Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets

What is Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets?

Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets are a combination oral formulation containing diclofenac sodium, an NSAID, and paracetamol, an analgesic and antipyretic. The combination is used for the management of pain and inflammatory symptoms when treatment with both active ingredients is clinically appropriate.

Uses / Indications

Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets may be used in the management of:

• Acute musculoskeletal pain
• Pain associated with inflammation
• Joint and soft-tissue pain
• Dental pain
• Pain following minor procedures, where clinically appropriate
• Other painful inflammatory conditions where combination analgesic therapy is indicated

The specific indication and duration of treatment should follow the approved product information and healthcare professional’s recommendation.

Benefits

• Combines the analgesic and anti-inflammatory activity of diclofenac with the analgesic and antipyretic activity of paracetamol.
• Provides oral treatment for pain associated with inflammatory conditions.
• Diclofenac contributes anti-inflammatory activity, while paracetamol provides additional analgesic and antipyretic effects.
• May be used when both therapeutic actions are clinically appropriate.
• Available as a fixed-dose tablet formulation containing diclofenac sodium 50 mg and paracetamol 325 mg.

Side Effects

Common Side Effects

Possible adverse effects may include:

• Nausea
• Vomiting
• Indigestion
• Abdominal discomfort
• Diarrhoea
• Headache
• Dizziness
• Skin rash

Less Common or Serious Side Effects

Clinically important adverse reactions may include:

• Gastrointestinal ulceration or bleeding
• Severe allergic or hypersensitivity reactions
• Bronchospasm in susceptible individuals
• Kidney-related adverse effects
• Fluid retention or oedema
• Increased blood pressure
• Liver-related adverse effects
• Severe skin reactions

Seek medical attention if severe abdominal pain, gastrointestinal bleeding, breathing difficulty, facial swelling, severe skin reactions or other significant symptoms occur.

How Does It Work?

Diclofenac Sodium

Diclofenac inhibits cyclooxygenase (COX) enzymes involved in the formation of prostaglandins. Prostaglandins contribute to pain and inflammation. By reducing prostaglandin synthesis, diclofenac helps decrease inflammatory activity and relieve pain.

Paracetamol

Paracetamol produces analgesic and antipyretic effects primarily through central mechanisms. It helps relieve pain and reduce fever but has relatively limited peripheral anti-inflammatory activity compared with NSAIDs.

Combination Effect

The two active ingredients provide complementary analgesic effects. Diclofenac contributes anti-inflammatory and analgesic activity, while paracetamol provides additional analgesic and antipyretic activity.

Dosage Guidelines

The appropriate dose and treatment duration depend on the patient’s age, indication, severity of symptoms, medical history, renal and hepatic function, cardiovascular and gastrointestinal risk factors, and other medicines being used.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For oral tablets:

• Take exactly as prescribed.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not crush, split, chew or dissolve the tablet unless permitted by the approved product information.
• Do not take additional paracetamol-containing or diclofenac-containing medicines without professional advice.
• Use the lowest effective dose for the shortest appropriate duration where clinically recommended.

When Not to Use

This combination should generally not be used in patients with:

• Known hypersensitivity to diclofenac, paracetamol, other NSAIDs, or any component of the formulation
• Previous serious allergic reactions associated with NSAIDs
• Active gastrointestinal ulceration or bleeding
• Severe hepatic impairment
• Severe renal impairment where use is contraindicated
• Severe heart failure or other conditions in which diclofenac is contraindicated

Diclofenac-containing medicines may also be contraindicated in certain patients with established cardiovascular disease or a history of significant gastrointestinal complications.

Drug / Product Interactions

Clinically relevant interactions may occur with:

• Other NSAIDs
• Aspirin and antiplatelet medicines
• Anticoagulants
• Corticosteroids
• Selective serotonin reuptake inhibitors (SSRIs)
• Diuretics and certain antihypertensive medicines
• Medicines that affect kidney function
• Methotrexate
• Lithium
• Cyclosporine or tacrolimus
• Other medicines containing paracetamol
• Certain medicines that affect hepatic metabolism

Patients taking multiple medicines should inform their healthcare professional before starting treatment.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service. Excessive paracetamol exposure can cause serious liver injury, while excessive NSAID exposure may cause significant gastrointestinal, renal or other complications.

Missed Dose

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose unless specifically instructed by a healthcare professional.

Pregnancy

Diclofenac should be used during pregnancy only when clinically appropriate and following professional medical advice. NSAIDs have important restrictions during later pregnancy.

Breastfeeding

Use during breastfeeding should be discussed with a healthcare professional, who can assess the potential benefits and risks.

Children

Use in children should follow age- and indication-specific recommendations in the approved product information. This fixed-dose combination may not be appropriate for every paediatric patient.

Elderly Patients

Older patients may have an increased risk of gastrointestinal, renal and cardiovascular adverse effects associated with NSAID treatment. Appropriate assessment and monitoring may be required.

Renal Impairment

Patients with renal impairment should seek professional medical advice before using diclofenac-containing medicines. Dose selection and suitability depend on the degree of renal impairment and other clinical factors.

Hepatic Impairment

Patients with liver disease should seek professional advice before use. Particular caution is required because excessive paracetamol exposure can cause serious liver injury.

Driving and Operating Machinery

Dizziness, drowsiness or visual disturbances may occur in some patients. Patients experiencing such effects should avoid driving or operating machinery until they know how the medicine affects them.

General Instructions

• Take the medicine according to the prescribed schedule.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not take additional medicines containing paracetamol or NSAIDs without appropriate medical advice.
• Do not exceed the recommended dose.
• Inform the healthcare professional about existing medical conditions and other medicines being taken.
• Keep the medicine in its original packaging where appropriate.
• Do not share prescription medicines with other people.
• Follow the approved product information and healthcare professional’s instructions.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Excessive alcohol consumption should be avoided or limited because it may increase gastrointestinal risk associated with NSAID treatment and may contribute to liver-related risk when combined with excessive paracetamol exposure.

Comparison with Other Treatments

Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets combine an NSAID with an analgesic and antipyretic. Diclofenac provides analgesic and anti-inflammatory activity, while paracetamol contributes analgesic and antipyretic effects.

Single-ingredient NSAIDs, paracetamol-containing formulations, or other analgesic combinations may be used in different clinical situations. Treatment selection depends on the type and severity of pain, inflammatory involvement, patient-specific risk factors, concurrent medicines and the approved indication.

Precautions & Warnings

• Check for previous hypersensitivity or allergic reactions to diclofenac, paracetamol or other NSAIDs.
• Avoid unnecessary concurrent use of other NSAIDs or paracetamol-containing products.
• Use cautiously in patients with a history of gastrointestinal disease.
• Consider renal function in patients at risk of kidney impairment.
• Consider hepatic function and total paracetamol exposure.
• Patients with cardiovascular disease, hypertension or fluid-retention problems should receive appropriate professional assessment before diclofenac use.
• Long-term NSAID treatment may require appropriate medical monitoring.
• Use during pregnancy and breastfeeding should be based on professional medical advice.
• Elderly patients may require closer monitoring for gastrointestinal, renal and cardiovascular adverse effects.
• Seek urgent medical attention for signs of gastrointestinal bleeding, severe allergic reactions, serious skin reactions or other significant adverse effects.

Can I Use It With Other Medicines?

Generally Compatible With

This combination may be used with other medicines when clinically appropriate and after consideration of the patient’s complete medication profile. Compatibility should be assessed by a healthcare professional.

Use With Caution / Avoid

Particular caution is required with:

• Other NSAIDs or aspirin used for analgesic purposes
• Anticoagulants and antiplatelet medicines
• Corticosteroids
• Medicines affecting kidney function
• Certain antihypertensive medicines and diuretics
• Lithium
• Methotrexate
• Cyclosporine or tacrolimus
• Other medicines containing paracetamol

Do not start, stop or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What are Diclofenac Sodium 50 mg & Paracetamol 325 mg Tablets used for?

They are used for the management of pain and inflammation in conditions where the combination of diclofenac and paracetamol is clinically appropriate.

2. What are the active ingredients in this formulation?

Each tablet contains Diclofenac Sodium 50 mg and Paracetamol 325 mg.

3. How does this combination work?

Diclofenac reduces the production of prostaglandins involved in pain and inflammation, while paracetamol provides analgesic and antipyretic effects.

4. Can I take another paracetamol medicine with this product?

Additional paracetamol should not be taken without professional advice because this product already contains paracetamol. Excessive total paracetamol exposure can cause serious liver injury.

5. Can this medicine be used by patients with kidney problems?

Patients with renal impairment should seek professional medical advice before using diclofenac-containing medicines. Suitability depends on renal function and other clinical factors.

6. Can it be used during pregnancy?

Diclofenac has important pregnancy-related restrictions, particularly during later pregnancy. Use during pregnancy should be determined by a qualified healthcare professional.

7. What should I do if I miss a dose?

Take the missed dose when remembered unless it is close to the next scheduled dose. Do not double the next dose unless specifically advised by a healthcare professional.

8. How should these tablets be stored?

Store the tablets according to the approved product label and package insert, protect them from excessive heat and moisture, and keep them out of reach of children.