RALOXIFENE HYDROCHLORIDE- raloxifene tablet 
Cipla USA Inc.

----------

                                                                                                                                                                    Medication Guide
                                                                                                                                               Raloxifene Hydrochloride Tablets, USP for Oral Use (ral·ox·i·fene)

Read the Medication Guide that comes with raloxifene hydrochloride tablets 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 tablets when you start taking it 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 if I am 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*:

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 Cipla Ltd. at 1-866-604-3268 or 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. It 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.

What are the ingredients in raloxifene hydrochloride tablets, USP?

Active Ingredient: raloxifene hydrochloride

Inactive Ingredients: mannitol, crospovidone, hydroxypropyl cellulose, poloxamer 407, magnesium stearate and opadry white (titanium Dioxide, hypromellose 2910 (3cP), hypromellose 2910 (6cP), macrogol/PEG 400 and polysorbate 80).

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

* All brand names mentioned are trademark of their respective owners and are not of Cipla Limited.

Manufactured for:
Cipla USA, Inc.
1560 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33323

Manufactured By:
InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788

Rev: 08/2019

SAP: 21078345

Revised: 9/2019
Cipla USA Inc.