IntimateTM is indicated for the treatment of erectile dysfunction (ED).
IntimateTM is indicated for the treatment of the signs and symptoms of benign prostatic
IntimateTM is indicated for the treatment of erectile dysfunction and the signs of benign
prostatic hyperplasia (ED/BPH).
DOSAGE & ADMINISTRATION
For Use as Needed
• The recommended starting dose of IntimateTM for use as needed in most patients is
10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy
and tolerability. The maximum recommended dosing frequency is once per day in most
For Once Daily Use
• The recommended starting dose of IntimateTM for once daily use is 2.5 mg, taken at
approximately the same time every day, without regard to timing of sexual activity.
• The IntimateTM dose for once daily use may be increased to 5 mg, based on individual
efficacy and tolerability.
Patients with BPH or with ED and BPH
Intimate for once daily use for BPH
The recommended dose of Intimate for once daily use is 5 mg, taken at approximately the
same time every day.
Intimate for once daily use for ED+BPH
The recommended dose of Intimate for once daily use is 5 mg, taken at approximately
the same time every day, without regard to timing of sexual activity.
Administration of tadalafil to patients who are using any form of organic nitrate, either
regularly and/or intermittently, is contraindicated. In clinical pharmacology studies,tadalafil was shown to potentiate the hypotensive effect of nitrates.
Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil.
Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome
and exfoliative dermatitis.
Body as a whole: hypersensitivity reactions including rash, urticaria, facial edema,
Stevens-Johnson syndrome, and exfoliative dermatitis.
Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial
infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia,
stroke, transient ischemic attacks, chest pain, palpitations, and tachycardia, may occur.
Most of the patients in whom these events have been reported had pre-existing
cardiovascular risk factors. Hypotension (more commonly reported when tadalafil is
given to patients who are already taking antihypertensive agents), hypertension, and
Skin and subcutaneous tissues: hyperhidrosis (sweating).
Gastrointestinal: abdominal pain and gastroesophageal reflux.
Nervous system: migraine, transient global amnesia.
Respiratory system: epistaxis (nose bleed).
Special senses: blurred vision, nonarteritic anterior ischemic optic neuropathy, retinal
vein occlusion, visual field defect.
Otologic: cases of sudden decrease or loss of hearing have been reported.
PREGNANCY & LACTATION
It is not indicated for use in newborn, children or women.