Nimesulide,Paracetamol & Serratiopeptidase Tablets

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Product Composition & Strength

We supply this product as a Precision-Blended, Multi-Particulate Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly delicate enzyme component.

Active IngredientStrengthPrimary Clinical Function
Nimesulide BP/Ph.Eur.100 mgPreferential COX-2 NSAID: Rapid abortion of localized musculoskeletal inflammation and tissue pain.
Paracetamol (Acetaminophen) BP/Ph.Eur.325 mgCentral Analgesic: Synergistic pain threshold elevation and antipyretic control.
Serratiopeptidase (as Enteric-Coated Granules)15 mg
(Equivalent to 30,000 Serratiopeptidase Units)
Proteolytic Enzyme: Direct breakdown of fibrin and inflammatory exudate to physically drain severe localized edema.
ExcipientsMethacrylic Acid Copolymer / Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K30 / Magnesium StearateEnteric Polymer Shield / Diluent / Superdisintegrant / Binder (Engineered specifically to protect the enzyme from gastric acid while allowing the analgesics to dissolve instantly in the stomach)

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, short-term acute dispensing to ensure patients do not exceed the mandated 15-day Nimesulide therapy limit).

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Description

Nimesulide, Paracetamol & Serratiopeptidase Tablets (100mg/325mg/15mg)

Healthy Inc is a specialized global supplier and exporter of advanced orthopedic, post-surgical, and acute trauma therapeutics. We provide ultra-high-purity, kinetically synchronized Nimesulide, Paracetamol & Serratiopeptidase Film-Coated Tablets (100mg/325mg/15mg), manufactured in WHO–GMP certified, high-precision multi-particulate oral solid dosage facilities. This “Triple-Action Analgesic & Proteolytic FDC” is a massive-volume, highly lucrative export to orthopedic clinics, maxillo-facial surgical centers, emergency departments, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for severe post-operative edema, sports trauma, and intense inflammatory pain.


Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes a preferential COX-2 inhibitor and a central analgesic with a highly potent proteolytic enzyme. Together, they not only block the sensation of pain but actively dismantle and drain the physical swelling at the injury site.

The “Proteolytic Drainage & Inflammatory Blockade” Specialist:

  • Mechanism 1 (The Edema Eraser – Serratiopeptidase): Serratiopeptidase is a powerful proteolytic enzyme originally derived from the silkworm. It works by actively breaking down abnormal proteins (like fibrin) and dead tissue at the site of trauma. By thinning the thick inflammatory fluids (exudate) and breaking down bradykinin (a severe pain-inducing chemical), it forcefully drains the localized swelling, instantly relieving the agonizing mechanical pressure inside the injured joint or surgical wound.
  • Mechanism 2 (The Inflammatory Blockade – Nimesulide): While the enzyme drains the swelling, Nimesulide preferentially targets the COX-2 enzyme at the injury site. It rapidly shuts down the production of inflammatory prostaglandins, stopping new inflammation from forming.
  • Mechanism 3 (The Central Pain Amplifier – Paracetamol): Paracetamol works centrally in the brain to elevate the body’s overall pain threshold. It acts as a massive synergistic amplifier to the NSAID component, dropping injury-induced fevers and providing profound systemic comfort.
  • The Post-Surgical / Dental Advantage: After intense procedures like wisdom tooth extractions or bone fractures, the localized swelling can be more painful than the injury itself. This triple-therapy guarantees that the patient experiences rapid pain relief while the physical swelling visibly deflates within 24 to 48 hours.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Orthopedic Distributors, and Hospital Procurement Boards.

HS Code3004.90.99 (Medicaments containing other active substances – Analgesics/Proteolytic FDC)
CAS Numbers51803-78-2 (Nimesulide) / 103-90-2 (Paracetamol) / 37312-62-2 (Serratiopeptidase)
Dosage FormFilm-Coated Tablet (Containing Enteric-Coated Enzyme Granules)
PackagingHigh-Density Alu-Alu Blisters (MANDATORY). Serratiopeptidase is incredibly sensitive to heat and moisture. Heavy-gauge Alu-Alu barrier packaging guarantees absolute enzymatic survival and full triple-potency across Zone IVb tropical climates.
StorageStore strictly below 25°C in a dry place. Protect heavily from Moisture and Heat.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Multi-Particulate Enteric Segregation Engineering (CRITICAL COMPLIANCE): Proteins and enzymes are instantly denatured and destroyed by stomach acid (pH 1.2). If a manufacturer simply presses raw Serratiopeptidase powder into a tablet, it is 100% clinically useless. Our facilities utilize advanced fluid-bed coating technology to wrap the Serratiopeptidase API in a strict, pH-dependent Methacrylic Acid Copolymer enteric shield, creating microscopic protected granules. These granules are then carefully blended with the rapid-release Nimesulide and Paracetamol powders. When swallowed, the painkillers dissolve immediately in the stomach, while the enzyme granules survive intact, passing into the alkaline intestines (pH 6.8) where they dissolve and absorb flawlessly into the bloodstream.

Therapeutic Indications (Human Use)

Indicated for the targeted, rapid management of severe acute pain accompanied by significant inflammatory edema (swelling):

  • Post-Surgical Trauma: Management of severe swelling and pain following orthopedic, maxillo-facial, and general surgeries.
  • Severe Dental Extractions: Relief of facial edema and pain following wisdom tooth removal or root canals.
  • Severe Sprains & Fractures: Management of sudden sports injuries with massive localized hematomas and swelling.
  • ENT Infections: Adjunct therapy in severe sinusitis or pharyngitis to break down thick, infected mucous exudate.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

  • Standard Adult Dosing: One tablet taken orally twice daily (every 12 hours).
  • The Intact Rule (CRITICAL): Because the tablet contains enteric-coated enzyme granules, the tablet MUST be swallowed completely whole. Chewing or crushing the tablet physically destroys the enteric coating, rendering the Serratiopeptidase completely useless.
  • The 15-Day Limit: Due to the Nimesulide component, this medication MUST NEVER be prescribed or consumed for more than 15 consecutive days to drastically reduce the risk of hepatotoxicity.
  • Administration: Must be taken after meals with a full glass of water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • BLACK BOX WARNING / CRITICAL ALERT (Fatal Hepatotoxicity): Both Nimesulide and Paracetamol place a heavy metabolic load on the liver. This FDC is strictly contraindicated in patients with any history of liver disease or active alcoholism. Patients must strictly avoid all alcohol consumption during therapy.
  • Coagulation & Bleeding Risk: Because Serratiopeptidase breaks down fibrin (the protein involved in blood clotting), it has mild blood-thinning properties. It must be used with extreme caution in patients with active bleeding disorders, severe gastric ulcers, or those taking heavy anticoagulants (like Warfarin or Clopidogrel).
  • Gastrointestinal Bleeding: Can cause serious gastrointestinal adverse events including bleeding and ulceration.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Surgical Hospital Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Acute Analgesic, Enzyme, and FDC Formulations. Whether you are looking for a reliable Surgical Clinic Supplier in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.

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