Sildalis

Basic Sildalis information

• INN (international nonproprietary name): sildenafil + tadalafil (Sildalis is a combination medicine and has no single INN).
• Brand name: Sildalis, a non-originator combination of sildenafil and tadalafil, usually supplied as red, oval tablets in blister packs.
• ATC code: G04BE03 (sildenafil) and G04BE08 (tadalafil).
• Forms and strengths: tablets containing 100 mg sildenafil + 20 mg tadalafil, in blister packs of 6–20.
• Manufacturers: generic companies (for example RSM Enterprises, Sunrise Remedies).
• Registration status in the United Kingdom: not registered with the MHRA as a combination product.
• OTC / Rx classification: Prescription only (Rx).

Legal status and availability in the UK

In our online pharmacy, Sildalis is available without a prescription, with discreet delivery to the United Kingdom in 9–21 days.

Clinical effectiveness in the UK

Do patients get better erections with combined therapy?

Sildenafil and tadalafil consistently improve erectile function as measured by validated scales such as the IIEF.

Tadalafil’s longer duration is often preferred for spontaneity while sildenafil is chosen for situational use.

Sildalis is not included in NHS formularies.

• Outcome measures: IIEF improvement, sexual encounter success rate, adverse event rates.
• Clinical practice: clinicians favour monotherapy, dose titration and lifestyle optimisation before considering combinations.

Indications and expanded uses

Are combined products licensed for extra uses like BPH or PAH?

The MHRA licenses each active ingredient separately.

Sildenafil is licensed for erectile dysfunction and in other brands at higher dose for pulmonary arterial hypertension.

Tadalafil is licensed for erectile dysfunction and for lower‑dose daily regimens for benign prostatic hyperplasia or lower urinary tract symptoms.

Sildalis is a combination of sildenafil citrate and tadalafil but is not registered as a combined product.

Licensed indications

• Sildenafil: erectile dysfunction (and, as Revatio, pulmonary arterial hypertension in a different formulation).
• Tadalafil: erectile dysfunction and daily regimens for BPH/lower urinary tract symptoms.

Off‑label uses

• Combination sildenafil + tadalafil is off‑label and not an MHRA‑approved indication.
• Some clinicians may use tadalafil off‑label for urinary symptoms, but combination regimens are not standard practice.

Clinical caveats

• Cardiological assessment is advised before any PDE5 inhibitor in patients with cardiovascular disease.
• Absolute contraindications: nitrates and riociguat must not be combined with either agent.

Composition and brand landscape

What exactly is inside a Sildalis tablet and who makes it?

Sildalis tablets combine sildenafil citrate and tadalafil, commonly in strengths of 100 mg sildenafil plus 20 mg tadalafil per tablet.

Packaging usually shows red, oval tablets in blister packs of 6–20.

Sildalis is made by generic manufacturers rather than by the originator companies Pfizer or Eli Lilly.

Contraindications and special precautions

Who should absolutely not take Sildalis?

Absolute contraindications for Sildalis mirror those for each individual component and are listed in product information.

Absolute contraindications

• Known allergy to sildenafil, tadalafil or excipients.
• Concurrent use with nitrates (for example nitroglycerin) due to risk of life‑threatening hypotension.
• Use with riociguat for pulmonary hypertension.
• Severe cardiovascular disease where sexual activity is not advised.

Relative contraindications / conditions requiring caution

• Significant hepatic impairment.
• Significant renal impairment.
• Recent stroke or myocardial infarction, unstable angina or heart failure.
• Rare retinal disorders such as retinitis pigmentosa.

Daily‑life precautions

• Avoid heavy alcohol around dosing because augmented hypotension can occur.
• Avoid driving if you experience dizziness or visual disturbance following dosing.
• Do not mix PDE5 inhibitors with certain recreational drugs, especially nitrates or potent vasodilators.

Cardiac risk assessment is recommended before prescribing any PDE5 inhibitor.

Dosage guidelines

What dose should be taken and who needs adjustments?

The typical Sildalis dose is one tablet containing 100 mg sildenafil plus 20 mg tadalafil taken about 30–60 minutes before sexual activity and not more than once in 24 hours.

Because sildenafil has a shorter half‑life and tadalafil a much longer one, combined dosing raises pharmacokinetic and safety concerns and lacks controlled study data.

Overdose / priapism checklist

• If priapism lasts longer than four hours, seek emergency care immediately.
• In suspected overdose with syncope or severe hypotension, call emergency services for symptomatic and supportive management.

Interactions overview

Which medicines and substances interact badly with PDE5 combinations?

The most dangerous interaction is with nitrates, which can cause life‑threatening hypotension if taken with sildenafil or tadalafil.

Strong CYP3A4 inhibitors such as ritonavir or ketoconazole increase plasma levels of both drugs and may require dose reduction or avoidance.

Alpha‑blockers can add orthostatic hypotension risk when co‑administered with PDE5 inhibitors.

Alcohol can potentiate dizziness and hypotension and may worsen erectile function when used heavily.

High‑risk drug classes

• Nitrates and nitric oxide donors.
• Riociguat for pulmonary hypertension.
• Strong CYP3A4 inhibitors and inducers.
• Alpha‑blockers and other antihypertensives.

Reporting and action steps

1. If an interaction is suspected, stop the medicine and seek clinical advice from GP or pharmacist.
2. Report suspected adverse reactions to the MHRA Yellow Card scheme.
3. In cases of severe hypotension or syncope, call emergency services.

Comparable medicines and preferences

What are safer, licensed alternatives to a combination tablet?

Common alternatives in UK practice include sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra), along with various generics.

• Clinical checklist for choosing alternatives: assess cardiac risk, review concomitant medication for interactions, consider lifestyle factors and patient preference.

Frequently asked questions

Q1: Is Sildalis available on the NHS?

A1: No. Sildalis is not registered with MHRA and is not an NHS‑commissioned product.

Q2: Can I take Sildalis with my heart medication?

A2: Do not take Sildalis with nitrates or riociguat. Many cardiac medicines need specialist review before adding a PDE5 inhibitor.

Q3: What should I do if I have side effects?

A3: Stop dosing if severe side effects occur such as syncope, chest pain or priapism lasting longer than four hours and seek emergency care.

Reporting: Report suspected adverse events via the MHRA Yellow Card scheme.

When to call NHS 111 or emergency services

• Severe chest pain or fainting: call 999.
• Priapism >4 hours: attend A&E urgently.
• Persistent severe visual disturbance or sudden hearing loss: seek urgent medical assessment.

Guidelines for proper use

How should pharmacists counsel patients who ask about Sildalis?

Screen for contraindications including nitrates and riociguat and assess cardiovascular risk before any PDE5 prescription or supply.

Check current medications for CYP3A4 inhibitors, alpha‑blockers and other antihypertensives.

Use a structured checklist covering medical history, recent cardiovascular events, visual or auditory symptoms and priapism risk.

• Pharmacist counselling checklist: medical history, current medications, recent CV events, vision/hearing symptoms, priapism history.
• Advise on onset and timing, common side effects and when to stop dosing.
• Safe storage advice: store below 30°C away from moisture and direct sunlight and keep out of reach of children.

Signpost patients to NHS resources such as the NHS App, NHS 111 and sexual health clinics for discreet, supervised care.

Report any suspected harms from unlicensed products to the MHRA Yellow Card scheme.

Delivery across the United Kingdom