MEFLOQUINE HYDROCHLORIDE- mefloquine hydrochloride tablet 
Rebel Distributors Corp

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Medication Guide

Mefloquine Hydrochloride Tablets

to Prevent Malaria

This Medication Guide is intended only for travelers who are taking mefloquinehydrochloride tablets (mefloquine) to prevent malaria. The information may not apply to patients who are sick with malaria and who are taking mefloquine to treat malaria.

An information wallet card is provided at the end of this Medication Guide. Cut it out and carry it with you when you are taking mefloquine.

This Medication Guide was revised in September 2003. Please read it before you start taking mefloquine and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your prescriber (doctor or other health care provider) about mefloquine and malaria prevention. Only you and your prescriber can decide if mefloquine is right for you. If you cannot take mefloquine, you may be able to take a different medicine to prevent malaria.

What is the most important information I should know about Mefloquine?

  1. Take Mefloquine exactly as prescribed to prevent malaria.
    Malaria is an infection that can cause death, and is spread to humans through mosquito bites. If you travel to parts of the world where the mosquitoes carry the malaria parasite, you must take a malaria prevention medicine. Mefloquine is one of a small number of medications approved to prevent and to treat malaria. If taken correctly, mefloquine is effective at preventing malaria but, like all medications, it may produce side effects in some patients.
  2. Mefloquine can rarely cause serious mental problems in some patients.
    The most frequently reported side effects with mefloquine, such as nausea, difficulty sleeping, and bad dreams are usually mild and do not cause people to stop taking the medicine. However, people taking mefloquine occasionally experience severe anxiety, feelings that people are against them, hallucinations (seeing or hearing things that are not there, for example), depression, unusual behavior, or feeling disoriented. There have been reports that in some patients these side effects continue after mefloquine is stopped. Some patients taking mefloquine think about killing themselves, and there have been rare reports of suicides. It is not known whether mefloquine was responsible for these suicides.
  3. You need to take malaria prevention medicine before you travel to a malariaarea, while you are in a malaria area, and after you return from a malaria area.
    Medicines approved in the United States for malaria prevention include mefloquine, doxycycline, atovaquone/proguanil, hydroxychloroquine, and chloroquine. Not all of these drugs work equally as well in all areas of the world where there is malaria. The chloroquines, for example, do not work in areas where the malaria parasite has developed resistance to chloroquine. Mefloquine may be effective against malaria that is resistant to chloroquine or other drugs. All drugs to treat malaria have side effects that are different for each one. For example, some may make your skin more sensitive to sunlight (mefloquine does not do this). However, if you use mefloquine to prevent malaria and you develop a sudden onset of anxiety, depression, restlessness, confusion (possible signs of more serious mental problems), or you develop other serious side effects, contact a doctor or other healthcare provider. It may be necessary to stop taking mefloquine and use another malaria prevention medicine instead. If you can’t get another medicine, leave the malaria area. However, be aware that leaving the malaria area may not protect you from getting malaria. You still need to take a malaria prevention medicine.

Who should not take Mefloquine?

Do not take mefloquine to prevent malaria if you

Tell your prescriber about all your medical conditions. Mefloquine may not be right for you if you have certain conditions, especially the ones listed below:

Tell your prescriber about all the medicines you take, including prescription andnon-prescription medicines, vitamins, and herbal supplements. Some medicines may give you a higher chance of having serious side effects from mefloquine.

How should I take Mefloquine?

Take mefloquine exactly as prescribed. If you are an adult or pediatric patientweighing 45 kg (99 pounds) or less, your prescriber will tell you the correct dosebased on your weight.

To prevent malaria

What should I avoid while taking Mefloquine?

In addition:

What are the possible side effects of Mefloquine?

Mefloquine, like all medicines, may cause side effects in some patients. The most frequently reported side effects with mefloquine when used for prevention of malaria include nausea, vomiting, diarrhea, dizziness, difficulty sleeping, and bad dreams. These are usually mild and do not cause people to stop taking the medicine.

Mefloquine may cause serious mental problems in some patients. (See “What is the most important information I should know about Mefloquine?”).

Mefloquine may affect your liver and your eyes if you take it for a long time. Your prescriber will tell you if you should have your eyes and liver checked while taking mefloquine.

What else should I know about preventing malaria?

General information about the safe and effective use of Mefloquine.

Medicines are sometimes prescribed for conditions not listed in Medication Guides. If you have any concerns about mefloquine, ask your prescriber. This Medication Guide contains certain important information for travelers visiting areas with malaria. Your prescriber or pharmacist can give you information about mefloquine that was written for health care professionals. Do not use mefloquine for a condition for which it was not prescribed. Do not share mefloquine with other people.

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

MANUFACTURED BY

BARR LABORATORIES, INC.

POMONA, NY 10970

BR-171

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Revised: 12/2010
Rebel Distributors Corp