The end of erectile problems? Touch wood.

Sidena. Your new firm favourite.

Sidena 50mg Tablets are now available over the counter in a 4 and 8 pack.

Abbreviated Prescribing Information

Product Name: Sidena 50 mg Tablets.

Composition: Each tablet contains, 50 mg sildena l (as citrate) .

Description: Light blue, round, slightly dotted tablets. Cross breaking notch on one side and marked ‘50’ on the other side. Can be divided into equal quarters. (Only two quarters of the 50 mg is covered by posology).

Indication(s): Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection su cient for satisfactory sexual performance.

Dosage: Adults and elderly: 50 mg taken as needed approximately one hour before sexual activity. Dose may be decreased to 25 mg. Max dose: 50mg once daily. Impaired renal and hepatic function: Sildena l clearance is reduced in hepatic and severe renal impairment. Consider a dose of 25 mg. Dose may be increased step-wise to 50 mg if tolerated. Children and adolescents below 18 years of age: Contraindicated. Use in patients using other medicines: Starting dose of 25 mg with CYP3A4 inhibitors (not advised to use with ritonavir). To minimise postural hypotension in patients receiving and alpha-blocker, stabilise patient rst on the alpha blocker and use a starting dose of 25 mg sildena l.

Contraindications: Hypersensitivity to sildena l or any of the excipients. Concomitant with ritonavir, nitric oxide donors or nitrates in any form, guanylate cyclase stimulators e.g. riociguat. In patients that sexual activity is inadvisable (e.g. severe cardiovascular disorders such as a recent (6 months) acute myocardial infarction (AMI) or stroke, unstable angina or severe cardiac failure). Refer these patients to a doctor. Patients with loss of vision in one eye due to NAION. Known hereditary degenerative retinal disorders. Severe hepatic impairment. Hypotension. Anatomical deformation of the penis. Women. Not intended if no erectile dysfunction.

Warnings and Precautions for Use: First diagnose erectile dysfunction and determine potential underlying causes (e.g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease), before considering pharmacological treatment. Consider the cardiovascular status of patients, since there is a degree of cardiac risk associated with sexual activity. Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildena l. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Sildena l has vasodilator properties, resulting in mild and transient decreases in blood pressure. Caution: Patients with anatomical deformation of the penis (such as angulation, cavernosal brosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Advise patients that in case of priapism, prolonged erections (longer than 4 hours) or sudden visual defect, they should stop taking sildena l and consult a physician immediately. Administer to patients with bleeding disorders or active peptic ulceration only after careful bene t-risk assessment, as there is no safety information available. Interactions: Inhibitors of the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route) isoenzymes such as CYP3A4 inhibitors: Itraconazole, ketoconazole, erythromycin, cimetidine, HIV protease inhibitor saquinavir: May reduce sildena l clearance and increase sildena l plasma levels. Consider a starting dose of 25 mg. Strong CYP3A4 inducers e.g. rifampicin may increase sildena l clearance and decrease sildena l plasma concentrations. Grapefruit juice: May give rise to modest increases in plasma levels of sildena l. Nicorandil (Hybrid of potassium channel activator and nitrate): Due to the nitrate component it has the potential to have serious interaction with sildena l. Sildena l potentiates the hypotensive e ect of nitrates. Alpha blocker: Concomitant administration of sildena l may lead to symptomatic hypotension in a few susceptible individuals. Patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildena l treatment. Sildena l potentiates the antiaggregatory e ect of sodium nitroprusside in vitro. Not recommended in patients with a history of bleeding disorders or active peptic ulceration. Not recommended to use with other pulmonary arterial hypertension treatment containing sildena l.

Ability to Drive and Use Machinery: Minor in uence, dizziness and altered vision were reported. Patients should be aware of how they react to sildena l before driving or using machinery. Undesirable E ects: Very common: Headache. Common: Dizziness, visual disorders, visual colour distortion, vision blurred, ushing, hot ush, nasal congestion, nausea, dyspepsia. See SPC for more adverse e ects.

Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork. Marketing Authorisation Number: PA 0711/170/002. Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417

E-mail: rowex@rowa-pharma.ie

Legal Category: Not subject to medical prescription.

Date of Preparation: Aug 2022

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie there is funding allocated for new drugs,” said the Minister. “This is something this Government is aware of and has acted on. The combined funding for new drugs in 2019 and 2020 was ¤10m. For 2021 and 2022 it was ¤80m. The full year impact of this ¤80m is ¤135m, which is a clear statement of intent from me and Government. The result was 112 new drugs approved, 35 of which are orphan drugs. This year already there are twenty-seven new orphan drugs undergoing pricing and reimbursement assessment.

“The Framework Agreements on the Supply and Pricing of Medicines 2021-2025 are central to the provision of these medicines and the State is committed to ongoing investment.

“Of course, this must deliver real and tangible value for the taxpayer as well as the patient. We have to ensure that the cost of drugs and medicines remains sustainable and that the economic benefits of innovation are realised for all. As you will all appreciate there are growing and extensive demands for enhanced and additional services across the health system, and notwithstanding the unprecedented investment in services by this Government, we must be cognisant that there are finite resources to work with.”

While Ireland’s pharmaceutical industry is one of the biggest producers in Ireland, our country is nonetheless pretty small, he reflected. “As such, partnerships like Beneluxa are critical, particularly when it comes to new medicines for rare diseases. Together we have secured access to Zolgensma for Spinal Muscular Atrophy and work continues with Libmeldy, a treatment for MLD. This is now under joint assessment for reimbursement, and Les Martin and I are in discussions about the process.

“Staying on the international theme, you are all of course aware of The Pharmaceutical Strategy for Europe, published in November 2020. It’s fundamentally about ensuring safe, affordable medicines for all citizens and patients. It looks to balance this patient-centred approach with protecting the competitiveness and innovative potential of the European pharmaceutical industry.

“I welcome the significant progress that has been made to date including the creation of the Health Emergency Response Authority, the Structured Dialogue initiative and delivery of the Clinical Trials Regulation.

“I know the Commission’s current work on the revision of the general pharmaceutical legislation, and the Orphan and Paediatric frameworks, is of major interest to you all, as it is to Government, and we await the formal publication of the proposal in the coming weeks.

“I expect that the proposal will contain a number of novel policy options to stimulate innovation, including in the area of antimicrobial resistance. These will warrant careful consideration and I know officials in my department will be keen to hear the views of all stakeholders.

“In conclusion, I look forward to continuing to engage with you in the months ahead as we work to ensure that patients in Ireland have timely access to the best medicines, that innovation is fostered and supported and that value for money is secured.”

An Tánaiste, Micheál Martin TD told delegates that as Ireland’s journey has been from one of the poorest countries in Europe, to becoming one of the wealthiest nations in the world, the pharmaceutical industry has been central to this.

“We are now home to nine out of the top ten pharmaceutical companies in the world. We export more than ¤100 billion. More than 42,000 men and women are employed in IDA client companies. We’re home to 90 manufacturing plants, with 50 of them FDA approved. And more than ¤12 billion has been invested in the industry in the last decade alone.

“It is a phenomenal performance, and I am very pleased to take the chance tonight to acknowledge and pay tribute to it.

“My primary responsibility is to look forward and make the decisions necessary to ensure that Ireland’s story continues to be one of expanding opportunity, better health outcomes for citizens, further sustainable economic growth, social solidarity, and strong, skilled employment.

“And I am confident that your industry will continue to be a big part of all of that,” he said.

Quoting Mark Henry, “The Great Big Miracle of Human Progress comes at a cost” – he went on to add, “Irish public health spending has increased 14-fold over the last 50 years and our state expenditure on pharmaceuticals has doubled in just the last ten years, from ¤1.3bn in 2012, to ¤2.6bn in 2022. It now represents one of the largest components of overall health expenditure and with the growth in demand for high tech and increasingly personalised drugs, the pressure for further increased spending is only going in one direction.

“But our successes as a nation notwithstanding, State resources are finite.

“Together, we need to find ways to enable you to continue innovating and bringing these miraculous products into the world, while at the same time ensuring access to them for as many people as possible while maintaining sustainable public finances. I believe that with good faith and mutual respect among all the parties, we can achieve that.

“Two new Framework Agreements on pricing and supply of medicines were signed in December 2021 with you and with your colleagues in Medicines for Ireland, taking us up to 2025.

These were an important step in reducing prices, improving access for patients and ensuring ongoing State investment in new drugs. The Pharmaceutical Strategy for Europe will be another important dynamic, while my colleague the Minister for Health Stephen Donnelly last week published the Mazars Report. I know Stephen talked to you this morning about what we’re doing with this and that you have welcomed publication of the report.

“I am hopeful that the new Department of Health / HSE Implementation Group that he is establishing to consider and progress the Report’s recommendations will get moving quickly.”

Michael O’Connell, IPHA President said, “The biopharmaceutical industry is Europe’s largest hightech industry. It employs 840,000 people and invests ¤42 billion each year in European R&D. We are calling for Government support to unlock its health, innovation and economic potential so that it can compete on a global scale and reverse a trend of so much investment taking place in the US and China rather than Europe.

“At home, IPHA is intent on working closely with the Government, health authorities and health officials in Ireland to shorten the time that it takes to make new medicines available to patients. We welcome Minister Donnelly’s actions upon the publication of the Mazars Report last week, including the establishment of a Working Group that is open to new ideas, where health authorities, patients’ organisations and industry can work together in new ways to improve the delivery of innovative medicines for patients. IPHA look forward to participating in this Working Group.”

Oliver O’Connor, IPHA Chief Executive added, “We must ensure that EU policies support the innovation and IP rights that are required for the development of new medicines. We need robust IP rights to incentivise investment in the development of innovative new medicines and clinical trials aimed at delivering better outcomes for patients with lifethreatening diseases and other serious medical conditions.”

No ‘Proposals’ for Chief Pharmacy Officer

There are currently no ‘active proposals’ to develop a Chief Pharmaceutical Officer role in the Department of Health, Minister for Health Stephen Donnelly has confirmed.

Free NRT Products

The HSE has announced that nicotine replacement therapies (NRT) are free from local stop smoking clinics as part of a package of supports on offer to people who quit smoking through the HSE QUIT service.

“In this regard a number of proposals and ways to progress the potential extension of the scope of practice of community pharmacists in the short, medium and longer term are currently being considered.

NRT are licensed medicines that safely give lower levels of nicotine to help smokers get through cravings and withdrawal symptoms that can double their chances of quitting for good.

Deputy Róisín Shortall recently asked the Minister if he intends to create such a post during a recent Dáil Éireann Debate.

Answering, he stated, “The Department of Health recognises the key role of Pharmacy in the Community, and the ongoing significant contribution made by this sector to patients and the public, particularly during the pandemic.

“The potential role that pharmacy may play in the development and implementation of future healthcare reform, especially in regard to the aims and vision of Sláintecare, is under consideration. The Department is open to exploring any evidence based appropriately governed services, delivered by appropriately trained professionals which will support this aim.

World Pharmacists Day 2023

on 25 September, FIP announced recently.

At a time when health systems around the world are recovering from the COVID-19 crisis and general consensus is that urgent action is needed if health services are to meet future needs, FIP’s 2023 World Pharmacists Day campaign presents opportunities to increase awareness of pharmacists as an intelligent solution.

The campaign is led by FIP every year, with the theme chosen by the FIP Council, and provides an opportunity to promote the pharmacy profession.

“Beyond doubt, pharmacy is essential to a strong healthcare system and COVID-19 has proven this. But there is a wide range of further needs that pharmacy can provide for to make health systems stronger. Our message is: Let pharmacies do more.

“I encourage colleagues across the globe to prepare to join me in this year’s campaign to celebrate our profession’s achievements in supporting our societies, but also to make its value and further potential in improving health more known,” said FIP president Dominique Jordan.

To answer the specific question, at this time currently there are no active proposals to develop a Chief Pharmaceutical Officer role in the Department of Health. “The Department has professionally qualified pharmacists among its staff. Furthermore a number of units within the Department have responsibility for advancing policy in key areas of our health system. They are cognisant of potential deliverables that can be realised by and through pharmacists and pharmacy services, to deliver patient centred care in line with the vision of Sláintecare.”

In 2022, almost one in five people in Ireland smoke* (Healthy Ireland, 2022). The prevalence of smoking in Ireland remains at 18% and has not declined since 2019.

Dr Paul Kavanagh, HSE Public Health Medicine Lead with the Tobacco Free Ireland Programme, outlines how NRT works. “NRT are safer than smoking because they don’t contain the other poisonous chemicals, like tar and carbon monoxide, which are present in tobacco smoke.

“They come in many different forms like patches, gum, lozenges, inhalers and mouth sprays and often work best when you combine them together in a way that suits you.

“Using NRT, over a full course of 12 weeks, doubles your chances of quitting smoking in combination with all the encouragement, emotional and behavioural support available from HSE Stop Smoking Advisors before and after you quit smoking. I would recommend anyone who is thinking about stopping smoking to consider making a quit attempt with help from NRT and a Stop Smoking Advisor to give themselves every chance of staying quit for good.

“NRT products are checked for safety by the Health Products Regulatory Agency (HPRA) in Ireland, and following a comprehensive assessment by the Health Information and Quality Authority (HIQA), they are recommended as a safe, effective and clinically sound way to stop smoking in the National Stop Smoking Guidelines.”