Who can use AVARANTE?

• Myocardial infarction in the last 3 months

• Unstable angina or angina during sex

• Heart failure in the last 6 months of NYHA Class 2 or more (New York Heart Association (NYHA) heart failure classification: Class 2 heart failure is defined as slight limitation of physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain)²¹

• Arrhythmia, hypotension (<90/50 mmHg; symptoms of which include dizziness and blurred vision), uncontrolled hypertension

• Stroke in the last 6 months

• NAION (non-arteritic anterior ischaemic optic neuropathy) causing loss of vision in one eye

• Allergy to the active ingredient, tadalafil, or any of the excipients, including lactose intolerance.²² Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

• Anatomical deformations of the penis:

  • Bent or curved penis (angulation)

  • Scar tissue on or below the surface of the penis (cavernosal fibrosis)

  • Peyronie’s disease

• Severe renal impairment

• Severe hepatic impairment

• Priapism or conditions that predispose to priapism:

  • Sickle cell anaemia

  • Multiple myeloma

  • Leukaemia

• Pelvic surgery or radical non-nerve sparing prostatectomy (the effectiveness of tadalafil is unknown in this group of patients)

• Hereditary degenerative retinal disorders (e.g. retinitis pigmentosa)

• Increased susceptibility to vasodilators

• Successful vascularisation, asymptomatic controlled hypertension or mild valvular disease

• Uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive and other cardiomyopathies, or significant arrythmias

• Breathlessness or chest pain from light to moderate physical activity

If the customer has any of these health conditions, AVARANTE may not be suitable and a benefit-risk assessment by a doctor is required before use. They should be referred to a doctor for assessment of suitability.

Customers with some low-risk cardiovascular conditions may be suitable for AVARANTE, as long as their doctor has advised they can resume sexual activity, e.g. those with asymptomatic controlled hypertension, mild valvular disease or who have had successful coronary artery bypass grafting, stenting or angioplasty.

• Nitric oxide (NO) donors or nitrates used for angina (e.g. molsidamine, nicorandil, glyceryl trinitrate, isosorbide dinitrate) or as the recreational drug “poppers” (amyl nitrite)

• Guanylate cyclase stimulators used for pulmonary hypertension (e.g. riociguat)

• Alpha blockers used for benign prostatic hypertrophy or hypertension (e.g. doxazosin)

• CYP1A2 substrates used for asthma or COPD (e.g. theophylline)

• CYP3A4 inhibitors used for:

  • HIV infections (e.g. ritonavir, saquinavir)

  • Fungal infections (e.g. ketoconazole, itraconazole)

  • Bacterial infections (e.g. clarithromycin, erythromycin)

  • Stomach ulcers or oesophageal reflux disease (e.g. cimetidine)

  • High blood pressure (e.g. diltiazem, verapamil)

• CYP3A4 inducers used for bacterial infection (e.g. rifampicin) or for epilepsy (e.g. phenobarbital, phenytoin and carbamazepine)

• 5-alpha reductase inhibitors used for benign prostatic hyperplasia or male pattern hair loss (e.g. finasteride)

• AVARANTE should not be taken with recreational drugs as this may lead to unpredictable and dangerous drug-drug interactions. This could result in dizziness, decrease in blood pressure, coma, stroke or heart attack, seizures and priapism. Recreational drugs include, but are not limited to:

  • Nitrous oxide

  • GHB (gamma-hydroxybutyrate)

  • GBL (gamma-butyrolactone)

  • Methamphetamine

  • MDMA/ecstasy (3,4-methylenedioxymethamphetamine)

  • Ketamine

  • Flunitrazepam (AKA rohypnol)

  • Cannabis

  • Opioids

  • Cocaine

  • Recreational nitrates such as “poppers” (e.g. amyl nitrite)