Uses of Tadalafil Tablets:

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

What do I need to tell my doctor BEFORE I take Tadalafil Tablets?

• If you are allergic to this medicine (tadalafil tablets); any part of this medicine (tadalafil tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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 a health problem called pulmonary veno-occlusive disease (PVOD).
• If you have a certain type of chest pain (unstable angina).
• 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 another drug like this one that is used to treat erectile dysfunction (ED) or high pressure in the lungs.
• If you are taking any of these drugs: Alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, or terazosin.
• If the patient is a child. This medicine is not approved for use in children.

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

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 this medicine (tadalafil tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tadalafil Tablets?

• Tell all of your health care providers that you take this medicine (tadalafil tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (tadalafil tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Very bad and sometimes deadly side effects like a heartbeat that does not feel normal, heart attack, stroke, and very bad high blood pressure have happened with this medicine (tadalafil tablets). Talk with the doctor.
• A very bad eye problem has rarely happened with this medicine (tadalafil tablets). This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• If you have bleeding problems, talk with your doctor.
• If you are 65 or older, use this medicine (tadalafil tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Tadalafil Tablets) best taken?

Use this medicine (tadalafil tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take this medicine (tadalafil tablets) at the same time of day.
• Keep taking this medicine (tadalafil tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• 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.
• Ringing in the ears, hearing loss, or any other changes in hearing.
• 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.

What are some other side effects of Tadalafil Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Headache.
• Back pain.
• Muscle pain.
• Upset stomach.
• Nose or throat irritation.
• Signs of a common cold.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tadalafil Tablets?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (tadalafil tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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