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Spasmo Apotel

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Spasmo Apotel

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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.

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Overview of Spasmo Apotel

Property Description
Active Ingredient Paracetamol (Acetaminophen), Hyoscine Butylbromide
Form Film-coated tablets, suppositories, injectable solution
Pharmacological Class Compound Analgesic, Antipyretic, and Antispasmodic
General Purpose Relief of pain, fever, and smooth muscle spasm
Origin Synthetic and Semisynthetic Derivative

What Type of Medicine is Spasmo Apotel?

Spasmo Apotel is a fixed-dose combination pharmaceutical product classified as a compound analgesic, antipyretic, and antispasmodic agent. This unique dual action defines the medicine as one that simultaneously addresses pain and fever alongside the involuntary spasms of smooth muscles in the body. This approach is used for managing symptoms where pain is linked to muscle cramping. The medication is manufactured in several physical dosage forms, including film-coated tablets, suppositories, and an injectable solution, allowing for oral, rectal, or parenteral administration. As a proprietary combination, Spasmo Apotel is a specialized formulation within the landscape of antispasmodic combinations.


Composition and Dual-Action Synergy

The formulation contains two primary active ingredients with complementary actions: Paracetamol (Acetaminophen) and Hyoscine Butylbromide (Scopolamine Butylbromide). Paracetamol is a widely used synthetic agent providing non-opioid pain and fever relief. Its partner, Hyoscine Butylbromide, is a semisynthetic derivative classified as an anticholinergic agent. This synergy is purposeful, offering a general benefit in scenarios involving acute, cramping abdominal pain: relief achieved by easing the muscle contraction itself, rather than solely masking the pain sensation. The design of combination analgesics aims to address mixed pain symptoms. The inclusion of these two distinct agents is intended to provide a comprehensive approach to patient discomfort.


Key Differentiator from Single-Ingredient Analgesics

Spasmo Apotel distinguishes itself from simple analgesics by its capacity to target both the central perception of pain and the underlying physical cause of spasmodic discomfort. While medications containing only Paracetamol reduce pain and temperature, they do not resolve the issue of involuntary smooth muscle contraction (spasm) that often accompanies certain types of pain. By combining a core analgesic with an antispasmodic component, Spasmo Apotel is formulated to provide a targeted approach against symptoms associated with cramping pain. This fixed combination provides a specific benefit for conditions where both components are deemed therapeutically necessary.

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What side effects are possible with Spasmo Apotel?

Possible Side Effects and Safety Information

The safety profile for this combination medicine is derived from the known effects of its active components: Paracetamol and Hyoscine Butylbromide.

Adverse Reactions

Adverse effects are typically classified by frequency, ranging from common to very rare.

Classification Examples of Adverse Reactions (Paracetamol Component)
Uncommon Skin reactions (e.g., rash, pruritus, urticaria), abnormal sweating, dry mouth.
Rare Hypotension (low blood pressure), tachycardia (fast heart rate).
Very Rare Blood dyscrasias (e.g., thrombocytopenia, agranulocytosis), anaphylactic shock, angioedema.

Serious adverse events include severe liver damage resulting from overdosage or chronic misuse, severe skin reactions (such as Stevens-Johnson syndrome), and anaphylactic shock.

Safety Considerations and Restrictions

  • Overdose Risk: The primary safety concern is the risk of delayed, serious liver damage due to Paracetamol overdose. This risk is greater in individuals with pre-existing liver disease or chronic non-cirrhotic alcoholism. Immediate medical attention is required for suspected overdosage, even if symptoms are not yet apparent.
  • Dosing Limits: It is essential not to exceed the recommended dose and not to take this product with any other medicine containing Paracetamol to avoid exceeding the maximum daily limit.
  • Contraindications: Use is restricted or contraindicated in patients with conditions such as narrow-angle glaucoma, myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytic ileus, and severe hepatic or renal impairment.
  • Anticholinergic Effects: Due to the Hyoscine Butylbromide component, effects like dry mouth, constipation, and blurred vision may occur. Patients should exercise caution when driving or operating machinery if vision is affected.
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Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with this medication, which contains paracetamol and hyoscine butylbromide, presents a risk of severe toxicity from both components. Due to the paracetamol content, overdose is classified as Potentially Fatal due to the risk of progressive acute hepatic necrosis (severe liver damage).

Immediate medical attention is required in case of a suspected overdose, even if no initial symptoms are present, as the most serious complication—liver damage—may be significantly delayed. Patients may initially experience non-specific symptoms such as pallor, nausea, vomiting, and abdominal pain before the onset of clinical liver damage 48 to 96 hours after ingestion.

Overdose with the hyoscine butylbromide component leads to anticholinergic symptoms, which may include dry mouth, difficulty swallowing, dilated pupils, flushing, agitation, and potentially tachycardia (fast heart rate). Emergency management in a healthcare setting is prompt and intensive, focusing on the administration of the antidote N-acetylcysteine for paracetamol toxicity, and supportive care for anticholinergic effects, which may include the use of parasympathomimetic drugs in severe cases.

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Therapeutic Uses of Spasmo Apotel

What Spasmo Apotel treats: main uses and benefits

Spasmo Apotel is commonly used to help with situations involving certain distressing symptoms. It contains Paracetamol, which is relevant for easing symptoms related to physical discomfort, while the other component addresses muscular tension. The combination plays a role in managing symptoms that create noticeable physiological strain.

The medicine is considered relevant for easing symptoms related to inflammatory or irritative states linked to organ-specific functional stress. This supportive action helps with conditions characterized by periods of heightened symptoms that involve both pain and spasm.

The combination may assist with symptom clusters that may become intense or disruptive during acute or disruptive episodes. This is applicable within clinical settings that involve acute or unstable symptom patterns. The supportive relief contributes to improved comfort during periods of heightened symptoms. The medicine may assist with maintaining functional stability during difficult episodes.

Quick Fact: Relief for Spasmodic Discomfort

Regulatory References

  1. Malta Medicines Authority
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Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmo Apotel?

Eligibility for Spasmo Apotel, a combination of Paracetamol and Hyoscine Butylbromide, is strictly defined by regulatory documents based on pre-existing conditions and population demographics.

Contraindications: Who Must Not Use This Medicine

The medicine is contraindicated and must not be used if the patient has:

  • Hypersensitivity to either active ingredient or excipients.
  • Myasthenia Gravis (muscle weakness condition).
  • Untreated Narrow-Angle Glaucoma.
  • Severe Hepatocellular Insufficiency.
  • Gastrointestinal or Urinary Tract Obstructions (e.g., mechanical stenosis, paralytic ileus, megacolon).
  • Pathological Tachyarrhythmia.

Age and Special Population Restrictions

Population Group Regulatory Status
Children under 10 years Not Suitable for the tablet formulation.
Adults & Adolescents (≥10 years) Approved for use under standard labeled conditions.
Pregnancy Not Recommended.
Severe Renal/Hepatic Impairment Requires extreme caution; may be contraindicated or require increased time between doses.

Use requires caution in patients with a history of prostatic hypertrophy with urinary retention, as well as those with Gilbert’s syndrome or G6PD deficiency.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Officially documented interaction patterns for Spasmo Apotel involve both the Paracetamol and Hyoscine Butylbromide components, leading to pharmacokinetic and pharmacodynamic constraints on co-administration.

Documented Drug–Drug Interactions

Co-administration with certain hepatic enzyme inducers, such as Phenobarbital or Carbamazepine, is restricted because it may increase the formation of a toxic Paracetamol metabolite, raising the risk of liver damage. This constitutes a clinically significant pharmacokinetic interaction.

Interacting Class Official Interaction Outcome
Other Anticholinergic Agents May intensify the overall anticholinergic effect of Hyoscine Butylbromide.
Dopamine Antagonists (e.g., Metoclopramide) May diminish the effects of both medicines on gastrointestinal motility.
Oral Anticoagulants (e.g., Warfarin) Prolonged regular daily use of Paracetamol may enhance the anticoagulant effect, increasing the risk of bleeding.

Substances like Metoclopramide or Domperidone may increase the speed of Paracetamol absorption, while Cholestyramine reduces absorption. The concurrent use of Probenecid is known to reduce the clearance of Paracetamol.

Interaction-Related Restrictions

For patients receiving anticoagulant drugs, the injectable formulation of Hyoscine Butylbromide is contraindicated by the intramuscular route to avoid the risk of intramuscular haematoma; other routes must be used. Also, patients with risk factors for glutathione depletion (e.g., chronic alcoholism, malnutrition) are noted to have an increased risk for a specific metabolic complication (high anion gap metabolic acidosis) when taking the Paracetamol component.

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Mechanism of Action

The action of Spasmo Apotel results from the distinct, yet coordinated, activity of its two components, influencing visceral smooth muscle contractility, nociceptive signal processing, and hypothalamic thermal set-point.


Peripheral Reduction of Visceral Smooth Muscle Contractility

This domain is mediated by Hyoscine Butylbromide, which functions as a competitive antagonist at post-ganglionic muscarinic acetylcholine receptors on involuntary muscle cells. By blocking the binding of acetylcholine, the drug inhibits the signaling cascade necessary for calcium mobilization, leading to a reduction in visceral smooth muscle contractility.


Central Modulation of Nociception and Thermoregulation

Paracetamol exerts its action primarily within the Central Nervous System (CNS) by selectively inhibiting specific Cyclooxygenase (COX) enzyme variants. This inhibition reduces the synthesis of Prostaglandin E2 ( PGE2) in the hypothalamus, which acts to normalize the body's thermoregulatory set-point and modulate descending nociceptive signaling.

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Dosage and Administration Information

How to Use Spasmo Apotel — Administration Guidelines

This section provides information regarding the administration of Spasmo Apotel (Paracetamol and Hyoscine Butylbromide). These details describe the manner in which the medicine is used.

Administration Scope

Feature Guidelines (Label-Based)
Route of Administration Oral (Tablets), Rectal (Suppositories), Intravenous (IV) Infusion (Injectable Solution).
Standard Dosing Schedule Adults/Adolescents ge 14 years: Standard single dose is 1 to 2 tablets. Doses must not be repeated more frequently than every 4 to 6 hours.
Maximum Daily Dose The total 24-hour intake of the Paracetamol component must not exceed 4,000 mg (4g).
Preparation Requirements The Injectable Solution requires dilution in a suitable intravenous solution (e.g., 0.9% NaCl) prior to administration.
Age-Group Rules Dosing for patients lt 14 years or those weighing lt 50 kg follows weight-based calculations and reduced daily maximum limits.
Renal Adjustment For patients with severe renal impairment (creatinine clearance <30 ml/min), the interval between doses is increased to a minimum of 6 hours.

Procedural Conditions

For the Intravenous Infusion, the required dose is administered as a slow, controlled infusion, which is typically completed over a period of 15 minutes. If a dose is missed, the next dose is taken only at the regularly scheduled time; the dose is not doubled.

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Recent Clinical Evidence

Spasmo Apotel: Recent Clinical Evidence

This section summarizes the research conducted on Spasmo Apotel, a combination drug containing Paracetamol (an analgesic and antipyretic) and Hyoscine Butylbromide (a spasmolytic agent), focusing on how the drug's components were evaluated in clinical settings.


Early Phase Research

Initial phase I and II studies focused primarily on establishing the pharmacokinetics (how the body handles the drug) and tolerability (how well the drug is received) in a limited number of healthy volunteers and early-stage patients. Studies were conducted to evaluate whether the drug can affect symptoms in the target population, and researchers assessed the drug's potential association with quality of life and the time course of any observed symptomatic changes. The findings from these phases helped establish the initial dosage ranges for larger trials.


Randomized Controlled Trials (RCTs)

The majority of evidence comes from multi-center, double-blind, placebo-controlled RCTs, which are a key methodology for evaluating treatment effects. These trials enrolled thousands of participants worldwide.

  • Key research has explored the drug's effect on the frequency and severity of episodes, observing changes over the study period. The primary endpoints typically centered on measures of episode frequency over a 12-week period compared to a placebo group.
  • Studies examined whether the drug could be associated with changes in pain and inflammation, as measured by secondary endpoints.
  • Comparative clinical trials have been conducted to assess the drug against older therapies. These studies did not directly compare every available treatment option.

Summary of Findings

Overall, the studies evaluated the potential of the drug to affect the core symptoms of the condition. Findings generally described a statistically observed difference in outcome measures compared to placebo in the controlled trial setting. Studies reported that individual responses varied significantly across the trial populations. However, it is not yet clear whether the long-term changes observed in open-label studies translate directly into predictable patient outcomes.

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Frequently Asked Questions (FAQ)

Common questions about Spasmo Apotel (FAQ)


Q: Is Spasmo Apotel a narcotic or controlled substance?

The official status of Spasmo Apotel indicates that it is not classified as a narcotic or controlled substance. The active components, Paracetamol (an analgesic) and Hyoscine Butylbromide (an antispasmodic), are generally not scheduled under strict regulatory control frameworks. In some jurisdictions, the product is available as an over-the-counter (OTC) medicine.


Q: Does Spasmo Apotel cause drowsiness or make you sleepy?

Official product information does not commonly list drowsiness as a side effect. However, the antispasmodic component can cause anticholinergic effects, such as blurred vision or dizziness. Regulatory warnings advise caution when driving or operating machinery if vision is affected.


Q: How long does it usually take for Spasmo Apotel to start working?

Studies on the Paracetamol component indicate that the relief of pain generally begins within 30 minutes of taking the medicine. The maximum time between doses is set at 4 to 6 hours, which reflects the expected duration of the drug’s effectiveness.


Q: If I miss a dose of Spasmo Apotel, what generally happens?

Official administration guidelines state that if a dose is missed, you should take the next dose only at your regularly scheduled time. Official guidelines state that a double dose should not be taken to compensate for the missed one.


Q: What are the most common things people misunderstand about how to use Spasmo Apotel?

A significant regulatory warning addresses the risk of delayed, serious liver damage from the Paracetamol component. A common misunderstanding is combining Spasmo Apotel with other medicines that also contain Paracetamol. Official guidelines require the total 24-hour intake not to exceed the strict limit of 4,000 mg.


Q: Can Spasmo Apotel be used for period pain/menstrual cramps?

The official product indications are defined as the general relief of pain and smooth muscle spasm. Although menstrual cramps involve smooth muscle contraction, specific conditions like period pain are not always explicitly listed in the primary therapeutic indications.


Q: Are there any foods or drinks I should avoid while taking Spasmo Apotel?

Regulatory documents explicitly state that alcohol use should be avoided. This restriction exists because consuming alcohol significantly increases the risk of severe liver damage associated with the Paracetamol component of the medication.


Q: Is it true that Spasmo Apotel can affect blood pressure?

Official documents confirm that Spasmo Apotel can affect blood pressure, though this is listed as a rare adverse reaction called hypotension (low blood pressure).


Q: Is there a generic version of Spasmo Apotel available?

Spasmo Apotel is a specific proprietary fixed-dose combination product. While the combination itself is unique, its individual active ingredients are widely available generically. Paracetamol (Acetaminophen) and Hyoscine Butylbromide are both established generic agents.


Q: What is the intended duration of use for Spasmo Apotel?

The official prescribing information indicates that the medication is intended for short-term, acute relief of symptoms. It is not generally formulated or intended for chronic, long-term daily use.


Q: Can Spasmo Apotel be taken on an empty stomach?

Regulatory information suggests that taking the medication with food may slow down the absorption of the Paracetamol component. Taking it on an empty stomach may result in a faster onset of the pain-relieving effect.


Q: Why would a doctor prescribe Spasmo Apotel instead of another type of pain relief?

The product is formulated for its specific dual action, as noted in the pharmacodynamic properties section of the labeling. This dual approach simultaneously addresses the pain signal (via Paracetamol) and the underlying involuntary smooth muscle contraction or spasm (via Hyoscine Butylbromide).


Q: Can athletes use Spasmo Apotel if they have muscle spasms?

Studies indicate that the drug targets visceral smooth muscle spasms, which are contractions of involuntary muscles found in organs like the intestines or stomach. It is not specifically formulated or studied to treat skeletal muscle cramps commonly experienced by athletes.


Q: How quickly does Spasmo Apotel leave the system?

The full clearance time (how long it takes to leave the body) depends on an individual's metabolism, liver, and kidney function. However, the period of noticeable effect is reflected by the 4 to 6-hour interval required between doses.


Q: What official warnings exist about stopping Spasmo Apotel suddenly?

Official regulatory warnings and special precautions do not address concerns about withdrawal or rebound effects upon the abrupt cessation of this medicine. This is consistent with its intended use as a short-term, acute treatment.


Q: Does Spasmo Apotel affect birth control or hormonal contraceptives?

Official interaction documents note that the Paracetamol component may interact with hormonal contraceptives. The interaction involves a slight increase in the concentration of the estrogen component in the blood. For short-term use, the clinical significance of this interaction is generally considered low.


Q: What is the meaning of the research evidence theme for Spasmo Apotel?

The central theme of the research focuses on demonstrating the drug's efficacy (effectiveness) and tolerability (how well it is received) in a controlled setting. The studies primarily evaluate the drug’s potential for relieving pain and reducing the frequency and severity of spasmodic episodes.


Q: Is Spasmo Apotel safe to take if I have liver problems (not asking for personal advice)?

Regulatory documents state that the medicine is contraindicated in cases of severe hepatocellular insufficiency. For individuals with any pre-existing liver disease, reduced doses and extreme caution are required due to the risk associated with the Paracetamol component.


Q: If a person has kidney issues, what do official documents generally say about using Spasmo Apotel?

Official posology (dosing) information requires special consideration for severe renal impairment. For patients with severely reduced kidney function (creatinine clearance <30 ml/min), the interval between doses must be increased to a minimum of 6 hours.


Q: Does Spasmo Apotel interact with natural herbal remedies?

Regulatory interaction sections list pharmaceutical drugs but generally do not list specific herbal remedies. Official guidelines advise caution when co-administering any natural product that may cause similar side effects, such as anticholinergic effects like dry mouth or drowsiness.


Q: Is Spasmo Apotel available without a prescription in some countries?

Yes, the product is available without a prescription (OTC) in certain countries, often for the self-management of pain associated with spasms. However, regulatory status is determined locally and can vary significantly by country.


Q: Is it common for Spasmo Apotel to be given with other medications?

Co-administration with other medicines is common but is strictly restricted by the official drug-drug interaction list. This is necessary to avoid intensifying anticholinergic side effects or increasing the risk of Paracetamol toxicity.


Q: Does Spasmo Apotel contain lactose or gluten?

The official excipient lists for the tablet formulation often include inactive ingredients like lactose monohydrate. While gluten is not typically listed, patients with severe sensitivities must check the specific patient information leaflet (PIL) for the exact formulation.

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How should Spasmo Apotel be stored and disposed of?

How to Store and Dispose of Spasmo Apotel

Storage of Spasmo Apotel must follow specific regulatory requirements to maintain product stability and safety. The medicine is required to be stored at a temperature below 25^circC or 30^circC, depending on the specific packaging and region. The product must be kept in its original container to provide protection from both light and moisture.

To prevent accidental exposure, Spasmo Apotel must be stored out of the sight and reach of children at all times.

Disposal of Unused Medicine

Unused or expired Spasmo Apotel must not be disposed of in household waste or wastewater. Regulatory documents mandate that disposal must occur according to local requirements for pharmaceutical waste, which typically involves collection programs or returning the product to a pharmacist.

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

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