Medication Guide

Medication Guide
Ambrisentan Tablets
(am" bri sen’ tan)

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?

• Serious birth defects.

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

  • Females should not be pregnant when they start taking ambrisentan tabletsor become pregnant during treatment with ambrisentan tablets.
  • Females who are able to get pregnant should have a negative pregnancy test before beginning treatment withambrisentan tablets. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do a pregnancy test, and will order a pregnancy test for you depending on your menstrual cycle.
    • Females who are ableto get pregnant are females who:
      • have entered puberty, even if they have not started their menstrual period, and
      • have a uterus, and
      • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
    • Females who are not ableto get pregnant are females who:
      • have not yet entered puberty, or
      • do not have a uterus, or
      • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
      • who are infertile for any other medical reason and this infertility is permanent and cannot be reversed

  Females who are able to get pregnant should use effective contraception before beginning ambrisentan tablets, during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body.

  • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment withambrisentan tablets.
  • 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.
  • 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 takingambrisentan tabletsbefore 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.

What are ambrisentan tablets?

• Ambrisentan tabletsare a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
• Ambrisentan tabletscan improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
• It is not known ifambrisentan tabletsare safe and effective in children.

Who should not take ambrisentan tablets?

Do not take ambrisentan tablets if:

• you are pregnant, plan to become pregnant, or become pregnant during treatment with ambrisentan tablets. Ambrisentan tabletscan cause serious birth defects. (See "What is the most important information I should know about ambrisentan tablets?" )
• you have a condition called Idiopathic Pulmonary Fibrosis (IPF)

What should I tell my doctor before taking ambristenan tablets?

Before you take ambrisentan tablets tell your doctor if you:

• have been told that you have a low red blood cell level (anemia)
• have liver problems
• have any other medical conditions

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 ofambrisentan tablets.

How should I take ambrisentan tablets?

• Takeambrisentan tabletsexactly as your doctor tells you to take it. Do not stop takingambrisentan tabletsunless your doctor tells you to stop.
• You can takeambrisentan tabletswith or without food.
• Do not split, crush or chewambrisentantablets.
• It will be easier to remember to takeambrisentan tabletsif you take it at the same time each day.
• If you take more than your regular dose ofambrisentan tablets, call your doctor right away.
• If you miss a dose, take it as soon as you remember that day. Take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What should I avoid while taking ambrisentan tablets?

• Do not get pregnantwhile takingambrisentan tablets. (See the serious birth defects section of the Medication Guide above called "What is the most important information I should know about ambrisentan tablets?" ) If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
• It is not known if ambrisentanpasses into your breast milk. You should not breastfeed if you are takingambrisentan tablets. Talk to your doctor about the best way to feed your baby if you takeambrisentan tablets.

What are the possible side effects of ambrisentan tablets?

Ambrisentan tabletscan cause serious side effects including:

• See "What is the most important information I should know about ambrisentan tablets?"
• Swelling all over the body(fluid retention) can happen within weeks after startingambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while takingambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
• Decreased sperm count.Decreased sperm counts have happened in some men taking a medicine that is likeambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.
• Low red blood cell levels(anemia) can happen during the first weeks after startingambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before startingambrisentan tablets. Your doctor may also do these tests during treatment withambrisentan tablets.

The most common side effects of ambrisentan tablets include:

swelling of hands, legs, ankles and feet (peripheral edema) stuffy nose (nasal congestion)

inflamed nasal passages (sinusitis) hot flashes or getting red in the face (flushing)

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

loss of appetite nausea or vomiting fever achiness

generally do not feel well pain in the upper right stomach (abdominal) area yellowing of your skin or the whites of your eyes dark urine itching

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 ofambrisentan 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 ambrisentan tablets?

Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes 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 useambrisentan tabletsfor a condition for which it was not prescribed. Do not giveambrisentan tabletsto other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information aboutambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information aboutambrisentan tabletsthat is written for health professionals.

What are the ingredients in ambrisentan tablets?

Active ingredient:ambrisentan

Inactive Ingredients:croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

The tablets are film-coated with a coating material containing FD&C Red # 40 aluminum lake 38-42% (10 mg only), FDC Red # 40 (5 mg only), polyethylene glycol, polyvinyl alcohol, Sunset yellow aluminum lake 40% (5 mg only), talc and titanium dioxide.

For more information, go to www.apotex.com or call 1-800-706-5575.

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

APOTEX INC.

Ambrisentan Tablets

5 mg and 10 mg

Manufactured by:	Manufactured for:
Apotex Inc. Toronto, Ontario Canada M9L 1T9	Apotex Corp. Weston, Florida USA 33326

Revised: September 2025

Rev. 11

Marketed by:
GSMS, Inc.
Camarillo, CA 93012 USA