Q&A for Tadalafil ^*1

1.  What is Tadalafil used to treat?

Tadalafil is approved for the treatment of men who experience difficulty having and maintaining an erection (impotence).

2.  How does Tadalafil work?

Tadalafil works by enhancing the effects of one of the chemicals the body normally releases into the penis during sexual arousal. This allows an increase of blood flow into the penis. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3.  How is Tadalafil different from the currently approved products for erectile dysfunction (ED)?

Tadalafil is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of Tadalafil to other products.

4.  How do I take Tadalafil?

Tadalafil is taken orally before sexual activity, not more than once daily. Tadalafil may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5.  Are there any side effects with Tadalafil?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with Tadalafil during the testing of the product were: 

·         headache

·         indigestion

·         back pain

·         muscle pain

·         flushing

·         stuffy nose 

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking Tadalafil and these usually go away by themselves within 48 hours. A small number of patients taking Tadalafil also reported abnormal vision.

6.  What important information should you know about   Tadalafil?

·         Tadalafil can cause your blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication. You could get dizzy, faint or have a heart attack or stroke.

·         Tell your healthcare provider that you take Tadalafil. If you need emergency medical care for a heart problem, it will be important for your health care provider to know when you last took Tadalafil.

·         After taking a single tablet, some of the active ingredient of   Tadalafil remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

·         Physicians should discuss with patients the potential for Tadalafil to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications.

7.  What should I talk to my doctor about when considering if  Tadalafil is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if Tadalafil is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with Tadalafil,  Tadalafil is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8.  Who should not take Tadalafil?

Tadalafil should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) because the combination of these with Tadalafil could significantly lower blood pressure and lead to fainting or even death in some men.

9.  Can Tadalafil be used with other treatments for impotence?

The safety and effectiveness of  Tadalafil when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with  Tadalafil is not recommended.

10. What if I am taking other drugs?

Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter) that way, you can receive the best advice for your own situation. Tadalafil is not recommended for people taking any form of nitroglycerin because the combination may lower blood pressure to an unsafe level.

*1 Q&A refers to US FDA description about tadalafil, useful link as follows, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-cialis-tadalafil