Sildalis
In brief
- Sildalis is not licensed in the UK; sildenafil and tadalafil are prescription-only medicines (POM) in the UK.
- Sildalis is used to treat erectile dysfunction; it combines sildenafil and tadalafil, both phosphodiesterase type 5 (PDE5) inhibitors that increase cyclic GMP, causing smooth muscle relaxation and increased blood flow to the penis.
- The usual dose is one tablet containing 100 mg sildenafil + 20 mg tadalafil, taken about 30–60 minutes before anticipated sexual activity and not more than once every 24 hours.
- The form of administration is an oral tablet.
- The effect typically begins within 30–60 minutes after taking the tablet.
- The sildenafil component usually lasts about 4–6 hours, while the tadalafil component can provide effects for up to 36 hours, so overall effects may persist up to 36 hours.
- Do not consume excessive alcohol; alcohol can increase the risk of dizziness, low blood pressure and reduce erectile response when taking PDE5 inhibitors.
- The most common side effect is headache; other frequent effects include flushing, nasal congestion, dizziness, indigestion and muscle/back pain.
- Would you like to try Sildalis without a prescription?
Basic Sildalis information
- INN (international nonproprietary name): Sildalis does not have an official INN; it is a combination of two active ingredients, sildenafil (as sildenafil citrate) and tadalafil
- Brand names available in the United Kingdom: Sildalis
- ATC code: G04BE03 (sildenafil) and G04BE08 (tadalafil)
- Forms and dosages: Tablets containing 100 mg sildenafil + 20 mg tadalafil
- Registration status in the United Kingdom: Not licensed in the UK; no combined sildenafil/tadalafil product is licensed by the MHRA
- OTC / Rx classification: Sildenafil and tadalafil are prescription-only medicines (POM) in the UK
Legal status and availability in the UK
Sildalis is not licensed in the UK. Sildenafil and tadalafil are prescription-only medicines (POM) in the UK.
In our online pharmacy, Sildalis is available without a prescription, with discreet delivery to the United Kingdom in 9–21 days.
Legal and regulatory status in the UK
MHRA and NHS stance
Is Sildalis approved by the MHRA?
No fixed-dose combination of sildenafil and tadalafil is licensed by the MHRA.
Sildalis is not an official INN and there is no public record of regulatory approval for this combination product.
Sildenafil and tadalafil individually are regulated and prescription only in the UK, and those products are covered by MHRA oversight.
- Unlicensed import
- Importing medicines that do not have local authorisation; these may lack UK regulatory oversight.
- Off-label
- Using a licensed medicine in a manner not described in its authorised product information.
- Prescription-only
- Medicines that legally require a prescriber before supply in the UK.
Composition, dose strengths and what each tablet contains
Active ingredients, typical strength and labelling practices
Each marketed Sildalis tablet commonly contains 100 mg sildenafil plus 20 mg tadalafil.
Both act as phosphodiesterase type 5 (PDE5) inhibitors and are the INNs sildenafil and tadalafil respectively.
| Component | INN / name | Strength per tablet |
|---|---|---|
| Active 1 | Sildenafil (sildenafil citrate) | 100 mg |
| Active 2 | Tadalafil | 20 mg |
| Form | Tablet | 1 tablet |
- INN
- International Nonproprietary Name; Sildalis does not have an INN for the combination.
- ATC codes
- G04BE03 (sildenafil) and G04BE08 (tadalafil).
- Combination product
- A medicine that contains two active pharmaceutical ingredients in one dosage form.
Pharmacology and expected onset/duration of effect
How sildenafil and tadalafil combine and what to expect
How do the two act together?
Both sildenafil and tadalafil inhibit PDE5 and increase penile blood flow in response to sexual stimulation.
Sildenafil generally has onset in 30–60 minutes and several hours of effect, while tadalafil has a slower onset and can last up to 36 hours.
Combining the two aims to deliver the faster onset of sildenafil with the prolonged duration of tadalafil, but the pharmacokinetics of the fixed-dose combination are not officially characterised by regulators.
Safety and pharmacokinetics for the combination are not formally established, and responses vary between individuals.
Factors that influence individual response
- Food intake, particularly a heavy fatty meal, which can delay sildenafil absorption.
- Alcohol, which can reduce efficacy and increase side-effect risks such as dizziness.
- Cardiovascular status and concurrent medications, which can alter drug effects.
It is sensible to trial a single dose under clinician oversight and to avoid combining with other unapproved agents.
Contraindications and key drug interactions
Absolute and relative contraindications
Who must not take Sildalis?
Absolute contraindications include known allergy to sildenafil or tadalafil, concurrent use of nitrates and use with riociguat for pulmonary hypertension.
Severe cardiovascular disease that makes sexual activity unsafe is another absolute contraindication.
Relative cautions include recent myocardial infarction or stroke, unstable angina, severe hepatic or renal impairment and rare retinal disorders such as retinitis pigmentosa.
Absolute contraindications
- Concurrent use of nitrates — risk of life-threatening hypotension.
- Concurrent use of riociguat — contraindicated.
- Known allergy to sildenafil, tadalafil or excipients.
Relative contraindications / cautions
- Recent MI or stroke, unstable angina or severe heart failure.
- Significant hepatic or renal impairment — dose adjustment for individual ingredients is usually required.
- Retinitis pigmentosa or other hereditary retinal disorders.
| Concomitant drug | Risk | Advice |
|---|---|---|
| Nitrates (eg nitroglycerin) | Severe hypotension | Do not take Sildalis; seek urgent medical advice. |
| Alpha-blockers | Additive hypotension | Monitor blood pressure; start low and stagger dosing. |
| Strong CYP3A4 inhibitors (eg some protease inhibitors) | Increased PDE5 levels and side effects | Consider dose reduction or avoid co-administration. |
Important safety warning
Do not take Sildalis if you are on nitrates — seek urgent medical advice if you have already combined them.
Side effect profile and red-flag symptoms
Common adverse effects and when to seek help
What side effects should patients expect?
Common side effects mirror those of sildenafil and tadalafil and include headache, flushing, nasal congestion, dizziness and indigestion.
Tadalafil is more associated with back and muscle pain, while sildenafil can cause transient visual disturbances.
Because the tablet exposes the body to both drugs, additive adverse effects such as hypotension, severe headache, visual symptoms or priapism may be more likely.
Common effects
- Headache.
- Flushing and nasal congestion.
- Dizziness and indigestion.
- Visual changes such as blurred vision or a bluish tinge.
- Back or muscle pain.
Serious red flags: seek urgent care
- Priapism — painful erection lasting more than four hours.
- Sudden vision loss or sudden decrease in vision.
- Sudden hearing loss or ringing in the ears with dizziness.
- Chest pain, severe dizziness or fainting.
Stop the medicine and seek immediate care for any red-flag symptoms. Adverse events can be reported to the MHRA Yellow Card scheme.
Comparing Sildalis with single-agent PDE5 inhibitors
Efficacy claims, onset, duration and safety trade-offs
How does Sildalis compare to licensed options?
Sildenafil and tadalafil as single agents are well-documented products licensed by the MHRA.
Sildalis is an unlicensed combination and lacks controlled evidence for combined dosing, pharmacokinetics and long-term safety.
Practical claims for Sildalis combine sildenafil’s faster onset with tadalafil’s prolonged duration, but clinical validation is absent.
| Drug | Typical dose | Onset | Duration | Regulatory status |
|---|---|---|---|---|
| Sildenafil | 50–100 mg as needed | 30–60 minutes | 4–6 hours | MHRA-licensed |
| Tadalafil | 10–20 mg as needed; 2.5–5 mg daily | Up to 2 hours | Up to 36 hours | MHRA-licensed |
| Sildalis (sildenafil + tadalafil) | 100 mg sildenafil + 20 mg tadalafil | Claims faster onset | Claims longer duration | Not licensed in the UK |
Licensed alternatives allow pharmacist-led screening, legal dispensing and clearer post-marketing surveillance.
Practical dosing advice, administration and missed-dose guidance
How to use Sildalis safely and realistic expectations
How should the marketed tablet be used?
Standard marketed tablet strength is 100 mg sildenafil + 20 mg tadalafil, taken once about 30–60 minutes before sexual activity and not more than one tablet per 24 hours.
Because Sildalis is taken as needed, there is no missed-dose protocol.
Take on a lighter stomach to reduce delay from a heavy meal; alcohol reduces efficacy and increases adverse-effect risk.
- Take one tablet approximately 30–60 minutes before sexual activity.
- Do not take more than one tablet in any 24-hour period.
- Avoid heavy meals before dosing and limit alcohol intake.
FAQs
Can I take Sildalis daily? No — marketed use is as-needed; daily use is not supported for the fixed combination.
What if I miss a dose? Not applicable for as-needed dosing.
Start with clinician review and consider a lower starting dose if frail or elderly.
Special populations: elderly, hepatic/renal impairment, and women/children
Who should avoid or modify dosing and what evidence is missing
Is Sildalis studied in older adults or children?
Sildalis is not approved for children or women for erectile dysfunction and safety and efficacy are unstudied in these groups.
Elderly patients and those with significant liver or kidney impairment require cautious dosing for the individual ingredients but there are no formal dose-adjustment studies for the combination.
- Elderly
- Start at the lowest effective dose and monitor for hypotension and other side effects.
- Hepatic/renal impairment
- Both sildenafil and tadalafil may require lower doses; Sildalis has no specific guidance.
- Women/children
- Not approved; avoid use for ED in these groups.
Overdose, emergency responses and handling adverse events
Symptoms, first aid and reporting procedures
What to do in an overdose or severe reaction?
Overdose may cause severe hypotension, syncope, prolonged erection (priapism) and intensified visual or neurological disturbances.
For overdose or severe reactions, emergency services should be contacted and management in hospital is symptomatic and supportive.
Seek immediate care for priapism lasting more than four hours, chest pain or sudden visual or hearing loss.
- Emergency action: stop the medicine, call NHS 111 or emergency services for severe symptoms.
- Priapism lasting >4 hours requires urgent hospital attendance to avoid permanent damage.
- Adverse events can be reported to the MHRA Yellow Card scheme.
Storage
How to store Sildalis
How should Sildalis be stored?
Store below 30°C, away from moisture and direct sunlight, and keep out of reach of children.
Delivery across the United Kingdom
| City | Region | Delivery Time |
|---|---|---|
| London | Greater London | 9–21 days |
| Birmingham | West Midlands | 9–21 days |
| Manchester | Greater Manchester | 9–21 days |
| Glasgow | Scotland | 9–21 days |
| Leeds | West Yorkshire | 9–21 days |
| Liverpool | Merseyside | 9–21 days |
| Bristol | South West | 9–21 days |
| Edinburgh | Scotland | 9–21 days |
| Cardiff | Wales | 9–21 days |
| Belfast | Northern Ireland | 9–21 days |
| Newcastle Upon Tyne | North East | 9–21 days |
| Nottingham | East Midlands | 9–21 days |
| Plymouth | South West | 9–21 days |
