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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 stimulators (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. Patient 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. Patient 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Sanofi drug safety department on 0800 0902522. By reporting side effects you can help provide more information on the safety of this medicine.