October 2024: Clonmel Healthcare, in conjunction with Opella, Sanofi’s consumer healthcare business unit are pleased to announce that Cialis for men® 10mg film-coated tablets tadalafil is now available without prescription in Irish pharmacies for the treatment of erectile dysfunction (ED). This marks a significant development in the management of ED, providing an accessible, pharmacist-supervised alternative to previous OTC treatments.
Cialis for men® offers a new OTC approach to managing ED with its active ingredient, tadalafil, which increases blood flow to the penis, helping men achieve and maintain an erection when sexually aroused. Its effect, lasting up to 36 hours, allows for greater flexibility and reduces the pressure on timing, thereby improving patient experience and satisfaction. Available exclusively in pharmacies throughout Ireland from today, Cialis for men® requires pharmacist oversight to ensure patient safety and suitability, providing guidance on the proper use of the medication.
Recent research highlights the prevalence of ED in Ireland, with nearly 3 in 10 Irish men reporting experiences with the condition. Despite the availability of treatments, awareness of over-the-counter options remains low, with 50% of men unaware of such solutions.1 The launch of Cialis for men® directly addresses this gap, offering a longer-lasting, accessible treatment that does not require a prescription, thereby removing barriers that may prevent men from seeking help.
The availability of Cialis for men® in pharmacies positions pharmacists at the forefront of men’s health, enabling them to play a critical role in supporting patients experiencing ED. As trusted healthcare professionals, pharmacists can provide discreet advice and support, ensuring that men receive accurate information and appropriate treatment.
Longford-based Pharmacist Paula Reilly comments: “With medications like Cialis for men® now available directly through pharmacies, men no longer need to visit their GP for treatment, which has removed a significant barrier to seeking help. This ease of access is paving the way to make a real difference in promoting better health outcomes for men and their partners.”
The research also revealed critical insights into the state of men’s sexual health in Ireland. More than 7 in 10 men believe there is still a significant stigma surrounding the discussion of men’s sexual health, however, making treatment options more accessible and raising awareness about the commonality of these conditions can help reduce that stigma. The study also highlights the impact of social media and online content, including pornography, on men’s perceptions of sexual performance. It found that 31% of men feel that social media has influenced their expectations, with nearly half (47%) of men aged 18-34 admitting to regularly comparing their sexual experiences to these often-unrealistic portrayals1.
Abbreviated Prescribing Information:
Presentation: Cialis for men 10mg film-coated tablets containing 10mg of tadalafil. Indications: Treatment of erectile dysfunction in adult males. 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. Cialis for men 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, New York Heart Association Class 2 or greater heart failure within last 6 months, uncontrolled arrhythmia, hypotension (<90/50mmHg), uncontrolled hypertension, stroke within 6 months, non-arteritic anterior ischaemic optic neuropathy (NAION) causing loss of vision in one eye, co-administration with guanylate cyclase stimulators (e.g. riociguat), 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 at the earliest opportunity for a clinical review of potential underlying conditions and risk factors associated with erectile dysfunction. Patients should consult their physician if symptoms of erectile dysfunction have not improved after taking Cialis for men on several consecutive occasions, or if their erectile dysfunction worsens. Patients who experience erections lasting longer than 4 hours should seek immediate medical assistance. Patients should consult their doctor before taking Cialis for men if they have: An anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), or conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), undergone pelvic surgery or radical non-nerve sparing prostatectomy, severe renal impairment, severe hepatic impairment, or in the event of sudden decrease or loss of hearing. Patients with pre-existing cardiovascular disease and/or risk factors should be advised of the potential cardiac risk associated with sexual activity. Cialis for men is not recommended for patients who experience chest pain or breathlessness after light or moderate activity. Concomitant administration of Cialis for men and alpha 1 adrenergic blockers may lead to symptomatic hypotension in some patients. Cialis for men contains lactose; Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Cialis for men. Visual defects, including central serous chorioretinopathy (CSCR) and cases of NAION have been reported in connection with treatment. In the case of sudden visual defect, visual acuity impairment and/or visual distortion, the patient should stop taking Cialis for men and consult a physician immediately. 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: Cialis for men is not indicated for use in women. Adverse Reactions: Adverse events observed from spontaneous reporting and clinical trials: Common (?1/100 to <1/10): Headache, flushing, nasal congestion, dyspepsia, back pain, myalgia, pain in extremity. Uncommon (?1/1,000 to <1/100): Hypersensitivity reactions, dizziness, blurred vision, sensations described as 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 to <1/1000): Angioedema, stroke (including haemorrhagic events), syncope, transient ischaemic attacks, migraines, seizures, transient amnesia, visual field defect, swelling of eyelids, conjunctival hyperaemia, NAION, 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. Tadalafil 10 mg demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients’ ability to attain and maintain erections for successful intercourse compared to placebo as early as 30 minutes following 10 mg dosing. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. You can report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;
Tel: + 353 1 676 4971; Fax: + 353 1 676 2517; Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
You can also report a side effect concerning a Clonmel Healthcare Ltd. medicinal product directly to Clonmel Healthcare Ltd. as follows:
Post: Clonmel Healthcare Ltd. Pharmacovigilance, Gurtnafleur Road, Clonmel, Co. Tipperary, E91 D768
Email: medicalinformation@clonmel-health.ie
Telephone: (052) 6177778; Fax (052) 6177791
Product not subject to medical prescription. Supply through pharmacies only.
Marketing Authorisation Number: PA25208/001/001.
Marketing Authorisation holder: A. Nattermann & Cie. GmBH, Brüningstra?e 50, 65929, Frankfurt am Main, Germany.
Further information is available from the distributor: Clonmel Healthcare Ltd. Pharmacovigilance, Waterford Road, Clonmel, Co. Tipperary, E91 D768.
Email: medicalinformation@clonmel-health.ie.
2024/ADV/CIA/248H
Date of preparation: October 2024
