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ADEMPAS- riociguat tablet, film coated


  1. Patient Information
  2. Adempas Is A Prescription Medicine Used To Treat Adults With:
  3. Do Not Take Adempas If:
  4. Before You Take Adempas, Tell Your Doctor If You:
  5. How Should I Take Adempas?
  6. What Should I Avoid While Taking Adempas?
  7. Adempas Can Cause Serious Side Effects Including:
  8. What Are The Ingredients In Adempas?
  9. Manufactured For:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

Instruct patients on the risk of fetal harm when Adempas is used during pregnancy[

Serious birth defects.
Adempas can cause serious birth defects if taken during pregnancy.
Females must not be pregnant when they start taking Adempas 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 tests, and order the tests for you depending on your menstrual cycle.
Females whoare ableto get pregnant are females who:
Have entered puberty, even if they have not started their period, and
Have a uterus,and
Have not gone through menopause (have not had a period for at least 12 months for natural reasons, or who have had their ovaries removed)
Females whoare not ableto get pregnant are females who:
Have not yet entered puberty,or
Do not have a uterus,or
Have gone through menopause (have not had a period for at least 12 months for natural reasons, or who have had their ovaries removed)

Females who are able to get pregnant must use 2 acceptable forms of birth control, during treatment with Adempas and for 1 month after stopping Adempas because the medicine may still be in the body.

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 about options for acceptable birth control that you may use to prevent pregnancy during treatment with Adempas.
If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.

Adempas Is A Prescription Medicine Used To Treat Adults With: 

chronic thromboembolic pulmonary hypertension (CTEPH)
treated with surgery but who continue to have high pulmonary blood pressure (persistent) or it comes back after surgery (recurrent),or
that cannot be treated with surgery.
CTEPH is a type of high blood pressure in the arteries of your lungs caused by blood clots that narrow or block blood flow. Adempas can improve your ability to exercise and can help to improve some of your symptoms.
pulmonary arterial hypertension (PAH)
PAH is a type of high blood pressure in the arteries of your lungs. Adempas can improve your ability to exercise, improve some of your symptoms, and help slow down the worsening of your physical condition.
It is unknown if Adempas is safe and effective in children.

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.(

Before You Take Adempas, Tell Your Doctor If You: 

smoke
have recently had serious bleeding from your lung, 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.

How Should I Take Adempas? 

Adempas will be provided to you by a certified pharmacy. Your doctor will give you complete details.

Do not take Adempas within 24 hours of sildenafil. Do not take Adempas 24 hours before or within 48 hours after tadalafil.
Take Adempas exactly as your doctor tells you. Do not stop taking Adempas or change your dose without talking to your doctor.
When you begin treatment with Adempas, your blood pressure should be monitored about every 2 weeks to help your doctor decide the correct dose of medicine for you.
Your doctor may change your dose during treatment, especially when you first start taking Adempas. It is important to tell your doctor if you have any symptoms of low blood pressure during this time, such as dizziness, lightheadedness, or fainting.
Take Adempas 3 times each day, about 6 to 8 hours apart.
Take Adempas with or without food.
Do not take more than a total of 7.5 mg of Adempas in 1 day unless your doctor tells you to.
If you take a heartburn medicine (antacid) that contains aluminum hydroxide or magnesium hydroxide, do not take it within1 hour of taking Adempas.
If you take too much Adempas, call your doctor right away or go to the nearest hospital emergency room.
If you miss a dose, take your next dose of Adempas at the regular time.
If you miss 3 or more days of treatment with Adempas, call your doctor for instructions before you restart Adempas.

What Should I Avoid While Taking Adempas? 

Do not get pregnantwhile taking Adempas. (

Adempas Can Cause Serious Side Effects Including: 

Serious birth defects.(

Store Adempas at room temperature between 59 F to 86 F (15 C to 30 C)

Keep Adempas and all medicines out of the reach of children.

General Information about Adempas

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adempas for a condition for which it is not prescribed. Do not give Adempas to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Adempas. If you would like more information about Adempas, talk with your doctor. You can ask your doctor or pharmacist for information about Adempas that is written for health professionals. For more information go to www.Adempas-us.com or call 1-888-842-2937.

What Are The Ingredients In Adempas? 

Active ingredient: riociguat

Inactive ingredients: cellulose microcrystalline, crospovidone, hypromellose 5cP, lactose monohydrate, magnesium stearate, sodium laurylsulfate, hydroxypropylcellulose, hypromellose 3cP, propylene glycol, titanium dioxide. Adempas 1 mg, 1.5 mg, 2 mg and 2.5 mg tablets also contain ferric oxide yellow. Adempas 2 mg and 2.5 mg tablets also contain ferric oxide red.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 1 2017

Manufactured For: 

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981

Manufactured in Germany

2013 Bayer HealthCare Pharmaceuticals Inc.

The following are representative examples of Adempas labeling. See the "How Supplied" section for a complete listing of all components.



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