Zuellig Pharma
Concise Prescribing Info
Erectile dysfunction. 5 mg: Symptomatic treatment of benign prostatic hyperplasia (BPH).
Dosage/Direction for Use
Adult Erectile dysfunction Recommended dose: 10 mg once daily taken at least 30 min prior to anticipated sexual activity, may be increased to 20 mg if tadalafil 10 mg does not produce an adequate effect. Patient who anticipate frequent use (ie, at least twice wkly) Recommended dose: 5 mg once daily. BPH Recommended dose: 5 mg once daily. Severe renal impairment Max recommended dose: 10 mg.
Should be taken on an empty stomach: Take at approx the same time each day.
Hypersensitivity. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in last 90 days, unstable angina or angina occurring during sexual intercourse, NYHA class ≥2 heart failure in last 6 mth, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled HTN, stroke w/in last 6 mth. Loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ guanylate cyclase stimulators eg, riociguat; organic nitrates.
Special Precautions
Discontinue use if sudden visual defect, decreased or loss of hearing occur. Patients w/ preexisting CV risk factors. Increased risk of acute NAION. Patients w/ anatomical penis deformation eg, angulation, cavernosal fibrosis or Peyronie's disease, or conditions predisposing to priapism eg, sickle cell anemia, multiple myeloma or leukaemia. Assess for CV conditions prior to treatment. Not recommended in combination w/ doxazosin. Concomitant use w/ antihypertensives, α1-blockers, other PDE5 inhibitors, CYP3A4 inhibitors. May affect ability to drive & use machines. Hepatic impairment. Not recommended for once-daily dosing in severe renal impairment. Not to be used in women. Avoid use during pregnancy. Not to be used during lactation.
Adverse Reactions
Back pain, myalgia. Headache; flushing; nasal congestion; dyspepsia; pain in extremity.
Drug Interactions
Increased exposure w/ CYP3A4 inhibitors. Potential drug interactions mediated by inhibition of transporters. Decreased plasma conc by CYP3A4 inducers. Augmented hypotensive effects of nitrates, antihypertensives. Increased BP-lowering effect of doxazosin, riociguat. Increased bioavailability of ethinylestradiol, terbutaline. 5α-reductase inhibitors, CYP1A2 substrates eg, theophylline.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Caliberi orodispersible film 20 mg
2 × 1's
Caliberi orodispersible film 5 mg
15 × 1's
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