RALOXIFENE HYDROCHLORIDE- raloxifene hydrochloride tablet, film coated 
Dr.Reddy’s Laboratories Inc

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                                                                                                                        Medication Guide

                                                                              RALOXIFENE (ral.ox.i.fene) Hydrochloride Tablets, USP 60 mg for oral use

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:
    • leg pain or a feeling of warmth in the lower leg (calf).
    • swelling of the legs, hands, or feet.
    • sudden chest pain, shortness of breath, or coughing up blood.
    • sudden change in your vision, such as loss of vision or blurred vision.
  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 is raloxifene hydrochloride?

Raloxifene hydrochloride is 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 tablets 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.

                                                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. For more information, call 1-855-724-3436 (toll-free).

                        What are the ingredients in raloxifene hydrochloride tablets, USP?

Active Ingredient: raloxifene hydrochloride USP

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.

*The brands listed are trademarks of their respective owners and are not trademarks of ScieGen Pharmaceuticals Inc. The makers of these brands are not affiliated with and do not endorse ScieGen Pharmaceuticals Inc and company or its products.

You can ask your pharmacist or doctor for information about Raloxifene Hydrochloride Tablets USP, or call 1-888-375-3784.

Rx Only

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788, USA

Manufactured for:
Dr. Reddy’s Laboratories Inc.
Princeton, New Jersey 08540, USA

Issued: 6/18

Revised: 8/2020
Dr.Reddy’s Laboratories Inc