RALOXIFENE HYDROCHLORIDE - raloxifene hydrochloride tablet, film coated 
Aurobindo Pharma Limited

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Medication Guide

Raloxifene Hydrochloride Tablets, USP for Oral Use

(ral ox' i feen hye'' droe klor' ide)


Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking them 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 tablets when you start taking them and at regular checkups.


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


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



1.   Before starting raloxifene hydrochloride tablets, 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 tablets 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 while taking raloxifene hydrochloride tablets?”)


What are raloxifene hydrochloride tablets?


Raloxifene hydrochloride tablets are a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene hydrochloride tablets are 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 tablets are not for use in premenopausal women (women who have not passed menopause).


Who should not take raloxifene hydrochloride tablets?


Do not take raloxifene hydrochloride tablets if you:



What should I tell my doctor before taking raloxifene hydrochloride tablets?


Raloxifene hydrochloride tablets may not be right for you. Before taking raloxifene hydrochloride tablets, 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 tablets. 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 tablets should not be taken with cholestyramine or estrogens.


How should I take raloxifene hydrochloride tablets?



What should I avoid while taking raloxifene hydrochloride tablets?


What are the possible side effects of raloxifene hydrochloride tablets?


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



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


The most common side effects of raloxifene hydrochloride tablets 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 tablets. 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 tablets, ask your doctor or pharmacist for more information.


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


What else should I know about raloxifene hydrochloride tablets?



How should I store raloxifene hydrochloride tablets?



General Information about the safe and effective use of raloxifene hydrochloride tablets


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


This Medication Guide is a summary of the most important information about raloxifene hydrochloride tablets. If you would like more information about raloxifene hydrochloride tablets, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene hydrochloride tablets that is written for health professionals. For more information, call 1-866-850-2876 (toll-free).


What are the ingredients in raloxifene hydrochloride tablets?


Active Ingredient: raloxifene hydrochloride


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


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


*All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
 

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 09/2021

Revised: 10/2021
Aurobindo Pharma Limited