Adempas contains the active ingredient riociguat, which is a soluble guanylate cyclase stimulator. It is available as an oral tablet with dosage strengths of 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg. Key inactive ingredients include cellulose microcrystalline, lactose monohydrate, and magnesium stearate. The tablets are intended to be taken orally.

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. Swallow the tablets whole. You may crush the tablet and put the contents in applesauce or water. Swallow the medication and applesauce right away. 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.

Take products with aluminium or magnesium in them at a different time of day than this medication. Take this medication 1 hour before or 1 hour after these products.

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 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose. If you miss 3 or more days of treatment contact your care team about what to do before you restart this medication.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 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, empty 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.

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
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

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

• Diarrhea
• Dizziness
• Headache
• Nausea
• 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.

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

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

• Bleeding disorders
• Heart disease
• Kidney disease
• Liver disease
• Low blood pressure
• Pulmonary hypertension associated with idiopathic interstitial pneumonias
• Pulmonary veno-occlusive disease (PVOD)
• Smoke tobacco cigarettes
• An unusual or allergic reaction to riociguat, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Avanafil
• Dipyridamole
• Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Sildenafil
• Tadalafil
• Theophylline
• Vardenafil
• Vericiguat

This medication may also interact with the following:

• Antacids
• Certain medications for fungal infections, such as ketoconazole or itraconazole
• Certain medications for HIV or AIDS, such as ritonavir
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• 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 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.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 1 month after stopping it. A negative pregnancy test is required before starting this medication. A negative pregnancy test is also required each month during treatment, even if you are not sexually active. Two reliable forms of contraception while you are taking this medication and for 1 month after you stop taking this medication is recommended. If you become pregnant, miss a menstrual cycle, or stop using contraception, stop taking this medication. Call your care team. Do not breast-feed an infant while taking this medication.

You may get drowsy or dizzy. 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.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

If you smoke, tell your care team if you notice this medication is not working well for you. Talk to your care team if you decide to stop smoking.

What are the most serious risks of this medication?

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.