Diclofenac Potassium & Paracetamol Tablets

Description

Diclofenac Potassium & Paracetamol Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd.
Exported by: Healthy Inc

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Diclofenac and Paracetamol tablet formulations in India. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), while Paracetamol (Acetaminophen) is an analgesic and antipyretic. Combination products may be used for short-term pain management where both components are clinically appropriate. Diclofenac potassium and diclofenac sodium are different salt forms and should not be described interchangeably; the exact salt and strength must match the registered product label.

2. Product Specifications

3. Manufacturing Technology

• Formulation Control: The exact Diclofenac salt, Paracetamol strength, excipients and coating system are controlled according to the registered master formula.
• Blend & Content Uniformity: Validated granulation/blending processes support consistent distribution of active ingredients.
• Coating: Film or enteric coating is applied only where specified for the particular registered formulation; an enteric-coated Diclofenac Sodium product should not be assumed to represent a Diclofenac Potassium combination.
• In-Process Controls: Tablet weight, hardness, friability, disintegration and other critical attributes are monitored against approved limits.

4. Quality Assurance

• Assay & Uniformity: Both active ingredients are tested against the applicable finished-product specification.
• Dissolution: Release testing follows the registered pharmacopoeial/in-house method and acceptance criteria rather than a universal release target.
• Impurities: Relevant Diclofenac and Paracetamol impurities, including applicable degradation products, are controlled according to approved specifications.
• Stability: Shelf life and storage conditions are supported by product-specific validated stability data.

5. Pharmacology and Clinical Use

Diclofenac reduces prostaglandin synthesis through cyclooxygenase inhibition, providing analgesic and anti-inflammatory effects. Paracetamol provides analgesic and antipyretic activity through predominantly central mechanisms.

• Musculoskeletal Pain: May be used for selected acute painful inflammatory conditions when appropriate.
• Dental / Post-Procedural Pain: May be prescribed for short-term pain where the benefits outweigh NSAID risks.
• Other Pain: Use should be based on the specific approved indication, patient risk factors and local clinical guidance.
• Important: Combination therapy does not eliminate Diclofenac's gastrointestinal/cardiovascular/renal risks or Paracetamol's dose-related liver toxicity.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD or other applicable registration documentation where available.
• Certificates: FSC, COPP and COA where applicable.
• Private Label: Contract manufacturing can be supported subject to formulation approval and destination-country regulatory requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Diclofenac & Paracetamol Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Diclofenac-based tablet formulations in India.

Q: Are Diclofenac Potassium and Diclofenac Sodium the same?
A: They contain the same active Diclofenac moiety but are different salt forms with different formulation characteristics. The salt stated on the registered label must be used; they should not be silently substituted in product specifications.

Q: Can other Paracetamol medicines be taken at the same time?
A: Taking multiple Paracetamol/Acetaminophen-containing products can unintentionally exceed the recommended total dose and cause serious liver injury. Check all medicine labels and follow clinician/pharmacist advice.

Q: Is this suitable for long-term pain treatment?
A: Diclofenac-containing products should generally be used at the lowest effective dose for the shortest appropriate duration. Longer treatment requires individualized assessment of gastrointestinal, cardiovascular, renal and other risks.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Use the exact dose and duration stated in the registered product information or prescribed by a qualified clinician. Do not infer dosing from a different Diclofenac salt or strength.
• Lowest Effective Exposure: Diclofenac should be used at the lowest effective dose for the shortest duration appropriate to the indication.
• Paracetamol Total: Account for Paracetamol/Acetaminophen from all concurrent products to avoid accidental overdose.

9. Side Effects and Precautions

• Gastrointestinal: Diclofenac can cause ulcers, bleeding or perforation, sometimes without warning. Risk is higher in older adults and with anticoagulants, corticosteroids, other NSAIDs or prior ulcer disease.
• Cardiovascular: NSAIDs can increase the risk of serious cardiovascular thrombotic events. Avoid inappropriate use in patients with significant cardiovascular risk and follow product contraindications/warnings.
• Renal: Diclofenac can impair kidney function, particularly in dehydration, kidney disease, heart failure or with interacting medicines.
• Hepatic: Paracetamol overdose can cause severe or fatal liver injury; Diclofenac can also affect liver function.
• Allergy / Asthma: Serious hypersensitivity and NSAID-associated bronchospasm can occur in susceptible patients.
• Pregnancy: NSAID use during pregnancy has important gestational-age-specific risks and should follow current product labeling and clinician guidance.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Keep in a dry place and protect from excessive heat, light and moisture.
• Keep in original packaging and out of reach of children.