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Managing some common
side effects of Adempas

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Every person is unique and may experience a different side effect when taking Adempas.

This section is intended to help you understand how to manage some of the most common side effects of Adempas.

Please note: this section does not take the place of talking with your healthcare provider about your condition or your prescribed treatment. If you have any questions about Adempas, be sure to ask your doctor, nurse, or pharmacist.

Before you start Adempas, tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you have any side effect that bothers you or does not go away. Adempas and other medicines may affect each other and cause side effects. These are not all the possible side effects of Adempas.

Do not start any new medicine until you check with your doctor.

Tips for managing some common side effects of Adempas
Headache?
Headache?
  • Reduce alcohol and caffeine consumption
  • Eat, sleep, and exercise on a regular schedule
  • Call your healthcare provider before you take an over-the-counter pain reliever. Some types of pain relievers can increase your chance of bleeding
Dizziness?
Dizziness?
  • Drink plenty of fluids and limit caffeine, salt, and alcohol during episodes of dizziness or low blood pressure
  • Stand up slowly, and do not change positions suddenly
  • Do not drive, operate machinery, or do other activities that require mental alertness or coordination if you feel dizzy, or until you know how Adempas affects you

Adempas reduces blood pressure, which may cause symptoms such as lightheadedness, chest pain, dizziness, and fainting; consult with your healthcare provider.

Indigestion?
Indigestion?
  • Avoid foods that can trigger indigestion, such as caffeine, alcohol, and spicy or fatty foods
  • Take over-the-counter heartburn medicine, if your doctor recommends it. They are called antacids, H2 blockers, and proton pump inhibitors (PPls)
  • Don't take heartburn medicine (antacid) that contains aluminium hydroxide or magnesium hydroxide within 1 hour of taking Adempas
Nausea/Vomiting?
Nausea/Vomiting?
  • Try small sips of ice water, ice chips, iced herbal teas, iced tea, and small tastes of fruit sorbets
  • Eat bland food, such as crackers, toasts, dry cereal, rice, and fruit. Avoid fatty or spicy foods
  • Avoid strong odors and any known triggers
Diarrhea?
Diarrhea?
  • Stay hydrated: drink plenty of water throughout the day
  • Restrict foods that may trigger symptoms (such as spicy foods)
  • Eat bland foods, such as rice and toast
  • Ask your doctor about whether or not an over-the-counter probiotic could help
  • Contact your healthcare provider if you become dehydrated. Your healthcare provider may recommend a fluid-replacement therapy or an over-the-counter medication

The most common side effects of Adempas are headache, dizziness, indigestion, swelling of your hands, legs, feet, and ankles (peripheral edema), nausea, diarrhea, and vomiting.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Adempas.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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MORE IMPORTANT SAFETY INFORMATION LESS IMPORTANT SAFETY INFORMATION

Adempas can cause serious birth defects if taken during pregnancy.

  • Females must not be pregnant when they start taking Adempas (riociguat) tablets or become pregnant during treatment with Adempas.
  • Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with Adempas, each month during treatment, and 1 month after you stop treatment with Adempas. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do the test.
    • Females who are able to get pregnant are females who:
      • Have entered puberty, even if they have not started their period, have a uterus, and have not gone through menopause (have not had a period for at least 12 months for natural reasons, or have had their ovaries removed).
    • Females who are not able to get pregnant are females who:
      • Have not yet entered puberty, do not have a uterus, or have gone through menopause.

Females who are able to get pregnant must use two acceptable forms of birth control, during Adempas treatment and for one month after stopping Adempas.

  • If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
  • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out how to prevent pregnancy during treatment with Adempas.
    • Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
    • Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.

If you are the parent or caregiver of a female child who started taking Adempas before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or any pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females can only receive Adempas through a restricted program called the Adempas Risk Evaluation and Mitigation Strategies (REMS) program. If you are a female who can become pregnant, you must talk to your doctor, understand the benefits and risks of Adempas, and agree to all of the instructions in the Adempas REMS program. Males can receive Adempas without taking part in the Adempas REMS program.

Do not take Adempas if:

  • you are pregnant, plan to become pregnant, or become pregnant during treatment with Adempas. Adempas can cause serious birth defects.
  • you take:
    • a nitrate medicine to treat high blood pressure or heart disease, such as nitroglycerin, or a medicine called a nitric oxide donor, such as amyl nitrite
    • certain other medicines that contain sildenafil (Revatio or Viagra), tadalafil (Adcirca or Cialis), vardenafil (Levitra or Staxyn), dipyridamole, or theophylline. Revatio and Adcirca are also used to treat PAH
  • you have pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Before you take Adempas, tell your doctor if you:

  • smoke; have recently had serious bleeding from your lungs, or if you have had a medical procedure called bronchial arterial embolization to stop you from coughing up blood; have problems with your heart or blood circulation; have low blood pressure; have liver problems; have kidney problems or are on dialysis; have narrowing of the pulmonary veins, a condition called pulmonary veno-occlusive disease or PVOD; have any other medical conditions.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Adempas and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your doctor.

What should I avoid while taking Adempas?

  • Do not get pregnant while taking Adempas. If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
  • It is not known if Adempas passes into your breast milk. You should not breastfeed if you take Adempas. Talk to your doctor about the best way to feed your baby if you take Adempas.
  • Adempas may make you feel dizzy. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Adempas affects you. Talk with your doctor if you are concerned about when it is safe for you to do these activities.
  • Smoking. Adempas may not work as well if you smoke during treatment. Tell your doctor if you stop smoking or start smoking during treatment with Adempas, because your dose of Adempas may need to be changed.

Adempas can cause serious side effects including:

  • Serious birth defects.
  • Reduced blood pressure. This may cause symptoms of low blood pressure, such as lightheadedness, chest pain, and dizziness especially in people who are dehydrated, have a severe blockage of blood flow out of the heart, or have certain other medical problems. Your doctor will check you for any of these problems.
  • Increased risk of bleeding, including bleeding from the respiratory tract. Tell your doctor right away if you cough up blood during treatment with Adempas.
  • Worsening of symptoms in people with Pulmonary Veno-Occlusive Disease (PVOD). If you have PVOD, treatment with Adempas may cause a build-up of fluid in your lungs (pulmonary edema) which may result in shortness of breath. Your doctor may tell you to stop taking Adempas and switch you to a different medicine.

The most common side effects of Adempas are:

  • Headache; dizziness; indigestion; swelling of your hands, legs, feet, and ankles (peripheral edema); nausea; diarrhea; and vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Adempas.