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Spasmine Forte

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Spasmine Forte

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Medically reviewed

Marina Burgos

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.

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Overview of Spasmine Forte

What is Spasmine Forte? Defining its Core Identity

Property Description
Active ingredient Alverine (typically as Alverine citrate)
Form Hard capsule
Pharmacological class Musculotropic spasmolytic agent
Common purpose Relief of smooth muscle spasm
Origin Synthetic compound

Spasmine Forte is a prescription-only oral medicine formulated as a hard capsule, used to relieve pain and tension caused by internal muscle spasms. It is fundamentally defined as a single-ingredient, or monotherapy, product centered around the active substance Alverine, a synthetic chemical compound. This medicine is clinically recognized for its utility in addressing gastrointestinal discomfort originating from muscle contraction.

The medicine is classified as a musculotropic spasmolytic agent, meaning its therapeutic action is focused specifically on the smooth muscle tissues of organs such as the intestines, biliary tract, and bladder. Its principal component works directly on these muscle cells to induce smooth muscle relaxation, addressing the physical cause of the cramping sensation. The direct mechanism is often preferred in the management of painful smooth muscle spasms where inflammation is not the primary factor.

The core efficacy of Spasmine Forte stems from its sole active ingredient, Alverine, which is responsible for providing relief by eliminating involuntary, painful muscle contractions known as spasms. Alverine acts directly on the muscles to produce an antispasmodic effect, contrasting with pain relievers that simply block pain signals. This provides a targeted approach to managing the physical sensation of cramping.

The designation "Forte" included in the product name is an indication that this formulation contains a higher content or concentration of the Alverine active ingredient compared to standard versions, reflecting its identity as a specific, standardized pharmaceutical preparation.

Regulatory References

  1. NIH LactMed Database
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What side effects are possible with Spasmine Forte?

Possible side effects and safety information for Spasmine Forte

Spasmine Forte contains alverine citrate and is generally considered well-tolerated. However, regulatory documents state that the frequency of most adverse reactions is Not Known (cannot be estimated from the available data).

Adverse Reaction Profile

System Organ Class Adverse Reactions (Frequency: Not Known)
Immune System Anaphylaxis, allergic reaction
Hepatobiliary Jaundice due to hepatitis, abnormal liver function tests
Nervous System Dizziness, headache
Gastrointestinal Nausea
Skin Rash, itching
Respiratory Dyspnoea (shortness of breath) and/or wheezing

Serious Adverse Reactions (documented in regulatory sources) include life-threatening allergic reactions like anaphylaxis and hepatitis (inflammation of the liver), which typically resolves upon cessation of the medication. Affected individuals should seek immediate medical attention if signs of a serious reaction, such as yellowing of the skin or eyes (jaundice), swelling, or severe difficulty breathing, occur.

Safety Restrictions and Contraindications

  • Contraindications: Use is strictly prohibited in patients with paralytic ileus, intestinal obstruction, or known hypersensitivity to the active substance or excipients.
  • Population-Specific: Use is not recommended during pregnancy or lactation due to insufficient safety data. The medicine is not recommended for children under 12 years of age.
  • Driving/Operating Machinery: As dizziness may occur, individuals should exercise caution or avoid driving and operating machinery until they know how the medication affects them.
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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes overdose with Spasmine Forte (Alverine citrate) as having the potential to cause severe, systemic toxicity, primarily categorized as atropine-like toxic effects. These documented effects are based on the product’s regulatory profile and necessitate immediate emergency response.

Documented Overdose Manifestations

Classification Manifestations Listed in Official Sources
Cardiovascular/Hemodynamic Hypotension (low blood pressure), Fast heart rate
Central Nervous System Confusion, Hallucinations, Dizziness
Other Systemic Effects Blurred vision, Dilated pupils, Dry mouth, Nausea

Required Emergency Action

Official prescribing information clearly states that a suspected overdose is a medical emergency. If too many Spasmine Forte capsules are taken, you must contact your doctor or nearest hospital emergency department immediately.

Overdose with very high doses carries a documented risk of fatality, reinforcing the need for immediate intervention. The management protocol required in the event of an overdose is structured similarly to that for atropine poisoning, which includes providing supportive therapy for hypotension and monitoring the patient’s condition. You should take the original packaging and any remaining capsules with you to the hospital to assist medical professionals with treatment assessment.

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Therapeutic Uses of Spasmine Forte

What Spasmine Forte Treats: Main Uses and Benefits

Spasmine Forte is considered relevant for managing symptoms related to heightened physiological activity and symptoms of increased neurological or muscular activity, particularly affecting the internal organs. This use is relevant for easing the overall symptom burden, and it may assist with maintaining functional stability when symptoms interfere with routine activities.

The main therapeutic domain of the active ingredients, such as phloroglucinol, is as a spasmolytic agent. Phloroglucinol is classified under drugs for functional gastrointestinal disorders. This classification is considered relevant in therapeutic areas that involve certain distressing symptoms associated with functional gastrointestinal issues. It is commonly used to help manage symptoms that become more disruptive during flare-ups in conditions involving spasms of the digestive system (like Irritable Bowel Syndrome), the urinary tract (such as renal colic), the biliary tract (e.g., hepatic colic), and the uterus (like painful menstruation). Generally, this medication may assist with managing symptom clusters that may become intense or disruptive. As a supportive measure, it contributes to easing the overall symptom load, and may help patients cope more steadily with symptom fluctuations.

Quick Fact: Relief for Symptoms of Increased Neurological or Muscular Activity

Regulatory References

  1. phloroglucinol is classified under drugs for functional gastrointestinal disorders
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Eligibility and Restrictions for Use

Who can and cannot use Spasmine Forte?

This information is based on official government regulatory documents (e.g., FDA, EMA) for the active ingredient Phentermine HCl, which is commonly associated with potent formulations.

Populations for whom use is Contraindicated (Must Not Use)

Classification Exclusion Criteria (Must Not Use)
Cardiovascular/Ocular History of coronary artery disease, uncontrolled hypertension, stroke, arrhythmias, congestive heart failure, or glaucoma.
Endocrine/Psychiatric Hyperthyroidism, agitated states, or a history of drug abuse.
Physiological State Pregnancy (Category X) and nursing mothers.
Co-Medication Concurrent use of, or use within 14 days of, Monoamine Oxidase Inhibitors (MAOIs).

Restricted and Conditional Use

Official labeling defines specific limits for certain groups:

  • Pediatric Use: Safety and effectiveness have not been established. The medicine is not recommended for patients 16 years of age or younger.
  • Renal Impairment: Avoid use in patients with estimated Glomerular Filtration Rate (eGFR) less than 15 mL/min/1.73m^2. Dose adjustments are required for patients with severe renal impairment.
  • Geriatric Patients: Use with caution due to a greater likelihood of decreased organ function.
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What should I know about interactions with other medicines?

Spasmine Forte Interactions with other medicines and products

The official interaction profile for Spasmine Forte (Alverine) is determined by its status in regulatory documents, which generally state that available data do not suggest the existence of clinically significant interactions with other medicinal products. This classification dictates the formal structure of the interaction information.

Interaction Category Official Regulatory Status
Contraindicated Combinations None documented.
Pharmacokinetic Interactions (CYP/Transporter) Not documented as clinically significant.
Pharmacodynamic Interactions None documented.
Timing/Separation Requirements None documented.
Food/Alcohol/Herbal Products No clinically significant interaction with food documented.

Official Interaction Statements

  • The regulatory prescribing information for Spasmine Forte does not list any specific medicinal products that are formally prohibited or contraindicated for co-administration.
  • Regulatory data do not identify clinically significant pharmacokinetic mechanisms such as major CYP-enzyme inhibition or transporter-mediated effects.
  • No mandatory administration timing rule, such as required dose separation, is specified in the official labeling.
  • The product’s labeling confirms that there is no documented interaction with food, allowing for administration regardless of meals.

Connection to the overall interaction profile

The official regulatory documentation for this product structures its interaction profile primarily by the formal finding that no specific drug-drug or drug-substance interactions were determined to be clinically significant enough to require enumeration. This results in an interaction section that does not contain specific restrictions or warnings regarding exposure-modifying effects or formal pharmacodynamic risks.

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Mechanism of Action

The mechanism of action of Spasmine Forte primarily involves dual-pathway modulation to induce smooth muscle relaxation, focusing on the reduction of visceral hypercontractility.

One core mechanistic domain is the antagonism of muscarinic cholinergic receptors, specifically the M3 subtype, located on the smooth muscle cells of the gastrointestinal and urinary tracts. The active agent binds competitively, preventing the neurotransmitter acetylcholine from initiating the Gq-protein signaling cascade. This action blocks the neural drive from the parasympathetic nervous system that promotes muscle contraction.

The second domain is direct spasmolysis, which involves interfering with the excitation-contraction coupling process at the cellular level. This component modulates intracellular signaling, often by affecting calcium ion ( Ca^2+) availability or by influencing intracellular messenger pathways. The resulting physiological consequence of both mechanisms is the reduction in free intracellular Ca^2+, leading to a generalized lowering of muscle tone and decreased motility in the affected visceral smooth muscle.

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Dosage and Administration Information

The administration of Spasmine Forte, formulated as a 120 mg hard capsule, is for oral use. The capsule is intended to be swallowed whole with water and must not be crushed, chewed, or opened prior to intake.

Standard Dosing and Frequency

The standard dose for adults is one capsule (120 mg of Alverine citrate) taken per instance. This single dose may be administered one to three times daily, based on the required pattern of use. The total intake over a 24-hour period must not exceed three capsules, equating to a maximum of 360 mg. The administration schedule is flexible regarding food, and the capsule may be taken before or after meals.

Population and Duration Guidance

The dosing regimen for older adults is identical to the standard adult dose, with no need for routine modification. Conversely, the use of this formulation is not recommended for pediatric patients under the age of 12 years. Regarding the duration of use, the administration is typically short-term; if symptoms show no improvement after a period of 2 weeks of administration, a health professional should be consulted for re-evaluation. If a dose is forgotten, the standard procedure is to skip the missed dose entirely and resume the schedule with the next planned dose; a patient must never take a double dose to compensate for the skipped amount.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Spasmine Forte

The clinical understanding of Spasmine Forte, which contains the active ingredient Alverine, is built upon research that primarily was evaluated in research exploring how symptoms change over time. Research documentation includes randomized controlled trials (RCTs), systematic reviews, and evidence recognized by regulators.


Evidence for Use in Irritable Bowel Syndrome (IBS) Symptoms

Research has explored Alverine in the context of symptoms associated with Irritable Bowel Syndrome (IBS), focusing on adult patients. Studies applied in trials assessing short-term symptom patterns used controlled designs comparing Alverine against placebo. Outcomes related to patient-reported outcomes describing perceived discomfort (such as abdominal pain frequency) were measured. Findings for Alverine monotherapy data show patterns related to symptom evolution that were statistically similar to the placebo response observed in the same trial populations, meaning the findings were mixed. Other research exploring combination products that include Alverine described findings that differed in symptom measures compared to placebo.


Evidence for Other Spasm Indications and Study Duration

Alverine was evaluated in research exploring symptoms associated with painful diverticular disease of the colon and primary dysmenorrhoea (painful menstruation). For these applications, the evidence often draws heavily from documentation that acknowledges the agent's classification and its status as classified by regulators. The majority of clinical research has been conducted over relatively limited time intervals, with follow-up durations typically ranging from approximately four weeks to an intermediate term of up to twelve weeks. Long-term effects are not fully established.


Evidence Gaps and Uncertainty

Research has focused on the general adult population, and studies examined whether it was observed in the elderly population. However, data for certain groups remain insufficient, with comparative evidence lacking for pediatric populations and specific comorbidity groups. Key limitations include the aforementioned mixed findings from monotherapy trials and the challenge posed by the high placebo response rate. The available evidence, therefore, findings describe patterns observed in the studies, indicating that research is ongoing.

Key Studies & References

  1. Summary of Product Characteristics (SPC) for Alverine citrate
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Frequently Asked Questions (FAQ)

Common questions about Spasmine Forte (FAQ)

Q: What is Spasmine Forte?

Spasmine Forte is a medication containing phloroglucinol and trimethylphloroglucinol, which belong to a class of drugs called spasmolytics. These substances are used to help relieve muscle spasms (cramps) in various organs, such as the digestive tract, biliary system, or urinary tract. It is typically prescribed to treat the symptoms of spasmodic pain.

Q: How does Spasmine Forte work to relieve pain?

Spasmine Forte works by acting directly on the smooth muscles of the body's internal organs. Smooth muscles are found in the walls of the intestines, bladder, and bile ducts. When these muscles contract involuntarily, they cause a spasm and result in pain. Phloroglucinol and trimethylphloroglucinol help to relax these muscles, which in turn relieves the painful cramps or spasms.

Q: What are the main uses of Spasmine Forte?

Spasmine Forte is primarily used to manage and relieve pain associated with muscle spasms in several areas:

  • Gastrointestinal tract: Used for conditions like irritable bowel syndrome or intestinal cramps.
  • Biliary system: Used for spasms related to gallbladder or bile duct issues.
  • Urinary tract: Used for spasms affecting the bladder or kidneys, such as renal colic.

It is used to treat the symptoms of the spasm, not the underlying cause.

Q: Who should not take Spasmine Forte?

Spasmine Forte should not be taken by individuals who have a known allergy or hypersensitivity to phloroglucinol, trimethylphloroglucinol, or any of the other ingredients in the formulation. It is important to always inform your healthcare provider of any past allergic reactions to medications.

Q: Can I take Spasmine Forte if I am pregnant or breastfeeding?

It is essential to consult your doctor before taking Spasmine Forte if you are pregnant, planning to become pregnant, or are breastfeeding. While studies may indicate a favorable safety profile, all medication use during these periods must be weighed against the potential risks. Your healthcare provider will determine if the potential benefit justifies the potential risk to the fetus or infant.

Q: Does Spasmine Forte interact with other medications?

Like many medications, Spasmine Forte has the potential to interact with other drugs. It is crucial to inform your doctor or pharmacist about all other medicines you are currently taking, including prescription drugs, over-the-counter medicines, and herbal supplements. Specifically, it is generally not recommended to combine Spasmine Forte with strong pain relievers (analgesics) of the morphine type, as these can potentially counteract the effect of the spasmolytic action.

Q: What are the common side effects of Spasmine Forte?

Spasmine Forte is generally well-tolerated. However, like all medicines, it can cause side effects, although not everyone gets them. Common side effects may include skin reactions such as rash, hives, or itching. In rare cases, more severe allergic reactions (e.g., angioedema) may occur. If you experience any unexpected or severe reactions, you should seek immediate medical attention.

Q: How should I store Spasmine Forte?

You should store Spasmine Forte as instructed on the packaging or by your pharmacist. Typically, it should be stored at room temperature, away from heat and moisture, and kept out of the sight and reach of children.

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How should Spasmine Forte be stored and disposed of?

How to Store and Dispose of Spasmine Forte

Storage and disposal of Spasmine Forte (Alverine Citrate) must adhere strictly to the conditions specified in the official regulatory labeling.

Official Storage and Handling

The medicine must be stored below 25 C to maintain product stability. To ensure product integrity, the capsules must be kept in their original container until use. You must not use the medicine after the expiry date shown on the packaging.

Child Safety and Disposal Requirements

Safety guidelines mandate that Spasmine Forte must be kept out of the sight and reach of children and pets at all times. Regarding disposal, the official instructions are to not throw away the medicine via household waste or wastewater. Unused or expired product must be discarded properly through a local pharmacy take-back program or other recognized pharmaceutical waste disposal system.

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

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