor (M-receptors), predominantly those located on the smooth muscle cells of the gastrointestinal and genitourinary tracts. The molecule operates as a competitive antagonist, binding to these receptors and inhibiting the physiological action of the endogenous neurotransmitter acetylcholine. This blockade prevents the intracellular signaling cascade (specifically the Gq-coupled pathway, which increases intracellular calcium concentration) necessary for smooth muscle contraction. The resulting molecular consequence is a reduction in the contractile tone and motility of the visceral smooth musculature.

Paracetamol: Central Prostaglandin Modulation

Paracetamol (acetaminophen) is a non-opioid, non-inflammatory analgesic component. Its primary mechanism is believed to involve the central nervous system, where it modulates the synthesis of prostaglandins. Paracetamol acts by interfering with the peroxidase site of the prostaglandin H2 synthase enzyme, also known as Cyclooxygenase (COX) enzymes, particularly in areas with low peroxide tone (such as the brain and spinal cord). This interaction reduces the formation of key pro-nociceptive prostaglandins within the central nervous system, influencing downstream neuronal signaling.

Dosage and Administration Information

How to Use Buscopan Compositum: Official Administration Guidelines

Buscopan Compositum is a Fixed-Dose Combination (FDC) with distinct administration protocols depending on the formulation and region. The official instructions define its use as a short-term, acute intervention, restricting dosage, frequency, and duration limits.

Parenteral Formulation (Hyoscine Butylbromide + Sodium Metamizole)

Usage Entity	Official Instruction
Route of Administration	Intravenous (IV) or Intramuscular (IM).
Dosing Schedule (Adult)	Single dose: 5 mL (2500 mg Metamizole / 20 mg HBB).
Frequency and Interval	May be repeated 2 to 3 times daily at intervals of several hours.
Supervision Setting	Must be administered under medical supervision and be monitored.
Special Conditions	Injection must be given slowly. Not to be administered subcutaneously.
Population Rules	Dosage may require reduction for older adults or those with damaged liver or kidney function.

Oral Formulation (Hyoscine Butylbromide + Paracetamol)

Usage Entity	Official Instruction
Route of Administration	Oral use.
Dosing Schedule (Adult)	Single dose: 1 to 2 tablets (10 mg HBB / 500 mg Paracetamol per tablet).
Frequency and Limit	Maximum of 3 times daily; total daily dose must not exceed 6 tablets.
Duration Constraint	Should not be taken for more than three days without medical direction.
Special Conditions	Tablets must be swallowed whole and not chewed.
Population Rules	Not recommended for children under 10 years of age.

These official administration guidelines standardize how the medicine is used, imposing procedural requirements like slow injection and self-administration limits to ensure adherence to regulatory approval.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Buscopan Compositum

Evidence for Acute Pain and Cramping from Smooth Muscle Spasm

Research examined this medicine's fixed-dose combination (FDC) in acute settings associated with physical discomfort and spasms in the abdominal area, the renal tract (kidney/ureter), and the biliary system. This combination was studied for conditions characterized by fluctuating or episodic manifestations where involuntary muscle contractions are observed. The research primarily consists of Randomized Controlled Trials (RCTs) and comparative studies that have explored how the individual components—an analgesic (Sodium Metamizole) and an antispasmodic (Hyoscine Butylbromide)—function alone or in similar combinations.

In these studies, researchers monitored patient-reported outcomes describing perceived discomfort and used validated scales to measure the change in pain intensity at short, defined time intervals, often within the first hour. Study populations was evaluated in adult patients presenting in acute care settings with severe, acute symptoms such as renal or abdominal colic.

Research Findings Described in Authoritative Reviews

Authoritative systematic reviews exploring the dual-action strategy described how the combination of an antispasmodic with an analgesic component (such as Metamizole or an NSAID) was observed in some studies regarding conditions like acute renal colic. The findings from some of these reviews suggest that co-administering an antispasmodic alongside an analgesic component may not provide an observed additional reduction in pain compared to the analgesic component used alone in that specific context. Overall, the evidence contributes to understanding symptom patterns and the role of the combined pharmacological effect in contexts capturing phases of heightened symptom activity.

Follow-up Duration and Understanding Long-Term Use

Research exploring short-term symptom changes was evaluated in studies focused on acute research scenarios. Due to this focus, the follow-up durations were limited. Long-term effects are not fully established, and there is limited information related to how symptoms change over time beyond the initial 24 to 72 hours.

Key Limitations and Areas of Research Uncertainty

The evidence base is limited by certain research limitation frames. Comparative evidence is lacking, meaning there are a limited number of large-scale Randomized Controlled Trials that directly compared the Hyoscine Butylbromide and Sodium Metamizole fixed-dose combination against all relevant standard-of-care treatments. Research for this specific combination is ongoing, and the existing evidence highlights what is known—and what is still uncertain—about using this dual-action strategy for managing conditions where symptoms may vary in intensity.

Key Studies & References

BUSCOPAN® COMPOSITUM Professional Information (SAHPRA Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Buscopan Compositum (FAQ)

Q: How quickly does Buscopan Compositum usually start working?

A: Official information indicates that this medicine is designed for use in acute pain situations. The injectable formulation is formulated to provide its effect rapidly in acute settings.

Q: How long do the effects of Buscopan Compositum typically last?

A: The duration of effect is tied to the way the body processes the ingredients. Official dosing guidelines reflect this, noting that repeat doses are typically set at intervals of several hours.

Q: Is Buscopan Compositum used for general stomach aches?

A: According to official product information, Buscopan Compositum is specifically indicated for visceral pain, which is discomfort that originates from internal organs. It is designed to treat pain caused by involuntary smooth muscle cramping and contraction in the gastrointestinal or genitourinary tracts, not all general abdominal aches.

Q: Can Buscopan Compositum help with muscle spasms outside the abdomen?

A: Official information describes the action of the antispasmodic component (Hyoscine Butylbromide) as targeting smooth muscle primarily in the gastrointestinal, biliary, and genito-urinary tracts. The pharmacological action is therefore focused on easing spasms in these internal visceral areas.

Q: Can Buscopan Compositum be taken by children?

A: Official guidelines provide distinct rules based on age and formulation. The oral formulation is not recommended for children under 10 years of age. For the injectable formulation, it is not recommended for individuals under 18 years because safety and efficacy have not been established for this population.

Q: Can Buscopan Compositum cause drowsiness or affect driving?

A: Official guidance includes warnings that the medicine may cause adverse effects like dizziness or visual accommodation disorders (difficulty focusing the eyes). Patients are generally informed that these effects may impact the ability to drive or operate machinery.

Q: Can I take Buscopan Compositum if I am also taking antidepressants?

A: Official regulatory documents caution that the anticholinergic effect of Buscopan Compositum may be intensified when taken alongside other drugs with similar anticholinergic properties. This includes certain types of antidepressants, specifically tri- and tetracyclic antidepressants.

Q: Can Buscopan Compositum be crushed or split?

A: Official instructions for the tablet formulation state that the tablets must be swallowed whole. Official instructions state that the tablets are designed to be swallowed whole.

Q: Does Buscopan Compositum interact with other over-the-counter pain relievers?

A: Yes, official warnings exist regarding co-administration with other painkillers. The medicine is formally prohibited with other compounds chemically related to Metamizole, such as pyrazolones. Additionally, Metamizole may risk compromising the anti-platelet effect of low-dose Aspirin.

Q: Is Buscopan Compositum suitable for elderly patients?

A: Official guidance notes that the parenteral (injectable) formulation requires special consideration for older adults. Clinical trials have included patients over 65, and no specific adverse reactions unique to this age group have been reported in these studies.

Q: What kinds of symptoms should prompt a person to stop taking Buscopan Compositum?

A: Official documents describe circumstances where medical attention is required, such as if severe, unexplained abdominal pain persists or worsens. Similarly, attention is required if pain is accompanied by symptoms such as fever, nausea, vomiting, or changes in bowel movements, as these may indicate a more serious underlying condition. This statement is included in the official safety information.

Q: Is it normal to feel a bit dizzy after taking Buscopan Compositum?

A: According to the official safety profile, dizziness is listed as a common side effect. This classification means it is reported to occur in up to 1 in 10 people who use the medicine.

Q: What types of clinical studies support the use of Buscopan Compositum?

A: The use of the medicine is supported by evidence derived from Randomized Controlled Trials (RCTs) and comparative studies. These studies primarily focused on acute settings, where researchers monitored how patients perceived changes in pain intensity over short time intervals.

Q: What should I do if I think I've taken too much Buscopan Compositum?

A: Official patient information states that in the event an individual believes they have taken too much of the medicine (an overdose), seeking immediate medical advice is required. This information is defined in the safety documentation.

Q: Is Buscopan Compositum an opioid or does it contain opioids?

A: No. Official classification defines this medicine as a combination of an antispasmodic (Hyoscine Butylbromide) and a potent non-opioid analgesic (Metamizole or Paracetamol). It does not contain any opioid substances.

Q: Is it true that Buscopan Compositum is sometimes used for kidney stones?

A: The medicine is officially indicated for treating pain and spasms that occur in the renal tract (the system involving the kidneys and ureters) and the biliary system. This often includes the acute symptoms associated with conditions such as renal colic.

Q: Is Buscopan Compositum for chronic or acute pain?

A: Regulatory documents define this medicine for use as a short-term, acute intervention. For the oral formulation, there is a duration constraint that it should not be taken for more than three days without medical direction.

Q: Is Buscopan Compositum known to cause constipation?

A: Yes. According to the official safety profile, constipation is listed as a common side effect. This means it has been reported to occur in up to 1 in 10 people taking the medicine.

Q: What types of pain is Buscopan Compositum not intended to treat?

A: The official purpose is focused on visceral pain that originates from smooth muscle spasms in the gut or urinary system. It is not indicated for treating pain originating from other sources, such as chronic musculoskeletal pain or nerve-related pain.

Q: Is there any research on Buscopan Compositum's effectiveness compared to its individual components?

A: Authoritative reviews have explored the dual-action strategy of combining an antispasmodic with an analgesic. Findings from some studies suggest that this combination may not provide an observed additional reduction in pain compared to the analgesic component used alone in certain acute contexts.

Q: Is it common for Buscopan Compositum to cause difficulty urinating?

A: Official safety documents list impaired micturition (difficulty passing urine) as a possible side effect. The medicine is also officially prohibited for patients with certain prostate conditions that increase the risk of urinary retention.

Q: What is the active ingredient that treats the spasm?

A: The active ingredient specifically responsible for treating the spasm is Hyoscine Butylbromide. This component works by relaxing the smooth muscles in the affected internal organs.

Q: Is Buscopan Compositum safe for people with the heart condition pronounced tachycardia?

A: Official regulatory documents indicate that the medicine is generally contraindicated for patients with conditions that may be worsened by its anticholinergic effect, which includes pronounced tachycardia (a severe increase in heart rate) and other unstable cardiovascular conditions. The need for caution is noted in official documentation.

Q: Does Buscopan Compositum interact with alcohol?

A: Official patient information notes that the use of alcohol is generally discouraged while using this medicine. Alcohol consumption may increase the chance of experiencing certain side effects.

How should Buscopan Compositum be stored and disposed of?

How to Store and Dispose of Buscopan Compositum

The storage and disposal of Buscopan Compositum (Hyoscine Butylbromide and Sodium Metamizole) must adhere strictly to the rules defined in official regulatory labeling to maintain product stability and ensure environmental safety.

Storage and Disposal Rule	Requirement
Temperature Limit	Do not store above 25 C.
Environmental Protection	Protect from light; store tablets in a dry place.
Packaging	Keep the medicine in the original outer carton.
Child Safety	Must be kept out of the sight and reach of children.
Stability After Opening	The injectable solution must be discarded 28 days after first opening.
Disposal Instructions	Dispose of unused product and waste in accordance with local requirements.
Environmental Note	The medicine should not be disposed of via wastewater.

These official rules ensure that the product is protected from heat and light degradation and is handled safely. The defined stability period for the injectable solution and the mandatory disposal instructions prevent inappropriate discarding of the pharmaceutical.

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