Tadalafil Suspension (Pulmonary Hypertension)

What is this medication?

TADALAFIL (tah DA la fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tadliq

What should I tell my care team before I take this medication?

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

• Abnormal penis shape or Peyronie's disease
• Blood diseases, such as sickle cell disease, leukemia, multiple myeloma
• Eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• Hearing loss or problems
• Heart disease
• High or low blood pressure
• History of painful and prolonged erection
• Kidney disease
• Liver disease
• Pulmonary veno-occlusive disease (PVOD)
• Stroke
• An unusual or allergic reaction to tadalafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 medication?

Do not take this medication with any of the following:

• Medications for erectile dysfunction, such as avanafil, sildenafil, vardenafil
• Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Riociguat
• Telaprevir

This medication may also interact with the following:

• Alcohol
• Certain antibiotics, such as erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications used for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Certain medications for high blood pressure
• Certain medications used for seizures, such as carbamazepine, phenobarbital, phenytoin
• Grapefruit juice
• Medications for prostate problems
• Rifabutin, rifampin, or rifapentine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Tell your care team right away if you have any change in your eyesight.

Tell your care team right away if you experience a sudden decrease or loss of hearing, this may happen with dizziness or ringing in the ears.

Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss, ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Prolonged or painful erection
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Facial flushing, redness
• Headache
• Muscle pain
• Runny or stuffy nose
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.