|Dosage and administration||
– The usual dose of tadalafil is 10 mg, only once per day, taken orally at least 30 to 12 hours with a full glass of water before sexual activity (with or without food).
Agitafil should not be used in:
|Warnings and precautions for use||
Prior to the treatment with tadalafil, the history of erectile dysfunction should be known, and patients should be examined to determine status of E.D and potential underlying causes.
|Recommendation for pregnancy and breastfeeding||
– Tadalafil should not be used during pregnancy and breastfeeding because research on pregnant women and lactating mothers is not adequate and appropriate.
|Effects on ability to drive and use machines||
Tadalafil may cause dizziness or changes in vision, thus, patients should be aware of how they react to tadalafil before driving or operating machinery.
|Interactions, incompatibilities of medicine||
– Tadalafil has a vasodilator effect, leading to a slight decrease in blood pressure and therefore has a synergistic effect on nitrates and alpha blockers, therefore, coadministration of tadalafil and these drugs is contraindicated.
|Undesirable effects (ADRs)||
Common: Headache, indigestion, dizziness, face flushing, stuffy nose, back pain, muscle pain.
|Overdose and management||
– Single doses up to 500 mg tadalafil have been tested in healthy subjects and multiple daily doses up to 100 mg have been administered to patients. The side effects were similar to those observed with lower doses.
– Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
– Agitafil is readily absorbed after oral administration and the maximum observed plasma concentration (Cmax) of tadalafil is achieved between 30 minutes and 6 hours (a median time of 2 hours).
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Tadalafil. . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg
Cardboard box containing 1 blisters of 1 film coated tablets.
– Agitafil is indicated for the treatment of erectile dysfunction, a condition of inability to achieve and maintain an erection sufficient to have sexual intercourse.
– In order for tadalafil to be effective, sexual stimulation is required.