Adcirca (tadalafil) relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Adcirca is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Another brand of tadalafil is Cialis which used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate) in men. Do not take Adcirca while also taking Cialis, unless your doctor tells you to.

Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

To treat high blood pressure in the lungs, take this medication by mouth as directed by your doctor, with or without food, usually once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

You should not take Adcirca if you are allergic to tadalafil, or:

• if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).

Do not take Adcirca if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate, butyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Some tadalafil can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems (chest pain, a heart rhythm disorder, heart failure);
• a heart attack or stroke;
• high or low blood pressure;
• liver disease;
• kidney disease (or if you are on dialysis);
• retinitis pigmentosa (an inherited condition of the eye);
• blindness in one or both eyes;
• hearing problems;
• blood circulation problems;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• pulmonary veno-occlusive disease (PVOD);
• a physical deformity of the penis (such as Peyronie's disease), or an erection lasting longer than 4 hours;
• a stomach ulcer; or
• health problems that make sexual activity unsafe.

A small number of people taking tadalafil have had sudden vision loss. Most of these people already had eye problems, or had diabetes or other health conditions that can affect blood vessels in the eyes. It is not clear whether tadalafil causes vision loss.

Do not start or stop taking Adcirca during pregnancy without your doctor's advice. Having pulmonary arterial hypertension (PAH) during pregnancy could harm may cause heart failure, stroke, or other medical problems in both mother and baby. Tell your doctor right away if you become pregnant.

You should not breastfeed while using tadalafil.

Cialis is not for use in women.

Adcirca is not approved for use by anyone younger than 18 years old.

Dizziness, lightheadedness, headache, muscle pain, flushing, nausea, stuffy nose, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

Get medical help right away if you have any very serious side effects, including: increased shortness of breath or trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems
• high or low blood pressure
• kidney disease
• liver disease
• pulmonary veno-occlusive disease (PVOD)
• stomach ulcers
• stroke
• an unusual or allergic reaction to tadalafil, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your medicine at regular intervals. Take both tablets at the same time, one after the other. Do not split your dose throughout the day. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• Do not take this medicine with any of the following medications:
• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• other medicines for erectile dysfunction like avanafil, sildenafil, vardenafil
• other tadalafil products (Cialis)
• riociguat

This medicine may also interact with the following medications:

• certain drugs for high blood pressure
• certain drugs for the treatment of HIV infection or AIDS
• certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
• certain drugs used for seizures like carbamazepine, phenytoin, and phenobarbital
• grapefruit juice
• macrolide antibiotics like clarithromycin, erythromycin, troleandomycin
• medicines for prostate problems
• rifabutin, rifampin or rifapentine

What should I watch for while using this medicine?

Do not change the dose of your medicine without asking your doctor. Call your doctor if your medication is not working for you. This may be a sign that your condition has become worse.

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using this medicine and call your health care provider right away if you have a loss of sight in one or both eyes.

For males, contact you doctor or health care professional right away if an erection lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain, or arm pain after taking this medicine, you should discuss the episode with your doctor or health care professional as soon as possible.

Do not drink more than 4 alcohol-containing drinks in a short period of time when taking this medicine. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.