RALOXIFENE HYDROCHLORIDE- raloxifene hydrochloride tablet, film coated 
Amneal Pharmaceuticals LLC

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Medication Guide

Raloxifene Hydrochloride (ral ox’ i feen hye” droe klor’ ide) Tablets, USP for Oral Use

Read the Medication Guide that comes with raloxifene hydrochloride before you start taking it and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene hydrochloride when you start taking it and at regular checkups.

What is the most important information I should know about raloxifene hydrochloride?

Serious and life-threatening side effects can occur while taking raloxifene hydrochloride. These include blood clots and dying from stroke:

  1. Before starting raloxifene hydrochloride, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), or have an irregular heartbeat.
  2. Stop taking raloxifene hydrochloride and call your doctor if you have:

3. Being still for a long time (such as sitting still during a long car or airplane trip or being in bed after surgery) can increase your risk of blood clots. (See “What should I avoid if I am taking raloxifene hydrochloride?”)

What is raloxifene hydrochloride?

Raloxifene hydrochloride is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene hydrochloride is for women after menopause, and has more than one use:

You and your doctor should talk about whether the possible benefit of raloxifene hydrochloride in lowering your chance of getting invasive breast cancer is greater than its possible risks.

Raloxifene hydrochloride is not for use in premenopausal women (women who have not passed menopause).

Who should not take raloxifene hydrochloride?

Do not take raloxifene hydrochloride if you:

What should I tell my doctor before taking raloxifene hydrochloride?

Raloxifene hydrochloride may not be right for you. Before taking raloxifene hydrochloride, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Especially tell your doctor if you take*:

If you are taking warfarin or other coumarin blood thinners, your doctor may need to do a blood test when you first start or if you need to stop taking raloxifene hydrochloride. Names for this test include “prothrombin time,” “pro-time,” or “INR.” Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinner.

Raloxifene hydrochloride should not be taken with cholestyramine or estrogens.

How should I take raloxifene hydrochloride?

What should I avoid while taking raloxifene hydrochloride?

What are the possible side effects of raloxifene hydrochloride?

Serious and life-threatening side effects can occur while taking raloxifene hydrochloride. These include blood clots and dying from stroke:

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

See “What is the most important information I should know about raloxifene hydrochloride?”

The most common side effects of raloxifene hydrochloride are hot flashes, leg cramps, swelling of the feet, ankles and legs, flu syndrome, joint pain and sweating. Hot flashes are more common during the first 6 months after starting treatment.

These are not all the side effects of raloxifene hydrochloride. Tell your doctor about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking raloxifene hydrochloride, ask your doctor or pharmacist for more information.

What else should I know about raloxifene hydrochloride?

How should I store raloxifene hydrochloride tablets?

General Information about the safe and effective use of raloxifene hydrochloride

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene hydrochloride for a condition for which it was not prescribed. Do not give your raloxifene hydrochloride to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide is a summary of the most important information about raloxifene hydrochloride. If you would like more information about raloxifene hydrochloride, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene hydrochloride that is written for health professionals. For more information, call 1-877-835-5472 (toll-free) or go to the following website: www.amneal.com.

What are the ingredients in raloxifene hydrochloride tablets?

Active Ingredient: raloxifene hydrochloride, USP

Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide and titanium dioxide.

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

*Trademarks are the property of their respective owners.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 08-2018-03

Revised: 12/2020
Amneal Pharmaceuticals LLC