Paracetamol & Diclofenac Potassium Tablets

1. Product Introduction

Paracetamol & Diclofenac Potassium Tablets combine paracetamol, an analgesic and antipyretic, with diclofenac potassium, a nonsteroidal anti-inflammatory drug (NSAID). The described strength is 500 mg paracetamol + 50 mg diclofenac potassium per tablet. The potassium salt is commonly used in immediate-release diclofenac products; however, the onset of action depends on the actual finished formulation, food, and individual patient factors.

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as exporter in the supplied information. Contract manufacturing, certifications, product registration and availability should be confirmed with current documentation. This fixed-dose combination should only be supplied and promoted where locally authorized.

2. Product Specifications

3. Manufacturing Technology

Development of this two-API tablet requires compatibility studies, validated blending and compression, content-uniformity controls, dissolution testing and appropriate moisture protection. Super-disintegrants such as crospovidone, buffering excipients and taste-masking coatings are possible formulation options, but their use in this product is not confirmed. Claims of disintegration within 60 seconds or absorption within 10–15 minutes require product-specific testing.

4. Quality Assurance

Appropriate controls include identity and assay for each API, dosage-unit uniformity, dissolution, related substances, packaging integrity and stability. Methods and limits must follow the approved dossier and relevant standards. A universal >85% release within 15 minutes, 90–110% assay or a particular salt-identification test cannot be asserted without an approved method and specification.

5. Pharmacology and Intended Use

Paracetamol helps relieve pain and reduce fever; it is not an NSAID. Diclofenac potassium inhibits cyclooxygenase-mediated prostaglandin synthesis and can reduce pain and inflammation. Immediate-release diclofenac potassium products may have a faster onset than some delayed-release diclofenac sodium products, but the difference is not universal across all formulations.

Potential uses may include acute painful conditions such as dental pain, menstrual cramps and musculoskeletal pain, only where this exact combination is approved. Do not claim guaranteed migraine abortion, 15-minute relief or superiority over every diclofenac sodium product.

6. Export and Regulatory Support

B2B buyers should request current manufacturing licenses, product permissions, batch COAs, approved labeling, stability information, packaging specifications and market-specific registration materials. Availability of CTD/ACTD dossiers, COPP, FSC, WHO-GMP evidence, Star Export House credentials and FOB/CIF arrangements must be confirmed directly. Regulatory requirements differ by destination country.

7. Frequently Asked Questions

Q: What is the composition?
A: Paracetamol 500 mg plus Diclofenac Potassium 50 mg per tablet, according to the supplied description.

Q: Is diclofenac potassium the same as diclofenac sodium?
A: They are different salts. Their dosage forms and release characteristics can differ; do not substitute products without checking the approved label.

Q: Does it work within 15 minutes?
A: A precise onset cannot be promised for this specific combination without supporting clinical and pharmacokinetic data.

Q: Is it equivalent to Cataflam?
A: No equivalence should be claimed. Cataflam is a diclofenac potassium brand; this product also contains paracetamol and has a different composition.

Q: Is it safe for the stomach?
A: Diclofenac may cause serious gastrointestinal ulcers or bleeding. Taking it with food does not eliminate these risks.

8. Dosage and Administration

Use only according to the locally approved label and qualified prescriber advice. The supplied proposed regimen—including a two-tablet initial dose—must not be used without approved prescribing information. Diclofenac should generally be used at the lowest effective dose for the shortest appropriate duration. Check all other medicines for paracetamol or NSAID duplication.

9. Side Effects and Precautions

• Gastrointestinal: Diclofenac can cause ulceration, bleeding or perforation, sometimes without warning.
• Cardiovascular: NSAIDs can increase heart attack and stroke risk.
• Kidney: Diclofenac may worsen renal function, especially with dehydration or pre-existing disease.
• Liver: Paracetamol overdose can cause severe liver damage; diclofenac can also affect liver function.
• Allergy: Avoid in patients with relevant NSAID hypersensitivity or aspirin-sensitive asthma.
• Pregnancy: NSAID use from around 20 weeks requires special caution and is contraindicated in later pregnancy in many markets.
• Interactions: Review anticoagulants, antiplatelets, corticosteroids, other NSAIDs and other paracetamol-containing products.

Seek urgent care for black stools, vomiting blood, chest pain, breathing difficulty, severe allergic reaction or suspected paracetamol overdose.

10. Storage Instructions

Store in original packaging, away from excessive heat and moisture, and out of reach of children. Follow the actual approved label for temperature and light-protection conditions. The proposed below-25°C condition and 36-month shelf life require validation against product stability data.