Adcirca

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Do not take Cialis while also taking Adcirca.

Tadalafil may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• medicines to treat erectile dysfunction or pulmonary arterial hypertension;

• an antibiotic or antifungal medicine;

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• drugs to treat high blood pressure or a prostate disorder; or

• seizure medicine.

This list is not complete. Other drugs may interact with tadalafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cold sweats
• confusion
• dizziness
• fainting
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• headache
• hearing loss
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness
• vomiting

• Painful or prolonged erection of the penis

• Abdominal or stomach pain
• blindness
• blistering, peeling, or loosening of the skin
• cough
• cracks in the skin
• decrease or change in vision
• diarrhea
• difficulty with speaking
• double vision
• fast, irregular, pounding, or racing heartbeat or pulse
• headache, severe and throbbing
• hives or welts
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching
• joint or muscle pain
• loss of heat from the body
• numbness or tingling of the face, hands, or feet
• red irritated eyes
• red skin lesions, often with a purple center
• red, swollen skin
• redness of the skin
• redness or soreness of the eyes
• scaly skin
• skin rash
• slow speech
• sores, ulcers, or white spots in the mouth or on the lips
• sudden cardiac death
• swelling of the feet or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

• Bloody nose
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• burning feeling in the chest or stomach
• congestion
• difficulty with moving
• difficulty with swallowing
• dry mouth
• dryness or soreness of the throat
• excessive eye discharge
• eye pain
• feeling of constant movement of self or surroundings
• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• fever
• hoarseness
• increased erection
• lack or loss of strength
• loose stools
• muscle aching or cramping
• muscle stiffness
• nasal congestion
• neck pain
• pain
• pain in the arms or legs
• pain or burning in the throat
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• reduced sensitivity to touch
• runny nose
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• spontaneous penile erection
• stomach upset
• swelling of the eyelids
• swelling or puffiness of the eyes or face
• swollen joints
• tearing
• tender, swollen glands in the neck
• tenderness in the stomach area
• trouble with sleeping
• unable to sleep
• upper abdominal or stomach pain
• voice changes
• watering of the eyes

• Changes in color vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat raised pressure in the lungs.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to tadalafil or any other part of Adcirca (tadalafil tablets (adcirca)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have certain hereditary eye problems like retinitis pigmentosa.
• If you have any of these health problems: Heart attack within the last 90 days, chest pain during sex, heart failure, a heartbeat that is not normal, high or low blood pressure, or a stroke within the last 6 months.
• If you use drugs called "poppers" like amyl nitrite and butyl nitrite.
• If you are taking any of these drugs: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, or ritonavir.
• If you are taking any of these drugs: Itraconazole or ketoconazole.
• If you are taking rifampin.
• If you are taking another drug that has the same drug in it.
• If you are taking or will be taking another drug like this one.
• If you are taking any of these drugs: Alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, or terazosin.
• If you have a health problem called pulmonary veno-occlusive disease (PVOD).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Adcirca with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Very bad headache.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in eyesight.
• Loss of eyesight.
• Hearing loss.
• Change in hearing.
• Ringing in ears.
• Very bad muscle pain, back pain, soreness, or weakness.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

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.

Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Common side effects of Adcirca include: back pain, dyspepsia, headache, limb pain, myalgia, nausea, and flushing. Other side effects include: nasal congestion. See below for a comprehensive list of adverse effects.