AMBRISENTAN- ambrisentan tablet, film coated
Quallent Pharmaceuticals Health LLC
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| Medication Guide
Ambrisentan (am" bri senʹ tan) Tablets |
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| 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. |
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| 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. o F emales should not be pregnant when they start taking ambrisentan tablets or become pregnant during treatment with ambrisentan tablets. o Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with ambrisentan 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.
● 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.
● 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 F emales 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. o 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 with ambrisentan tablets. o 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. o 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. o T ell 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 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. |
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What are Ambrisentan Tablets?
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| Who should not take ambrisentan tablets?
Do not take ambrisentan tablets if:
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| W h at should I tell my doctor before taking am brisentan tablets?
Before you take am brisentan tablets, tell your doctor if you:
E specially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of ambrisentan tablets. |
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| How should I take Am brisentan Tablets?
● Take ambrisentan tablets exactly as your doctor tells you to take it. Do not stop taking ambrisentan tablets unless your doctor tells you to stop. ● You can take ambrisentan tablets with or without food. ● Do not split, crush or chew ambrisentan tablets. ● It will be easier to remember to take ambrisentan tablets if you take it at the same time each day. ● If you take more than your regular dose of ambrisentan 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. |
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| What should I avoid while taking Ambrisentan Tablets?
● Do not get pregnant while taking ambrisentan 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 ambrisentan passes into your breast milk. You should not breastfeed if you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets. |
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| 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: |
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| S om e medicines that are like am brisentan tablets can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:
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| 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. |
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| How should I store am brisentan tablets?
Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes in. Ambrisentan Tablets come in child-resistant bottle pack of 30's. Keep am brisentan tablets and all medicines out of the reach of children. |
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| G eneral information about the safe and effective use of am brisentan 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. |
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| W h at are the ingredients in am brisentan tablets?
A ctive ingredient : ambrisentan Inactive Ingredients: croscarmellose sodium, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, 5 mg tablet contains: FD&C red#40 aluminum lake. Medication Guide available at www.quallentpharmaceuticals.com or call 1-877-605-7243. This Medication Guide has been approved by the U.S. Food and Drug Administration. |
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| Manufactured By:
Zydus Lifesciences Ltd. Ahmedabad, India Manufactured for: Quallent Pharmaceuticals Health LLC Grand Cayman, Cayman Islands |
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| Rev.: 04/25 |
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