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Details for: MEFLOQUINE

Company: AA PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02244366MEFLOQUINEMEFLOQUINE (MEFLOQUINE HYDROCHLORIDE)250 MGTABLETORAL
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Summary Reports

Summary Safety Review - Mefloquine - Assessing the potential risk of rare long-lasting and permanent adverse events related to the brain and nervous system (neurological) and mental health (psychiatric)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

MEFLOQUINE is a medicine used to treat and prevent Malaria.
Malaria is a serious disease that is spread by mosquitoes in certain parts of the world.

What it does

MEFLOQUINE is a medicine that belongs to a class of drugs called antimalarials. It works by killing the small living things (parasites) that cause malaria.

When it should not be used
  • An allergy to MEFLOQUINE, similar medicines such as quinine or quinidine or any ingredients in MEFLOQUINE (see “What are the ingredients in MEFLOQUINE?” section above).
  • Any mental health illness that affects mood, thinking and behavior such as :
    • depression
    • anxiety
    • psychosis
    • Schizophrenia
    • suicide attempt, suicidal or self-harming thought or behaviour
    • other mental health problems including anxiety, unusual behavior or thought etc.
  • Seizures (fits).

If any of the above applies to you, make sure your healthcare professional knows, so that your healthcare professional can prescribe a different medicine to prevent or treat malaria.

What the medicinal ingredient is

mefloquine hydrochloride

What the non-medicinal ingredients are

microcrystalline cellulose, magnesium stearate, croscarmellose sodium and colloidal silicon dioxide

What dosage form it comes in

MEFLOQUINE 250 mg: Each white, round, biconvex tablet, cross scored on one side, and plain on the other side, contains 250 mg mefloquine ( as mefloquine hydrochloride). Available in blister packs of 8’s.

Warnings and precautions

Serious Warnings and Precautions

  • MEFLOQUINE may not be right for you. Tell your healthcare professional if you suffer from any mental health illness that affect mood, thinking and behavior such as depression, anxiety, psychosis, schizophrenia – either now, or in the past.

  • MEFLOQUINE can cause serious mental problems in some people. These serious side effects may occur suddenly and may last for months to years after stopping MEFLOQUINE. Symptoms of serious mental problems may include:
    • anxiety
    • unreasonable feeling that people are trying to harm you, do not like you, etc. (Paranoia)
    • depression
    • seeing or hearing things that are not there (hallucinations)
    • thought of suicide or harming yourself
    • feeling restless,
    • feeling confused
    • unusual behavior

  • MEFLOQUINE can cause serious nervous system problems in some people. 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 sound in your ears (tinnitus)
    • convuslions (seizures) in people who already have seizures (epilepsy)
    • unable to sleep (insomnia)
    • dizziness, vertigo, tinnitus, and loss of balance

  • These serious mental and nervous system side effects may occur at any time while you are taking MEFLOQUINE, and in a small number of people, may last for months or years after stopping MEFLOQUINE. In some people, dizziness, vertigo, tinnitus, and loss of balance may become permanent.

  • Seek medical help right away if you have any of the symptoms listed above. You may have to stop Mefloquine because of its side effects. If you stop Mefloquine, you will need another medicine to prevent malaria.

  • An information wallet card is provided at the end of this leaflet. Cut it out and carry it with you when you are taking MEFLOQUINE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MEFLOQUINE. Talk about any health conditions or problems you may have, including if you:

  • Have currently, or in the past suffer from any mental health problems that affect mood, thinking and behavior such as :
    • depression,
    • anxiety
    • psychosis,
    • Schizophrenia
    See the serious Warnings and Precautions box above.
  • Have heart disease, especially a rare heart problem that may cause irregular heartbeat, fainting, or sudden death (QT prolongation).
  • Have liver problems
  • Have seizures or epilepsy
  • Have diabetes
  • Have anemia (a lower than normal number of red bloods cells)
  • Have eye problems
  • Have blood clotting problems or take blood thinner medicines (anticoagulants)
  • Are pregnant. Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if MEFLOQUINE is safe in pregnancy. Use birth control while you are taking MEFLOQUINE and for 3 months after you stop MEFLOQUINE. Tell your healthcare professional right away; if you get pregnant while taking MEFLOQUINE.
  • Are breast feeding or plan to breast feed. MEFLOQUINE can pass through your milk and may harm the baby. Therefore, ask a healthcare professional whether you will need to stop breast feeding or use another medicine.

Other warnings you should know about:

  • Protect yourself against Mosquito bites. MEFLOQUINE decreases your risk of getting malaria. However MEFLOQUINE does not guarantee that you will not become sick. There is a chance you could still get malaria during or after taking MEFLOQUINE. Take the following steps to avoid mosquito bites while in an area where malaria is common:
    • Wear long sleeves and long pants
    • Use mosquito repellants
    • Sleep in a room that is screened against mosquitoes or use a bed net

  • If you develop a fever or flu-like symptoms during your travels or within 2 to 3 months after you leave the malaria area, contact your healthcare professional right away.

  • If you cannot continue taking MEFLOQUINE due to side effects or for other reasons, contact a healthcare professional immediately.

  • If you take MEFLOQUINE for a year or longer, your healthcare professional should check:
    • your eyes, especially if you have trouble seeing while you take MEFLOQUINE
    • your liver function to see if there has been damage to your liver.

  • Do not drive or perform activities requiring 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 after you stop taking MEFLOQUINE.
Interactions with this medication

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with MEFLOQUINE:

  • Medicines that may cause serious heart problems which can cause death
    • Halofantrine used to treat malaria (no longer available in Canada)
    • Ketoconazole used to treat fungal infections
      Do not take halofantrine or ketoconazole if you are already taking, or have taken MEFLOQUINE within the last 15 weeks.
  • Other medicines to prevent or treat malaria such as quinine, quinidine or chloroquine. Do not take quinine or chloroquine with MEFLOQUINE. You may have a greater risk for seizures or serious heart problems.
  • Medicines to treat heart problems or high blood pressure:
    • anti-arrhythmic medicines,
    • beta-adrenergic blocking medicines such as atenolol, metoprolol, propranolol
    • calcium channel blockers such as amlodipine, diltiazem, nifedipine,verapamil
  • Medicines used to treat allergies (antihistamines or H1-blocking agents)
  • Medicines used to treat depression:
    • Tricyclic anti-depressants such as amitriptyline, nortriptyline
    • selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram
    • bupropion
  • Medicines used to treat mental problems such as phenothiazines
  • Tramadol (a pain killer)
  • Medicines used to treat seizures such as valproic acid, carbamazepine, phenobarbital, and phenytoin.
  • Medicines to treat infections such as rifampicin
  • Medicines for diabetes
  • Blood thinner medicines (anticoagulants)

Some of these drugs may increase your chance of having serious side effects. Your healthcare professional may need to change the dose of your medications or check you regularly for side effects.

In addition:

  • Be aware that certain vaccines may not work if given while you are taking MEFLOQUINE. Your healthcare professional may want you to finish taking your vaccines at least 3 days before starting MEFLOQUINE.

  • MEFLOQUINE may interact with alcohol and increase your risk of experiencing mental problems. Limit alcohol intake while taking mefloquine and do not drink alcohol on the day you take your mefloquine tablet for malaria prevention.
Proper use of this medication

To Prevent Malaria

  • Adults and pediatric patients weighing over 45 kg: Take 1 tablet of MEFLOQUINE once a week, on the same day each week.
  • Adult or pediatric patient weighing 45 kg (99 pounds) or less: Your doctor will decide the right dose for you.
  • MEFLOQUINE is not recommended in children less than 3 months old or weighing less than 5 kg.

Important:

  • Take the tablet once a week (on the same day each week).
  • Take the first dose of MEFLOQUINE at least 2 weeks before you travel to a malaria area. This is to help you see how MEFLOQUINE affects you and the other medicines you take.
  • Continue to take MEFLOQUINE on the same day of the week throughout your stay and for 4 weeks after you return.
  • Take MEFLOQUINE just after a meal and with at least 1 cup (8 ounces) of water; do not take MEFLOQUINE on an empty stomach.
  • If you vomit after taking MEFLOQUINE, contact your doctor to see if you should take another dose.
  • For children or people who cannot swallow MEFLOQUINE Tablets whole: the tablets may be crushed and mixed with small amount of water, milk or other beverage.
  • Your healthcare professional will tell you the correct dose for your child based on his weight.
  • Take MEFLOQUINE exactly as your healthcare professional tells you to take it.

.
To Treat Malaria:
Your healthcare professional will tell you how much medicine you need to take.

Overdose

If you think you have taken too much MEFLOQUINE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget a dose of MEFLOQUINE, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and follow your usual schedule. Do not take a double dose (two doses on the same day) to make up for a forgotten dose.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking MEFLOQUINE. If you experience any side effects not listed here, contact your healthcare professional. Please also see the SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of the leaflet.

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
  • abdominal pain
  • dizziness or loss of balance (vertigo), which in some people may continue for months after stopping MEFLOQUINE
  • headache
  • sleep problems (difficulty sleeping, bad dreams)

Tell your doctor if any of the side effects listed above bother you or do not go away.
The most common side effects in people who take Mefloquine for treatment include:

  • dizziness
  • muscle pain
  • nausea
  • fever
  • headache
  • vomiting
  • chills
  • diarrhea,
  • skin rash
  • abdominal pain
  • fatigue
  • loss of appetite
  • ringing in the ears

MEFLOQUINE may cause serious mental and serious nervous system problems in some patients (see the Serious Warnings and Precautions box at the beginning of this leaflet and the serious side effects table below).

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Frequency : Not known (cannot be estimated from the available data):
Effect: Serious Mental Problems:
Symptoms:
  • severe anxiety
  • depression
  • unreasonable feeling that people are trying to harm you, do not like you, etc. (Paranoia)
  • seeing or hearing things that are not there (hallucinations)
  • thoughts of suicide or harming yourself
  • feeling restless,
  • feeling confused
  • feeling disoriented
  • unusual behavior
  • unusual changes in your mood
  • panic attacks
     ✔
Frequency : Not known
Effect : Nervous system changes
Symptoms
  • dizziness, a feeling that you or things around you are moving
  • spinning,
  • ringing in the ears
  • loss of balance
  • fits (seizures or convulsions)
     ✔
Frequency : Not known
Effect: Heart Problems
Symptoms:
  • abnormal heart beat or pounding, racing or skipped beats (palpitations)
     ✔
Frequency : Not known
Effect: inflammation of the lungs (pneumonitis)
Symptoms:
  • fever
  • chills
  • cough
  • shortness of breath
  • chest pain
     ✔
Frequency : Not known
Effect: serious liver problems:
Symptoms: jaundice
  • yellowing of skin or the white of your eyes
  • dark colored urine
  • light coloured stools
  • generalized itchiness
     ✔
Frequency : Not known
Problem with the nerves (neuropaty)
Symptoms:
  • prickling or tingling sensation in the affected body part
  • numbness and loss of an ability to feel pain or changes in temperature, particularly in your feet
  • a burning or sharp pain, usually in the feet
  • loss of balance or co-ordination
  • feeling pain from a very light touch
  • Muscle weakness or paralysis
     ✔
Frequency : Not known
Effect: serious disorder of the skin (Stevens Johnson syndrome)
Symptoms:
  • skin pain
  • red or purple skin rash
  • blisters on your skin and the mucous membranes of your mouth, nose, eyes and genitals
  • shedding of your skin
     ✔
Frequency : Not known
Effect: Allergic reactions:
Symptoms:
  • difficulty breathing
  • swelling of the face , tongue or throat
  • itching and severe skin rash
     ✔
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional right away.
How to store

Store 15-30°C. Sensitive to moisture. Keep in the blister until consumed.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by :

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information
  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or by contacting the sponsor, AA Pharma Inc. at 1-877-998-9097.

This leaflet was prepared by AA Pharma Inc.

Last Revised: September 20, 2017

Information Wallet Card to carry when you are taking MEFLOQUINE.
Please read the Patient Medication Information for additional information on MEFLOQUINE

MEFLOQUINE (mefloquine hydrochloride) Tablets – For Prevention of Malaria
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. Serious heart problems. Do not take halofantrine or ketoconazole 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 or quinidine with MEFLOQUINE. Stop taking MEFLOQUINE if it makes your heart beat irregularly.
2. Serious mental problems. Symptoms of serious mental problems may include: severe anxiety; depression; unreasonable feeling that people are trying to harm you, do not like you, etc. (Paranoia); seeing or hearing things that are not there (hallucinations); thoughts of suicide or harming yourself; feeling restless / confused / disoriented; unusual behavior; unusual changes in your mood and panic attacks.
3. Serious nervous systems problems. Do not take quinine or chloroquine with MEFLOQUINE. You may have a greater risk for seizures. Symptoms of serious nervous system problems may include: dizziness; a feeling that you or things around you are moving or spinning; loss of balance ringing in your ears; convulsions in people who already have seizures; and unable to sleep.
Seek medical help right away if you have any of the symptoms listed above. You may have to stop Mefloquine because of its side effects. If you stop Mefloquine, you will need another medicine to prevent malaria. These serious mental and nervous system side effects may occur at any time while you are taking MEFLOQUINE, and in a small number of people, may last for months or years after stopping MEFLOQUINE. In some people, dizziness, vertigo, tinnitus, and loss of balance may become permanent.

Revised: September 20, 2017

Date modified: