Cialis Soft (Tadalafil): Comprehensive Patient Information for Australia
Basic Product Information
| International Nonproprietary Name (INN) | Tadalafil |
|---|---|
| Australia Brand Names | Cialis, Cialis Soft, Adcirca, Tadalis |
| ATC Code | G04BE08 |
| Available Forms & Strengths | Oral tablets: 2.5 mg, 5 mg, 10 mg, 20 mg; Soft or dispersible tablets: usually 20 mg |
| Manufacturers | Eli Lilly Australia, various generic manufacturers |
| Prescription Status | Prescription only (S4) |
Mechanism of Action
For Patients: Cialis Soft contains tadalafil, which helps increase blood flow to the penis, aiding men with erectile dysfunction (ED) to achieve and maintain an erection when sexually aroused. It works by relaxing and opening the blood vessels in that area.
For Healthcare Professionals: Tadalafil is a selective inhibitor of phosphodiesterase type 5 (PDE5), preventing the breakdown of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. This prolongs smooth muscle relaxation and enhances erectile response to sexual stimulation.
Pharmacokinetics
- Absorption: Well-absorbed orally, with peak plasma concentrations within 30 minutes to 2 hours. Soft tablets may act faster due to sublingual/buccal absorption.
- Metabolism: Predominantly hepatic (CYP3A4-mediated).
- Elimination: Major route via faeces (~61%) and urine (~36%).
- Duration of Action: Long half-life (average 17.5 hours); effects can last up to 36 hours, hence called the “weekend pill.”
Use in Everyday Life and Best Practices
- Typical Doses: For ED, commonly a 10 mg or 20 mg tablet, taken before anticipated sexual activity. For daily use (for men with frequent sexual activity), 2.5 mg or 5 mg daily is possible (prescribed by your doctor).
- How to Use: Place Cialis Soft under the tongue or allow it to dissolve in the mouth for rapid effect. It can be taken with or without water and typically works within 15–30 minutes.
- Australian Context Advice: Only use as prescribed by your GP or sexual health physician. Ask your pharmacist if you have any questions. Keep the tablets out of reach of children.
Dosing: Morning vs Evening
- Morning: Taking in the morning is preferred for men who expect intimacy at any time, given the long duration. May suit those who wish to avoid planning.
- Evening: Useful when sexual activity is anticipated within a few hours. May reduce disruption to daily activities.
- Consistency: If prescribed for daily use, take at the same time each day for best results. Pick a regular time (morning or evening) that fits your schedule.
Taking with Food or on an Empty Stomach
Cialis Soft can be taken with or without food. Meals, including those with fat or dairy typical in Australian diets, do not significantly delay its onset. However, heavy or very fatty meals may slow absorption in rare cases. Coffee, tea, and light snacks are fine.
Interaction Warnings
| Interaction | Advice |
|---|---|
| Alcohol | Limit to minimise risk of low blood pressure, dizziness, and fainting. |
| Nitrates (e.g., glyceryl trinitrate, isosorbide dinitrate) | Do not combine — severe drop in blood pressure may occur. |
| Alpha-blockers | Caution: May enhance hypotensive effect; dose adjustment or clinical monitoring recommended. |
| Other ED medicines (e.g., Viagra®, Levitra®) | Do not use together — risk of additive adverse effects. |
| Antifungal & HIV drugs (e.g., ketoconazole, ritonavir) | May increase tadalafil levels; specialist supervision needed. |
| Grapefruit juice | May increase side effect risk; best avoided. |
Indications
| Indication | Status |
|---|---|
| Erectile dysfunction (ED) | Approved |
| Benign prostatic hyperplasia (BPH) symptoms | Approved (some forms) |
| Pulmonary arterial hypertension (PAH) | Approved (Adcirca®) |
| Raynaud's phenomenon, female sexual dysfunction | Investigational/off-label |
Dosing According to Clinical Indication
| Indication | Adult Dose | Elderly Dose (≥65) | Paediatric Dose |
|---|---|---|---|
| Erectile dysfunction (on demand) | 10–20 mg before activity | Start at 10 mg | Not recommended |
| Erectile dysfunction (daily) | 2.5–5 mg once daily | Start at lower range | Not recommended |
| BPH symptoms | 5 mg once daily | 5 mg once daily | Not recommended |
| Pulmonary arterial hypertension | 40 mg once daily (Adcirca) | Consider lower dose | Specialist only |
Safety Profile and Side Effects
- Common (≥1/10): Headache, indigestion, back pain, muscle aches, flushing, nasal congestion.
- Occasional (1/100–1/10): Dizziness, blurred vision, eye pain, tinnitus.
- Rare (<1/1000): Persistent painful erection (priapism), sudden vision or hearing loss, serious allergic reactions.
- Warnings: Seek urgent advice if chest pain, severe dizziness, visual or auditory changes, or erection >4 hours occur.
Guidelines for Proper Use in Australia
- Discuss your full medical history with your GP, especially heart problems, liver or kidney disease, or if you take nitrates or heart medicines.
- Follow the prescribed dose — do not exceed once per day.
- Keep hydrated and limit alcohol intake.
- Store at <30°C in a dry place, away from children.
- Do not share your medicine with anyone, even with similar symptoms.
- If you miss a daily dose, take it as soon as remembered, but never double up.
- If you experience any severe or unusual symptoms, contact your doctor or ring Healthdirect (1800 022 222).
Alternative Treatment Options
- Sildenafil (Viagra®, generic): Shorter action, may need to be taken 1 hour before sexual activity. More affected by food. Often PBS-reimbursed for specific populations.
- Vardenafil (Levitra®, generic): Similar onset to sildenafil, also food interactions.
- Avanafil (Spedra®): Fast onset, shorter duration.
- Non-pharmacological options: Vacuum devices, penile injections (alprostadil), psychotherapy/sexual counselling.
Pros and Cons Table
| Option | Key Advantage | Key Disadvantage |
|---|---|---|
| Cialis Soft (Tadalafil) | Long duration, works within 15–30 min, less affected by food | Not subsidised on PBS for most; prescription only |
| Sildenafil | Well-known, PBS for certain groups | Shorter duration, food effect |
| Avanafil | Fastest onset | Not widely available; not PBS subsidised |
| Vacuum/other physical therapies | No medicines required | Less spontaneity; some discomfort |
Legal, Registration, and Reimbursement Status in Australia
- Registered with the TGA (Therapeutic Goods Administration).
- Supplied on prescription only (Schedule 4 - S4 medication). Not available over the counter.
- Not listed for PBS subsidy for ED; some PBS subsidy available for other indications (e.g., PAH).
- Imported generic or brand forms must comply with TGA regulations; online purchase is legal only with valid local prescription.
Latest Research and Clinical Guidance (2022–2025)
- 2024: TGA and RACGP guidelines reaffirm tadalafil as a first-line ED option for most men not taking nitrates or alpha-blockers.
- Clinical trials (2022–2024) confirm long-term safety; daily low-dose shown effective for men with frequent ED or co-existing BPH (ANZUP 2023 report).
- Australian Men’s Health Forum Review 2025: Highlights patient preference for Cialis Soft for its rapid and discreet action; considered non-inferior to standard tadalafil in efficacy and safety.
- New guidance: Ongoing studies into use for women and other vascular disorders, but not currently approved for these uses.
Availability and Delivery in Australia
| Pack Size | Indicative Price (AUD) | Delivery Times |
|---|---|---|
| 2 tablets (trial) | $19–$29 | Express: 1–2 business days (metro); Standard: 2–5 days |
| 8 tablets | $60–$90 | Express: 1 day (Sydney, Melbourne, Brisbane); up to 5 days (regional/remote) |
| 16 tablets | $120–$160 | Express: 1–2 days (metro); Standard: 3–7 days |
| Pack subscription (monthly) | $70–$135 | Recurring, free delivery in most urban areas |
Please note: Prices and availability may differ between pharmacies. Always purchase from a registered pharmacy and check for TGA approval.
Frequently Asked Questions (FAQ)
- Can I use Cialis Soft if I have heart disease?
Not if you are on nitrates or certain blood pressure medicines. Always consult your cardiologist or GP before using ED medicines, especially if you have any heart, kidney, or liver conditions. - Can I drink alcohol with Cialis Soft?
A small amount is generally safe, but excess alcohol increases risk of side effects (dizziness, low blood pressure, fainting). Aim to limit to 1–2 standard drinks. - Do I need to time sexual activity within a certain window?
Cialis Soft works within 15–30 minutes and lasts up to 36 hours. No strict time window, offering flexibility. - Is Cialis Soft available over the counter?
No, it is prescription-only (S4 medication) in Australia. - What do I do if I experience a side effect?
For mild symptoms (headache, flushing), rest and hydrate. For severe reactions (chest pain, vision loss, or erection >4 hours), seek immediate medical help or call 000.
For more information or personalised advice, consult your pharmacist or GP, or visit the NPS MedicineWise tadalafil page for Australian patients.
