Tadalafil PDE-5 Inhibitor Therapy

INFORMED CONSENT FOR TADALAFIL THERAPY

§1 PURPOSE, CONTEXT, AND SCOPE

§1.1 This document constitutes an informed consent agreement between the Patient identified herein (the “Patient”) and the Prescribing Physician acting on behalf of the Clinic. It is intended to document that the Patient has received, understood, and accepted comprehensive information regarding the proposed use of tadalafil.

§1.3 Health optimization context: The Patient understands that the Clinic operates as a proactive health optimization / longevity practice. The Clinic is not an emergency provider. The Patient is responsible for maintaining an appropriate relationship with a primary care physician and/or relevant specialist(s) for diagnosis and management of disease, acute care, and emergencies.

§1.4 This consent is governed by the laws of Denmark and the European Union, including but not limited to the Danish Health Act (Sundhedsloven) and Regulation (EU) 2016/679 (General Data Protection Regulation).

§1.5 By signing this document, the Patient confirms they have had adequate time to read, consider, and ask questions, and that their questions have been answered to their satisfaction.

§3 MEDICATION, CLASS, AND DESCRIPTION OF TREATMENT

§3.1 Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by promoting smooth muscle relaxation and increased blood flow, primarily in the penile and pelvic vasculature. Tadalafil is one of the most widely prescribed medications in its class and has an established safety profile spanning over two decades of clinical use. It is available over the counter in some countries.

§3.3 Products include Cialis (brand name) and generic tadalafil from various manufacturers.

§3.4 Intended use in this Clinic: Tadalafil may be prescribed for:

  • On-label use: Treatment of erectile dysfunction (ED) and/or signs and symptoms of benign prostatic hyperplasia (BPH).
  • Off-label / optimization use: Low-dose daily tadalafil (typically 2.5–5 mg) for vascular health optimization and endothelial function support. Emerging evidence suggests PDE5 inhibitors may have broader vascular benefits beyond erectile function.

§3.5 When prescribed primarily for vascular health optimization (rather than for ED or BPH), this constitutes off-label use.

§3.6 Tadalafil may be prescribed as:

  • Daily low dose: 2.5–5 mg once daily (for ongoing vascular support, BPH, or continuous ED coverage)
  • On-demand dose: 10–20 mg as needed before anticipated sexual activity (for ED)

§4 REGULATORY STATUS

§4.1 Tadalafil is EMA-authorised for treatment of erectile dysfunction, benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. It is well-established, widely used, and available without prescription in some jurisdictions.

§4.2 Use for vascular health optimization or endothelial function support is considered off-label. Evidence supporting these uses is derived from mechanistic studies and secondary analyses of clinical trials.

§5 EXPECTED BENEFITS

§5.1 Potential benefits include:

  • Erectile function: Improved ability to achieve and maintain erections. Tadalafil has a long duration of action (up to 36 hours on-demand; continuous with daily dosing).
  • BPH symptom relief: Reduced urinary frequency, urgency, and improved flow.
  • Vascular health: PDE5 inhibition may improve endothelial function, nitric oxide bioavailability, and microvascular blood flow. Some data suggest potential cardioprotective effects.
  • Exercise capacity: Some evidence suggests improved exercise tolerance and oxygen delivery.

§5.2 Benefits are variable and not guaranteed. Individual responses differ.

§6 POSSIBLE SIDE EFFECTS

§6.1 Tadalafil is generally well tolerated. Most side effects are mild, transient, and decrease with continued use.

§6.2 Common side effects (may affect up to 1 in 10 people):

  • Headache (most common, typically mild)
  • Indigestion or stomach discomfort
  • Back pain or muscle aches (more common with on-demand dosing; usually resolve within 48 hours)
  • Nasal congestion
  • Flushing (warmth or redness of face)

§6.3 Less common side effects:

  • Dizziness
  • Mild drop in blood pressure
  • Reflux

§6.4 Rare side effects: Very rarely, PDE5 inhibitors have been associated with sudden changes in vision or hearing. If the Patient experiences sudden vision loss or sudden hearing loss, they should stop the medication and contact the Clinic or seek medical attention.

§6.5 Prolonged erection: In very rare cases, an erection lasting more than 4 hours (priapism) may occur. If this happens, the Patient should seek medical attention to prevent complications.

§7 IMPORTANT SAFETY INFORMATION

§7.1 NITRATES — DO NOT COMBINE (critical):

  • Tadalafil must not be taken together with nitrate medications (e.g., nitroglycerin/GTN tablets or spray, isosorbide, or amyl nitrite/“poppers”)
  • The combination can cause a dangerous drop in blood pressure
  • Due to tadalafil’s long half-life, nitrates should not be taken within 48 hours of the last tadalafil dose
  • The Patient must inform any treating physician or emergency department that they take tadalafil before receiving nitrate-containing medication

§7.2 Other precautions:

  • The Patient should inform the Clinic of any heart conditions, recent stroke, or blood pressure issues
  • Alpha-blockers (e.g., tamsulosin for prostate) may increase the risk of dizziness or low blood pressure when combined with tadalafil. The Clinic will advise on safe co-administration
  • Tadalafil should be used with caution alongside strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir); dose adjustment may be needed
  • Do not combine with other PDE5 inhibitors (sildenafil, vardenafil)
  • Excessive alcohol may increase the chance of dizziness or blood pressure changes

§7.3 The Patient should inform the Clinic before starting any new medication or supplement.

§8 CONTRAINDICATIONS

§8.1 Tadalafil should not be used in the following situations:

  • Known allergy to tadalafil
  • Current use of nitrates in any form (see §7.1)
  • Current use of guanylate cyclase stimulators (e.g., riociguat)
  • Recent heart attack (within 90 days) or stroke (within 6 months)
  • Unstable angina or severe heart failure
  • Severely low blood pressure (<90/50 mmHg) or uncontrolled high blood pressure

§9 MONITORING AND FOLLOW-UP

§9.1 Tadalafil requires minimal monitoring in most patients. The Clinic may check:

  • Blood pressure at baseline and follow-up
  • Medication review to ensure no interactions
  • Assessment of treatment response and tolerability

§9.2 The Patient should contact the Clinic if side effects persist, if the medication is not effective, or if they start any new medications.

§10 ALTERNATIVES

§10.1 Alternatives may include:

  • Lifestyle interventions (exercise, weight management, sleep, stress reduction)
  • Other PDE5 inhibitors (sildenafil, vardenafil, avanafil)
  • Addressing underlying causes (testosterone optimization, cardiovascular health)
  • Specialist referral
  • No pharmacological treatment

§10.2 The Patient may decline or stop treatment at any time.

§12 LIMITATION OF LIABILITY

§12.1 The Patient understands that medicine is not an exact science and no outcomes can be guaranteed.

§12.2 Nothing in this consent excludes liability that cannot be excluded under applicable Danish law.

§13 WITHDRAWAL OF CONSENT

§13.1 The Patient may withdraw consent at any time by contacting the Clinic.

§14 DATA PROTECTION

§14.1 The Patient’s personal data and health information will be processed in accordance with GDPR and applicable Danish law.

§14.2 This consent may be retained as part of the Patient’s medical record.

§15 ACKNOWLEDGMENTS AND DECLARATIONS

By consenting, the Patient confirms the following:

  • I have read this consent document and I understand its contents.
  • I understand the medication prescribed (tadalafil) and the purpose of treatment.
  • I understand whether my prescription is for erectile dysfunction/BPH or for vascular health optimization (off-label), as explained by my clinician.
  • I understand the common side effects (headache, indigestion, back pain, flushing, nasal congestion) and that these are generally mild and transient.
  • I understand that tadalafil must not be combined with nitrates (including GTN spray/tablets, isosorbide, and amyl nitrite) and that I must inform any emergency physician that I take tadalafil.
  • I have disclosed all relevant medical history and current medications to the Clinic.
  • I have had the opportunity to ask questions and my questions were answered.
  • I voluntarily consent to commence or continue treatment with tadalafil under the regimen agreed with my clinician.