MEFLOQUINE HYDROCHLORIDE- mefloquine hydrochloride tablet
Hikma Pharmaceuticals USA Inc.
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Important:
Your doctor or pharmacist will give you an Information Wallet Card along with this Medication Guide. It has important information about mefloquine and should be carried with you at all times while you take mefloquine.
What is the most important information I should know about mefloquine?
Mefloquine can cause serious side effects, including:
1. Heart Problems.
Do not take halofantrine (used to treat malaria) or ketoconazole (used for fungal infections) with mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart problems (problems with the electrical system of your heart called QT prolongation) that can lead to death. Do not take quinine (Qualaquin) or quinidine (used to treat malaria or irregular heart beat) with mefloquine. You may get serious heart problems.
2. Mental problems. Symptoms of serious mental problems may include:
Some people who take mefloquine think about suicide (putting an end to their life). Some people who were taking mefloquine committed suicide. It is not known if mefloquine was responsible for those suicides.
If you have any of these serious mental problems, or you develop other serious side effects or mental problems, you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria.
3. Problems with your body’s nervous system. Symptoms of serious nervous system problems may include:
Dizziness, vertigo, tinnitus, and loss of balance can go on for months or years after mefloquine is stopped or may become permanent in some people.
Important:
You need to take malaria prevention medicine before you travel to a malaria area, while you are in a malaria area, and after you return from a malaria area.
What is mefloquine?
Mefloquine is a prescription medicine used to prevent and treat malaria. Malaria can be a life-threatening infection. Mefloquine does not work for all types of malaria.
It is not known if mefloquine is safe and effective in children under 6 months old for the treatment of malaria. It is not known how well mefloquine works to prevent malaria in children weighing less than 44 pounds (20 kilograms).
Who should not take mefloquine?
Do not take mefloquine if you have:
Talk to your doctor before you take mefloquine if you have any of the medical conditions listed above.
What should I tell my doctor before taking mefloquine?
Before taking mefloquine, tell your doctor about all your medical conditions, including if you have:
Contact your doctor right away if you have a fever after leaving a malaria area.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Mefloquine and other medicines may affect each other causing side effects.
How should I take mefloquine?
What should I avoid while taking mefloquine?
Avoid activities such as driving a car or using heavy machinery or other activities needing alertness and careful movements (fine motor coordination) until you know how mefloquine affects you. You may feel dizzy or lose your balance. This could happen for months or years after you stop taking mefloquine and can be permanent in some cases. See “What are the possible side effects of mefloquine?”
What are the possible side effects of mefloquine?
See “What is the most important information I should know about mefloquine?”
Mefloquine may cause serious side effects, including:
Call your healthcare provider right away if you have unexplained symptoms such as nausea or vomiting, stomach pain, fever, weakness, itching, unusual tiredness, loss of appetite, light colored bowel movements, dark colored urine, yellowing of your skin or the white of your eyes.
The most common side effects of mefloquine include:
The most common side effects in people who take mefloquine for treatment include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mefloquine. For more information, ask your doctor or pharmacist.
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 mefloquine?
Keep mefloquine and all medicines out of the reach of children.
General information about the safe and effective use of mefloquine.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mefloquine for a condition for which it was not prescribed. Do not give mefloquine to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about mefloquine. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about mefloquine that is written for health professionals.
What are the ingredients in mefloquine?
Active ingredients: mefloquine hydrochloride, USP
Inactive ingredients: ammonium-calcium alginate blend, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 331, povidone and pregelatinized starch.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distr. by: Hikma
Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
C50001018/01
Revised January 2021
Information Wallet Card: Mefloquine Hydrochloride Tablets, USP
It is important that you read the entire Medication Guide for additional information on mefloquine. Carry this wallet card with you when you are taking mefloquine.
Important: You need to take malaria prevention medicine before you travel to a malaria area, while you are in a malaria area, and after you return from a malaria area.
Mefloquine can cause serious side effects, including:
1. Heart problems.
Do not take halofantrine (used to treat malaria) or ketoconazole (used for fungal infections) with mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart problems that can lead to death. Do not take quinine (Qualaquin) or quinidine (used to treat malaria or irregular heart beat) with mefloquine. You may get serious heart problems. Mefloquine may cause serious problems with the electrical system of your heart, called QT prolongation.
2. Mental problems. Symptoms of serious mental problems may include severe anxiety, paranoia (feelings of mistrust towards others), hallucinations (seeing or hearing things that are not there), depression, feeling restless, unusual behavior or feeling confused. Some people who take mefloquine think about suicide (putting an end to their life). Some people who were taking mefloquine committed suicide. It is not known if mefloquine was responsible for those suicides.
If you have any of these serious mental problems you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria.
3. Problems with your body’s nervous system.
Do not take quinine (Qualaquin) or chloroquine (Aralen) (used to treat malaria) with mefloquine. You may have a greater risk for convulsions (seizures).
Symptoms of serious nervous system problems may include dizziness, a feeling that you or things around you are moving or spinning (vertigo), loss of balance, ringing in your ears (tinnitus), convulsions (seizures) in people who already have seizures, or you are unable to sleep (insomnia).
These serious mental and nervous system side effects can go on for months or years after mefloquine is stopped or may become permanent in some people.
If you are told by a doctor to stop taking mefloquine because of the side effects or for other reasons, you will need to take a different malaria medicine.
If you do not have access to a doctor or to a different medicine and have to stop taking mefloquine, leave the malaria area and contact a doctor as soon as possible because leaving the malaria area may not protect you from getting malaria. You will still need to take a malaria prevention medicine for another 4 weeks after you leave the malaria area.
Mefloquine may cause serious liver problems. Symptoms of liver problems include nausea, vomiting, loss of appetite, unusual tiredness, stomach pain, fever, weakness, itching, light-colored bowel movements, dark colored urine, yellowing of your skin or the white of your eyes. The most common side effects of mefloquine include nausea, vomiting, diarrhea, abdominal pain and headache.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mefloquine. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
What should I avoid while taking mefloquine?
Avoid activities such as driving a car or using heavy machinery or other activities needing alertness and careful movements (fine motor coordination) until you know how mefloquine affects you. You may feel dizzy or lose your balance. This could happen for months or years after you stop taking mefloquine and can be permanent in some cases.
Distr. by: Hikma
Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
C50001018/01
Revised January 2021