EXEMESTANE - exemestane tablet 
Zydus Pharmaceuticals (USA) Inc.

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FDA- Approved Patient Labeling

Patient Information

Exemestane (ex″ e mes′ tane) Tablets, USP

1     What are exemestane tablets?

Exemestane tablets are used in women who are past menopause for the treatment of:

It is not known if exemestane tablets are safe and effective in children.

2   Who should not take exemestane tablets?

Do not take exemestane tablets if: you are allergic to exemestane or any of the ingredients in exemestane tablets. See end of this leaflet for complete list of ingredients in exemestane tablets.

Before you take exemestane tablets, tell your doctor about all your medical conditions including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take medicines that contain estrogen, including other hormone replacement therapy or birth control pills or patches. Exemestane tablets should not be taken with medicines that contain estrogen as they could affect how well exemestane works.

How should I take Exemestane Tablets?

4    What are the possible side effects of exemestane?

Exemestane may cause serious side effects, including:

The most common side effects of exemestane tablets in women with early breast cancer include:

•   hot flashes
•   headache
•   feeling tired
•   trouble sleeping
•   joint pain
•   increased sweating
  

The most common side effects of exemestane tablets in women with advanced breast cancer include:

• hot flushes
• nausea
• feeling tired
• increased sweating
• increased appetite

Your doctor will do blood tests to check your vitamin D level before starting treatment with exemestane. Exemestane may cause decreased fertility in males and females. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of exemestane. 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 Exemestane Tablets?

General information about the safe and effective use of exemestane tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use exemestane tablets for a condition for which it was not prescribed. Do not give exemestane tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about exemestane tablets that is written for health professionals.

What are in exemestane tablets?

Active ingredient: exemestane, USP

Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.:1-877-993-8779.

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Revised: 8/2021
Zydus Pharmaceuticals (USA) Inc.