Super Tadapox (Tadalafil/Dapoxetine) – Patient Information for Australia
1. Basic Product Information
| International Nonproprietary Name (INN) | Tadalafil, Dapoxetine |
|---|---|
| Australian Brand Names | Super Tadapox, Tadapox, other equivalent generics |
| ATC Code | G04BE08 (Tadalafil) / N06AX22 (Dapoxetine) |
| Available Forms & Strengths | Film-coated tablets: Tadalafil 40mg + Dapoxetine 60mg, 10/pack |
| Manufacturers | Sunrise Remedies, Centurion Laboratories*, others (*not registered with TGA as of June 2024) |
| Prescription Status | Prescription only (Schedule 4 medication in Australia) |
2. Mechanism of Action
For Patients: Super Tadapox combines tadalafil (used for erectile dysfunction) and dapoxetine (used for premature ejaculation). Tadalafil helps in achieving and maintaining an erection by relaxing blood vessels in the penis, increasing blood flow during sexual stimulation. Dapoxetine helps delay ejaculation by acting on chemicals in your brain, allowing greater control over ejaculation.
For Healthcare Professionals:
- Tadalafil: Selective PDE5 inhibitor, enhances nitric oxide–mediated vasodilation in corpus cavernosum.
- Dapoxetine: Short-acting SSRI, increases synaptic serotonin, delaying ejaculatory latency by modulating pudendal motor neurons.
3. Pharmacokinetics
- Absorption: Tadalafil is rapidly absorbed (Tmax 2 h); dapoxetine peaks at 1–2 h post-dose.
- Metabolism: Both drugs are predominantly metabolised via hepatic CYP enzymes (Tadalafil: CYP3A4, Dapoxetine: CYP2D6/CYP3A4).
- Elimination: Tadalafil: ~36 h half-life. Dapoxetine: 1.5 h (elimination half), clears within 24 h.
- Duration of Action: Tadalafil lasts up to 36 h (“weekend pill”). Dapoxetine’s effect remains for about 6–10 h post-dose.
4. Use in Everyday Life and Best Practices
Super Tadapox is designed for adult men with both erectile dysfunction (ED) and premature ejaculation (PE). It should be taken as a single tablet approximately 1–3 hours before sexual activity. Do not take more than one tablet in 24 hours. Always follow your health professional’s guidance.
- It’s not intended for everyday use—use it only when sexual activity is anticipated.
- Do not split or crush tablets. Swallow whole with water.
- Seek medical review if underlying health conditions (heart, liver, kidney).
5. Morning vs Evening Dosing
- Morning: May offer flexibility due to the “weekend” action of tadalafil, but may cause drowsiness with dapoxetine in some users. Not typically preferred unless advised by a doctor.
- Evening: Commonly recommended. Take 1–3 hours before planned sexual activity, which is often in the evening; aligns with social and relationship patterns in Australia.
- Tips: Be consistent in timing to gauge response; avoid taking at irregular intervals.
6. Taking with Food or on an Empty Stomach
- Food: Meals do not significantly affect tadalafil absorption, but a heavy or high-fat meal may slightly delay onset.
- Advice: In Australia, typical balanced meals (with moderate protein/carbs) are fine. Avoid very fatty or large meals immediately before dosing.
- Hydration: Take with water; avoid grapefruit juice (interaction risk).
7. Interaction Warnings
| Interaction | Notes |
|---|---|
| Alcohol | May increase risk of dizziness, fainting, impaired judgment. Avoid excess alcohol. |
| Nitrates (angina meds e.g., GTN spray, isosorbide) | Dangerous drop in blood pressure – never combine. |
| Alpha-blockers (hypertension, prostate) | Risk of low blood pressure, fainting. Monitor closely if used together. |
| SSRIs, MAOIs, tricyclic antidepressants | Potential risk of serotonin syndrome with dapoxetine. |
| Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) | May increase blood levels of both drugs; dose adjustment may be needed. |
| Grapefruit juice | Can increase side effects; avoid completely. |
| Recreational drugs (“poppers”, ecstasy, amphetamines) | Severe interactions possible. Do not mix. |
8. Indications
| Indication | Status | Notes |
|---|---|---|
| Treatment of erectile dysfunction (ED) with premature ejaculation (PE) | Off-label combination in Australia | Only available as two separate medicines officially; combination not TGA-registered |
| Single-agent ED (tadalafil alone) | Registered | Brand names: Cialis®, Adcirca® |
| Single-agent PE (dapoxetine alone) | Not registered in Australia | Used overseas (e.g., Priligy®), specialist prescribing |
| BPH (benign prostatic hyperplasia) | On label for tadalafil | Lower tadalafil doses, usually not in combination with dapoxetine |
9. Dosing According to Clinical Indications
| Group | Typical Dose | Comments |
|---|---|---|
| Adult Men (18–64 years) | 1 tablet (40 mg tadalafil + 60 mg dapoxetine) as needed, 1–3 hours before intercourse | Do not exceed 1 tablet in 24 hours. For use with specialist advice. |
| Elderly (>65 years) | Lower starting dose advised – seek specialist review | Increased risk of side effects; renal/hepatic caution. |
| Paediatric (<18 years) | Not recommended or approved | Safety and efficacy not established. |
| Renal/hepatic impairment | Contraindicated or requires dose reduction | Consult specialist; higher adverse risk. |
10. Safety Profile and Side Effects
- Common Side Effects:
- Headache
- Dizziness, lightheadedness
- Flushing (warmth, redness)
- Nasal congestion
- Back pain, muscle aches
- Nausea, indigestion
- Diarrhoea
- Less Common (seek urgent help if severe):
- Sudden vision or hearing loss
- Chest pain, palpitations
- Priapism (painful, persistent erection > 4 hours)
- Mood changes, anxiety, agitation (esp. with dapoxetine)
- Severe allergic response (rash, swelling, breathing difficulty)
- Warnings: Dapoxetine may cause transient drowsiness or fainting. Avoid activities needing alertness (driving, machinery) shortly after dosing. Seek medical attention if side effects are severe, persistent, or worrying.
11. Guidelines for Proper Use (Advice from Australian Pharmacists/Clinics)
- See your doctor for a full check-up before starting any ED treatment, especially if you have heart, liver, or kidney issues.
- Tell your pharmacist about all prescription, over-the-counter, and herbal medicines you take.
- Never use more than the recommended dose. Misuse can lead to dangerous side effects.
- Monitor your response. If no benefit after multiple attempts, seek review.
- Store at room temperature, away from moisture and heat; keep out of reach of children and pets.
- Do not use if packaging is damaged or out-of-date.
- If you experience severe or “atypical” symptoms (chest pain, breathing difficulty, vision changes), seek help immediately (triple zero 000 in Australia).
12. Alternative Treatment Options
- Sildenafil (Viagra® and generics): Reimbursed for specific cases; faster onset, shorter duration than tadalafil.
- Tadalafil (Cialis®): Longer-acting; TGA-registered; available for ED and BPH.
- Vardenafil (Levitra®): Alternative oral PDE5 inhibitor, TGA-listed.
- Dapoxetine: Only available via overseas or unregistered import. SSRIs also used off-label for PE (paroxetine, sertraline).
- Non-drug options: Psychological counselling, pelvic floor physiotherapy, couples therapy.
- Mechanical and surgical options: Vacuum erection devices, penile prostheses (for severe ED).
Pros of Super Tadapox: Combined effect for dual problems; convenient single dosing.
Cons: Not officially registered in Australia, so may be less regulated; higher risk of side effects due to double action; not suitable for all patients.
13. Legal, Registration, and Reimbursement Status in Australia
- “Super Tadapox” (tadalafil + dapoxetine combination) is not registered on the Australian Register of Therapeutic Goods (ARTG) as of June 2024.
- Tadalafil (as Cialis®) is TGA-registered and available by prescription (Schedule 4).
- Dapoxetine is not registered or reimbursed by the Pharmaceutical Benefits Scheme (PBS); specialists may prescribe single-ingredient dapoxetine under special circumstances (“personal importation” for personal use but subject to TGA and Customs rules).
- Combination products such as Super Tadapox cannot be legally promoted, imported, or supplied in bulk commercial quantities or via pharmacies unless specifically permitted by the TGA.
- Doctor’s prescription required for any PDE5 inhibitor in Australia.
14. Latest Research and Clinical Guidance (2022–2025)
- International guidelines (including European Association of Urology and British Society for Sexual Medicine) continue to support use of PDE5 inhibitors for ED, and SSRIs for PE. Dapoxetine remains the only SSRI registered for on-demand PE use internationally.
- Recent reviews (BJU Int 2023) confirm combination therapy can be effective in patients affected by both ED and PE, improving satisfaction and control, but adverse effects are more likely versus monotherapy.
- Australian prescribers are advised to prioritise approved, TGA-listed medications wherever possible. Personal importation of unregistered products carries risks; always seek specialist guidance.
- Citation: “Combination therapy for patients with erectile dysfunction and premature ejaculation: a contemporary update.” BJU Int 2023;131(S2):46-54. ; EAU Guidelines 2024; Therapeutic Guidelines Australia 2024.
15. Availability and Delivery in Australia
- Super Tadapox is not available from Australian community or online pharmacies registered with TGA as of 2024.
- Some patients may access via personal importation from international suppliers (subject to TGA’s Personal Importation Scheme), but this is not recommended without medical supervision. Imported medicines may not meet Australian quality and safety standards.
| Pack Size | Indicative Price (AUD) | Delivery Estimate (International; major cities) |
|---|---|---|
| 10 tablets | $70–$120 | 7–15 business days (Sydney, Melbourne, Brisbane) |
| 20 tablets | $135–$200 | 7–15 business days |
Note: Prices and delivery times depend on supplier and may vary. Australian customs may seize unauthorised prescription medications.
16. Frequently Asked Questions (FAQ)
- Q1: Is Super Tadapox legal to buy in Australia?
A: No, it is not legally supplied or registered in Australia. Personal importation may be possible for personal use if you have a prescription and follow all TGA rules, but this carries risks. - Q2: What should I do if I miss a dose?
A: Super Tadapox is taken as needed, not as a regular daily dose. If you forget to take it before planned intercourse, do not double up; wait until next opportunity. Never take more than one tablet in 24 hours. - Q3: Can I drink alcohol with Super Tadapox?
A: Avoid excessive alcohol, as it can worsen side effects such as fainting, dizziness, and impaired sexual performance. - Q4: What if I get severe side effects?
A: Stop taking the medicine and seek immediate medical help (triple zero 000) if you develop chest pain, breathing problems, severe allergy, or an erection longer than 4 hours. - Q5: Is there a “safe” source for Super Tadapox?
A: No Australian pharmacy sells Super Tadapox legally. Always seek alternatives approved by the TGA and your doctor’s advice before considering imported medicines.
Important: Always consult your healthcare provider for personalised medical advice. This information is intended as a general educational resource for Australia and does not replace medical consultation.
