ALOSETRON HYDROCHLORIDE- alosetron hydrochloride tablet, film coated 
Amneal Pharmaceuticals LLC

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Medication Guide

Alosetron (a-LO-ze-tron) Hydrochloride Tablets

Read the Medication Guide you get with each refill for alosetron hydrochloride tablets. There may be new information. This Medication Guide does not take the place of talking with your doctor.

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

Alosetron hydrochloride tablets are a medicine only for some women with severe chronic irritable bowel syndrome (IBS) whose:

Some people  have developed serious bowel side effects while taking alosetron hydrochloride tablets. Serious bowel (intestine) side effects can happen suddenly, including the following:

These complications may lead to a hospital stay and, in rare cases, blood transfusions, surgery and death. People who are older, who are weak from illness, or who take other constipating medicines may be more likely to have serious complications of constipation with alosetron hydrochloride tablets.

To lower your chances of getting serious complications of constipation, do the following:

Stop taking alosetron hydrochloride tablets and call your doctor or get medical help if you have symptoms of ischemic colitis such as new or worsening stomach-area (abdominal) pain, bloody diarrhea or blood in the stool.

What are alosetron hydrochloride tablets?

Alosetron hydrochloride tablets are a prescription medicine used only for some women with severe chronic IBS whose:

Alosetron hydrochloride tablets do not cure IBS and it may not help every person who takes it. For those who are helped, alosetron hydrochloride tablets reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency) and diarrhea from IBS. If you stop taking alosetron hydrochloride tablets, your IBS symptoms may return within 1 or 2 weeks to what they were before you started taking alosetron hydrochloride tablets.

It is not known if alosetron hydrochloride tablets are safe and effective in men with IBS.

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

Who should not take alosetron hydrochloride tablets?

Do not take alosetron hydrochloride tablets if you:

What should I talk about with my doctor before taking alosetron hydrochloride tablets?

Talk with your doctor:

How should I take alosetron hydrochloride tablets?

What are the possible side effects of alosetron hydrochloride tablets?

Alosetron hydrochloride tablets may cause serious side effects, including:

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

The most common side effects of alosetron hydrochloride tablets include:

These are not all the possible side effects of alosetron hydrochloride tablets.

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 alosetron hydrochloride tablets?

Keep alosetron hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of alosetron  hydrochloride tablets

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

You can ask your pharmacist or healthcare provider for information about alosetron hydrochloride tablets that is written for healthcare professionals. You can also contact the company that makes alosetron hydrochloride tablets (toll free) at 1-877-835-5472 or at www.amneal.com.

What are the ingredients of alosetron hydrochloride tablets?

Active Ingredient: alosetron hydrochloride.

Inactive Ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film-coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film-coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.

*Trademarks are the property of their respective owners.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

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

Rev. 04-2019-01

Revised: 12/2020
Amneal Pharmaceuticals LLC