IMOFLORA 2 MG/ 125 MG ( LOPERAMIDE / SIMETHICONE ) 20 TABLETS

IMOFLORA 2 mg / 125 mg

Loperamide Hydrochloride 2 mg + Simethicone 125 mg

Antidiarrheal & Antiflatulent Tablets – 20 Tablets

Medical Description

IMOFLORA Tablets contain a combination of loperamide hydrochloride 2 mg and simethicone 125 mg. This combination is designed for the symptomatic treatment of acute diarrhea accompanied by gas-related abdominal discomfort, including bloating, abdominal cramps and excessive gas.

Loperamide helps reduce diarrhea by slowing intestinal movement and reducing the loss of fluids and electrolytes into the bowel, while simethicone acts locally as an antifoaming agent, helping relieve symptoms caused by excess intestinal gas.

The combination therefore addresses both major components of "diarrhea plus gas": reducing the frequency of loose stools while helping relieve associated bloating, pressure and cramps.

Active Ingredients

Each tablet contains:

• Loperamide Hydrochloride – 2 mg
• Simethicone – 125 mg

Dosage form: Oral tablets
Pack size: 20 tablets
Pharmacological classes: Antidiarrheal + antiflatulent

The Egyptian Drug Authority identifies IMOFLORA as a 2 mg/125 mg loperamide hydrochloride/simethicone tablet and lists its use in adults and adolescents over 12 years of age.

Indications

IMOFLORA is indicated for the symptomatic relief of acute diarrhea associated with gas-related abdominal discomfort, including:

• Frequent loose or watery stools
• Diarrhea accompanied by excessive gas
• Abdominal bloating
• Abdominal cramps
• Gas-related abdominal pressure or discomfort
• Flatulence associated with acute diarrhea

Clinical studies of the loperamide/simethicone combination demonstrated faster relief of acute nonspecific diarrhea and gas-related abdominal discomfort compared with either component alone or placebo.

Mechanism of Action

Loperamide Hydrochloride

Loperamide is a peripherally acting opioid-receptor agonist that acts primarily on receptors in the intestinal wall.

It:

• Reduces intestinal propulsive motility.
• Prolongs intestinal transit time.
• Allows greater absorption of water and electrolytes.
• Reduces the frequency and urgency of bowel movements.
• Helps improve stool consistency.

Importantly, loperamide is intended to act predominantly in the gastrointestinal tract rather than producing the central opioid effects associated with conventional opioids when used at recommended doses.

Simethicone

Simethicone is a physically acting antiflatulent. It reduces the surface tension of gas bubbles within the gastrointestinal tract, facilitating their combination and elimination.

It does not reduce the production of intestinal gas; rather, it helps relieve symptoms associated with trapped gas, including bloating, pressure, fullness and cramps.

Combination Effect

The combination provides complementary symptomatic relief:

Loperamide → controls diarrhea
Simethicone → relieves gas-related discomfort

Clinical trials have shown that the combination can provide faster relief of both diarrhea and gas-related abdominal discomfort than either ingredient alone.

Clinical Benefits

IMOFLORA may:

• Reduce the frequency of loose bowel movements.
• Improve stool consistency.
• Help control symptoms of acute nonspecific diarrhea.
• Relieve gas-related abdominal cramps.
• Reduce bloating and abdominal pressure.
• Relieve discomfort associated with excessive intestinal gas.
• Provide combined antidiarrheal and antiflatulent action in a single tablet.

Dosage & Administration

Adults and Adolescents Over 12 Years

A commonly used regimen for the loperamide/simethicone 2 mg/125 mg combination is:

Take 2 tablets initially, followed by 1 tablet after each subsequent loose stool, without exceeding the maximum daily dose specified in the approved product leaflet.

For the current U.S. OTC loperamide/simethicone labeling, the maximum is 4 tablets in 24 hours for adults and children ≥12 years. However, because approved dosing can vary by country and product, the IMOFLORA package leaflet should be followed for the exact maximum dose.

Important Administration Instructions

• Take orally with adequate fluid.
• Maintain adequate fluid and electrolyte intake during diarrhea to reduce the risk of dehydration.
• Do not exceed the recommended dose.
• IMOFLORA is intended for short-term symptomatic treatment of acute diarrhea.
• If diarrhea persists for more than 48 hours, worsens, or is accompanied by concerning symptoms, discontinue self-treatment and seek medical advice.

Important Warnings & Precautions

Do not use IMOFLORA for self-treatment when:

• There is blood or mucus in the stool.
• There is a high fever.
• Severe or persistent abdominal pain is present.
• Diarrhea occurs with significant abdominal distension.
• Antibiotic-associated diarrhea is suspected.
• An inflammatory or invasive intestinal infection is suspected.

Loperamide can slow intestinal motility and may be inappropriate when diarrhea is associated with certain invasive infections or inflammatory conditions.

Dehydration

Diarrhea can cause substantial loss of water and electrolytes.

Oral rehydration and adequate fluid intake remain an important component of diarrhea management. IMOFLORA provides symptomatic relief but does not replace fluid and electrolyte replacement.

Cardiovascular Safety

Do not exceed the recommended dose.

Excessive doses of loperamide have been associated with serious and potentially fatal cardiac arrhythmias, including QT prolongation and torsades de pointes.

The risk is particularly important with intentional or accidental overdose.

Children

IMOFLORA in the Egyptian OTC listing is intended for adults and adolescents over 12 years of age.

Loperamide should not be administered to children under 2 years of age because of the risk of serious respiratory and cardiac adverse effects.

Possible Side Effects

Possible adverse effects may include:

• Constipation
• Nausea
• Abdominal discomfort
• Abdominal cramps
• Dizziness
• Headache
• Dry mouth
• Fatigue

Serious adverse effects are uncommon when used appropriately, but excessive doses of loperamide can cause severe cardiac toxicity.

Seek immediate medical attention for:

• Rapid or irregular heartbeat
• Fainting
• Severe dizziness
• Loss of consciousness
• Severe abdominal distension
• Severe constipation or ileus

Drug Interactions

Patients should inform their healthcare professional about all medicines they are taking.

Particular caution may be required with medicines that can:

• Increase loperamide concentrations.
• Affect cardiac conduction or prolong the QT interval.
• Produce significant drug interactions through CYP or P-glycoprotein pathways.

Examples of medicines specifically highlighted in loperamide safety information include certain antiarrhythmics and other medicines associated with QT prolongation.

Patients should never increase the dose of IMOFLORA to obtain a stronger or faster effect.

Pregnancy & Breastfeeding

Pregnant or breastfeeding patients should consult a healthcare professional before using IMOFLORA.

The decision to use loperamide during pregnancy or breastfeeding should be based on the individual's clinical condition, potential benefits and potential risks.

When to Seek Medical Advice

Medical evaluation is recommended if:

• Diarrhea persists for more than 48 hours despite treatment.
• Diarrhea becomes severe or progressively worse.
• There is blood or mucus in the stool.
• There is high fever.
• Severe abdominal pain or marked abdominal distension develops.
• Signs of dehydration occur, such as excessive thirst, very little urination, dizziness or weakness.
• Diarrhea follows recent antibiotic treatment.
• Diarrhea is recurrent or unexplained.
• The patient has significant underlying gastrointestinal disease.

Loperamide is intended to control symptoms and does not treat the underlying infectious or inflammatory cause of diarrhea.

Storage

• Store according to the manufacturer's labeled storage conditions.
• Keep in the original package.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Do not use after the expiry date.

Key Product Advantages

IMOFLORA 2 mg/125 mg Tablets provide:

• Loperamide HCl 2 mg + Simethicone 125 mg per tablet
• Dual-action symptomatic relief
• Helps control acute diarrhea
• Helps relieve gas-related cramps and abdominal discomfort
• Helps reduce bloating and abdominal pressure
• Convenient oral tablet formulation
• Suitable for adults and adolescents over 12 years according to the Egyptian OTC listing.

Patient Disclaimer

This information is provided for educational purposes only and does not replace the advice of a qualified healthcare professional. IMOFLORA should be used according to the approved product information and/or as directed by a physician. It is intended for short-term symptomatic relief of acute diarrhea with associated gas-related discomfort and does not treat the underlying cause of diarrhea. Do not exceed the recommended dose. Seek medical attention if diarrhea persists, worsens, is accompanied by fever or blood in the stool, or if severe abdominal pain, dehydration, or other concerning symptoms occur.

References

• Egyptian Drug Authority (EDA) — Egyptian Non-Prescription Medicinal Products (OTC) List, identifying IMOFLORA as loperamide HCl 2 mg + simethicone 125 mg and specifying use in adults and adolescents over 12 years.
• DailyMed / U.S. National Library of Medicine — Loperamide Hydrochloride + Simethicone official labeling.
• MedlinePlus / NIH — Loperamide drug information and safety warnings.
• MedlinePlus / NIH — Simethicone drug information.
• PubMed / NCBI — Randomized controlled clinical trial of loperamide + simethicone for acute diarrhea with gas-related abdominal discomfort.
• WHO — Guidance and evidence regarding management of acute diarrhea and rehydration.

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