BOSENTAN - bosentan tablet, film coated 
Sun Pharmaceutical Industries, Inc.

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Medication Guide



Bosentan (boe-SEN-tan) Tablets

Read the Medication Guide that comes with bosentan tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about bosentan tablets?

Bosentan tablets are only available through the Bosentan REMS Program. Before you begin taking bosentan tablets, you must read and agree to all of the instructions in the Bosentan REMS Program.
Bosentan tablets can cause serious side effects including:

Liver damage.




Serious birth defects.





See the chart below for Acceptable Birth Control Options during treatment with bosentan tablets.




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

Acceptable birth control options




Option 1

Option 2
Option 3
Option 4
One method from this list:
or
One method from this list:
or
One method from this list:
or
One method from this list:
Standard intrauterine device (Copper T 380A IUD)
Intrauterine system (LNg 20 IUS: progesterone IUS)
Tubal sterilization

Estrogen and progesterone oral contraceptives (“the pill”)
 
Estrogen and progesterone transdermal patch
 
Vaginal ring
 
Progesterone injection
Progesterone implant
 
Diaphragm with spermicide

Cervical cap with spermicide
 
Partner’s vasectomy
 
PLUS
One method from this list:
PLUS
One method from this list:
 
Male condom
 
Diaphragm with spermicide
 
Cervical cap with spermicide
 
Estrogen and progesterone oral contraceptives (“the pill”)
 
Estrogen and progesterone transdermal patch
 
Vaginal ring
 
Progesterone injection
 
Progesterone implant
Male condom
PLUS
One method from this list:
Male condom
 
Diaphragm with spermicide
 
Cervical cap with spermicide



See “What are the possible side effects of bosentan tablets?” for more information about side effects.


What are bosentan tablets?
Bosentan tablets are a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.


Bosentan tablets can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Bosentan tablets lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.


Bosentan tablets are only:
Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program.
Available to people who understand and agree to enroll in the Bosentan REMS Program.


Who should not take bosentan tablets?


Do not take bosentan tablets if you:



What should I tell my healthcare provider before taking bosentan tablets?
Bosentan tablets may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:



Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bosentan tablets and other medicines may affect how each other works and cause side effects. Especially tell your healthcare provider if you take:



There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.


How should I take bosentan tablets?
Your healthcare provider will give you detailed information about the Bosentan REMS Program.



What are the possible side effects of bosentan tablets?
Bosentan tablets can cause serious side effects, including:



The most common side effects of bosentan tablets include:



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 bosentan tablets. For more information, ask your doctor or pharmacist.


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


How should I store bosentan tablets?



Keep bosentan tablets and all medicines out of the reach of children.


General information about bosentan tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bosentan tablets for a condition for which it was not prescribed. Do not give bosentan tablets 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 bosentan tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about bosentan tablets that is written for health professionals. For more information, call 1-800-818-4555.


What are the ingredients in bosentan tablets?
Active ingredient: bosentan
Inactive ingredients: corn starch, pregelatinized maize starch, sodium starch glycolate, povidone, glyceryl behenate, magnesium stearate, hydroxypropylmethylcellulose, triacetin, talc, titanium dioxide, iron oxide yellow, iron oxide red, ethylcellulose.


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


Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512


Manufactured by:
Sun Pharmaceutical Industries Ltd.
Survey No. 259/15,
Dadra-396 191, (U.T. of D & NH), India.


PGPI0347E
ISS.05/2019

Revised: 5/2019
Sun Pharmaceutical Industries, Inc.