Fildena Extra Power (Sildenafil Citrate): Comprehensive Patient Information
Basic Product Information
| International Nonproprietary Name (INN) | Sildenafil Citrate |
|---|---|
| Australia Brand Names | Fildena Extra Power, Viagra, Revatio (for PAH) |
| ATC Code | G04BE03 |
| Available Forms & Strengths | Tablets, 100 mg (Extra Power); also available in 25 mg, 50 mg, 120 mg, 150 mg, 200 mg (varies by manufacturer) |
| Manufacturers | Fortune Healthcare, Cipla, Pfizer (for Viagra) |
| Prescription Status (Australia) | Prescription only (Schedule 4, S4) |
Mechanism of Action
For patients: Fildena Extra Power contains sildenafil citrate, which works by relaxing blood vessels in the penis. This allows increased blood flow when you are sexually aroused, making it easier to get and keep an erection.
For specialists: Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). By inhibiting PDE5, contraindicated in the corpus cavernosum, sildenafil enhances the effect of nitric oxide (NO), further increasing cGMP, smooth muscle relaxation, and penile erection during sexual stimulation.
Pharmacokinetics
- Absorption: Rapid; peak plasma concentrations typically reached within 30 to 120 minutes (median 60 minutes).
- Bioavailability: Approximately 40% after oral administration.
- Metabolism: Primarily by hepatic enzymes CYP3A4 and CYP2C9 into an active metabolite.
- Elimination: Mainly via faeces (approx. 80%) and urine (approx. 13%).
- Duration of Action: Effects can last up to 4–6 hours. Some men may notice effects for up to 12 hours.
Use in Everyday Life and Best Practices
Typical Dose: For erectile dysfunction, adults generally start with 50–100 mg at least 30 minutes before sexual activity. Maximum: once every 24 hours. Take the tablet whole with a glass of water. Only take when required. Your doctor may adjust your dose based on response and tolerability.
Practical advice: In Australia, Fildena Extra Power and equivalent medications are used by many men experiencing erectile difficulties. It is important to obtain your tablets from a licensed Australian pharmacy with a valid prescription. Always follow your doctor's directions.
Dosing: Morning vs Evening
- Sildenafil can be taken at any time of day, but should be taken about 1 hour before planned sexual activity.
- There is no clinical preference for morning or evening dosing; timing should align with your anticipated need.
- Avoid taking two doses within a 24-hour period for safety.
- Taking consistently around the same time may help you develop a routine; however, only take on days needed, unless advised otherwise by a doctor.
Taking with Food or on an Empty Stomach
Food, especially high-fat meals (such as fried breakfasts or large cooked English dinners) can delay the effect of sildenafil and decrease how much gets absorbed. For best results, take Fildena Extra Power on an empty stomach or after a light meal. Avoid heavy, fatty foods around the time of dosing.
Interaction Warnings
| Substance | Effect | Recommendation |
|---|---|---|
| Nitrates (e.g. GTN spray, isosorbide dinitrate) | Severe, potentially life-threatening drop in blood pressure | Absolute contraindication: Never combine |
| Other ED Medicines (vardenafil, tadalafil, avanafil) | Increased risk of side effects | Do not take together |
| Alpha-blockers (e.g. prazosin, doxazosin) | Hypotension, fainting | Careful monitoring, stagger doses if necessary |
| Alcohol | Can worsen hypotension and dizziness | Limit or avoid |
| CYP3A4 Inhibitors (ritonavir, ketoconazole) | Increase sildenafil levels; higher risk of side effects | Possible dose adjustment or avoidance |
| Grapefruit juice | May increase medicine levels in blood | Avoid grapefruit products |
Indications
| Indication | Status |
|---|---|
| Erectile dysfunction | Official (PBS-subsidised in select circumstances) |
| Pulmonary arterial hypertension (Revatio brand) | Official |
| Raynaud's phenomenon | Occasional off-label |
| Female sexual arousal disorder, other sexual dysfunctions | Off-label, limited evidence |
Dosing by Clinical Indication
| Group | Indication | Usual Dose | Max Dose |
|---|---|---|---|
| Adult Men | Erectile dysfunction | 50-100 mg once as needed | 100 mg/24h |
| Elderly | Erectile dysfunction | Start at 25 mg, titrate as tolerated | 100 mg/24h |
| Adults | Pulmonary arterial hypertension | 20 mg three times daily (Revatio only) | Up to 80 mg/day (as divided doses) |
| Pediatric | Not recommended for ED use | N/A | N/A |
Safety Profile and Side Effects
- Common side effects (1-10%): Headache, flushing, nasal congestion, indigestion, dizziness, vision changes (colour tinge, blurred vision)
- Occasional (<1%): Rash, muscle pain, increased heart rate, nosebleeds
- Rare (<0.1%): Prolonged erection (>4 hours, priapism), sudden hearing loss, severe visual changes, allergic reactions (rash, swelling)
- Serious: Seek immediate medical attention for chest pain, severe dizziness, persistent erection, sudden visual or hearing loss
- Do not use with nitrate medication or if you have significant heart, liver, or recent stroke/cardiac event unless cleared by a specialist.
Guidelines for Proper Use (Australia)
- Consult an Australian registered doctor for a suitable script and medical assessment.
- Use only as directed. Start at the prescribed dose and do not exceed recommendations.
- Purchase from a registered Australian pharmacy (not overseas online sellers) to ensure quality and legal compliance.
- Store away from heat and moisture, out of sight and reach of children.
- If you miss a dose (for daily PAH use): take as soon as remembered, but never double dose.
- Inform your doctor of all other medicines and supplements.
- Do not drive or operate heavy machinery if you feel dizzy or have vision changes.
Alternative Treatment Options
| Alternative | Drug Class | Reimbursed By PBS? | Pros & Cons |
|---|---|---|---|
| Tadalafil (Cialis) | PDE5 inhibitor | Yes (in select cases) | Longer action (up to 36 hrs); daily & on-demand dosing; can be more expensive |
| Vardenafil (Levitra) | PDE5 inhibitor | Limited | Similar efficacy; some men report fewer vision effects |
| Avanafil (Stendra) | PDE5 inhibitor | No | Very rapid onset; currently less availability in Australia |
| Alprostadil (injection or suppository) | Prostaglandin E1 analogue | Yes (with PBS approval) | Non-oral; direct effect; invasive, more side effects |
| Penile prosthesis, vacuum devices, counselling | Physiological/psychological | Partial (device, limited) | Surgical/permanent options; for non-responders only |
Legal, Registration and Reimbursement Status in Australia
- Legal status: Prescription-only medicine (Schedule 4, S4) regulated by the Therapeutic Goods Administration (TGA).
- Registration: Listed on the Australian Register of Therapeutic Goods (ARTG) for ED and PAH.
- Reimbursement: Sildenafil is subsidised under the Pharmaceutical Benefits Scheme (PBS) for pulmonary arterial hypertension, and for ED only in cases of specific conditions (e.g., diabetes, prostatectomy).
- Generic versions are available and widely supplied by community pharmacies with a valid prescription.
Latest Research and Clinical Guidance (2022–2025)
- Recent guidelines from the Australian Therapeutic Guidelines (2023) and the European Association of Urology (EAU, 2024) confirm sildenafil as a suitable first-line therapy for most men with erectile dysfunction.
- Combination of lifestyle modification (healthy diet, physical activity, reduction in alcohol intake) with PDE5 inhibitors is advised to maximise effectiveness and overall vascular health. (White et al., Lancet Diabetes Endocrinol, 2023)
- Studies emphasise the importance of shared decision-making and regular follow-up with GPs and pharmacists (Royal Australian College of General Practitioners, Red Book, 2024).
- Revatio (low-dose sildenafil) continues to be recommended as a key therapy for pulmonary hypertension (Australian Pulmonary Hypertension Registry, 2022).
Availability and Delivery
| Pack Size | Common Tablet Strength | Indicative Retail Price (AUD) |
|---|---|---|
| 4 tablets | 100 mg | $30–$45 |
| 8 tablets | 100 mg | $58–$80 |
| 12 tablets | 100 mg | $95–$110 |
| 28 tablets (PBS, select indications) | 25/50/100 mg | Co-payment or full price |
| City | Standard Pharmacy Delivery (days) | Express Option |
|---|---|---|
| Sydney | 1–2 | Yes (same/next day) |
| Melbourne | 1–2 | Yes (same/next day) |
| Brisbane | 2–3 | Yes |
| Adelaide | 2–3 | Yes |
| Perth | 3–5 | Yes (plus shipping) |
| Darwin | 3–5 | Yes |
Frequently Asked Questions (FAQ)
- 1. How long does it take Fildena Extra Power (sildenafil) to work?
- Usually 30–60 minutes. Sexual stimulation is required for the medicine to be effective.
- 2. Can I use Fildena Extra Power with alcohol?
- It is best to limit or avoid alcohol when taking sildenafil, as it may reduce effectiveness and increase risk of side effects such as dizziness or low blood pressure.
- 3. Do I need a prescription in Australia?
- Yes, sildenafil (including Fildena Extra Power) is prescription-only (S4). Always obtain via a local GP or telehealth service and a licensed pharmacy.
- 4. Is Fildena Extra Power covered by the PBS?
- Only for certain medical conditions (e.g. diabetes, prostate surgery). Otherwise, it is privately purchased but generic options may be affordable.
- 5. What should I do if I develop chest pain, vision change, or a prolonged erection?
- Stop taking sildenafil and seek immediate medical help, as these are potentially serious side effects.
Summary
Fildena Extra Power (sildenafil citrate) is a proven and widely used treatment for erectile dysfunction and some other conditions in Australia. To ensure safe, effective use, always consult your doctor or pharmacist, take it as directed, and be aware of potential side effects and interactions. If you have further questions, do not hesitate to speak to your healthcare provider.
