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1.
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What is the most important information I should know about LOTRONEX?
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A.
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LOTRONEX is a medicine only for some women with severe chronic irritable bowel syndrome
(IBS) whose:
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main problem is diarrhea and
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IBS symptoms have not been helped enough by other treatments.
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B.
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Some patients have developed serious bowel side effects while taking LOTRONEX. Serious
bowel (intestine) side effects can happen suddenly, including the following:
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1.
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Serious complications of constipation: About 1 out of every 1,000 women who
take LOTRONEX may get serious complications of constipation. 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 LOTRONEX.
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To lower your chances of getting serious complications of constipation, do
the following:
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If you are constipated, do not start taking LOTRONEX.
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If you get constipated while taking LOTRONEX, stop taking it right away and
call your doctor.
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If your constipation does not get better after stopping LOTRONEX, call your
doctor again.
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If you stopped taking LOTRONEX, do not start taking LOTRONEX again unless
your doctor tells you to do so.
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2.
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Ischemic colitis (reduced blood flow to the bowel): About 3 out of every
1,000 women who take LOTRONEX over a 6-month period may get a serious problem where
blood flow to parts of the large bowel is reduced. This is called ischemic colitis.
The chance of getting ischemic colitis when you take LOTRONEX for more than 6 months
is not known. Ischemic colitis may lead to a hospital stay and, in rare cases, blood
transfusions, surgery, and death.
To lower your chances of getting serious complications
of ischemic colitis, stop taking LOTRONEX and call your doctor right away
if you get:
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new or worse pain in your stomach area (abdomen) or
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blood in your bowel movements.
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C.
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Is LOTRONEX right for you?
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LOTRONEX may be right for you if all of these things are true about you:
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Your doctor has told you that your symptoms are due to IBS.
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Your IBS bowel problem is diarrhea.
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Your IBS has lasted for 6 months or longer.
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You tried other IBS treatments and they did not give you the relief you need.
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Your IBS is severe.
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You can tell if your IBS is severe if at least 1 of the following
is true for you:
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You have lots of painful stomach cramps or bloating. |
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You often cannot control the need to have a bowel movement, or you have "accidents"
where your underwear gets dirty from diarrhea or bowel movements. |
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You cannot lead a normal home or work life because you need to be near a bathroom. |
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Enough testing has not been done to confirm if LOTRONEX works in men or children
under age 18. |
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D.
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There is a special prescribing program for LOTRONEX.
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Only doctors who have signed up with the company that makes LOTRONEX should write
prescriptions for LOTRONEX. As part of signing up, these doctors have said that
they understand about IBS and the possible side effects of LOTRONEX. They have agreed
to use a special sticker on written prescriptions for LOTRONEX, so
the pharmacist will know that the doctors have signed up with the company. No telephone,
facsimile, or computerized prescriptions are permitted with this program. Refills
may be written on prescriptions. You may be taught about LOTRONEX by your doctor or healthcare provider under a doctor’s
direction. Your doctor will ask you to sign a Patient Acknowledgement Form after
you read this Medication Guide for the first time. Signing the Patient Acknowledgement
Form means that you understand the benefits and risks of LOTRONEX and that you have
read and understand this Medication Guide.
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2.
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What is LOTRONEX?
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LOTRONEX is a medicine only for some women with severe chronic IBS whose:
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main problem is diarrhea and
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IBS symptoms have not been helped enough by other treatments.
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LOTRONEX does not cure IBS, and it may not help every person who takes it. For those
who are helped, LOTRONEX 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 LOTRONEX, your IBS symptoms may return within 1 or 2 weeks to
what they were before you started taking LOTRONEX.
LOTRONEX is not recommended for children.
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3.
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Who should not take LOTRONEX?
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LOTRONEX is not right for everyone. Do not take LOTRONEX if any of the following
apply to you:
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Your main IBS problem is constipation or you are constipated most of the time.
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You have had a serious problem from constipation. If you are constipated now,
do not start taking LOTRONEX.
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You have had serious bowel blockages.
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You have had blood flow problems to your bowels, such as ischemic colitis.
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You have had blood clots.
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You have had Crohn’s disease, ulcerative colitis, diverticulitis, or severe liver
disease.
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You do not understand this Medication Guide or the Patient
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Acknowledgement Form, or you are not willing to follow them.
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You are taking fluvoxamine (LUVOX®).
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4.
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What should I talk about with my doctor before taking LOTRONEX?
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Talk with your doctor:
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about the possible benefits and risks of LOTRONEX.
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about how much of a problem IBS is in your life and what treatments you have tried.
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about any other illnesses you have and medicines you take or plan to take. These
include prescription and non-prescription medicines, supplements, and herbal remedies.
Certain illnesses and medicines can increase your chance of getting serious side
effects while taking LOTRONEX. Other medicines may interact with how the body handles
LOTRONEX.
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about any allergies that you have. See the end of the Medication Guide for a complete
list of ingredients in LOTRONEX.
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if you are pregnant, planning to get pregnant, or breastfeeding.
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5.
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How should I take LOTRONEX?
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Take LOTRONEX exactly as your doctor prescribes it. You can take LOTRONEX with or
without food.
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Begin with 0.5 mg two times a day for 4 weeks to see how LOTRONEX affects you. You
and your doctor may decide that you should keep taking this dose if you are doing
well.
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Check with your doctor 4 weeks after starting LOTRONEX:
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If you try 0.5 mg two times a day for 4 weeks, it may not control your symptoms.
If you do not get constipation or other side effects from LOTRONEX, your doctor
may increase your dose up to 1 mg two times a day.
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If 1 mg two times a day does not work after 4 weeks, LOTRONEX is not likely to help
you. You should stop taking it and call your doctor.
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If you miss a dose of LOTRONEX, just skip that dose. Do not take 2 doses
the next time. Wait until the next time you are supposed to take it and then take
your normal dose.
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Follow the important instructions in the section "What is the most important information
I should know about LOTRONEX?" about when you must stop taking the medicine
and when you should call your doctor.
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If you see other doctors about your IBS or side effects from LOTRONEX, tell
the doctor who prescribed LOTRONEX.
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6.
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What are the possible side effects of LOTRONEX?
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Constipation is the most common side effect among women with IBS who take LOTRONEX.
Some patients have developed serious bowel side effects while taking LOTRONEX.
Read the section "What is the most important information I should know about LOTRONEX?"
at the beginning of this Medication Guide for information about the serious side
effects you may get with LOTRONEX.
This Medication Guide does not tell you about
all the possible side effects of LOTRONEX. Your doctor or pharmacist can give you
a more complete list.
Call your doctor for medical advice about side effects. You
may report side effects to the FDA at 1-800-FDA-1088.
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7.
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How should I store LOTRONEX?
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Store LOTRONEX between 59°F to 86°F (15°C to 30°C).
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Protect LOTRONEX from light and getting wet (moisture).
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Keep LOTRONEX and all medicines out of the reach of children.
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8.
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General information about the safe and effective use of LOTRONEX
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Medicines are sometimes prescribed for purposes other than those listed in a Medication
Guide. If you have any questions or concerns about LOTRONEX, ask your doctor. Do
not use LOTRONEX for a condition for which it was not prescribed. Do not share your
medicine with other people. It may harm them.
Your doctor or pharmacist can give you more information about LOTRONEX that was
written for healthcare professionals. You can also contact the company that makes
LOTRONEX at 1-888-423-5227 or at www.lotronexppl.com.
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9.
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What are the ingredients of LOTRONEX?
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Active Ingredient: alosetron hydrochloride.
Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline
cellulose, and pregelatinized starch. The white film-coat for the 0.5 mg tablet
contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the
1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.
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