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Supply scenarios

In most situations, the decision on whether Cialis Together can be supplied to a patient will be uncomplicated. However, there are a few situations where the decision may be less obvious.

Consider each of the scenarios below and whether you would supply Cialis Together to the patient.

Scenario 1 The middle-aged office worker

Mr M is 50 years old and works long hours with a major corporation. He is aware that his lifestyle could be healthier and thinks that his difficulty getting an erection could be a symptom of his working pattern and lifestyle, but he cannot change this at the moment and would like to try Cialis Together to see if it helps. He sometimes experiences chest pain when he runs for the train but puts it down to not being very fit.

SUGGESTED ACTIONS

Symptoms suggest underlying cardiovascular disease

Do not supply Cialis Together. Refer Mr M to his doctor for an assessment of his chest pain on exertion, and to confirm his suitability before supplying him with Cialis Together.

Explain to Mr M that the chest pain he experiences when he runs could be a sign of a cardiovascular condition, therefore he needs to see his doctor for advice and to assess his suitability for taking Cialis Together.

Scenario 2 The late-night drinker

Mr A is a 45-year-old chef who works long hours in a busy restaurant in town. He tends to socialise late after his shift, and drinks heavily. He has noticed that he sometimes has difficulty maintaining his erection but is confident it can be resolved with medication and would like to try Cialis Together. He is otherwise fit and healthy with no cardiovascular disease or other contraindications and is not taking any medication.

SUGGESTED ACTIONS

Lifestyle advice required

Cialis Together can be supplied to Mr A but he should be advised not to drink heavily while taking it. The combination of large volumes of alcohol and Cialis Together could cause a drop in his blood pressure when standing up, leading to dizziness.

Explain that alcohol can be a cause of erection problems, especially in large quantities and provide lifestyle advice to help him manage his ED.

Scenario 3 The pensioner who has had a mild heart attack

Mr J is 67 years old and is a retired teacher who had a mild heart attack 15 months ago. He is now fully recovered and starting to enjoy life again. Since his heart attack, however, he sometimes experiences problems getting an erection. He has come to the pharmacy to see if he can buy something to help. He has no cardiovascular symptoms and is able to exercise without chest pain or breathlessness. He is taking aspirin, an ACE inhibitor and a statin.

SUGGESTED ACTIONS

CVD is stable but watch out for further symptoms

Cialis Together can be supplied to Mr J. His heart attack was more than 3 months ago and his CVD is stable and well managed on his current medication.

Check whether he has been given a short-acting nitrate (GTN) as a ‘rescue medication’ should he experience chest pain and ensure he understands that he must not use nitrates if he is taking Cialis Together because of the risk of a dangerous fall in blood pressure.

Advise him to tell his doctor that he is taking Cialis Together and to seek immediate medical help should he experience chest pain within 48 hours of taking Cialis Together, or dizziness or nausea during or after sex.

Scenario 4 BPH and finasteride

Mr Y, who is 62 years old, has BPH for which he has been taking finasteride for the last 3 years. Over the past 12 months he has experienced problems with erections and sometimes has difficulty maintaining the erection. This is causing some stress in his relationship with his wife, and he is keen to see whether Cialis Together can help.

SUGGESTED ACTIONS

A medical benefit/risk assessment is needed

Mr Y may be suitable for Cialis Together but should be referred to his doctor to confirm suitability before use.

No drug-drug interaction studies have been performed for concomitant use of 5-alpha reductase inhibitors like finasteride so a medical benefit/risk assessment should be conducted before use.

Scenario 5 Controlled hypertension

Mr L has recently met someone having been alone for the last 5 years following his wife’s death. He is now 67 years old and has not had sex since his wife died. He is very nervous about what will happen in this new relationship because the last few times he had sex with his wife, he had problems maintaining his erection. He has seen the adverts for Cialis Together and thinks that this might be the solution.

He is generally fit and well but has high blood pressure which has been difficult to manage. However, his current medication - a combination of an angiotensin-II receptor antagonist and a thiazide diuretic - which he has been taking for the last 6 months, seems to be working and his doctor is happy that his blood pressure is sufficiently controlled on this treatment.

SUGGESTED ACTIONS

Tell the GP and be alert for medication changes

You can supply Cialis Together to Mr L. His hypertension has been well controlled on medication for the last 6 months and he is not taking any contraindicated medication.

Explain to Mr L that he should tell his doctor that he is taking Cialis Together, especially if his blood pressure medication needs to be changed again.

References

1. Goldstein I, Goren A, Li V et al. Epidemiology Update of Erectile Dysfunction in Eight Countries with High Burden. Sex Med Rev 2020;8:48-58

2. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. J Urol 1994;151:54–61

3. Hatzimouratidis K, Giuliano F, Moncada I, et al. EC. EAU guidelines on Male Sexual Dysfunction 2018 retrieved from https://uroweb.org/guideline/male-sexualdysfunction/

4. Johannes GB, Araujo AB, Feldman HA, et al. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts Male Aging Study. J Urol. 2000;163(2):460-3

5. Sun P and Swindle R. Are men with erectile dysfunction more likely to have hypertension than men without erectile dysfunction? A naturalistic national cohort study. R J Urol. 2005;174(1):244-8

6. Evans J, Hill S. A comparison of the available phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction: a focus on avanafil. Patient Prefer Adherence. 2015;9:1159-1164

7. Mobley DF, Khera M, Baum N. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. 2017;93:679-685

8. Sun P, Cameron A, Seftel A, et al. Erectile Dysfunction- An Observable Marker of Diabetes Mellitus. A Large National Epidemiological Study. J Urology 2016;176:3,1081-85

9. Yafi FA, Jenkins L, Albersen M, et al. Erectile dysfunction. Nat Rev Dis Primers. 2017;2:1600

10. McCabe MP, Althof SE. A systematic review of the psychosocial outcomes associated with erectile dysfunction: Does the impact of erectile dysfunction extend beyond a man’s inability to have sex? J Sex Med 2014;11:347-363

11. Dean J, Hackett GI, Gentile V, et al. Psychosocial outcomes and drug attributes affecting treatment choice in men receiving sildenafil citrateand tadalafil for the treatment of erectile dysfunction: Results of a multicenter, randomized, open-label, crossover study. J Sex Med 2006;3:650–661

12. Rosen RC, Seidman SN, Menza MA, et al. Quality of life, mood, and sexual function: a path analytic model of treatment effects in men with erectile dysfunction and depressive symptoms. Internal Journal of Impotence Research 2004a;16:334-340

13. Althof SE, Rubio-Aurioles E, Kingsberg S, et al. Impact of tadalafil once daily in men with erectile dysfunction-- including a report of the partners’ evaluation. Urology. 2010 Jun;75(6):1358-63

14. Cairoli C, Reyes LA, Henneges C, et al. PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study. Int Braz J Urol. 2014 May- Jun;40(3):390-9

15. Eardley I, Montorsi F, Jackson G, et al. Factors associated with preference for sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy: post hoc analysis of data from a multicentre, randomized, open-label, crossover study. BJU Int. 2007 Jul;100(1):122-9

16. Hatzimouratidis K, Buvat J, Büttner H, et al. Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study. Int J Impot Res. 2014 Nov- Dec;26(6):223-9

17. Tolra JR, Campana JMC, Ciutat LF, et al. Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking the three PDE-5 inhibitors. J Sex Med 2006;3(5):901-909)

18. Gong B, Ma M, Xie W, et al. Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction: a systematic review and meta-analysis. Int Urol Nephrol 2017;49(10):p1731-1740

19. Conaglen, HM, Conaglen, JV. Investigating women’s preference for sildenafil or tadalafil use by their partners with erectile dysfunction: the partners’ preference study. J Sex Med 2008;5(5):p1198-1207

20. Bai, WJ, LI HJ, Jin JJ, et al. A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction. Asian J Androl 2017;19(4):p500-504

21. Li HJ, Bai WJ, Dai YT, et al. An analysis of treatment preferences and sexual quality of life outcomes in female partners of Chinese men with erectile dysfunction. Asian J Androl. 2016 Sep-Oct;18(5):773-9

22. Cialis Together (tadalafil) Summary of Product Characteristics, January 2023

23. Burnett AL. The role of nitric oxide in erectile dysfunction: implications for medical therapy. J Clin Hypertens (Greenwich). 2006 Dec;8(12 Suppl 4):53-62.

24. Huang SA, Lie JD. Phosphodiesterase-5 (PDE5) Inhibitors In the Management of Erectile Dysfunction. P T. 2013 Jul;38(7):407-19.

25. Cruz-Burgos M, Losada-Garcia A, Cruz- Hernandez CD, Cortes-Ramirez SA, Camacho-Arroyo I, Gonzalez-Covarrubias V, Morales-Pacheco M, Yrujillo-Bornois SI, Rodriguez-Dorantes M. New approaches in oncology for repositioning drugs: The case of PDE5 inhibitor sildenafil. Front Oncol 2021;11:627229.

26. NICE: https://cks.nice.org.uk/topics/erectile-dysfunction/

27. Sanofi Data on File. Prepared 10.02.2023

28. Viagra Connect SPC 2022. https://www.medicines.org.uk/emc/product/8725

29. Cialis Together (tadalafil) Patient Information Leaflet, December 2022.

30. Hackett G, Kirby M, Wylie K et al. British Society for Sexual Medicine guidelines on the management of erectile dysfunction in Men - 2017. J Sex Med 2018; 15: 430–457

Online references last accessed May 2023

Product information

Cialis Together 10mg tablets Product Information


Presentation: Cialis Together 10mg film-coated tablets containing 10mg of tadalafil.
Indications: Erectile dysfunction in adult men. In order for Cialis Together to be effective, sexual stimulation is required.
Dose and administration: Men 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 Together 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, NYHA class 2 or greater heart failure in the last 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 Cialis Together on several consecutive occasions or if their erectile dysfunction worsens, patients should consult their doctor. Patients who have undergone pelvic surgery or radical non-nerve sparing prostatectomy or with known hereditary degenerative retinal disorders (e.g. retinitis pigmentosa) should consult their doctor before taking Cialis Together. 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. Cialis Together is not recommended for patients who experience chest pain or breathlessness after light or moderate activity. Patients should consult their doctor before resuming sexual activity if they have: uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive and other cardiomyopathies, significant arrhythmias, had coronary artery bypass surgery or angioplasty, asymptomatic controlled hypertension, mild valvular disease. Patients with an increased susceptibility to vasodilators including patients with left ventricular outflow obstructions (e.g. aortic stenosis) or multiple atrophy should consult their doctor before taking Cialis Together. Patients should check with their doctors before taking Cialis Together with doxazosin and other alpha blockers. In case of sudden visual defect or sudden decrease or loss of hearing, patients should stop Cialis Together and seek medical attention immediately. Patients with severe renal impairment and severe hepatic impairment should consult their doctor before taking Cialis Together. Patients who experience erections lasting 4 hours or more should seek immediate medical assistance. Patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia), should consult a doctor before taking Cialis Together. Cialis Together should not be used in a patient who has an anatomical deformation of the penis. Patients taking potent CYP3A4 inhibitors should consult a doctor before taking Cialis Together. Patients should avoid drinking excessive amounts of grapefruit juice. The use of Cialis Together with other treatments for erectile dysfunction is not recommended. Patients should not drink large amounts of alcohol before sexual activity. Use of Cialis Together with recreational drugs (including but not limited to “poppers”, nitrous oxide, GHB/GBL, methamphetamines, MDMA/ecstasy, ketamine, flunitrazepam, cannabis, opioids, cocaine, etc.) may lead to adverse events such as dizziness, decrease of blood pressure, stroke or heart attack, seizures, priapism and coma. Cialis Together contains lactose; patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Cialis Together.
Effects on ability to drive and use machines: Cialis Together has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Cialis Together before driving or using machines.
Interactions: Patients should not take Cialis Together with nitrate medicines (glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate), nitric oxide donors (such as amyl nitrite (“poppers”), nicorandil, molsidomine or sodium nitroprusside), riociguat or other guanylate cyclase stimulators. Patients should consult their pharmacist or doctor before taking Cialis Together with doxazosin and other alpha 1 adrenergic blockers, 5-alpha reductase inhibitors (e.g. finasteride), antihypertensives, other treatments for erectile dysfunction, theophylline, ethinylestradiol or terbutaline. CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, clarithromycin, cimetidine and grapefruit juice should be administered with caution as they may increase the incidence of adverse reactions. CYP3A4 inducers such as rifampicin, phenobarbital, phenytoin and carbamazepine may decrease plasma concentrations of tadalafil and decrease efficacy.
Pregnancy and breastfeeding: Cialis Together is not indicated for use in women.
Adverse Reactions: 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 (ex VAT): 8 tablets pack: £31.66, 4 tablets pack: £18.33
Legal category: P. Product Licence: Cialis Together has a GB licence; Licence number: PLGB 53886/0074.
Product licence holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT.
Email: uk-medicalinformation@sanofi.com
Document number: MAT-XU-2301953 v1.0
Date of preparation: May 2023.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to the Sanofi drug safety department on 0800 0902522

Job number MAT-XU-2302845 v1.0