What Schedule is Panadeine Forte in Australia?

What Schedule is Panadeine Forte in Australia?

Panadeine Forte is Schedule 4 under Australia's Therapeutic Goods Administration (TGA) Poisons Standard. Schedule 4 medicines are classified as "Prescription Only Medicine" or "Prescription Animal Remedy," meaning they require a prescription from a registered medical practitioner, dentist, or authorized prescriber.

As of November 2025, Panadeine Forte remains firmly classified as Schedule 4 with no regulatory changes anticipated. This classification has been in effect since February 1, 2018, when the TGA implemented nationwide up-scheduling of all codeine-containing products.

Each Panadeine Forte tablet contains:

• Codeine phosphate 30mg (Schedule 4 opioid analgesic)
• Paracetamol 500mg (Unscheduled analgesic and antipyretic)

The Schedule 4 classification is triggered by the codeine component. While paracetamol alone is unscheduled and available without restriction, the addition of codeine (an opioid derived from opium) elevates the product to prescription-only status due to addiction potential, abuse liability, and safety concerns.

Why is Panadeine Forte Schedule 4 Instead of Schedule 3?

Panadeine Forte is Schedule 4 rather than Schedule 3 because it contains 30mg of codeine per tablet, which historically exceeded the threshold for Schedule 3 classification. However, this distinction became irrelevant in February February 1, 2018 when the TGA up-scheduled all codeine-containing products to Schedule 4.

Prior to the February 1, 2018 regulatory change, Australia had a tiered codeine scheduling system:

• Schedule 2 (Pharmacy Medicine): Low-dose codeine (≤8mg per dose) combined with paracetamol or ibuprofen
• Schedule 3 (Pharmacist Only Medicine): Medium-dose codeine (12-15mg per dose) requiring pharmacist consultation
• Schedule 4 (Prescription Only): High-dose codeine (≥30mg) requiring prescription

Under this old system, Panadeine Forte (30mg codeine) was always Schedule 4, while regular Panadeine (8mg codeine) was Schedule 2 or 3 depending on pack size. The February February 1, 2018 change eliminated this tiered approach entirely, making all codeine products Schedule 4 regardless of strength.

Why Did the TGA Up-Schedule All Codeine Products?

The TGA's decision was based on compelling evidence of harm from over-the-counter codeine availability:

• Codeine-related deaths: Codeine was implicated in a significant number of Australian deaths, many involving low-dose over-the-counter products
• Widespread dependence: A substantial number of Australians were dependent on over-the-counter codeine
• Inappropriate long-term use: Products intended for short-term pain relief were being used continuously for months or years
• Progression to stronger opioids: Over-the-counter codeine served as a gateway to prescription opioid misuse
• Liver and kidney damage: High-dose paracetamol consumption (from taking multiple codeine combination tablets) caused liver and kidney toxicity

Can You Buy Panadeine Forte Over the Counter in Australia?

No, you cannot buy Panadeine Forte over the counter anywhere in Australia. Schedule 4 classification legally prohibits pharmacies from dispensing the medication without a valid prescription. This applies nationwide across all states and territories with no exceptions.

To obtain Panadeine Forte, you must:

1. Consult a registered medical practitioner (GP, specialist, dentist, or authorized prescriber)
2. Receive a prescription if the doctor determines it is clinically appropriate
3. Present the prescription to a pharmacy for dispensing
4. Provide identification if requested by the pharmacist (common for Schedule 4 opioids)

Prescriptions for Panadeine Forte are typically valid for 6 months from the date of issue, though doctors often specify a shorter validity period or limited repeats for opioid prescriptions. Some states require additional recording for Schedule 4 opioids beyond standard prescription requirements.

What Happens If You Try to Buy Without a Prescription?

Attempting to purchase Panadeine Forte without a prescription is illegal and can result in:

• Refusal of sale by the pharmacist (mandatory under Australian law)
• Potential police notification if fraud or deception is attempted
• Criminal charges for prescription fraud, forgery, or drug diversion
• Fines and potential imprisonment for serious offenses

Pharmacists are legally obligated to verify prescription authenticity and may contact the prescriber to confirm legitimacy if they have any concerns. They also maintain records of all Schedule 4 opioid dispensing for audit and monitoring purposes.

What is the Difference Between Panadeine and Panadeine Forte?

The primary difference between Panadeine and Panadeine Forte is codeine strength, though both are now Schedule 4 prescription-only medicines.

Formulation Comparison:

Panadeine Forte contains 3.75 times more codeine per tablet (30mg vs 8mg), making it significantly stronger but also carrying higher risks:

Key Differences:

• Analgesic potency: Panadeine Forte provides stronger pain relief but increased opioid side effects
• Addiction potential: Higher codeine dose carries substantially greater dependence risk
• Constipation: More severe and more common with Panadeine Forte
• Drowsiness and impairment: Greater sedation and cognitive effects with higher dose
• Duration of use: Panadeine Forte typically limited to shorter treatment periods (3-5 days for acute pain)
• Workers comp approval: Panadeine Forte faces stricter authorization requirements and more frequent denials

Clinical Appropriateness:

Evidence-based prescribing guidelines generally recommend:

• Start with non-opioid analgesics (paracetamol alone, NSAIDs) for most musculoskeletal pain
• Consider Panadeine (8mg) before Panadeine Forte if opioid component needed
• Reserve Panadeine Forte for severe acute pain unresponsive to lower-strength options
• Limit duration to 3-5 days (maximum 7 days without specialist review)
• Avoid in chronic pain conditions where opioids are not evidence-based

How Does Schedule 4 Classification Affect Workers Compensation Claims?

Schedule 4 classification of Panadeine Forte creates specific requirements and restrictions for workers compensation claims across all Australian jurisdictions.

Documentation Requirements:

Claims managers must verify and document:

• Valid prescription from authorized prescriber with date, dosage, quantity, and repeats specified
• Clinical indication for use (specific injury or condition requiring opioid analgesia)
• Duration of treatment and review schedule
• Alternative non-opioid treatments trialed or contraindicated
• Prescription dispensing records showing actual usage patterns

State-Specific Workers Compensation Restrictions:

Note: State workers compensation policies are subject to frequent updates. The examples below represent general guideline principles but should be verified against current jurisdiction-specific requirements.

NSW (SIRA Guidelines):

• Codeine products limited to 5 days for acute pain without additional justification
• Prescription beyond 14 days triggers mandatory medication review
• Requires documentation of functional improvement to justify continued use
• Concurrent benzodiazepine prescription flags as high-risk combination

Victoria (WorkSafe Guidelines):

• Schedule 4 opioids require treating doctor justification for use beyond 1 week
• Independent medical examination may be required for ongoing use beyond 2 weeks
• Must demonstrate objective functional improvement to continue authorization

Queensland (WorkCover Guidelines):

• Prior approval required for Schedule 4 opioid prescriptions exceeding 14 days total duration
• Higher doses (>6 tablets daily) require specialist consultation
• Regular urine drug screening may be mandated for ongoing opioid treatment

Western Australia (WorkCover WA):

• Codeine products generally limited to 10 days without pre-authorization
• Must demonstrate inadequate response to non-opioid alternatives
• Pain management plan required for any opioid use beyond 2 weeks

Red Flags for Claims Managers:

These prescribing patterns warrant immediate review:

• Early refills: Prescription filled before 70% of previous supply should be consumed (suggests overuse or diversion)
• Multiple prescribers: Panadeine Forte prescriptions from more than one doctor (potential "doctor shopping")
• Multiple pharmacies: Dispensing at different pharmacies without clear reason (potential diversion)
• Long-term use: Continuous prescribing beyond 4-6 weeks for acute workplace injury
• High daily doses: More than 6-8 tablets per day (240mg codeine exceeds typical therapeutic range)
• Concurrent CNS depressants: Prescribed alongside benzodiazepines, Z-drugs, or other opioids
• Lack of functional improvement: Continued prescribing despite no documented return-to-work progress

What Are Evidence-Based Alternatives to Panadeine Forte?

Current evidence supports prioritizing non-opioid alternatives for most musculoskeletal workplace injuries. The Australian Commission on Safety and Quality in Health Care recommends the following treatment hierarchy:

First-Line Analgesics (Try First):

• Paracetamol: 1g every 4-6 hours (maximum 4g daily); Panadol Osteo 665mg modified-release is preferred for sustained pain control
• NSAIDs: Ibuprofen 400mg three times daily, naproxen 500mg twice daily, or diclofenac 50mg twice daily (if no cardiovascular or gastrointestinal contraindications)
• Topical NSAIDs: Voltaren Emulgel, Nurofen Gel for localized musculoskeletal pain without systemic side effects

Second-Line Options (If Inadequate Response):

• Combination therapy: Paracetamol + NSAID together (more effective than either alone)
• Neuropathic agents: Lyrica (pregabalin) or amitriptyline if neuropathic component suspected
• Muscle relaxants: Physical therapy preferred; medications have limited evidence

Third-Line (Short-Term Only When Others Failed):

• Tramadol: Schedule 4 opioid with slightly lower dependence risk than codeine
• Codeine combinations: Panadeine (8mg) before escalating to Panadeine Forte (30mg)
• Short-acting opioids: Only for severe acute pain, maximum 3-5 days, with clear review plan

Non-Pharmacological Approaches (Essential for All Patients):

• Active physiotherapy and exercise programs
• Graded return to work with modified duties
• Heat/cold therapy, TENS units
• Cognitive behavioral therapy for pain management
• Ergonomic workplace modifications

Evidence demonstrates that early, active management with non-opioid approaches produces better functional outcomes and faster return to work than opioid-based strategies.

How AllMeds.ai Manages Schedule 4 Medication Compliance

AllMeds.ai medication risk assessment automatically identifies Schedule 4 opioids and applies jurisdiction-specific compliance rules:

• Schedule classification verification: Confirms medication schedule status against current TGA Poisons Standard
• Duration monitoring: Flags prescriptions exceeding jurisdiction-specific time limits (typically 5-14 days)
• Prescription validation: Checks for valid prescriber, date, dosage, and quantity
• Interaction checking: Identifies concurrent CNS depressants (benzodiazepines, other opioids)
• OME calculation: Calculates total oral morphine equivalent dose if multiple opioids present
• Guideline compliance: Assesses against SIRA, WorkSafe, WorkCover treatment guidelines
• Alternative recommendations: Suggests evidence-based non-opioid alternatives for prescriber consideration

The system specifically identifies Panadeine Forte and other codeine-containing products requiring Schedule 4 prescription verification and duration monitoring.