tadalafil

What is the most important information I should know about tadalafil?

Taking tadalafil with certain other medicines can cause a sudden and serious decrease in blood pressure.

Do not take tadalafil if you also use riociguat, or a nitrate drug such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as “poppers.”

Get medical help at once if you have nausea, chest pain, or dizziness during sex.

What is tadalafil?

The Cialis brand of tadalafil is used in men to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Adcirca and Alyq are used in men and women to treat pulmonary arterial hypertension (PAH) and to improve exercise capacity.

Do not take Cialis for erectile dysfunction if you are taking Adcirca or Alyq for pulmonary arterial hypertension.

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

What should I discuss with my healthcare provider before taking tadalafil?

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

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

Do not take tadalafil 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.

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 tadalafil 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.

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

How should I take tadalafil?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

When taking Adcirca or Alyq, you may need 2 tablets for a full dose. Take both tablets one after the other. Do not split the dose.

Take Cialis just before sexual activity, but not more than once per day. Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.

Do not break or split a Cialis tablet. Swallow it whole.

Take the medicine at the same time each day, with or without food.

Do not change your tadalafil dose or stop taking this medicine without your doctor’s advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Cialis is used as needed, you are not likely to miss a dose.

If you miss a dose of Adcirca or Alyq, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tadalafil?

Avoid drinking alcohol. It may increase your risk of dizziness or fainting.

Grapefruit may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of tadalafil?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tadalafil and call your doctor at once if you have:

heart attack symptoms –chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
vision changes or sudden vision loss;
ringing in your ears or sudden hearing loss; or
an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).

Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.

Common side effects may include:

headache;
flushing (warmth, redness, or tingly feeling);
nausea, upset stomach;
runny or stuffy nose; or
muscle pain, back pain, pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tadalafil?

Do not take Cialis with similar medications such as avanafil (Stendra), sildenafil (Viagra) or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction.

Tell your doctor about all your other medicines, especially:

medicines to treat erectile dysfunction or pulmonary arterial hypertension;
drugs to treat high blood pressure or a prostate disorder;
an antibiotic such as clarithromycin, erythromycin, rifampin, or telithromycin;
antifungal medicine such as ketoconazole or itraconazole;
medicine to treat HIV/AIDS, such as ritonavir and others; or
seizure medicine such as carbamazepine or phenytoin.

This list is not complete. Other drugs may affect tadalafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about tadalafil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.