Paracetamol 325mg, Caffeine 30mg & Diclofenac Sodium 50mg Tablets Tablet

What is Paracetamol 325mg, Caffeine 30mg & Diclofenac Sodium 50mg Tablets Tablet?

Paracetamol 325 mg, Caffeine 30 mg and Diclofenac Sodium 50 mg Tablets is a combination oral analgesic formulation containing an analgesic-antipyretic, an NSAID and caffeine. It is generally used for the management of pain and inflammation where combination therapy is clinically appropriate.

Uses / Indications

This combination may be used in the management of:

• Mild to moderate acute pain associated with inflammation
• Musculoskeletal pain
• Joint and soft-tissue pain
• Pain associated with inflammatory conditions
• Headache or other painful conditions where the combination is clinically indicated
• Short-term symptomatic management of pain and inflammation

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

Benefits

• Combines analgesic and anti-inflammatory activity in a single oral formulation.
• Paracetamol provides analgesic and antipyretic activity.
• Diclofenac sodium provides NSAID-mediated analgesic and anti-inflammatory activity.
• Caffeine may provide supportive effects in combination analgesic formulations.
• Suitable for pharmaceutical supply as an oral tablet formulation.

Side Effects

Common Side Effects

Possible side effects may include:

• Nausea
• Indigestion or abdominal discomfort
• Heartburn
• Diarrhoea
• Dizziness
• Headache
• Drowsiness or fatigue
• Increased nervousness or difficulty sleeping in some individuals

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
• Liver injury, particularly with excessive paracetamol exposure
• Kidney function impairment
• Fluid retention or increased blood pressure
• Serious skin reactions
• Cardiovascular events associated with NSAID use

Seek medical attention if severe abdominal pain, gastrointestinal bleeding, breathing difficulty, severe allergic symptoms, chest pain or other serious reactions occur.

How Does It Work?

Paracetamol

Paracetamol provides analgesic and antipyretic activity through central effects involved in pain perception and temperature regulation.

Caffeine

Caffeine is a methylxanthine with central nervous system stimulant activity. In combination analgesic formulations, it may provide supportive effects and enhance the analgesic activity of certain analgesics.

Diclofenac Sodium

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It inhibits cyclooxygenase enzymes involved in prostaglandin synthesis, thereby reducing mediators associated with pain and inflammation.

Together, the components provide complementary analgesic and anti-inflammatory effects.

Dosage Guidelines

The appropriate dose and treatment duration depend on the patient’s age, indication, severity of symptoms, medical history, kidney and liver function, 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 administration:

• Take exactly as directed.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not exceed the recommended dose.
• Avoid taking additional paracetamol- or diclofenac-containing products unless specifically advised.
• Do not crush, split, chew or dissolve the tablet unless permitted by the approved product information.
• Use the lowest effective dose for the shortest appropriate duration when directed by a healthcare professional.

When Not to Use

This combination should generally not be used in patients with known hypersensitivity to diclofenac, paracetamol, caffeine or any component of the formulation.

Diclofenac-containing products may also be unsuitable in patients with:

• Active gastrointestinal ulceration or bleeding
• Previous serious reactions to aspirin or other NSAIDs
• Severe renal impairment
• Severe hepatic impairment
• Certain serious cardiovascular conditions
• Perioperative use in the setting of coronary artery bypass graft surgery

Appropriate professional advice is required where significant gastrointestinal, cardiovascular, renal or hepatic risk factors are present.

Drug / Product Interactions

Potentially relevant interactions may occur with:

• Other NSAIDs
• Aspirin
• Anticoagulants
• Antiplatelet medicines
• Corticosteroids
• Certain antihypertensive medicines
• Diuretics
• Medicines that may affect kidney function
• Medicines that may affect liver function
• Methotrexate
• Lithium
• Certain medicines affecting caffeine metabolism

Particular caution is required when using other medicines containing paracetamol or diclofenac because duplicate exposure may increase the risk of adverse effects.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Paracetamol overdose can cause serious liver injury, while excessive NSAID exposure may cause significant gastrointestinal, renal and other complications.

Missed Dose

If the medicine is being taken on a scheduled basis, take the missed dose when remembered unless it is nearly time for the next dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose.

Driving

Dizziness or drowsiness may occur in some individuals. Patients should understand how the product affects them before driving or operating machinery.

Alcohol

Alcohol may increase the risk of gastrointestinal irritation and liver injury, particularly with excessive use. Avoid excessive alcohol consumption while taking this product.

Pregnancy

Diclofenac and other NSAIDs have important pregnancy-related restrictions, particularly later in pregnancy. Use during pregnancy should only follow appropriate medical assessment.

Breastfeeding

The suitability of this combination during breastfeeding should be discussed with a qualified healthcare professional.

Children

Paediatric use should follow the age-specific recommendations of the approved product information. Do not use in children unless specifically appropriate and clinically indicated.

Elderly Patients

Older adults may have increased susceptibility to gastrointestinal, renal and cardiovascular adverse effects associated with NSAIDs and may require appropriate medical assessment.

Renal Impairment

Patients with renal impairment should seek professional advice before use. Diclofenac may affect renal function, particularly in susceptible patients.

Hepatic Impairment

Patients with liver disease should use this paracetamol-containing combination only under appropriate professional guidance.

General Instructions

• Take the medicine according to the approved product information or prescribed schedule.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not exceed the recommended dose.
• Avoid taking additional medicines containing paracetamol or diclofenac without professional advice.
• Do not combine with other NSAIDs unless specifically advised.
• Avoid excessive alcohol consumption.
• Do not share prescription medicines with other people.
• Keep the medicine in its original packaging where appropriate.
• 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.

Avoid excessive alcohol consumption because it may increase gastrointestinal and liver-related risks.

Because the formulation contains caffeine, excessive additional caffeine from coffee, tea, energy drinks or other sources may increase nervousness, restlessness or difficulty sleeping in susceptible individuals.

Comparison with Other Treatments

This product combines diclofenac sodium and paracetamol with caffeine, providing both NSAID-mediated anti-inflammatory activity and analgesic-antipyretic activity.

Single-ingredient analgesics may be used when only one pharmacological action is required, while other combination products may contain different analgesics or anti-inflammatory agents. The appropriate treatment depends on the nature and severity of pain, patient-specific risk factors, concurrent medicines and the approved indication.

Precautions & Warnings

• Do not exceed the recommended paracetamol dose.
• Avoid concurrent use with other paracetamol-containing products unless advised.
• Avoid combining with other NSAIDs unless specifically directed.
• Use caution in patients with a history of gastrointestinal ulceration or bleeding.
• Patients with cardiovascular disease, hypertension or risk factors for cardiovascular disease should seek professional advice before NSAID use.
• Use appropriate caution in renal or hepatic impairment.
• Elderly patients may require closer monitoring for NSAID-related adverse effects.
• Stop use and seek medical advice if signs of gastrointestinal bleeding or severe allergic reaction occur.
• Pregnancy and breastfeeding use should be based on appropriate professional assessment.
• Avoid excessive alcohol and caffeine intake.

Can I Use It With Other Medicines?

Generally Compatible With

This combination may be used with other medicines when clinically appropriate, but compatibility depends on the patient’s complete medication profile.

Use With Caution / Avoid

Particular caution is required with:

• Other NSAIDs
• Aspirin
• Anticoagulants and antiplatelet medicines
• Corticosteroids
• Diuretics and certain antihypertensive medicines
• Medicines affecting kidney function
• Methotrexate or lithium
• Other medicines containing paracetamol or diclofenac
• Products providing substantial additional caffeine

Patients taking regular medicines should consult a healthcare professional before starting this combination.

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 is Paracetamol 325 mg, Caffeine 30 mg & Diclofenac Sodium 50 mg Tablets used for?

This combination is generally used for the symptomatic management of pain and inflammation when combination analgesic and anti-inflammatory treatment is clinically appropriate.

2. What are the active ingredients in this tablet?

Each tablet contains Paracetamol 325 mg, Caffeine 30 mg and Diclofenac Sodium 50 mg.

3. How does this combination work?

Diclofenac provides anti-inflammatory and analgesic activity, while paracetamol provides analgesic and antipyretic activity. Caffeine provides supportive effects in the combination.

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

Care is required because the product already contains paracetamol. Additional paracetamol-containing medicines should not be taken without appropriate professional advice.

5. Can I take this medicine with another NSAID?

Concurrent use with another NSAID may increase the risk of adverse effects, particularly gastrointestinal and renal effects. It should generally be avoided unless specifically advised by a healthcare professional.

6. Can this product be used during pregnancy?

Diclofenac has important pregnancy-related restrictions. Use during pregnancy should be based on appropriate medical assessment.

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

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. Do not double the next dose.

8. How should these tablets be stored?

Store according to the conditions stated on the approved product label and package insert, and keep the product out of reach of children.