The score reflected the moderate degree

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Consensus was reached on how likely 12 out of 14 incremental risks were to occur and of a low clinical impact for 11 of them (Table 4, shaded boxes). The overall attribute scores were much lower than for the benefits, ranging from 0.2 to 2.2, with 11 risks scoring 1.0 or less. An increase in drug-drug interactions were deemed unlikely for tadalafil with nitrates due to their low and decreasing usage in Germany (0.8); in 2020, there were 53 million defined daily doses (DDD) of long-acting nitrates prescribed (reduced from 233 million DDDs in 2011), 52 million DDDs of molsidomine and 31 million DDDs of glyceryl trinitrate. In the context of this reducing use, the warning on the package (see below) was considered sufficient mitigation for this risk. IMPORTANT: Do not use if you are taking either of the following two medicines: • Nitrate medicine for chest pain (angina pectoris) or heart failure • Nitrate medicine for chest pain (angina pectoris) or heart failure • Riociguat for high blood pressure in the lungs • Riociguat for high blood pressure in the lungs The warning messages in the PIL are: What you need to know before you take *TM* (*TM* is a placeholder for the approved brand name).

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Take any medicines called nitrates or nitric oxide donors (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate for the relief of chest pain or heart failure, or amyl nitrite also known as “poppers”, nicorandil, molsidomine or sodium nitroprusside). These are often used for the relief of chest pain (angina pectoris), or heart failure. Using *TM* with any of these medicines may lead to a dangerous fall in blood pressure. If it were to occur, the mean clinical impact score was rated low to moderate (1.7). All experts agreed there was very low likelihood of an increase tadalafil for premature ejaculation in drug-drug interaction with doxazosin (0.5) or other alpha-blockers (0.7) and that there would be a minimal clinical impact (0.7) as they are not regularly used in Germany for hypertension. of clinical impact such a drug-drug

Product	Dosage	Quantity + Bonus	Price
Tadalista Super Active	20mg	10 Pills	55.64€ 52.99€
Cialis Generic	40mg	270 + 10 Pills	382.19€ 363.99€
Cialis Generic	5mg	180 + 10 Pills	159.65€ 152.05€
Cialis Generic	40mg	120 + 8 Pills	206.98€ 197.12€
Cialis Generic	40mg	90 + 6 Pills	171.35€ 163.19€
Cialis Generic	20mg	360 + 10 Pills	427.34€ 406.99€
Cialis Generic	60mg	180 + 10 Pills	313.11€ 298.20€
Cialis Generic	5mg	20 Pills	41.99€ 39.99€
Tadalista Super Active	20mg	90 + 10 Pills	314.14€ 299.18€
Cialis Generic	2.5mg	60 + 4 Pills	83.43€ 79.46€
Cialis Generic	40mg	20 Pills	59.47€ 56.64€
Cialis Generic	20mg	20 Pills	54.72€ 52.11€
Cialis Generic	20mg	270 + 10 Pills	335.21€ 319.25€
Cialis Generic	5mg	360 + 10 Pills	268.08€ 255.31€
Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€
Cialis Generic	10mg	270 + 10 Pills	308.71€ 294.01€
Cialis Generic	60mg	120 + 8 Pills	240.18€ 228.74€

reaction would have, but there was

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There were also differences of opinion regarding the level of health consultations that take place in pharmacies in Germany compared to the United Kingdom. However, there was general agreement that people are more likely to access services when provided locally, such as the increased take-up of flu vaccinations when provided at pharmacies. From the patient’s perspective it is more convenient to go straight to the pharmacy to get the medication rather than having to go to the doctor first for a prescription. There was some agreement that men may not want to see a doctor for ED because of embarrassment and therefore prefer to buy PDE5 inhibitors from a pharmacy. Recent TV advertising was believed to have raised awareness of ED and reduced inhibition thresholds to seek treatment. general agreement that this scenario would

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In 2020, there were 123 million defined daily doses (DDDs) of alpha blockers used to treat hypertension compared with 2,589 million DDDs of calcium channel blockers and 6,050 million DDDs of ACE inhibitors (Schwabe/Ludwig Hrsg, 2021). Similarly, there was low concern about any increase in interaction with other antihypertensives, with an overall attribute score of 0.4 because of the evidence of extremely few cases of such complications in the post-marketing safety data for 84,674,000 patients who have been exposed to Cialis worldwide from 2002 to 15 October 2020. The expert panel viewed the likelihood of an increase in interaction with riociguat a little higher because of the recent approval for treatment of post thrombotic pulmonary hypertension meaning more men could be at risk. The mean clinical impact score of 1.7 and overall attribute score of 2.2 reflected a moderate level of concern, but being under the care of a specialist and the clear warning messages on the pack (shown above) and in the PIL (see below) were felt to be strong mitigating factors. The warning message in the PIL is: Do not take *TM* if you are taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators), used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs due to blood clots).

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There was agreement that the likelihood of alcohol interaction occurring more frequently if tadalafil were available without prescription was low, as was the clinical impact with an overall score of 0.6, reflecting the evidence from clinical pharmacology studies that was reviewed by the experts during the meeting. The experts also agreed that men may be more likely to use tadalafil to enhance sexual performance (2.3), but that this would have a low clinical impact (0.7) as there was no evidence to suggest that the risks to health from use to enhance clinical performance would be clinically significant. There were mixed opinions on whether intentional use at a higher dose/frequency would increase, but consensus was that this would have a low clinical impact (0.5) according to the evidence and patient reported experiences. The overall attribute scores reflected consensus of a low likelihood or clinical impact of increased use in men with severe renal or hepatic disease (0.7), failure to read/understand safety information for men unfit to have sex due to cardiovascular disease (CVD) (1.0), use with “poppers” (1.0), use in women (0.2) or accidental ingestion by children (0.4). All considerations of the low clinical impact were based on evidence from published studies and 18 years of post-marketing safety data for patients exposed to Cialis worldwide that were reviewed by the experts in the meeting. be unlikely because men would be

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under specialist clinical supervision and would

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also see the risk mitigation warning

Form	Dosage Strengths	Onset of Action	Duration of Effect	Common Use Cases
Tablets	5 mg, 10 mg, 20 mg	30-60 min	Up to 36 hours	Erectile dysfunction
Sublingual	10 mg, 20 mg	15-30 min	Up to 36 hours	Quick relief
Topical	Experimental	N/A	N/A	Under research

messages on the packaging and PIL.

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Finally, there were differing views on the likelihood (1.0) and clinical impact (0.8) of delayed diagnosis of CVD and other underlying conditions. If ED were the only early symptom of CVD, it was felt to be unlikely that a man would arrange to see a cardiologist, therefore taking tadalafil would not delay a diagnosis of CVD. However, self-treating ED may reduce the likelihood of seeing an urologist and so could lead to a delay in diagnosis of an underlying urological condition. On balance, the 10 mg tadalafil overall attribute of this scenario was scored low (0.7). If tadalafil were to be reclassified to non-prescription status in Germany, training would be provided to pharmacists highlighting the contraindications, potential drug-drug interactions and conditions where men should first consult their physician.

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Messages on the carton and patient information leaflet (PIL) would include contraindications, safety information, dosage and side effects. These messages have been tested in men in three separate studies to ensure comprehension. The expert panel felt that these measures were appropriate and sufficient to mitigate against the identified incremental risks and that the results of the studies demonstrated that the information was sufficiently well understood and that consumers would make appropriate self-selection decisions. An additional suggested measure was to add a warning regarding the potential drug-drug interaction with veriziguat which was recently approved for chronic heart failure. The Brass decision analysis tool worked well in terms of achieving the objectives of the meeting.

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