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Meftal-Spas DPS

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Meftal-Spas DPS

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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 Meftal-Spas DPS

This foundational section provides a clear, identity-level explanation of the Dicycloverine and Simethicone oral suspension, clarifying its components, type, and general function for patients.


Quick Facts

Property Description
Active Ingredients Dicycloverine (Dicyclomine), Simethicone
Form Oral Drop Suspension (DPS)
Pharmacological Class Antispasmodic / Antiflatulent Combination
General Purpose Relieves smooth muscle cramps and gas pressure
Origin Synthetic

What Type of Medicine is Dicycloverine and Simethicone Oral Suspension?

Meftal-Spas DPS is a brand-specific, prescription-only, fixed-dose combination (FDC) product formulated as an oral drop suspension, specifically designed for administration to infants and children. The designation "DPS" typically signifies "Pediatric Drop Solution," highlighting its specialized preparation as a liquid pharmaceutical preparation suitable for the pediatric patient target audience and the oral route of administration. This structure provides a dual-action therapy in a single, measurable dose, making the product clinically recognized for its suitability in pediatric use.


Composition: Antispasmodic Agent and Antiflatulent Combination

This medicine contains two distinct synthetic active ingredients: Dicycloverine Hydrochloride and Simethicone, categorized as an antispasmodic and an antiflatulent agent, respectively. Dicycloverine (also known as Dicyclomine) is classified as an anticholinergic drug, which acts primarily as a smooth muscle relaxant. This classification confirms that the medicine works by blocking specific body signals that cause the intestinal muscles to tighten painfully. Simethicone, the second component, is a non-systemic agent that physically manages gas within the gut. Simethicone is used as an antiflatulent that reduces the surface tension of gas bubbles. This function is pharmacologically supported to help break up large gas pockets into smaller ones, easing pressure.


What is the General Purpose of This Combination?

The general purpose of this combination is to simultaneously relieve the pain caused by smooth muscle spasm and the pressure caused by trapped gas in the digestive system. The formulation is aimed at mitigating the acute discomfort associated with conditions like infantile colic, a typical use scenario where both cramping and distension contribute to general abdominal pain in its young users. By addressing both the cramping issue (via the antispasmodic agent) and the bloating issue (via the antiflatulent agent), the medicine provides comprehensive, localized relief to the affected area.

Regulatory References

  1. MedlinePlus
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What side effects are possible with Meftal-Spas DPS?

Possible Side Effects and Safety Information

This section presents the officially documented safety profile and potential side effects of Dicycloverine and Simethicone oral suspension, based strictly on government regulatory sources. As a fixed-dose combination, the safety information largely reflects the established profile of the active anticholinergic component, Dicycloverine.


Classification of Adverse Reactions by System-Organ Class

Adverse reactions primarily stem from Dicycloverine's anticholinergic nature and are classified across various system-organ classes (SOCs). Frequency classifications are based on the criteria established in official regulatory labeling.

System-Organ Class Common Adverse Reactions (Reported ge 5%) Other Documented Adverse Reactions
Gastrointestinal Disorders Dry mouth, Nausea, Constipation Vomiting, Paralytic ileus
Nervous System Disorders Dizziness, Somnolence (Drowsiness) Headache, Syncope, Lethargy
Eye Disorders Vision blurred Diplopia, Mydriasis, Increased ocular tension
Renal and Urinary Disorders None listed as Common Urinary hesitancy, Urinary retention

The most frequently reported adverse reactions include Dry Mouth, Dizziness, and Vision Blurred.


Documented Serious Adverse Reactions and Safety Constraints

Official regulatory documentation specifies a number of serious adverse reactions and safety constraints.

  • Serious Respiratory Symptoms: Administration to infants has been followed by reports of serious respiratory symptoms, including apnea and asphyxia, as well as seizures and coma. The drug is contraindicated in infants less than 6 months of age.
  • Gastrointestinal Complications: Suppression of intestinal motility may lead to paralytic ileus or precipitate toxic megacolon in individuals with ulcerative colitis.
  • Safety Restrictions: The medicine is contraindicated in individuals with obstructive uropathy, obstructive disease of the GI tract, severe ulcerative colitis, and reflux esophagitis.
  • Time-Related Patterns: The occurrence and severity of certain side effects are reported to be related to dose escalation.
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Overdose and Emergency Response

Overdose and When to Seek Help

Meftal-Spas DPS is a combination drug containing Mefenamic Acid (a nonsteroidal anti-inflammatory drug or NSAID) and Dicyclomine Hydrochloride (an antispasmodic).


Recognising Overdose Symptoms

Taking more than the prescribed dose can lead to an overdose. Since it is a combination product, symptoms may relate to either or both components.

Component Potential Overdose Symptoms
Mefenamic Acid Drowsiness, lethargy, nausea, vomiting, epigastric pain, upper gastrointestinal bleeding, acute renal failure, tremors, seizures, and coma.
Dicyclomine Blurred vision, dilated pupils, headache, dryness of mouth/skin, dizziness, confusion, excitability, hallucinations, muscle weakness, and fast heart rate (tachycardia). In severe cases, respiratory depression and loss of consciousness may occur.

When to Seek Immediate Medical Attention

Meftal-Spas DPS overdose is a medical emergency. If an overdose is suspected, or if symptoms such as severe confusion, seizures, difficulty breathing, or loss of consciousness occur, immediately contact emergency medical services or a poison control center. Treatment for overdose is supportive and symptomatic, often involving gastric emptying and general supportive measures depending on the severity and nature of the symptoms.

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Therapeutic Uses of Meftal-Spas DPS

The core therapeutic purpose of this medicine, a fixed-dose combination, is commonly used for managing symptoms related to smooth muscle spasm in the gastrointestinal tract. This dual-action formulation is commonly used across conditions presenting with acute episodes of digestive distress in pediatric patients, including Infantile Colic and Irritable Bowel Syndrome (IBS) symptoms. The antispasmodic component may assist with symptoms related to heightened physiological activity, such as spasms in the gastrointestinal tract.

The medicine helps address symptom clusters that may become intense or disruptive, specifically focusing on painful muscle spasms, abdominal cramping, bloating, and flatulence. Applied during phases of increased distress, it provides support that contributes to easing the overall symptom load of intestinal pressure and spasms. The dual action helps patients cope more steadily with difficult episodes. This combination is commonly used to provide symptomatic assistance when both cramping and gas interfere with daily comfort.


Quick Fact: Supportive Assistance for Dual Gastrointestinal Discomfort

Symptom Domain General Therapeutic Benefit
Spasmodic Pain / Cramping Helps support a more manageable experience of acute discomfort.
Intestinal Gas / Bloating Contributes to easing the overall symptom load of internal pressure.
Common Use Context Acute episodes of functional digestive upset in young children.

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Eligibility and Restrictions for Use

This section outlines the official eligibility and contraindication information for Meftal-Spas DPS (Mefenamic Acid and Dicyclomine Hydrochloride), based strictly on regulatory documents.


Eligibility and Contraindications

Classification Populations/Conditions
Contraindicated Patients with a known hypersensitivity to the drug or any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The medicine is also strictly prohibited for individuals with active ulceration or chronic inflammation of the upper or lower gastrointestinal tract, and those with pre-existing renal disease or obstructive uropathy.
Use Not Recommended Pregnancy, particularly the third trimester (due to risks to the fetus and labor). It is also not recommended for nursing mothers due to potential serious adverse reactions in the infant.
Special Caution Required The medicine should be used with caution in elderly patients (65 years and older) and those with impaired liver function, heart disease (such as heart failure or hypertension), glaucoma, prostate hypertrophy, or a history of asthma or aspirin-sensitive asthma.
Age Restrictions The tablet formulation is generally not recommended for use in children below 12 years of age, and is contraindicated for infants below six months.

Regulatory Basis: Official regulatory documents clearly define who must not use this medicine (contraindications) and for whom use is not recommended, focusing on preventing severe allergic reactions, minimizing the risk of gastrointestinal bleeding/perforation, and protecting vulnerable populations like pregnant women and infants.

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What should I know about interactions with other medicines?

Meftal-Spas DPS, a combination of mefenamic acid (a Non-Steroidal Anti-Inflammatory Drug or NSAID) and dicyclomine (an anticholinergic), can interact with several other medications. It is essential to inform your doctor or pharmacist about all prescription, over-the-counter drugs, vitamins, and herbal supplements you are taking.

Increased Bleeding Risk (Mefenamic Acid Component)

Combining this medication with drugs that affect blood clotting can increase the risk of serious gastrointestinal bleeding and hemorrhage. Avoid or use with close monitoring:

  • Anticoagulants (blood thinners) like warfarin.
  • Antiplatelet drugs such as aspirin (low-dose for cardiac protection may be affected).
  • Other NSAIDs (e.g., ibuprofen, naproxen) or COX-2 inhibitors.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs).

Effect on Blood Pressure and Kidney Function

The mefenamic acid component can reduce the effectiveness of several antihypertensive drugs (blood pressure medications) and diuretics (water pills). Concomitant use with ACE inhibitors, Angiotensin Receptor Blockers (ARBs), or diuretics, especially in older or dehydrated patients, may increase the risk of kidney function deterioration or acute renal failure. Drugs like lithium and methotrexate may have increased blood levels, leading to toxicity, when taken with mefenamic acid.

️‍️ Increased Anticholinergic Side Effects (Dicyclomine Component)

Using dicyclomine with other medicines that also have anticholinergic properties can lead to additive side effects like increased drowsiness, dry mouth, blurred vision, difficulty urinating, or constipation. This includes some antipsychotics, tricyclic antidepressants, and certain medications for Overactive Bladder (OAB). Dicyclomine may also interfere with the absorption of certain drugs, such as digoxin, and can counteract the effects of medications that improve gastrointestinal motility (like metoclopramide).

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Mechanism of Action

How Meftal-Spas DPS Works

The drug's mechanism involves the distinct pharmacodynamic actions of its two components: Dicyclomine and Mefenamic Acid.

Dicyclomine is an anticholinergic agent that functions as a specific antagonist of muscarinic acetylcholine receptors. This interaction decreases the binding of acetylcholine at postganglionic parasympathetic nerve endings. The resulting reduction in cholinergic activity leads to a relaxation and decreased contractile force in the smooth muscle of the gastrointestinal tract.

Mefenamic Acid is a non-steroidal anti-inflammatory drug (NSAID) that acts as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition blocks the enzymatic conversion of arachidonic acid into pro-inflammatory and algogenic prostaglandins. The resulting decrease in prostaglandin synthesis reduces localized modulation of pain and inflammatory pathways.

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Dosage and Administration Information

How to Use Meftal-Spas DPS — Official Administration Guidelines

Meftal-Spas DPS is administered according to standardized dosage and administration instructions. These guidelines establish the method for taking the medicine.

Administration Details

Guideline Element Instruction
Route of Administration Oral route (swallowing the tablet)
Standard Dosage Form Uncoated tablet containing Mefenamic Acid 250 mg and Dicyclomine Hydrochloride 10 mg
Dosing Schedule (Adults/Adolescents) 1 to 2 tablets per dose
Frequency Up to three times daily
Timing Relative to Meals Should be taken preferably with or after food

Constraints and Special Instructions

Standard instructions impose limits on the duration of use to ensure proper administration. The total course of therapy must not exceed 7 days at a time. The total daily dose of Mefenamic Acid in any formulation (including Double Strength) should not exceed 1500 mg.

Population-Specific Use

For elderly patients, administration must be managed with caution, and an appropriate dose reduction is indicated to ensure correct use of the medicine. There are no specific instructions documented regarding steps to take for a missed dose in the reviewed clinical documentation.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Meftal-Spas DPS

Evidence for Use in Infantile Colic

The primary area of research involved studies that examined the components of this oral suspension in infants presenting with colic. This clinical context is characterized by conditions involving periods of heightened symptoms and frequent acute or disruptive episodes. Research has primarily focused on the evaluation of the individual active ingredients, Dicycloverine and Simethicone, in this specific age group.

The research primarily relied upon short-term Randomized Controlled Trials (RCTs). Researchers applied these trials in studies conducted during periods of increased symptom activity, observing infants, generally those under six months of age, who were experiencing colic. Researchers monitored daily crying time and patient-reported outcomes describing perceived discomfort during the study period.


Component 1: Dicycloverine (Antispasmodic) Research Focus

For the antispasmodic component, Dicycloverine, studies explored outcomes reflecting daily functioning or activity level, such as the duration of crying. Studies reported observations of daily crying time in the studied infant populations. The available evidence, largely from older sources, has been broadly classified as evidence suggests a moderate level of insight into the component’s use in this context. Reported outcomes were generally based on short-term observation periods (less than a month).

Component 2: Simethicone (Antiflatulent) Research Focus

For the antiflatulent component, Simethicone, research also involved short-term Randomized Controlled Trials with infants experiencing colic. The studies explored outcomes describing episodic or acute changes related to physical discomfort, such as bloating and gas. Studies reported that findings were mixed across many of these studies. This led to the evidence being classified as having a low certainty in scientific reviews for its use in this context.


Evidence for Related Gastrointestinal Symptoms (Antispasmodic Component)

The Dicycloverine component was studied for outcomes related to physical discomfort in conditions characterized by smooth muscle spasm and presenting with cycles of stability and flare-ups, such as Irritable Bowel Syndrome (IBS) in adults. Findings describe patterns observed in these studies related to outcomes related to physical discomfort, but the evidence specific to Dicycloverine is often derived from older, limited studies.

Gaps, Limitations, and Unanswered Research Questions

Scientific reviews highlight several key areas where the evidence for this combination medicine remains insufficient or uncertain. A central limitation is the lack of comparative evidence from high-quality trials evaluating the specific fixed-dose combination of Dicycloverine and Simethicone against placebo in the targeted pediatric population.

Furthermore, much of the supportive research is considered dated. The follow-up durations were limited in nearly all studies. Consequently, long-term effects are not fully established, and there is limited information about the progression of symptoms over time in children who receive this treatment. This research provides context but research does not determine whether an individual will respond similarly.

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Frequently Asked Questions (FAQ)

Common questions about Meftal-Spas DPS (FAQ)


Q: What should I do if I miss a dose of Meftal-Spas DPS?

According to official regulatory documents, if a dose is missed, official guidance typically states that it should be taken as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the general recommendation is to skip the missed dose and resume the regular schedule. Official guidance states that a double dose should not be taken to make up for one that was missed.


Q: Is Meftal-Spas DPS safe to take during pregnancy or while breastfeeding?

Official information indicates that the Mefenamic Acid component of this medicine is contraindicated, or prohibited, during the third trimester of pregnancy due to risks to the fetus. Use during the first and second trimesters requires caution. For breastfeeding, due to the potential for serious adverse reactions in the infant, a healthcare provider may advise discontinuing nursing or discontinuing the drug.


Q: What are the signs of an allergic reaction to Meftal-Spas DPS?

Signs of a serious allergic reaction, as documented for the active ingredients, may include swelling of the face, eyes, lips, or tongue, difficulty breathing, or hives (itchy, raised patches of skin). Some severe drug reactions can also affect internal organs, which may present as fever, swollen glands, or yellowing of the skin or eyes. If these signs are observed, patients are typically advised to seek emergency medical care.


Q: How should I store the Meftal-Spas DPS tablets?

Regulatory guidance for the Meftal-Spas tablets specifies that they should be stored at room temperature and kept away from direct heat, light, and excessive moisture. For safety, the medicine should be kept out of the reach and sight of children.


Q: Is it safe to drink alcohol while taking Meftal-Spas DPS?

Official product information generally states that alcohol should be avoided while taking this medication. This is because alcohol consumption can increase the risk of serious side effects like gastrointestinal bleeding. It may also worsen central nervous system effects such as drowsiness and dizziness caused by the Dicyclomine component.


Q: How do I dispose of expired or unused Meftal-Spas DPS tablets?

General regulatory guidelines for drug disposal state that expired or unused tablets should not be disposed of in household trash or flushed down the toilet. The recommended practice is to return the medication to a local pharmacy, hospital, or drug take-back program for safe and proper disposal, following local pharmaceutical waste regulations.

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How should Meftal-Spas DPS be stored and disposed of?

Storage and Disposal of Meftal-Spas DPS

The storage of Dicycloverine and Simethicone oral suspension must comply strictly with the conditions defined in the official regulatory labeling to ensure product stability.

Requirement Condition
Temperature Store below 25°C
Prohibited Environment Protect from freezing
Environmental Protection Store in a dry place and protect from light
Container Rule Keep in the original container
Child Safety Store out of the sight and reach of children

The official labeling mandates that the product must not be disposed of using household waste or wastewater. Any unused or expired Meftal-Spas DPS must be discarded in accordance with specific local pharmaceutical waste regulations.

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

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