Riociguat Oral Tablet 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg

Instructions

If unable to swallow the tablet, crush and mix with water or soft foods (such as applesauce). Mix well and take immediately.

Keep the medicine in its original container.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Do not take antacids 1 hour before or 1 hour after taking this medicine.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Use effective birth control to avoid pregnancy.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than three times during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Smoking may affect the level of this medicine in your body. Tell your doctor if you smoke, or stop smoking while on this medicine.

Do not take any medicine containing nitrates while on this medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use 2 reliable forms of birth control while taking this medicine and for 4 weeks after stopping to prevent pregnancy.

Do not take this medicine with other medicines called PDE5 inhibitors (Viagra, Levitra, Cialis). Your doctor will let you know if it is safe for you to do so.

Do not take St. John's wort while on this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• dizziness
• lack of energy and tiredness
• headaches
• vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding that is severe or takes longer to stop
• blurry vision
• confusion
• coughing up blood or vomit that looks like coffee grounds
• severe or persistent headache
• slurred speech
• bloody or dark, tarry stools
• blood in urine
• vaginal bleeding or spotting between periods
• weakness on one side of the body

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.