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Liberez

Liberez

tadalafil

Manufacturer:

Idaman Pharma

Distributor:

Pharmaniaga Logistics
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction. 5 mg: Symptomatic treatment of benign prostatic hyperplasia.
Dosage/Direction for Use
Adult Erectile dysfunction 10 mg once daily at least 30 min prior to anticipated sexual activity, may be increased to 20 mg once daily if 10 mg does not produce adequate effect. Benign prostatic hyperplasia 5 mg once daily. Hepatic & severe renal impairment Max recommended dose: 10 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Not to be used in 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 & HTN, hypotension (<90/50 mmHg); stroke w/in last 6 mth. Loss of vision in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ guanylate cyclase stimulators eg, riociguat; organic nitrates.
Special Precautions
Discontinue use if sudden vision defect, decreased or hearing loss occurs. Increased risk of acute NAION. Patients w/ pre-existing CV risk factors; undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukaemia. Assess CV status prior to treatment. Not recommended for continuous daily use. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not to be used in combination w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Not recommended in combination w/ doxazosin. Concomitant use w/ antihypertensives, α1-blockers, potent CYP3A4 inhibitors. May affect ability to drive & use machines. Severe hepatic insufficiency (Child-Pugh class C). Not to be used in women. Avoid use during pregnancy. Not to be used during lactation. 5 mg: Rule out presence of prostate carcinoma prior to initiation. Not recommended for once-daily dosing in patients w/ severe renal impairment.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased plasma conc w/ protease (eg, ritonavir, saquinavir) & CYP3A4 (eg, ketoconazole, erythromycin, clarithromycin, itraconazole) inhibitors, grapefruit juice. Potential drug interactions mediated by transport inhibitors. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, phenobarb, phenytoin, carbamazepine. Augmented hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. Augmented hypotensive effects w/ riociguat. Increased oral bioavailability of ethinylestradiol, terbutaline. Concomitant use w/ α-blockers, 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.
Presentation/Packing
Form
Liberez FC tab 20 mg
Packing/Price
4 × 2's
Form
Liberez FC tab 5 mg
Packing/Price
3 × 10's
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