25 minute read
Ireland’s spending on medicines ‘stable’
Ireland’s spend on medicines as a proportion of overall health expenditure is below the average of 15 other European countries, according an industry analysis of official Irish figures, alongside an international study. However, some countries that spend roughly the same proportion of their health budgets on medicines are much faster in making the latest treatments available to patients. Last year, the State spent ¤2.54 billion on medicines, pharmacy and wholesaling costs – 13.4% of the overall health budget of almost ¤19 billion – according to estimated figures from Irish Government Economic Evaluation Service in the Department of Public Expenditure and Reform. A new study by health analysts IQVIA for EFPIA, the biopharmaceutical industry’s representative organisation in Europe, called ‘Understanding Net Pharmaceutical Expenditure Dynamic in Europe’, shows that spending on medicines in 15 European countries is around 15% of total healthcare expenditure. The surveyed countries were Norway, UK, Sweden, Demark, Slovenia, Belgium, Ireland, Croatia, France, Italy, Germany, Spain, Hungary, Bulgaria and Czechia. The IQVIA analysis shows that Belgium, France, Italy, Germany and Spain spend between 14% and 18% of their overall health expenditure on medicines. But all of these countries are, on average, faster than Ireland in making new medicines available to their patients. Belgium is seven days faster, France is 44 days faster, Italy is 112 days faster, Germany is 408 days faster and Spain is 24 days faster. The figures are from the latest EFPIA Patient WAIT Indicator Survey which measured time to reimbursement of medicines newly authorised by the European Medicines Agency. In the survey, Ireland places 24th out of 35 countries reporting data for time to availability for 160 innovative new medicines, with an average of 541 days to reimbursement. In 2016, the State spent ¤1.9 billion on medicines while the overall health budget was ¤13.5 billion. That means, based on current Government health expenditure estimates for 2021, we are spending almost 1% less on medicines today than we did five years ago as a proportion of the overall health budget. EFPIA’s study finds that spending on medicines has been ‘stable’ as a share of total healthcare expenditure in surveyed countries for the past 20 years. “In that period, the innovation pipeline has been strong,” said a spokesperson for the Irish Pharmaceutical Healthcare Association, the organisation representing the research-based biopharmaceutical industry. “But even when spending on medicines as a proportion of overall health expenditure is roughly in line with other western European countries, Ireland is much slower to make the latest treatments available to patients. Through sustained Government investment and the new supply Agreement, Ireland should aspire to be among the fastest countries in Europe to adopt innovative new medicines.
“New lines of cancer medicines like targeted therapies and immunotherapies are improving patient outcomes. Hepatitis C medicines are curing patients and, sometimes, replacing liver transplants. Many rare diseases, which previously had no treatments, can now be managed. Despite these breakthroughs, spending on medicines in many European countries, including Ireland, has been stable.” The EFPIA study finds that overall healthcare expenditure has been growing faster than medicines expenditure. It argues that health systems have a long-term sustainability problem driven by ageing populations and the burden of chronic disease and multi-morbidity. “For many chronic diseases like diabetes and cardiovascular disease, the cost of medicines is a very small part of the overall cost of the disease, especially if you count the broader societal costs. Medicines reduce unnecessary emergency visits, hospitalisations and complications. “The recent visit to Dublin by Emily Whitehead, the first paediatric patient in the world to receive a CAR-T, shows the impact of innovation. Emily, who had a rare cancer, is now 17. Some advanced therapies, like CAR-T, come with high upfront costs. But they could off-set a lifetime of chronic treatment.
“That means they have long-term value – both for the patient and for the health system that pays for them. We need new payment models that are suitable for this new paradigm. These challenges can only be cracked through multi-stakeholder dialogue, especially between industry, State patients and doctors,” said the IPHA spokesperson.
Dr Hugh Gallagher and Keith Cassidy
Smarmore Castle Clinic, a 32-bed detox and addiction rehab clinic near Ardee, Co. Louth, has been awarded a major international accreditation recognising Excellence in International Best Practice, Legislation and Regulatory Standards. The prestigious award was received from the Comparative Health Knowledge System (CHKS), a UK health organisation which provides independent recognition of commitment to quality improvement for boards, external regulators and patients. The CHKS award follows a comprehensive assessment by a team of external senior healthcare professionals which examined a range of activities undertaken at Smarmore Castle Clinic.
Located in a 13th century castle, and surrounded by 15 acres of gardens, Smarmore Castle Clinic offers an unrivalled environment in which patients can take the first steps on the road to recovery from addiction.
News of the recognition comes as the Health Service Executive (HSE) has entered into an agreement with Smarmore Castle Clinic to provide public funding for patients in need of inpatient detox and rehab from alcohol and drugs. Keith Cassidy, Clinic Manager at Smarmore Castle Clinic, said, “We are delighted to receive this esteemed award which recognises the tireless work undertaken in this clinic towards the rehabilitation of patients. Our healing and selfreflective approach seek to show both patients and their families that there is life after addiction. Lives can be rebuilt.
“Smarmore Castle Clinic has quickly become one of the leading addiction treatment centres in Ireland and we are committed to offering people freedom from addiction. We will continue to improve our services in the months and years ahead, with recovery front and centre of everything that we do.”
Addressing Gaps in Doctor Training
An RCSI working group, established to review the training and career development supports that are available to NCHD in the Irish Healthcare System, has made a series of recommendations that if implemented will help support surgical NCHD’s in their career development and lead to the improvement of their skills and knowledge all of which should lead to better outcomes for patients.
More than 1,000 non-consultant hospital doctors (NCHDs) work in Irish surgical departments. NCHDs provide the backbone of 24/7 emergency surgical services. It is essential that they possess the requisite skills and competencies needed to deliver high quality and safe care. The majority (64%) of surgical NCHDs do not occupy a specialist training post approved by the National Doctors Training and Planning and funded by the HSE. These doctors are referred to as non-training scheme doctors (NTSDs).
In November 2020, the President of RCSI established a Short Life Working Group (SLWG) tasked with investigating the recruitment and career expectations of surgical NTSDs, to report on the educational opportunities and support structures available and to provide recommendations on how RCSI could support NTSD development and professional needs. The Working Group, chaired by Council Member, Mr James Geraghty, included significant NTSD representation.
Mr James Geraghty said: ‘The majority of the non-training scheme doctors are from outside the EU and are not graduates of an Irish Medical School. These doctors make an invaluable contribution to the delivery of healthcare in Ireland. The majority of surgical units across the country depend on NTSDs to maintain emergency surgical services. The aim of the RCSI Short Life Working Group was to address the gap in education and training and support these doctors to enhance their clinical skills and knowledge, career development and professional needs. The recommendations, if implemented, will enrich our health service and ultimately benefit patients.’
As part of its remit the SLWG undertook an in-depth survey among NTSDs to gain greater understanding of NTSD recruitment, career expectations and training supports.
The survey revealed that although the NTSDs generally reported a positive experience working and living in Ireland, their expectations were very different to the reality they experienced. Many had come to Ireland expecting to be able to access specialist training programmes. They felt they had not received adequate information regarding available career pathways and found themselves on short term (6 -12 month) contracts with the recurrent stresses of visa and work permit renewal.
The SLWG has made a series of recommendations across a range of areas including: recruitment and retention of non-EU doctors; pre-employment information on living and working in Ireland; and continued professional development.
The recommendations are pragmatic and designed to have a positive impact on quality and patient safety in the Irish healthcare system, to support a culture of NTSD supervision and training and to improve the quality of life for NTSDs and their families.
Summer Conferring Ceremonies
RCSI University of Medicine and Health Sciences’ summer conferring ceremonies continued yesterday with 80 candidates graduating from the 2021 and 2022 classes.
From the School of Postgraduate Studies, 11 Master of Science (MSc) by research candidates, 12 Doctor of Medicine (MD) graduates and 44 Doctor of Philosophy (PhD) graduates were conferred in the ceremony at the RCSI campus on St Stephen’s Green. The candidates have carried out cutting-edge studies in research areas including COVID-19, tuberculosis and Down’s syndrome. The degree of Master of Science (MSc) Physician Associate was awarded to 13 candidates. The MSc in Physician Associate Studies was launched by RCSI in 2016 and is the only programme of its kind in Ireland. Highly-skilled healthcare professionals, physician associates provide a broad range of medical services in a wide variety of workplaces (including all types of hospital and surgical care, GP practices and community health services). The RCSI Honorary Doctorate was awarded to Professor Patrick McGorry, an Irish-born, Australian psychiatrist known worldwide for his development and scaling up of early intervention and youth mental health services, and for mental health innovation, advocacy and reform. Commenting on the success of RCSI’s newest cohort of graduates, Professor Cathal Kelly, Vice Chancellor and CEO/Registrar of RCSI, said: “We are delighted to be able to gather in person once again to celebrate with the graduates on this momentous day. Today’s conferring marks the culmination of many years of hard work and is a testament to the graduates’ RCSI Honorary Doctorate was awarded to Professor Patrick McGorry, an Irish-born, Australian psychiatrist known worldwide for his development and scaling up of early intervention and youth mental health services, and for mental health innovation, advocacy and reform
dedicated focus to a career in health sciences. They are now part of the RCSI graduate community who faced adversity and challenge to continue and complete their studies during a global pandemic. Their hard work and resilience will be long-remembered.” The graduates were addressed by Professor Laura Viani, Vice President of RCSI, who told them: “Health science professionals of the future will need to be adaptive to the constant expansion of medical, pharmacy and systems knowledge, changes in technology, medicines, increased patient, and societal expectations in addition to regulatory change; all of which require a commitment to life-long learning and an ability to adapt to the changing world that we live in. The awards presented here today will give you a solid foundation to continue on this exciting journey. “RCSI is proud of our commitment to developing healthcare leaders who make a difference worldwide; this is our ambition for you.”
Multi Million Euro State-of-the-Art Breast Opens
Last month saw the Beaumont Breast Centre, of which Breast Cancer Ireland is a major donor, officially open its doors with Mrs Sabina Higgins present as Guest of Honour – making the First Lady of Ireland one of the very first to step inside the doors of this world class facility, that will benefit over 10,000 Irish women per year, for decades to come.
This brand-new Breast Centre, which cost circa ¤6m, is spread across three floors in a purposebuilt facility in Beaumont Hospital, Dublin. The building incorporates eight consulting suites, five imaging rooms with the very latest tomosynthesis 3D mammography and breast ultrasound equipment, a prosthesis and post mastectomy underwear fitting suite, and a dedicated counselling suite. The Cancer Clinical Trials Unit which coordinates and facilitates national and international clinical trials / translational research is on the top floor with offices for clerical staff, clinical nurse specialists and data managers. A separate board room will allow the entire multidisciplinary team to discuss personalised patient treatment plans. Professor Arnold Hill, Breast Cancer Ireland Chairman and Professor of Surgery, Beaumont Hospital and a driving force behind the development of the new Breast Centre said, “What’s most important is that there are a number of aspects of the building that will fundamentally change breast cancer care for the better. With everything in the one location, including imaging and examination facilities, along with a fully integrated Cancer Clinical Trials Unit under the one roof, this is the key to advancing breast cancer care. Through clinical trials we can learn what is going to prolong survival and this will allow us to defeat this disease in the long term”. He continued “One such trial that we’re particularly excited by is in the area of HER2 positive breast cancer, funded by Breast Cancer Ireland via the 100k in 30 Days initiative. This trial involves a particular drug that is relatively non-toxic and allows us to reduce, potentially, the amount of chemotherapy that women might need, while achieving a 100% response rate. This would, in effect, mean a transformation in the outcome for this particular subtype of breast cancer. This new concept of “chemotherapy deescalation” whereby you reduce the amount of chemotherapy by only giving it to those who will benefit from it for the shortest possible time represents a major breakthrough in treatment. Through constant research we can be immensely optimistic for the 450 patients that will be diagnosed with breast cancer each year in this building.” 1.7 million women worldwide face a diagnosis of breast cancer each year, of whom 460,000 are in the EU and 3,800 are in Ireland. However, data shows that survival rates are improving year on year, currently standing at 85% with mortality rates reducing by 2% each year, and importantly, local control of breast cancer is improving year on year.
Professor Arnold Hill, Breast Cancer Ireland Chairman and Professor of Surgery, Beaumont Hospital with Dr Deirdre Duke, Consultant Radiologist, Beaumont Hospital
Ireland Professionals Regulator Launches New Strategy
CORU, Ireland’s health and social care professional’s regulator, is predicting significant growth in the number of professionals it regulates. By 2026, CORU estimates it will oversee the work of 35,000 registrants, an increase of almost 50% on today’s number of over 23,000. However, the body has cautioned that such growth will require a change in how it regulates to deliver a more sustainable regulatory model. CORU was established in 2005 as a multi-profession health and social care regulator. The body currently regulates the work of over 23,000 professionals across 12 distinct professions, while a further six have been designated for regulation. Launching the new strategy Chairperson Mo Flynn said, “CORU plays a vital role in protecting the public, by ensuring that the country’s health and social professionals consistently deliver care to the highest standards. An absolute priority for CORU over the coming years will be opening statutory registers for all designated professions. “Significant progress has been made over the past two years and Ireland’s Social Care Workers Register will now open in November 2023. This will be the largest of the 17 professions that CORU will regulate. Considering they often work with some of the most vulnerable members of our society this will be a milestone in our mission to protect the public.” “We are focussed on making similar progress with the other professions designated for regulation. Much work has already been done on advancing the regulation of Counsellors, Psychotherapists and Psychologists and this will be a strong focus in the years ahead.” CORU has identified five strategic priorities for the coming years: • Progress regulation of the six remaining designated professions • Ensure regulation protects the public and supports health and social care professionals • Build the organisational capabilities while evolving a sustainable regulatory model • Increase awareness of
CORU’s role to the public and professionals • Anchor regulatory interventions in evidence informed research and insights With a significant increase in the remit of CORU Ms. Flynn cautioned that a more sustainable model of regulation needs to be implemented. “The current model of regulation CORU must operate is too complex, too reliant on a large number of volunteers and requires over 120 statutory meetings a year. As we add more boards these pressures will increase.” “A new governance structure is required to ensure the efficient delivery of appropriate regulation. We are committed to working with the Department of Health to achieve this and deliver ‘right touch’ regulation while maintaining a relentless focus on public protection.” Concluding Mo Flynn, Chairperson of the Health and Social Care Professionals Council, paid tribute to health and social care workers for their efforts throughout the pandemic. “Our registrants continued to provide care and treatment to the public despite risk of infection, fear of transmission to family members and friends and unprecedented restrictions. Throughout the pandemic, they have been an embodiment of professionalism and demonstrated tremendous dedication to their patients and service users. The country is better off for their efforts.”
A combined force against LUTS and BPH
49% of men with LUTS report bladder and prostate symptoms1
VESOMNI treats the symptoms of both the bladder and prostate2
Abbreviated Prescribing Information - Vesomni 6 mg/0.4 mg modified release tablets. Please read the Summary of Product Characteristics (SPC) before prescribing. Presentation: Each tablet contains a layer of 6 mg solifenacin succinate, corresponding to 4.5 mg solifenacin free base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base. Indication: Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy. Posology and method of administration: Adult males, including older people: One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or without food. The maximum daily dose is one Vesomni tablet. The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet. Special populations (see also contraindications below): Renal impairment: Severe renal impairment (creatinine clearance ≤ 30 mL/min): Treat with caution, maximum daily dose in these patients is one Vesomni tablet. Hepatic impairment: Moderate hepatic impairment (Child-Pugh score of 7-9): Treat with caution, maximum daily dose in these patients is one Vesomni tablet. In patients with severe hepatic impairment (Child-Pugh score > 9), the use of Vesomni is contraindicated. Concomitant treatment with moderate and strong inhibitors of CYP450 3A4: e.g. verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole: Treat with caution, maximum daily dose should be limited to one Vesomni tablet. Paediatric population: There is no relevant indication for use of Vesomni in children and adolescents. Contraindications: Patients with hypersensitivy to the active substance(s) or to any of the excipients (see SPC). Patients undergoing haemodialysis. Patients with severe hepatic impairment. Patients with severe renal impairment who are also treated with a strong cytochrome P450 (CYP)3A4 inhibitor e.g. ketoconazole. Patients with moderate hepatic impairment who are also treated with a strong CYP3A4 inhibitor e.g. ketoconazole. Patients with severe gastrointestinal conditions (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and patients at risk for these conditions. Patients with a history of orthostatic hypotension. Special Warnings and Precautions for Use: Vesomni should be used with caution in patients with: severe renal impairment; risk of urinary retention; gastrointestinal obstructive disorders; risk of decreased gastrointestinal motility; hiatus hernia/ gastroesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis; autonomic neuropathy. The patient should be examined in order to exclude the presence of other conditions, which can cause similar symptoms to benign prostatic hyperplasia. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Vesomni is initiated. If a urinary tract infection is present, appropriate antibacterial therapy should be started. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia, who are treated with solifenacin succinate. Angioedema with airway obstruction has been reported in some patients on solifenacin succinate and tamsulosin. If angioedema occurs, Vesomni should be discontinued and not restarted. Appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, Vesomni should be discontinued and appropriate therapy and/or measures should be taken. As with other alpha1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Patients starting treatment with Vesomni should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have disappeared. The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation. Therefore, the initiation of therapy with Vesomni in patients for whom cataract or glaucoma surgery is scheduled is not recommended. Discontinuing treatment with Vesomni 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with Vesomni in order to ensure that appropriate measures will be in place to manage IFIS during surgery. Vesomni should be used with caution in combination with moderate and strong inhibitors of CYP3A4 and it should not be used in combination with strong inhibitors of CYP3A4, e.g., ketoconazole, in patients who are of the CYP2D6 poor metaboliser phenotype or who are using strong inhibitors of CYP2D6, e.g., paroxetine. Interactions: Pharmacological interactions: Concomitant medication with other anticholinergic medicinal products may result in more pronounced therapeutic and undesirable effects. Allow approximately one week after stopping treatment with Vesomni before commencing any anticholinergic therapy. The therapeutic effect of solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Pharmacokinetic interactions: Pharmacokinetic interactions involving the potential for other medicinal products to affect Vesomni exposures: Interactions with CYP3A4 and CYP2D6 inhibitors: See Contraindications, Posology and administration and Special warnings and precautions above. Concomitant administration may lead to increased exposure to both solifenacin (ketoconazole 400 mg/day resulted in a 1.5-fold increase in Cmax and a 2.8-fold increase in AUC). and tamsulosin (ketoconazole 400 mg/day resulted in a 2.2-fold increase in Cmax and a 2.8-fold increase in AUC). Vesomni should be used with caution in combination with strong CYP3A4 inhibitors. Vesomni should not be given together with strong CYP3A4 inhibitors in patients who are also CYP2D6 poor metabolizer phenotype or who are using strong CYP2D6 inhibitors. See SPC for details of the effects of other CYP3A4 and CYP2D6 inhibitors. Inducers: Inducers of CYP3A4 (e.g. rifampicin) may decrease the plasma concentrations of solifenacin and tamsulosin. Information available for the individual active substances: Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastrointestinal tract, such as metoclopramide and cisapride. Solifenacin did not affect the pharmacokinetics of digoxin, or the pharmacokinetics or effect on prothrombin time of R- or S-warfarin. Co-administration of tamsulosin and other alpha1-adrenoreceptor antagonists could lead to hypotensive effects. Diclofenac and warfarin may increase the elimination rate of tamsulosin. No interactions have been seen when tamsulosin was given concurrently with atenolol, enalapril or theophylline. Fertility, pregnancy and lactation: The effect of Vesomni on fertility has not been established. Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase. Vesomni is not indicated for use in women. Driving and use of machines: No studies have been performed, however patients should be informed about the possible occurrence of dizziness, blurred vision, fatigue and uncommonly somnolence, which may negatively affect the ability to drive or use machines. Undesirable Effects: Summary of the safety profile: Vesomni may cause anticholinergic undesirable effects of, in general, mild to moderate severity. The most frequently reported adverse reactions during the clinical studies performed for the development of Vesomni were dry mouth (9.5%), followed by constipation (3.2%) and dyspepsia (including abdominal pain; 2.4%). Other common undesirable effects are dizziness (including vertigo; 1.4%), vision blurred (1.2%), fatigue (1.2%), and ejaculation disorder (including retrograde ejaculation; 1.5%). Acute urinary retention (0.3%, uncommon) is the most serious adverse drug reaction that has been observed during treatment with Vesomni in clinical studies. List of adverse reactions: the ‘Vesomni frequency’ below reflects adverse drug reactions that have been observed during the double-blind clinical studies performed for the development of Vesomni (based on reports of treatment-related adverse events, which have been reported by at least two patients and occurred with a frequency higher than for placebo in the double-blind studies). The ‘solifenacin frequency’ and ‘tamsulosin frequency’ below reflect adverse drug reactions (ADRs) previously reported with one of the individual components (as presented in the Summary of Product Characteristics (SmPCs) of solifenacin 5 and 10 mg and tamsulosin 0.4 mg respectively that may also occur when receiving Vesomni (some of these have not been observed during the clinical development program of Vesomni). The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The adverse events are grouped by MedDRA system organ class preferred term (PT). Vesomni frequency: Nervous system disorders: Common: dizziness Eye disorders: Common: vision blurred Gastrointestinal disorders: Common: dry mouth, dyspepsia, constipation Skin and subcutaneous tissue disorders: Uncommon: pruritus Renal and urinary disorders: Uncommon: Urinary retention*** Reproductive system and breast disorders: Common: ejaculation disorders including retrograde ejaculation and ejaculation failure General disorders and administration site conditions: Common: fatigue Solifenacin 5mg & 10mg frequency#: Infections and infestations: Uncommon: urinary tract infection, cystitis Immune system disorders: Not known: anaphylactic reaction* Metabolism and nutrition disorders: Not known: decreased appetite*, hyperkalemia* Psychiatric disorders: Very rare: hallucination*, confusional state* Not known: delirium* Nervous system disorders: Uncommon: somnolence, dysgeusia Rare: dizziness*, headache* Eye disorders: Common: vision blurred Uncommon: dry eyes Not known: glaucoma* Cardiac disorders: Not known: palpitations*, Torsade de Pointes*, electrocardiogram QT prolongation*, atrial fibrillation*, tachycardia* Respiratory, thoracic and mediastinal disorders: Uncommon: nasal dryness Not known: dysphonia* Gastrointestinal disorders: Very common: dry mouth Common: dyspepsia, constipation, nausea, abdominal pain Uncommon: gastro-oesophageal reflux disease, dry throat Rare: vomiting*, colonic obstruction, faecal impaction, Not known: ileus*, abdominal discomfort* Hepatobiliary disorders: Not known: liver disorder*, liver function test abnormal* Skin and subcutaneous tissue disorders: Uncommon: dry skin Rare: pruritus*, rash* Very rare: urticaria*, angioedema*, erythema multiforme* Not known: exfoliative dermatitis* Musculoskeletal and connective tissue disorders: Not known: muscular weakness* Renal and urinary disorders: Uncommon: difficulty in micturition Rare: urinary retention***Not known: renal impairment* General disorders and administration site conditions: Uncommon: fatigue, perhiperal oedema Tamsulosin 0.4mg frequency#: Nervous system disorders: Common: dizziness Uncommon: headache Rare: syncope Eye disorders: Not known: vision blurred*, Intraoperative Floppy Iris Syndrome (IFIS)**, visual impairment* Cardiac disorders: Uncommon: palpitations Not known: atrial fibrillation*, arrhythmia*, tachycardia* Vascular disorders: Uncommon: orthostatic hypotension Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis Not known: dyspnoea*, epistaxis* Gastrointestinal disorders: Uncommon: constipation, nausea, diarrhea, vomiting Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash, urticaria Rare: angioedema Very Rare: Stevens-Johnson syndrome Not known: erythema multiforme*, exfoliative dermatitis* Reproductive system and breast disorders: Common: ejaculation disorders including retrograde ejaculation and ejaculation failure Very rare: priapism General disorders and administration site conditions: Uncommon: asthenia. #: The ADRs from solifenacin and tamsulosin included are the ADRs listed in the summary of product characteristics of both products. *: from post-marketing reporting. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of solifenacin or tamsulosin and their causation cannot be reliably determined. **: from post-marketing reporting, observed during cataract and glaucoma surgery. ***: see Special warnings and precautions for use. Long-term safety of Vesomni: The profile of undesirable effects seen with treatment up to 1 year was similar to that observed in the 12-week studies. The product is well-tolerated and no specific adverse reactions have been associated with long-term use. Description of selected adverse reactions: For urinary retention see Special warnings and precautions for use. Older people: The therapeutic indication of Vesomni, moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with BPH, is a disease affecting elderly men. The clinical development of Vesomni has been performed in patients 45 to 91 years of age, with an average age of 65 years. Adverse reactions in the elderly population were similar to the younger population. Reporting of suspected adverse reactions: see below. Overdose: Overdosage with the combination of solifenacin and tamsulosin can potentially result in severe anticholinergic effects plus acute hypotension. Refer to SPC for details of treatment of overdose. Legal Category: Prescription Only Medicine (SIB). Nature and contents of container: Aluminium blister packs containing 30 tablets. Product Authorisation Number: PA1241/016/001. Marketing Authorisation holder: Astellas Pharma Co. Ltd. Further information is available from: Astellas Pharma Co. Ltd, 5 Waterside, Citywest Business Campus, Naas Road, Dublin 24. Phone: +3531 467 1555. Summary of Product Characteristics with full prescribing information available upon request. Job number: VESOM_2019_0001_IE Date of preparation of API: 24 May 2019
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. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance Astellas Pharma Co. Ltd Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555 Tel: +353 1 6764971 E-mail: Irishdrugsafety@astellas.com Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie.
