Alosetron tablets

What is this medicine?

ALOSETRON (al OH se tron) is used to treat irritable bowel syndrome (IBS) in women. It is reserved for those women who have severe diarrhea as the main symptom and who have not had success with other treatments. This medicine has not been shown to work in men with IBS.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine is not for use in children.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blood in stool, bloody diarrhea or rectal bleeding

• constipation

• dark urine

• hemorrhoids

• fever

• irregular heart beat

• unusually weak or tired

• worsening of abdominal pain

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• anxiety

• difficulty sleeping

• dry mouth

• frequent urination

• gas

• headache

• nausea

• restlessness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• antidiarrheal medicines, like Imodium, Kaopectate, or Lomotil

• enoxacin

• fluvoxamine

• mexiletine

• zileuton

This medicine may also interact with the following medications:

• certain antibiotics like ciprofloxacin, clarithromycin, erythromycin or troleandomycin

• cimetidine

• hydralazine

• isoniazid, INH

• medicines for fungal infections like ketoconazole, itraconazole and voriconazole

• medicines for HIV or AIDS

• procainamide

What if I miss a dose?

If you miss a dose, skip that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• constipation

• Crohn's disease

• diverticulitis

• history of ischemic colitis, impaired intestinal circulation, bleeding, or blood clots

• history of a stomach, bowel, or intestine problems

• kidney disease or liver disease

• toxic megacolon

• ulcerative colitis

• an unusual or allergic reaction to alosetron, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Constipation is a common and serious side effect of this medicine. Stop taking this medicine and call your health care provider immediately if you become constipated. Only restart this medicine if your constipation has resolved and you and your doctor have agreed to restart treatment. You should not start taking this medicine if you are already constipated or constipated most of the time.

Ischemic colitis is a serious and potentially life-threatening condition that has been rarely reported with this medicine. If you experience new or worsening abdominal pain, bloody diarrhea or blood in the stool, immediately stop taking this medicine and contact your doctor or health care professional.

This medicine may not work for all women who take it. For women who are helped by this medicine, relief may occur within the first week or within four weeks of starting the drug. If you stop taking this medicine, it is likely that your symptoms will return within one week.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase drowsiness or dizziness. Avoid alcoholic drinks.