7287 8x12 fojded Mefjoquine MG 06!2013_Layout 1 6/13/13 4:51 PM Page 1

FRONT 8" x 12" FOLD = 8" x 6" FOLD NON TEXT AREA

MEDICATION GUIDE Mefloquine Hydrochloride Tablets, USP

Important: • loss of balance Your doctor or pharmacist will give you an • ringing sound in your ears (tinnitus) Information Wallet Card along with this Medication • convulsions (seizures) in people who already Guide. It has important information about meflo­ have seizures (epilepsy) quine and should be carried with you at all times • convulsions (seizures) in people who take qui­ while you take mefloquine. nine or chloroquine (used to treat malaria) with mefloquine. Do not take quinine What is the most important information I should (Qualaquin) or chloroquine (Aralen) with know about mefloquine? mefloquine. Mefloquine can cause serious side effects, • unable to sleep (insomnia) including: Dizziness, vertigo, tinnitus, and loss of bal­ 1. Heart Problems. ance can go on for months or years after meflo­ Do not take halofantrine (used to treat malaria) or quine is stopped or may become permanent in ketoconazole (used for fungal infections) with some people. mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart prob­ Important: lems (problems with the electrical system of your You need to take malaria prevention medicine heart called QT prolongation) that can lead to before you travel to a malaria area, while you are death. Do not take quinine (Qualaquin) or quini­ in a malaria area, and after you return from a dine (used to treat malaria or irregular heart beat) malaria area. with mefloquine. You may get serious heart • If you are told by a doctor to stop taking meflo­ problems. quine because of the side effects or for other 2. Mental problems. Symptoms of serious mental reasons, you will need to take different malaria problems may include: medicine. • severe anxiety • If you do not have access to a doctor or to another • paranoia (feelings of mistrust towards others) medicine and have to stop taking mefloquine, (Continued) skin or the white of your eyes. The most of balance, ringing in your ears (tinnitus), convul­ • hallucinations (seeing or hearing things that are leave the malaria area and contact a doctor as side effects of mefloquine include nausea, not there) soon as possible because leaving the malaria sions (seizures) in people who already have seizures, diarrhea, abdominal pain and headache. • depression area may not protect you from getting malaria. You or you are unable to sleep (insomnia). Tell your doctor if you have any side These serious mental and nervous system side • feeling restless will still need to take a malaria prevention medi­ bothers you or that does not go away. These • unusual behavior cine for another 4 weeks after you leave the effects can go on for months or years after meflo­ all the possible side effects of mefloquine. For • feeling confused malaria area. quine is stopped or may become permanent in information, ask your doctor or pharmacist. some people. Some people who take mefloquine think about sui­ Call your doctor for medical advice about cide (putting an end to their life). Some people who If you are told by a doctor to stop taking meflo­ effects. You may report side effects to What is Mefloquine? were taking mefloquine committed suicide. It is not Mefloquine is a prescription medicine used to quine because of the side effects or for other reasons, 1­800­FDA­1088. you will need to take a different malaria medicine. known if mefloquine was responsible for those prevent and treat malaria. Malaria can be a life­ What should I avoid while taking suicides. threatening infection. Mefloquine does not work for If you do not have access to a doctor or to a dif­ Avoid activities such as driving a If you have any of these serious mental problems, all types of malaria. ferent medicine and have to stop taking mefloquine, heavy machinery or other activities ne leave the malaria area and contact a doctor as soon or you develop other serious side effects or mental It is not known if mefloquine is safe and effective and careful movements (fine motor problems, you should contact your doctor right in children under 6 months old for the treatment of as possible because leaving the malaria area may not until you know how mefloquine aff away as it may be necessary to stop taking meflo­ malaria. It is not known how well mefloquine works protect you from getting malaria. You will still need may feel dizzy or lose your balance. T to take a malaria prevention medicine for another 4 quine and use a different medicine to prevent malaria. to prevent malaria in children weighing less than 44 pen for months or years after you sto 3. pounds (20 kilograms). weeks after you leave the malaria area. quine and can be permanent in some cases. Problems with your body’s nervous system. Symptoms of serious nervous system problems Mefloquine may cause serious liver problems. 06­2013M Symptoms of liver problems include nausea, vom­ may include: Who should not take Mefloquine? 7287 • dizziness iting, loss of appetite, unusual tiredness, stomach Sandoz Inc. Do not take Mefloquine if you have: • a feeling that you or things around you are • depression or had depression recently pain, fever, weakness, itching, light­colored bowel Princeton, NJ 08540 movements, dark colored urine, yellowing of your moving or spinning (vertigo) 3. 4.

Reference ID: 3347763 7287 8x12 fojded Mefjoquine MG 06!2013_Layout 1 6/13/13 4:51 PM Page 2

NON TEXT AREA

• had recent mental problems, including anxiety • If you vomit after taking mefloquine, contact your side effects in people who General information about the safe and effective disorder, schizophrenia, or psychosis (losing doctor to see if you should take another dose. treatment include: use of mefloquine. touch with reality) • Continue taking mefloquine for 4 weeks after Medicines are sometimes prescribed for pur­ • seizures or had seizures (epilepsy or convulsions) returning from a malaria area. poses other than those listed in a Medication Guide. • an allergy to quinine, quinidine, mefloquine or • Mefloquine tablets may be crushed and mixed Do not use mefloquine for a condition for which it any ingredients in mefloquine. See the end of with a small amount of water, milk or other bev­ was not prescribed. Do not give mefloquine to other this Medication Guide for a complete list of ingre­ erage for children or other people unable to swal­ people, even if they have the same symptoms that dients in mefloquine. low mefloquine whole. Your doctor will tell you you have. It may harm them. Talk to your doctor before you take mefloquine if the correct dose for your child based on your This Medication Guide summarizes the most you have any of the medical conditions listed above. child’s weight. side effect that important information about mefloquine. If you • If you take Mefloquine for a year or longer, your These are not would like more information, talk with your doctor. What should I tell my doctor before taking meflo­ doctor should check your uine. For more You can ask your pharmacist or doctor for infor­ quine? • eyes (especially if you have trouble seeing pharmacist. mation about mefloquine that is written for health Before taking mefloquine, tell your doctor about while you take mefloquine) advice about side professionals. all your medical conditions, including if you have: • liver function (to see if there has been damage FDA at 1­800­ • heart disease to your liver) What are the ingredients in mefloquine? • liver problems • Use protective clothing, insect repellents, and Active ingredients: mefloquine hydrochloride • seizures or epilepsy bednets to protect you from being bitten by mos­ Inactive ingredients: crospovidone, lactose mono­ • diabetes quitoes. Medicine alone does not always stop temperature between hydrate, low­substituted hydroxypropyl cellulose, • blood clotting problems or take blood thinner you from catching malaria from mosquito bites. magnesium stearate, microcrystalline cellulose, medicines (anticoagulants) out of date or pregelatinized starch and talc. • mental problems What should I avoid while taking mefloquine? This Medication Guide has been approved by the • are pregnant or plan to become pregnant. It is not Avoid activities such as driving a car or using medicines out of the U.S. Food and Drug Administration. known if mefloquine will harm your unborn baby. heavy machinery or other activities needing alertness 06­2013M Talk to your doctor if you are pregnant or plan to and careful movements (fine motor coordination) 7287 become pregnant. until you know how mefloquine affects you. You Sandoz Inc. • You should use birth control while you take may feel dizzy or lose your balance. This could hap­ Princeton, NJ 08540 mefloquine and for 3 months after you stop pen for months or years after you stop taking meflo­ 3. mefloquine. If you have an unplanned preg­ quine and can be permanent in some cases. See nancy, talk to your doctor right away. “What are the possible side effects of meflo­ • are breast­feeding or plan to breast­feed. quine?” Mefloquine Hydrochloride Tablets, USP Mefloquine can pass into your milk and may harm your baby. Ask your doctor if you will need What are the possible side effects of mefloquine? Medication Guide for additional information on mefloquine. to stop breast­feeding or use a different medicine. See “What is the most important information I with you when you are taking mefloquine. Contact your doctor right away if you have a fever should know about mefloquine?” prevention ings of mistrust towards others), hallucinations after leaving a malaria area. Mefloquine may cause serious side effects, area, (seeing or hearing things that are not there), depres­ Tell your doctor about all the medicines you including: after you sion, feeling restless, unusual behavior or feeling take, including prescription and nonprescription • liver problems confused. Some people who take mefloquine think medicines, vitamins, and herbal supplements. Call your healthcare provider right away if you have ffects, about suicide (putting an end to their life). Some peo­ Mefloquine and other medicines may affect each unexplained symptoms such as nausea or vomiting, ple who were taking mefloquine committed suicide. other causing side effects. stomach pain, fever, weakness, itching, unusual It is not known if mefloquine was responsible for tiredness, loss of appetite, light colored bowel move­ ria) or those suicides. How should I take Mefloquine? ments, dark colored urine, yellowing of your skin or meflo­ If you have any of these serious mental problems • Take mefloquine exactly as your doctor tells you the white of your eyes. meflo­ you should contact your doctor right away as it to take it. Your doctor will tell you how many The most common side effects of mefloquine at can may be necessary to stop taking mefloquine and use mefloquine tablets to take and when to take them. include: (Qualaquin) or a different medicine to prevent malaria. • You will start taking mefloquine to prevent malaria • nausea irregular heart 3. Problems with your body’s nervous system. between 1 to 3 weeks before you travel to a • vomiting serious heart Do not take quinine (Qualaquin) or chloroquine malaria area. • diarrhea prob­ (Aralen) (used to treat malaria) with mefloquine. You • Take mefloquine just after eating your largest • abdominal pain heart, may have a greater risk for convulsions (seizures). meal of the day and with at least 1 cup (8 ounces) • headache Symptoms of serious nervous system problems of water. mental may include dizziness, a feeling that you or things • Do not take mefloquine on an empty stomach. (feel­ around you are moving or spinning (vertigo), loss 2. (See Reverse)

Reference ID: 3347763 7287 8x12 fojded Mefjoquine MG 06!2013_Layout 1 6/13/13 4:51 PM Page 2

BACK 8" x 12" FOLD = 8" x 6"

• had recent mental problems, including anxiety • If you vomit after taking mefloquine, cont The most common side effects in people who General information about the safe and effective disorder, schizophrenia, or psychosis (losing doctor to see if you should take another take mefloquine for treatment include: use of mefloquine. touch with reality) • Continue taking mefloquine for 4 wee • muscle pain Medicines are sometimes prescribed for pur­ • seizures or had seizures (epilepsy or convulsions) returning from a malaria area. • fever poses other than those listed in a Medication Guide. • an allergy to quinine, quinidine, mefloquine or • Mefloquine tablets may be crushed an • chills Do not use mefloquine for a condition for which it any ingredients in mefloquine. See the end of with a small amount of water, milk or ot • skin rash was not prescribed. Do not give mefloquine to other this Medication Guide for a complete list of ingre­ erage for children or other people unable • fatigue people, even if they have the same symptoms that dients in mefloquine. low mefloquine whole. Your doctor wil • loss of appetite you have. It may harm them. Talk to your doctor before you take mefloquine if the correct dose for your child based • irregular heart beat This Medication Guide summarizes the most you have any of the medical conditions listed above. child’s weight. Tell your doctor if you have any side effect that important information about mefloquine. If you • If you take Mefloquine for a year or longer, bothers you or that does not go away. These are not would like more information, talk with your doctor. What should I tell my doctor before taking meflo­ doctor should check your all the possible side effects of mefloquine. For more You can ask your pharmacist or doctor for infor­ quine? • eyes (especially if you have troubl information, ask your doctor or pharmacist. mation about mefloquine that is written for health Before taking mefloquine, tell your doctor about while you take mefloquine) Call your doctor for medical advice about side professionals. all your medical conditions, including if you have: • liver function (to see if there has been effects. You may report side effects to FDA at 1­800­ • heart disease to your liver) FDA­1088. What are the ingredients in mefloquine? • liver problems • Use protective clothing, insect repelle Active ingredients: mefloquine hydrochloride • seizures or epilepsy bednets to protect you fr being bitten How should I store mefloquine? Inactive ingredients: crospovidone, lactose mono­ • diabetes quitoes. Medicine alone does not alw • Store mefloquine at room temperature between hydrate, low­substituted hydroxypropyl cellulose, • blood clotting problems or take blood thinner you from catching malaria from mosquitoom 68ºF to 77ºF (20ºC to 25ºC) magnesium stearate, microcrystalline cellulose, medicines (anticoagulants) • Safely throw away medicine that is out of date or pregelatinized starch and talc. • mental problems What should I avoid while taking no longer needed. This Medication Guide has been approved by the • are pregnant or plan to become pregnant. It is not Avoid activities such as driving a Keep mefloquine and all medicines out of the U.S. Food and Drug Administration. known if mefloquine will harm your unborn baby. heavy machinery or other activities ne reach of children. 06­2013M Talk to your doctor if you are pregnant or plan to and careful movements (fine motor 7287 become pregnant. until you know how mefloquine aff Sandoz Inc. • You should use birth control while you take may feel dizzy or lose your balance. T Princeton, NJ 08540 mefloquine and for 3 months after you stop pen for months or years after you sto mefloquine. If you have an unplanned preg­ quine and can be permanent in nancy, talk to your doctor right away. “What are the possible side effe • are breast­feeding or plan to breast­feed. quine?” Mefloquine can pass into your milk and may harm your baby. Ask your doctor if you will need What are the possible side effects of to stop breast­feeding or use a different medicine. See “What is the most important Contact your doctor right away if you have a fever should know about mefloquine?” after leaving a malaria area. Mefloquine may cause serious side Tell your doctor about all the medicines you including: take, including prescription and nonprescription • liver problems medicines, vitamins, and herbal supplements. Call your healthcare provider right away if Mefloquine and other medicines may affect each unexplained symptoms such as nausea or other causing side effects. stomach pain, fever, weakness, itching, tiredness, loss of appetite, light colored How should I take Mefloquine? ments, dark colored urine, yellowing of your • Take mefloquine exactly as your doctor tells you the white of your eyes. to take it. Your doctor will tell you how many The most common side effects of mefloquine tablets to take and when to take them. include: • You will start taking mefloquine to prevent malaria • nausea between 1 to 3 weeks before you travel to a • vomiting malaria area. • diarrhea • Take mefloquine just after eating your largest • abdominal pain meal of the day and with at least 1 cup (8 ounces) • headache of water. • Do not take mefloquine on an empty stomach. 2.

Reference ID: 3347763