PRODUCT INFORMATION
1. Product Information
1.1 Summary of Product Characteristics
PARACETAMOL 500 mg & DICLOFENAC SODIUM 50 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains:
Paracetamol IP – 500 mg
Diclofenac Sodium IP – 50 mg
Excipients – q.s.
3. PHARMACEUTICAL FORM
Oral tablet
White to off-white, round, biconvex uncoated tablets
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Used for the relief of:
Mild to moderate pain (e.g., headache, dental pain, musculoskeletal pain)
Inflammatory conditions including osteoarthritis, rheumatoid arthritis
Postoperative and post-traumatic inflammation and pain
Fever reduction
4.2 Posology and Method of Administration
Adults: 1 tablet up to 2–3 times daily after meals, or as directed by the physician
Maximum daily dose: Should not exceed 4000 mg Paracetamol and 150 mg Diclofenac
Route: Oral
Use the lowest effective dose for the shortest duration necessary
4.3 Contraindications
Hypersensitivity to paracetamol, diclofenac, or any excipients
Active peptic ulcer or gastrointestinal bleeding
Severe hepatic or renal impairment
History of asthma, urticaria, or allergic-type reactions after NSAIDs
Pregnancy (especially third trimester) and lactation unless deemed necessary
4.4 Special Warnings and Precautions for Use
Use with caution in patients with liver or kidney disease
Monitor liver function with prolonged use
Avoid alcohol during therapy
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PRODUCT INFORMATION
Increased risk of gastrointestinal bleeding, ulceration, and perforation with prolonged NSAID use
Use cautiously in elderly and dehydrated patients
4.5 Interaction with Other Medicinal Products
Paracetamol: May enhance effects of warfarin and other coumarins
Diclofenac: May interact with antihypertensives, lithium, methotrexate, and diuretics
Avoid concurrent use with other NSAIDs or high-dose paracetamol
4.6 Fertility, Pregnancy, and Lactation
Not recommended during the third trimester of pregnancy
Use only if clearly needed during the first and second trimesters or during lactation
Diclofenac may impair female fertility; not recommended for women attempting conception
4.7 Effects on Ability to Drive and Use Machines
May cause dizziness or drowsiness; caution advised when driving or operating machinery
4.8 Undesirable Effects
Paracetamol-related (rare):
Hepatotoxicity in overdose, allergic skin reactions
Diclofenac-related:
Gastrointestinal discomfort, nausea, vomiting, abdominal pain
Rare: GI bleeding, peptic ulcers, renal dysfunction, rash, dizziness
4.9 Overdose
Paracetamol overdose:
Symptoms: Nausea, vomiting, liver damage
Treatment: Activated charcoal, N-acetylcysteine as antidote
Diclofenac overdose:
Symptoms: Headache, dizziness, GI bleeding, renal impairment
Treatment: Supportive measures, symptomatic care
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Paracetamol: Analgesic and antipyretic; inhibits prostaglandin synthesis in CNS
Diclofenac: NSAID with analgesic, anti-inflammatory, and antipyretic properties; inhibits COX
enzymes
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PRODUCT INFORMATION
5.2 Pharmacokinetic Properties
Paracetamol:
o Rapid absorption
o Peak plasma levels in 30–60 mins
o Metabolized in liver, excreted in urine
Diclofenac:
o Rapidly absorbed
o Extensively protein-bound
o Metabolized in liver, excreted via urine and bile
5.3 Preclinical Safety Data
Both drugs are well studied with established safety at therapeutic doses
No evidence of mutagenicity or carcinogenicity in animal studies
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Microcrystalline cellulose
Maize starch
Magnesium stearate
Lactose
Povidone
6.2 Incompatibilities
Not applicable for oral solid dosage form
6.3 Shelf Life
24 months from the date of manufacture
6.4 Special Precautions for Storage
Store below 25°C
Protect from moisture and light
Keep out of reach of children
6.5 Nature and Contents of Container
PVC blister pack or HDPE bottle
Pack sizes: 10, 15, or 30 tablets per strip/bottle
6.6 Special Precautions for Disposal
Do not dispose of in wastewater or household waste
Follow local regulations for drug disposal
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PRODUCT INFORMATION
7. MARKETING AUTHORISATION HOLDER
Manufactured by:
M/s 9M India Limited
Paraswani Road, N.H.6,
Birkoni, Distt. Mahasamund,
Chhattisgarh- 493445, India
8. MARKETING AUTHORISATION NUMBER
FORM 25- CG/25/02/2022; FORM 28- CG/28/01/2022
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
06/11/2023
10. DATE OF REVISION OF THE TEXT
01/10/2026
