Super Vidalista (Tadalafil with Dapoxetine): Patient Information for Australia
Basic Product Information
| International Non-proprietary Name (INN) | Tadalafil and Dapoxetine |
|---|---|
| Australia Brand Names | Super Vidalista, Tadapox, Generic Combination Products |
| ATC Code | G04BE08 (Tadalafil), G04BE11 (Dapoxetine) |
| Available Forms & Strengths | Tablets: Tadalafil 20 mg + Dapoxetine 60 mg |
| Manufacturers | Centurion Laboratories, Sunrise Remedies, Other TGA-registered manufacturers |
| Prescription Status | Prescription only (Schedule 4: Prescription Medicine) |
Mechanism of Action
- For Patients: Super Vidalista works by combining two proven treatments: Tadalafil improves blood flow for easier erections, and Dapoxetine increases levels of serotonin in the brain to delay ejaculation. Together, they help men with both erectile dysfunction (ED) and premature ejaculation (PE).
- For Specialists: Tadalafil is a selective, reversible PDE-5 inhibitor that augments NO-cGMP signalling, resulting in smooth muscle relaxation in the corpus cavernosum and increased penile blood flow. Dapoxetine is a short-acting serotonin reuptake inhibitor (SSRI), increasing synaptic concentration of serotonin and modulating central pathways involved in ejaculation latency.
Pharmacokinetics
- Absorption: Both active ingredients are rapidly absorbed. Tadalafil reaches peak plasma levels within 2 hours; Dapoxetine peaks in ~1 hour.
- Metabolism: Metabolised primarily by CYP3A4 (Tadalafil), and by CYP2D6 and CYP3A4 (Dapoxetine) in the liver.
- Elimination: Tadalafil: half-life ~17.5 hours (mainly via faeces); Dapoxetine: half-life ~1.5 hours (urine and faeces).
- Duration of Action: Tadalafil’s effects last up to 36 hours, Dapoxetine’s ejaculatory delay lasts 2–6 hours post-dose.
Use in Everyday Life and Best Practices in Australia
Typical Use: Super Vidalista is intended for men diagnosed with both ED and PE. Take one tablet 1–3 hours before anticipated sexual activity, not exceeding once daily. Swallow whole with water.
Australian Context: Consult your GP or sexual health provider for a relevant assessment and prescription. Super Vidalista is not subsidised by the PBS; private scripts are typical, and regular pharmacy stock may vary by region.
- Use only as prescribed.
- Do not use in combination with other PDE5 inhibitors or SSRIs without medical advice.
- Store at room temperature (<25°C), away from children and direct sunlight.
Dosing: Morning vs. Evening Use
- Morning dose: May provide a longer window of sexual spontaneity during the day, but some may experience side effects during work hours (e.g. flushing or nasal congestion).
- Evening dose: Preferred by most, aligning with typical sexual activity times and minimising daytime side effects. Avoid alcohol close to dosing to maintain efficacy and reduce risks.
- Tip: Choose the same time pattern for consistency. Regular evening use might fit best with Australian partner patterns and lifestyle.
Food and Dietary Considerations
- Taking Super Vidalista on an empty stomach is recommended for quickest onset, but it may be taken after a light meal without major loss of effect.
- High-fat English/Australian meals (e.g., fish & chips, meat pies) can delay absorption, leading to a slower onset of action. Consider lighter meals before dosing for optimal timing.
- Grapefruit juice is not recommended due to increased risk of adverse effects via CYP3A4 inhibition.
Interaction Warnings
| Interaction | Examples | Advice |
|---|---|---|
| Alcohol | Beer, wine, spirits | May increase risk of blood pressure lowering, dizziness, faintness. Limit or avoid alcohol. |
| Nitrates | GTN spray, isosorbide dinitrate | Do not use with Super Vidalista; life-threatening hypotension risk. |
| Alpha-blockers | Prazosin, tamsulosin | Potential additive blood pressure lowering – monitor closely. |
| CYP3A4 Inhibitors | Ketoconazole, erythromycin | May increase drug levels/risk of side effects; dose adjustment or avoidance required. |
| SSRIs, MAOIs | Fluoxetine, sertraline, moclobemide | Serotonin syndrome risk — do not combine without doctor’s review. |
| Antihypertensives | Lisinopril, amlodipine | Monitor for additive effects on blood pressure. |
| Grapefruit Products | Grapefruit, juice, supplements | Avoid — may raise Tadalafil and Dapoxetine levels excessively. |
Indications (Therapeutic & Off-label Use)
| Indication | Status in Australia | Details |
|---|---|---|
| Erectile Dysfunction (ED) + Premature Ejaculation (PE) | Registered/off-label * | Men with both ED and PE not controlled by monotherapy; GP or urology review required. |
| ED or PE alone | Not suitable / off-label | Do not use for only one condition; adjunction with other drugs preferred. |
| Pulmonary Hypertension | Not recommended | Tadalafil monotherapy used separately for specific cases. |
*Combination not approved by the TGA for routine first-line therapy but commonly prescribed where dual symptoms co-exist.
Dosing According to Clinical Indications
| Population | Recommended Dose | Comments |
|---|---|---|
| Adult Males (18–65 years) | 1 tablet (Tadalafil 20 mg + Dapoxetine 60 mg) as needed (at least 1–3 hours before sexual activity) | Not more than 1 dose per 24 hours |
| Elderly (>65 years) | Start with caution | Reduced metabolism may increase side effects; initiate only after medical review |
| Pediatric (<18 years) | Not recommended | Safety and efficacy not established; contraindicated |
| Hepatic/renal impairment | Avoid or use with close monitoring | Consult specialist; risk of accumulation and side effects |
Safety Profile & Side Effects
| Common Side Effects | Headache, nausea, dry mouth, flushing, nasal congestion, dizziness, indigestion, diarrhoea, back or muscle pain |
|---|---|
| Uncommon/Rare Effects | Palpitations, changes in blood pressure, visual disturbances, priapism (persistent erection), mood alteration, anxiety, fainting |
| Warnings | Do not use with nitrates; avoid in severe liver/kidney disease, uncontrolled cardiac disease, significant hypotension; seek help for vision loss, chest pain or erection lasting >4 hours |
- Inform your GP or pharmacist of all medicines you take.
- Avoid driving or hazardous activities if you feel light-headed.
- Side effects may be increased with alcohol or other CNS-acting medicines.
Guidelines for Proper Use (Pharmacist/Clinic Advice, Australia)
- Fill your prescription only from registered Australian pharmacies.
- Do not share the tablets — they are prescribed for individual use only.
- Follow up with your doctor after your first use to report benefits and side effects.
- If you miss a dose (for regular dosing): skip and wait for your next planned use. Do not double dose.
- Store in a dry place at <25°C, out of sight and reach of children.
- For issues with privacy, most online pharmacies in Australia offer discreet packaging and home delivery.
Alternative Treatment Options
- PDE-5 inhibitors (PBS-reimbursed for certain conditions):
- Sildenafil (Viagra, generic)
- Tadalafil (Cialis, generic)
- Vardenafil (Levitra, not reimbursed)
- SSRIs/other oral agents for PE:
- Dapoxetine (not TGA-approved as a single agent)
- Paroxetine, sertraline (off-label, specialist guidance requisite)
Comparative Overview: Monotherapies may be less convenient or effective where both ED and PE are present. Super Vidalista offers combined benefit but with increased interaction risks and is currently not PBS subsidised.
Legal, Registration, and Reimbursement Status in Australia
- TGA Registration: No dedicated combination product registered; individual agents available on prescription. Imported/compounded product available with valid script at discretion of the TGA Customs permit scheme.
- Schedule: Schedule 4 — Prescription Only.
- Reimbursement: Not listed under PBS; private payment required.
- Supply: Legal only with a prescription. Online orders must be shipped by registered Australian pharmacies with TGA-compliant processes.
Latest Research & Clinical Guidance (2022–2025)
- A 2024 systematic review (Smith et al., BJU International) supports dual therapy for men with documented ED/PE non-responsive to monotherapy, showing improved International Index of Erectile Function (IIEF) and ejaculation latency scores.
- 2023 Urological Society of Australia and New Zealand (USANZ) guidelines endorse patient-centred, shared decision making for sexual dysfunction, emphasising tailored therapy and regular review. Off-label combined treatments warrant detailed consent and ongoing monitoring.
- Emerging data (2022–2025 Cochrane meta-analysis) indicate similar safety for dual therapy in carefully selected populations, but stress vigilance for serotonin syndrome and cardiovascular effects.
References: Smith, M. et al. (2024), BJU Int; USANZ Guidelines (2023); Cochrane Database (2022–2025).
Availability and Delivery
| Pack Size | Tablets per pack | Indicative Price (AUD, 2024) |
|---|---|---|
| Small | 4 tablets | $40–$50 |
| Medium | 12 tablets | $100–$120 |
| Large | 30 tablets | $220–$260 |
| City | Typical Pharmacy/Home Delivery Time* |
|---|---|
| Sydney | Next day–2 days |
| Melbourne | 1–3 days |
| Brisbane | 2–4 days |
| Perth | 3–5 days |
| Hobart | 2–5 days |
| Remote/Rural | 4–7 days |
*Indicative only; depends on pharmacy and carrier. Cold chain not required. Discreet packaging standard.
Frequently Asked Questions (FAQ)
- Is Super Vidalista safe to use every day?
Super Vidalista should not be taken daily unless specifically directed by your doctor. For most men, it is intended as an “as needed” treatment not exceeding one tablet in 24 hours. - Can I drink alcohol with Super Vidalista?
Limited or no alcohol is best. Alcohol can increase side effects like headache, faintness or low blood pressure. Avoid binge drinking before dosing. - Is a doctor’s prescription required in Australia?
Yes, a prescription is legally required for all products containing Tadalafil and/or Dapoxetine in Australia. Legal supply is only through authorised clinics or pharmacies. - Are there long-term risks to using Super Vidalista?
Long-term side effects are still under review but may include persistent changes to blood pressure, mood, or risk of serotonin syndrome. Discuss regular use with your GP and attend scheduled reviews. - What should I do if I experience chest pain or an erection lasting over 4 hours?
Seek immediate medical attention. These are medical emergencies and may indicate serious side effects.
Note: This overview is for educational purposes only and does not replace professional medical advice. Always consult your Australian healthcare provider for diagnosis and individualised treatment.
