Tadalafil
Indications for use
- OTC tadalafil 10 mg (available as Cialis Together® and as generic Pharmacy-licensed tadalafil 10 mg tablets in the UK) is indicated in adult men with erectile dysfunction
- Not all tadalafil 10 mg products are Pharmacy medicines – some remain prescription-only. Always confirm the legal category of the specific product being supplied
Age
- Individuals aged 18 years and over (dose adjustments are not required in elderly patients)
Dose/directions
- One 10 mg tablet taken at least 30 minutes prior to anticipated sexual activity, with or without food. The maximum dosing frequency is once per day
Duration
- Not recommended for continuous daily use. Men who use this product frequently (i.e. at least twice weekly) should consult their doctor to discuss whether a once daily regimen with the lowest doses of tadalafil would be more suitable
Contra-indications/referral criteria
- Hypersensitivity to the active substance or to any of the excipients
- Co-administration with nitric oxide donors (such as amyl nitrite also known as “poppers”, nicorandil or molsidomine) or nitrates
- Men with cardiac disease for whom sexual activity is inadvisable. Cialis Together is contraindicated in the following groups of patients with cardiovascular disease: myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, New York Heart Association Class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, patients with a stroke within the last 6 months
- Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure
- Co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension
- Cialis Together should not be used in patients with anatomical deformation of the penis
- Cialis Together is not indicated for use by women
- Cialis Together is not intended for men without erectile dysfunction
- Cialis Together is not intended for men under 18 years of age
Examples of drug interactions
- Tadalafil exposure is increased with CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, erythromycin, clarithromycin, cimetidine and grapefruit juice)
- Alpha blocker treatment (e.g. alfuzosin, doxazosin or tamsulosin)
Side-effects
- Commonly reported adverse reactions include: headache, dyspepsia, back pain and myalgia. The majority of headaches reported with Cialis Together once-a- day dosing is experienced within the first 10 to 30 days of starting treatment. Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking Cialis Together and seek prompt medical attention in the event of sudden decrease or loss of hearing
Other pertinent information
- In order for the product to be effective, sexual stimulation is required. Most men will achieve an erection the first or second time they use Cialis Together. If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a doctor
- Drinking excessive alcohol can temporarily reduce a man's ability to get an erection. Men should be advised not to drink large amounts of alcohol before sexual activity
- 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
- Reclassified POM→P: 2023