AMBRISENTAN - ambrisentan tablet, film coated 
Sun Pharmaceutical Industries, Inc.

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Medication Guide


Ambrisentan (am" bri senʹ tan) Tablets

Read this Medication Guide before you start taking ambrisentan tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

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

Ambrisentan tablets can cause serious birth defects if taken during pregnancy.

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

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.

See the chart below for Acceptable Birth Control Options during treatment with
ambrisentan tablets.
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 IUD)


Tubal sterilization


Progesterone implant
Estrogen and progesterone oral contraceptives (“the pill”)

Estrogen and progesterone transdermal patch


Vaginal ring


Progesterone injection
Diaphragm with spermicide

Cervical cap with spermicide
Partner’s vasectomy
PLUS
One method from this list:
Male condom

Diaphragm with spermicide


Cervical cap with spermicide


Estrogen and progesterone oral contraceptive (“the pill”)


Estrogen and progesterone transdermal patch


Vaginal ring


Prolgesterone injection
PLUS
One method from this list:
Male condom
PLUS
One method from this list:
Male condom

Diaphragm with spermicide


Cervical cap with spermicide

If you are the parent or caregiver of a female child who started taking ambrisentan tablets 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 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 ambrisentan tablets through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Ambrisentan REMS. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of ambrisentan tablets, and agree to all of the instructions in the Ambrisentan REMS.

Males can receive ambrisentan tablets without taking part in the Ambrisentan REMS.



What are ambrisentan tablets?


Who should not take ambrisentan tablets?

Do not take ambrisentan tablets if:

What should I tell my doctor before taking ambrisentan tablets?

Before you take ambrisentan tablets, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.
Especially tell your doctor if you take the medicine cyclosporine (Gengraf*, Neoral*, Sandimmune*). Your doctor may need to change your dose of ambrisentan tablets.

How should I take ambrisentan tablets?


What should I avoid while taking ambrisentan tablets?

What are the possible side effects of ambrisentan tablets?

Ambrisentan tablets can cause serious side effects including:

The most common side effects of ambrisentan tablets include:

Some medicines that are like ambrisentan tablets can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ambrisentan 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. For more information call 1-800-818-4555.

How should I store ambrisentan tablets?

Store ambrisentan tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC), in the package they come in.

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


General information about the safe and effective use of ambrisentan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan 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 ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.



What are the ingredients in ambrisentan tablets?

Active ingredient: ambrisentan

Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

* All trademarks are the property of their respective owners.


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.

PGPI0364B

ISS. 10/2019

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

Revised: 10/2019
Sun Pharmaceutical Industries, Inc.