Riociguat Oral tablet

What is this medicine?

RIOCIGUAT (rye oh sig ue at) is used to treat pulmonary hypertension. This medicine may help make exercise and breathing easier.

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

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

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

• bleeding disorders

• heart disease

• kidney disease

• liver disease

• low blood pressure

• pulmonary veno-occlusive disease (PVOD)

• smoke tobacco

• an unusual or allergic reaction to riociguat, 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. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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

Overdosage: If you think you've 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, continue with the next regularly scheduled dose. Do not take double or extra doses. If you miss 3 or more days of treatment contact your doctor or healthcare professional for instructions before you restart this medicine.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• dipyridamole

• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

• sildenafil

• tadalafil

• theophylline

• vardenafil

This medicine may also interact with the following medications:

• antacids

• antiviral medicines for HIV or AIDS

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• itraconazole

• ketoconazole

• rifampin

• St. John's Wort

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 medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

This medicine can cause birth defects. Do not get pregnant while taking this drug. Females with child-bearing potential will need to have a negative pregnancy test before starting this medicine, every month while taking this medicine, and 1 month after stopping this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away.

Because of the risks of birth defects, females can only receive this medicine through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Males do not need to participate in this program to receive this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• dizziness

• feeling faint or lightheaded, falls

• unusual bleeding or bruising

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• nausea, vomiting

• swelling of the ankles, feet, hands

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.