Opisco

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Opisco

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Opisco

Quick Facts

Property Description
Active Ingredients Hyoscine Butylbromide & Papaveretum
Forms Solution for Injection (Parenteral) and Tablet (Oral)
Pharmacological Class Antispasmodic and Opioid Analgesic
General Purpose Relief of acute visceral cramps and associated pain
Origin Combination of Semisynthetic Derivative and Natural Opium Alkaloids

What is Opisco?

Opisco is a fixed-dose combination drug precisely formulated to provide powerful, concurrent relief from severe visceral discomfort by targeting both muscle spasm and the associated pain simultaneously. This preparation is defined by its dual identity, combining the effects of a peripheral antispasmodic agent with a centralized opioid analgesic complex. This formulation offers a robust approach for managing acute painful episodes.


What Type of Medicine is Opisco?

Opisco is classified as an Antispasmodic and Opioid Analgesic due to its composition, which delivers two distinct pharmacological actions. The antispasmodic action is provided by the first component, which acts as an anticholinergic agent, primarily achieving targeted muscle relaxation within the gastrointestinal and genitourinary tracts. The second component is an opioid analgesic complex, which works within the central nervous system to significantly modulate the perception of moderate-to-severe pain. This integrated dual action is intended to interrupt the painful cycle of spasm and associated discomfort, a necessity clinically recognized for treating acute abdominal pain.


What is Opisco Made Of?

The medicine is composed of two primary active ingredients: Hyoscine Butylbromide and Papaveretum. Hyoscine Butylbromide is a semisynthetic derivative of the scopolamine alkaloid, and its chemical structure is that of a quaternary ammonium compound designed to limit central nervous system effects, ensuring its antispasmodic effect remains focused on the smooth muscle tissue. Papaveretum is an opioid analgesic complex containing a blend of natural opium alkaloids, including Morphine Hydrochloride (for primary pain relief), Codeine Hydrochloride, and Papaverine Hydrochloride, ensuring robust centralized pain management. The presence of these combined alkaloids is recognized for providing strong pain relief in acute settings.


What is the General Purpose of Opisco?

The general therapeutic purpose of Opisco is the swift alleviation of acute, intense visceral cramps and the pain they cause. The formulation is intended for situations, such as during the intense pain associated with renal colic, where powerful, simultaneous relief from both the physiological cause (spasm) and the resulting symptom (pain) is necessary. This synergistic dual action ensures a comprehensive approach to managing intense visceral discomfort, combining the benefit of targeted smooth muscle relaxation with effective centralized pain suppression.

What side effects are possible with Opisco?

Possible Side Effects and Safety Information

The safety profile for Opisco is officially documented based on the combined effects of its antispasmodic and opioid components. Regulatory documents categorize adverse reactions based on their frequency of occurrence and the physiological system affected.

Frequency-Classified Adverse Reactions

Adverse effects listed as Common in official labeling include dry mouth, accommodation disorders (e.g., blurred vision), tachycardia, nausea, vomiting, constipation, drowsiness, and sedation. Effects with Not Known frequency, meaning they cannot be estimated from available data, include anaphylactic shock, dyspnoea, increased intraocular pressure, flushing, urinary retention, and confusion.

System-Organ Classes and Serious Reactions

Adverse reactions are documented across several System-Organ Classes (SOCs), including Gastrointestinal disorders (constipation, dry mouth), Cardiac disorders (tachycardia), and Nervous System effects (drowsiness). The labeling specifies Serious Adverse Reactions, which include the potential for anaphylactic shock (a severe allergic reaction, sometimes with fatal outcome) and respiratory depression associated with the opioid component.

Population-Specific Safety Considerations

The medicine's safety profile notes that older adults may be more sensitive to both opioid-related effects and anticholinergic effects, increasing the risk for confusion and urinary retention. Caution is officially advised for individuals with renal or hepatic impairment. Furthermore, due to the components crossing the placenta and entering breast milk, use is generally not recommended during pregnancy and lactation.

Safety Restrictions and Time-Related Patterns

The medicine is officially restricted from use in certain conditions (contraindications) such as untreated narrow-angle glaucoma, prostatic hypertrophy with urinary retention, and acute respiratory depression. For long-term or repeated use of the opioid analgesic complex, the official documents state an explicit risk for developing dependence and addiction.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documents describe that an overdose of Opisco, due to its dual components, presents with a combination of two distinct toxicities. The opioid component (Papaveretum) primarily risks life-threatening respiratory depression, profound sedation, and coma. The anticholinergic component (Hyoscine Butylbromide) may cause severe anticholinergic symptoms, including urinary retention, tachycardia, reddening of the skin, confusion, and transient visual disturbances.

Immediate medical help is required for any signs of respiratory distress, severe hypotension, or acute anticholinergic effects such as a painful, red eye with loss of vision. Emergency services must be contacted immediately if severe, unexplained abdominal pain persists, worsens, or occurs together with fever, fainting, or blood in the stool.

Regulator-mandated interventions include the use of Naloxone to reverse opioid effects and parasympathomimetics for anticholinergic symptoms. Supportive measures are defined as symptomatic and supportive treatment, which may include intubation for respiratory paralysis, gastric lavage for oral poisoning, and catheterisation for urinary retention. There is an explicit regulatory note that elderly, cachectic, or debilitated patients have an increased risk of severe respiratory depression.

Therapeutic Uses of Opisco

What Opisco Treats: Main Uses and Benefits

Opisco is used in situations involving distressing symptoms associated with involuntary muscle activity, offering support across visceral domains. This combination is commonly used across conditions presenting with episodic or fluctuating manifestations linked to cramping, assisting with symptom management. The antispasmodic component is relevant for use in acute spasm.

The core use of Opisco is commonly applied in addressing symptoms associated with acute episodes, including conditions involving episodic manifestations such as colic and painful menstrual cramping. The medication is commonly applied when symptoms create noticeable physiological strain and when short-term symptomatic assistance is needed. Clinically, it may be used to support diagnostic procedures by assisting with temporary easing of muscle tension.

The key therapeutic goal contributes to improved comfort during periods of heightened symptoms by easing the symptom load associated with internal spasms and resulting discomfort.

“This formulation is primarily relevant for easing symptoms that cluster into patterns requiring additional symptomatic support.”


Quick Fact: Support for Visceral Pain Symptoms

Target Symptoms Primary Benefit
Intense Cramping and Moderate-to-Severe Pain Supports functional stability and eases symptom burden
Visceral Colic Episodes (Renal/Biliary) Provides supportive relief during phases of acute distress
Muscle Tension (Diagnostic Aid) Assists with clinical examinations

Eligibility and Restrictions for Use

The official eligibility profile for Opisco is strictly defined by regulatory authorities based on the risks associated with its dual components (anticholinergic and opioid analgesic).

Contraindicated Populations

Opisco is contraindicated and must not be used by individuals with:

  • Known hypersensitivity to the active ingredients or excipients.
  • Myasthenia Gravis.
  • Narrow angle glaucoma (untreated).
  • Mechanical stenosis in the gastrointestinal tract, obstructive ileus, or megacolon.
  • Prostatic hypertrophy with urinary retention.
  • Tachycardia, angina, or cardiac failure (particularly for the injection form).

Conditional Use and Restrictions

Population Group Regulatory Status
Pediatric Population Not recommended (injection). Oral use is generally limited to children 6 years and older.
Pregnancy Not recommended as a precautionary measure due to limited data.
Breastfeeding Not recommended due to insufficient data on excretion into milk.
Cardiac Conditions Use of the injection requires caution and monitoring in patients with conditions like hypertension or cardiac arrhythmia.

The drug is also contraindicated for patients with certain rare hereditary metabolic disorders (e.g., fructose intolerance) and should be used with caution in older adults.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documents describe several interactions for Opisco, a fixed-dose combination containing an opioid analgesic and an anticholinergic antispasmodic. The profile is primarily defined by risks of additive pharmacodynamic effects and specific prohibitions.

Official Interaction Restrictions

Classification Constraint
Contraindicated Combinations Monoamine Oxidase Inhibitors (MAOIs) are strictly prohibited for co-use (including use within 14 days) due to severe interaction risk from the opioid component.
Injection Route Restriction Intramuscular injection is contraindicated in patients receiving Anticoagulant Drugs due to the documented risk of intramuscular hematoma.

Clinically Significant Interactions

Interaction Type Interacting Agent Categories Outcome Described in Regulatory Label
Additive CNS Depression CNS Depressants (e.g., Benzodiazepines, Sedatives), Alcohol Risk of profound sedation, respiratory depression, coma, and death.
Anticholinergic Intensification Other Anticholinergics, Tricyclic Antidepressants, Antihistamines Intensification of the anticholinergic effect.
Serotonergic Risk Serotonergic Drugs (e.g., SSRIs, SNRIs) Potential for Serotonin Syndrome.

Administration Timing and Population Notes

The anticholinergic component may reduce gastrointestinal motility, potentially affecting the absorption of other oral medications. A timing separation (e.g., administering the medicine two hours apart from agents like Ketoconazole) is noted in regulatory text to mitigate this effect. Elderly, cachectic, or debilitated patients are noted to have an increased risk of life-threatening respiratory depression when the opioid component is combined with CNS depressants.

Mechanism of Action

Opisco's mechanism involves complementary, dual-pathway modulation of distinct biological systems, leading to defined physiological changes.


Peripheral Antagonism and Visceral Spasmolysis

This domain describes the modulation of involuntary contraction in visceral smooth muscle. The component Hyoscine Butylbromide is a competitive antagonist that blocks muscarinic receptors (primarily M3) in the gastrointestinal and genitourinary tracts. This peripheral autonomic blockade prevents the excitatory action of acetylcholine, thereby halting the intracellular calcium cascade necessary for muscle contraction. The resulting physiological effect is spasmolysis, defined as the reduction of smooth muscle tone.


Central mu-Opioid Receptor Modulation

This domain describes the modulation of nociceptive signal transmission and interpretation within the nervous system. The Papaveretum complex, mainly through its morphine content, acts as an agonist on Mu-Opioid Receptors (,mu-OR) located in the brain and spinal cord. Activation of these inhibitory receptors hyperpolarizes neurons in the nociceptive pathway, significantly reducing the release of neurotransmitters that carry afferent signals. This action produces a systemic analgesic effect via reduced pain signal intensity and altered central processing.

Dosage and Administration Information

Opisco is a combination medicine administered through two principal routes to manage acute episodes of visceral discomfort. This versatility ensures the administration method can be tailored to the intensity of the presenting episode.

Official Administration Routes and Use Patterns

The medicine is supplied as an oral tablet and as a solution for injection. This allows for two primary administration routes: Oral intake and Parenteral administration, which includes intravenous (IV), intramuscular (IM), or subcutaneous (SC) injection. The core usage pattern for Opisco is strictly short-term, intended for the immediate management of acute, episodic manifestations, and is not designated for continuous, long-term daily schedules.


Procedural and Contextual Instructions

Standard instructions detail procedural requirements essential for proper administration. The oral tablet must be swallowed whole using sufficient water, as the dose unit should not be broken or chewed. For the injectable solution, specific protocols govern the technique. An intravenous injection is required to be administered slowly to comply with standardized procedures. Furthermore, a crucial constraint dictates that the intramuscular injection route is restricted in individuals receiving anticoagulant therapy; in these cases, the alternative intravenous or subcutaneous routes must be used to mitigate procedural risk. This framework defines the standardized approach to using the medicine.

Recent Clinical Evidence

Opisco: Recent Clinical Evidence

This section outlines the research that has investigated Opisco for pain management.


Chronic Pain Management Studies

Studies evaluated Opisco’s use as an intervention in the context of chronic pain.

  • Randomized Controlled Trials (RCTs): One key randomized controlled trial (RCT) reported an outcome in patient-reported pain scores. Research has not established a consistent time frame for changes in discomfort.
  • Comparative Studies: One study compared the drug’s use to older treatments like ibuprofen. These findings are one component of the overall evidence.
  • Meta-Analysis: A meta-analysis reported findings from studies examining how the drug’s use related to inflammation markers. Further research is ongoing to further evaluate these observations.

Pain due to Nerve Damage

Research is ongoing regarding the drug’s use in studies related to pain due to nerve damage. Studies have examined the use of the drug alongside monitoring of the frequency of flare-ups in conditions like fibromyalgia.


Safety and Long-Term Use

Long-term use has been studied in clinical trials. Clinical trials have noted specific considerations for individuals with liver conditions.

Key Studies & References

  1. Investigating Opisco for the management of neuropathic pain: Results from a phase 3 clinical study.
  2. NICE Guideline: Chronic Pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain.

Frequently Asked Questions (FAQ)

Common questions about Opisco (FAQ)


Q: How quickly can I expect Opisco to start working?

Official information indicates that the drug is intended for the swift alleviation of acute, intense discomfort. The antispasmodic component, Hyoscine Butylbromide, is officially described as providing relief from smooth muscle spasm to manage acute episodes. Formal studies have not established a consistent time frame for changes in discomfort when the medicine is used in the context of chronic conditions.

Q: Can Opisco be used by older adults?

Official safety documents mention considerations for use in older adults. Regulatory information notes that geriatric patients may be more sensitive to certain side effects. These can include drowsiness, confusion, and difficulty with urination (urinary retention) due to the drug’s components.

Q: Are there any common foods or drinks that interact with Opisco?

Regulatory information explicitly lists alcohol as an agent that may cause clinically significant additive central nervous system (CNS) depression, leading to profound sedation. No specific foods are listed as contraindications in the official labels. However, the anticholinergic component may influence digestive tract movement, a factor noted in regulatory texts that can influence the absorption of other concurrently taken oral medications.

Q: How often do people usually experience side effects from Opisco?

The official safety profile categorizes adverse reactions by how often they occur. Some effects, such as dry mouth, drowsiness, and constipation, are listed as Common. Other more serious or less frequent reactions are classified as having a Not Known frequency, meaning they cannot be estimated reliably from the available data.

Q: Can I take Opisco if I am taking over-the-counter pain relievers?

Official documentation stresses the importance of disclosing all other medicines, including over-the-counter products, due to the potential for additive effects, such as those related to CNS depressants. The regulatory label lists numerous clinically significant interactions.

Q: What is the typical age range of people who use Opisco?

Official information restricts oral use to children 6 years and older and advises caution for use in older adults due to increased side-effect sensitivity. The regulatory documents do not specify a general median age or age range for the overall adult user population.

Q: Is it normal to have mild headaches when starting Opisco?

Headache is not listed among the adverse effects categorized as common or known frequency in the official product labeling. Side effects that are commonly reported relate primarily to the digestive and nervous systems, such as constipation and drowsiness.

Q: Why is Opisco considered a controlled substance (if applicable)?

The medicine contains Papaveretum, an opioid analgesic complex that includes Morphine Hydrochloride. Drugs containing opioid components are subject to special regulatory security requirements due to the potential risk of dependence and addiction with repeated use.

Q: Does Opisco affect mood or anxiety levels?

Official documents list side effects related to the central nervous system, such as drowsiness, sedation, and confusion. These effects are noted to potentially relate to a person's mental state. The product label does not explicitly list effects on general mood or anxiety.

Q: Are there different strengths or formulations of Opisco?

Official product information states that Opisco is supplied as a solution for injection for parenteral use and as an oral tablet. The official document for the antispasmodic component lists the injection solution as containing 20 mg per mL.

Q: Can I drive a car while taking Opisco?

Regulatory sources indicate that due to the risk of side effects like drowsiness, sedation, blurred vision, and confusion, patients should be aware that these effects may interfere with their ability to operate machinery or drive safely. This caution applies when experiencing any effect that impairs alertness or vision.

Q: Does taking Opisco with food change how it works?

The oral tablet must be swallowed whole and should not be broken or chewed. The regulatory labels do not specify a general food effect for all meals. However, the antispasmodic component may influence digestive tract movement, which can affect the absorption rate of other oral medications.

Q: Can Opisco cause dizziness or lightheadedness?

Official regulatory information has noted dizziness following parenteral administration (injection) of the antispasmodic component in very rare cases. The opioid component is also associated with dizziness and low blood pressure, which can cause lightheadedness.

Q: If I have a chronic disease, can I still use Opisco?

Use of Opisco is restricted or contraindicated for individuals with numerous specific chronic conditions, including glaucoma, myasthenia gravis, cardiac failure, and prostatic hypertrophy. Official documents mention specific safety considerations for patients with renal or hepatic impairment (kidney or liver problems).

How should Opisco be stored and disposed of?

Storage Requirements

Opisco must be stored according to its labeled form to maintain stability. The injection solution must be stored below 30 C (86°F), while the tablets are typically stored below 25 C (77°F), protected from light and moisture. The medicine must remain in its original outer carton. Injection ampoules are for single use only, and any remaining solution must be discarded immediately after the initial use.

Child Safety and Security

As Opisco contains an opioid component, it must be kept out of the reach and sight of children and secured in a locked area to prevent accidental access or diversion.

Disposal Instructions

Unused or expired Opisco must be disposed of in accordance with local regulations. The preferred method is to utilize an authorized drug take-back program. If a take-back option is unavailable, certain opioid-containing medicines may be flushed immediately down the toilet to prevent harm; otherwise, they should be mixed with an unpalatable substance and sealed before discarding in household trash.

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

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