Presentation: Avarante 10mg tablets. Contains tadalafil

Indication: Erectile dysfunction in adult men

Dose and Administration: Men (including the elderly) 18 years of age or over: The recommended dose is one 10mg tablet taken at least 30 minutes prior to anticipated sexual activity. The maximum dosing frequency is once per day. Avarante is not recommended for continuous daily use.

Contraindications: Hypersensitivity to the active substance or to any of the excipients, co-administration with nitric oxide donors or nitrates, cardiac disease in patients where sexual activity is inadvisable, myocardial infarction within the last 90 days, unstable angina or angina during sexual intercourse, heart failure within 6 months, uncontrolled arrhythmia, hypotension (<90/50 mm Hg), uncontrolled hypertension, stroke within 6 months, non-arteritic anterior ischaemic optic neuropathy causing loss of vision in one eye, co-administration with guanylate cyclase simulators (e.g. riociguat), deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), women, those without erectile dysfunction and men under 18 years of age.

Warnings and Precautions: All men with erectile dysfunction should be advised to consult their doctor within 6 months for a clinical review of potential underlying conditions and risk factors associated with erectile dysfunction. If symptoms of erectile dysfunction have not improved after taking Avarante on several consecutive occasions or if their erectile dysfunction worsens patients should consult their doctor. Patients who experience erections lasting longer than 4 hours should seek immediate medical assistance. Patients should consult their doctor before taking Avarante if they have: undergone pelvic surgery or radical non-nerve sparing prostatectomy, known hereditary degenerative retinal disorders (e.g. retinitis pigmentosa), had coronary artery bypass surgery or angioplasty, asymptomatic controlled hypertension, mild valvular disease, severe renal impairment, severe hepatic insufficiency, previous diagnosis of uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive cardiomyopathies or significant arrhythmia, increased susceptibility to vasodilators including those with left ventricular outflow obstructions (e.g. aortic stenosis) or those with the rare syndrome of multiple atrophy, sickle cell anaemia, multiple myeloma or leukaemia. Patients with cardiovascular disease should be advised that sexual activity carries a cardiac risk and if they experience chest pain during sexual activity they should refrain from any further sexual activity and seek medical attention immediately. Avarante is not recommended for patients who experience chest pain or breathlessness after light or moderate activity. Avarante contains lactose; patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Avarante. Avarante is not recommended to be taken concurrently with recreational drugs. Interactions: Nitrates, nitric oxide donors (nicorandil, molsidomine), doxazosin and other alpha 1 adrenergic blockers, antihypertensives, riociguat, 5-alpha reductase inhibitors (e.g. finasteride), theophylline, ethinylestradiol, terbutaline, alcohol, CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, clarithromycin, and grapefruit juice should be administered with caution as they may increase the incidence of adverse reactions. Inducers of CYP3A4 such as rifampicin, phenobarbital, phenytoin and carbamazepine may decrease plasma concentrations of tadalafil and decrease efficacy.

Pregnancy and breastfeeding: Avarante is not indicated for use in women.

Side Effects: Adverse events observed from spontaneous reporting and clinical trials: Common (≥1/100 and <1/10): Headache, flushing, nasal congestion, dyspepsia, back pain, myalgia, pain in extremity. Uncommon (≥1/1,000 and <1/100): Hypersensitivity reactions, dizziness, blurred vision, eye pain, tinnitus, tachycardia, palpitations, hypotension, hypertension, dyspnoea, epistaxis, abdominal pain, vomiting, nausea, gastro-oesophageal reflux, rash, haematuria, prolonged erections, chest pain, peripheral oedema, fatigue. Rare (≥1/10,000 and <1/1000): Angioedema, stroke (including haemorrhagic events), syncope, transient ischaemic attacks, migraine, seizures, transient amnesia, visual field defect, swelling of eyelids, conjunctival hyperaemia, non-arteritic anterior ischemic optic neuropathy, retinal vascular occlusion, sudden hearing loss, myocardial infarction, unstable angina pectoris, ventricular arrhythmia, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, hyperhydrosis, priapism, penile haemorrhage, haematospermia, facial oedema, sudden cardiac death.

RRP: 2 pack £11.99, 4 pack £21.99, 8 pack £37.99

Supply classification: P Product licence number: PLGB 46302/0243

Product licence holder: Mylan Products Ltd, Station Close, Potters Bar, Herts, EN6 1TL, UK

Document number: UK-AVT-2024-00028

Date of preparation: November 2024