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MEFLOQUINE 250MG TABLETS

Active substance(s): MEFLOQUINE / MEFLOQUINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lariam® 250mg Tablets / Mefloquine 250mg Tablets
(mefloquine hydrochloride)
This medicine is available as either of the above names but will be referred to as Lariam
throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.




experienced a mild to serious potential life threatening allergic reaction to Lariam or any
of its ingredients
low blood glucose due to a pre-existing condition called congenital hyperinsulinemic
hypoglycaemia

Some side effects may occur after you have stopped taking Lariam. In a small number of
patients it has been shown that depression, dizziness or vertigo and loss of balance may
persist for months or longer, even after you have stopped taking Lariam.
Children
Experience with Lariam in infants less than 3 months old or weighing less than 5 kg is
limited.
Other medicines and Lariam
Before taking Lariam, make sure your doctor knows if you are taking other medicines
(including those you have obtained without a prescription).

It occurs when small parasites are passed from one person to another by the bites of
certain mosquitoes. Lariam is especially useful if you are travelling to countries where there
is a type of malaria which is particularly difficult to treat. No single medicine is effective
against all malaria parasites. The choice of a particular medicine depends on the sensitivity
of the malaria parasites found in the area to be visited. Your doctor will advise you whether
Lariam is suitable for the area to which you wish to go.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines including:
▪ halofantrine, or you have been prescribed a course of halofantrine (see section 2
“Things you should know before taking Lariam”)
▪ medicines such as quinine, quinidine, or chloroquine, used to treat or to prevent malaria
▪ medicines for any heart trouble, or high blood pressure, such as β-blocking agents,
calcium channel blockers
▪ antihistamines for allergies
▪ medicines for some mental problems (psychiatric disorders). Anti-depressants such as
tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), bupropion or
anti-psychotics such as phenothiazines
▪ medicines used to treat epilepsy, such as sodium valproate, carbamazepine,
phenobarbital, phenytoin
▪ ketoconazole (used to treat fungal infections) – you should also ask your doctor for
advice before taking ketoconazole within 15 weeks after taking Lariam
▪ antibiotics used to treat bacterial infections for example rifampicin, penicillins,
cephalosporins
▪ efavirenz (used to treat HIV infections)
▪ tramadol (used to treat severe pain)
▪ medicines for blood clotting disorders or diabetes, as your doctor may wish to monitor
you before you travel

To help minimise your chance of catching the disease and to protect you from
possible serious side effects it is important that you read this leaflet carefully. Ask
your doctor to explain anything you do not understand.

If you need an oral vaccine to help prevent you from catching typhoid, you should arrange
to receive it at least 3 days before you need to start taking Lariam. Otherwise, Lariam may
stop the vaccine from working properly.

2. What you need to know before you take Lariam

Pregnancy and breast-feeding
Pregnant women should not normally take these tablets.

What is in this leaflet
1. What Lariam is and what it is used for
2. What you need to know before you take Lariam
3. How to take Lariam
4. Possible side effects
5. How to store Lariam
6. Contents of the pack and other information
1. What Lariam is and what it is used for
Lariam contains the active ingredient mefloquine. Lariam is used to treat malaria and to
help prevent you from catching malaria.
Malaria is a life threatening disease and a major health risk for travellers visiting tropical
countries.

Do not take Lariam if you have or have previously experienced:
▪ an allergy to mefloquine or any of the other ingredients of this medicine (see section 6
“Contents of the pack and other information”) or to similar medicines such as quinine or
quinidine
▪ depression, thoughts about suicide and self-endangering behaviour
▪ any other mental problem, including anxiety disorder, schizophrenia or psychosis (losing
touch with reality)
▪ fits (seizures or convulsions)
▪ severe liver problems
▪ blackwater fever (a complication of malaria that affects the blood and kidneys)
If any of the above applies to you, make sure your doctor knows, so that your doctor
can prescribe a different medicine for prevention or treatment of malaria.
Also, consult your doctor immediately if you are already being treated with halofantrine, or
you have been prescribed a course of halofantrine. Halofantrine (which is used to treat
malaria) and Lariam taken at the same time can slow the heartbeat to a dangerous level.
Therefore, to help avoid the possibility of a dangerous alteration in heart rhythm, you must
not take halofantrine if you are already taking, or have taken Lariam within the last 15
weeks.
Warnings and precautions
Lariam may cause serious mental problems in some people. Tell your doctor
immediately if you experience any of the following while taking Lariam:
▪ suicidal thoughts
▪ self-endangering behaviour
▪ severe anxiety
▪ feelings of mistrust towards others (paranoia)
▪ seeing or hearing things that are not there (hallucinations)
▪ nightmares / abnormal dreams
▪ depression
▪ feeling restless
▪ unusual behaviour
▪ feeling confused
Please seek medical help immediately if you experience serious mental problems
while taking Lariam. Lariam should be stopped immediately and replaced with
another medicine to prevent malaria.
Talk to your doctor, pharmacist, or nurse before taking Lariam if you have:
▪ epilepsy
▪ fits (seizures or convulsions)
▪ heart problems, especially changes in heart rhythm
▪ liver or kidney problems
▪ eye problems (e.g. loss of fine detail, colours seem faded, sudden loss of vision, poor
vision at night)
▪ blood or lymphatic disorder (abnormal blood test showing a decrease or an increase in
white blood cells, a decrease in red blood cells or platelets)
▪ neuropathy with signs of e.g. pins and needles, weakness, numbness, new or worsening
clumsiness or unsteadiness on your feet, or shaking of the hands and fingers
▪ inflammation of the lungs, also known as pneumonitis. This is a serious, potentially lifethreatening allergic reaction in the lungs which may cause fever, chills, cough, shortness
of breath or chest pain.
▪ previously contracted malaria even though you were taking Lariam for malaria
prevention

Due to the seriousness of malaria during pregnancy, it is recommended that you should not
travel to an area where you could become infected with malaria if you are pregnant, think
that you may be pregnant, or if you are planning to have a baby.
Lariam should be avoided by women who are breast-feeding.
If you are pregnant or breast-feeding, think that you may be pregnant, or planning to have a
baby, ask your doctor for advice before taking this medicine, as he or she may decide that
you should not use this medicine.
Driving and using machines
Take special care if you perform activities requiring alertness and coordination (accurate
small movements) and spatial awareness (being aware of distances) such as driving,
piloting an aircraft, operating machinery, cycling and deep-sea diving as Lariam can cause
dizziness, loss of balance and mental problems. If you are in any doubt about whether you
can do a particular activity, talk to your doctor.
In a small number of patients it has been shown that dizziness, vertigo and loss of balance
may persist for months or longer after stopping Lariam.
Lariam contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as
lactose or galactose, you should not take Lariam. Contact your doctor before taking this
medicinal product.
3. How to take Lariam
Always take this medicine exactly as your doctor has told you. Check with your doctor if
you are not sure. The advice you are given will depend on whether you are taking the
tablets for prevention or treatment of malaria. Take the tablets with plenty of water, and
preferably after a meal. Swallow the tablets whole, do not suck or chew them.
Malaria prevention
Please read the following section if you are taking the tablets to help prevent you from
catching malaria.
Important
Take the tablets once a week, always on the same day.
st
Take the 1 dose 10 days before you leave: this is to make sure that Lariam is well
nd
tolerated. Take the 2 dose 3 days before you leave.
• Continue taking the tablets on the same day of the week throughout your stay and for 4
weeks after your return.
• The full course of tablets is at least 6 weeks, depending on your length of stay.
• For effective prevention you must take the full course of tablets.
• No anti-malarial tablets can be 100% guaranteed to work. There is a chance you
could still get malaria during or after taking medicine to prevent it. If you develop a
fever or flu-like symptoms during your travels or within 2 to 3 months after you leave
the malarious area, check with a doctor immediately.



Adults and children over 45 kg body weight, dose:
One tablet weekly (always on the same day).
A pack of 8 tablets is enough to help prevent you from catching malaria if you are staying
for 2 weeks in an area where malaria is present and you start taking the tablets at 10 days
and 3 days before departure.
Adults weighing less than 45 kg (99 lbs) should take the children’s dose (see below).
Whether you are an adult or a child you should not take the tablets for more than 12
months.

Children's dose:
The tablets are not recommended for children under 3 months of age, i.e., those who weigh
less than 5 kg (11 lbs). For children over this weight, the dose is shown in the table below.
The tablets can be divided by breaking along the score lines. As in adults, the dose should
be taken once weekly on the same day, and continued for 4 weeks after return.
Weight
5 – 19kg (approx. 11 – 43 lbs)
20 – 30kg (approx. 44 – 67 lbs)
31 – 45kg (approx. 68 – 99 lbs)

Age (approx.)
3 months – 5 years
6 – 8 years
9 – 14 years

Dose
¼ tablet
½ tablet
¾ tablet

Malaria treatment
Please read the following section if you are taking the tablets to treat malaria.









Your doctor will tell you how much medicine you need to take. This will depend on your
weight and whether you have been living in a malarious area. Normally, you should not
receive more than 6 tablets in total. You may be advised to split the total dose into 2 or 3
smaller doses, 6 - 8 hours apart, to reduce the likelihood or severity of side effects.




If you take more Lariam than you should, either for prevention or treatment
If you take too many tablets the likelihood and severity of the side effects as described in
section 4 may increase. There are no specific antidotes.






If you take too many tablets or someone else accidentally takes your medicine, contact
your doctor, pharmacist or nearest hospital immediately.
If you forget to take Lariam, either for prevention or treatment
If you miss a dose, take it as soon as possible. If it is nearly time for your next dose, skip
the missed dose and carry on as before. Do not take a double dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Lariam may cause serious mental problems in some people. Stop taking this
medicine and contact your doctor immediately if you experience any of the following
while taking Lariam:
Common (may affect up to 1 in 10 people):
▪ depression
▪ anxiety
Not known (frequency cannot be estimated from the available data):
▪ suicide
▪ attempted suicide
▪ suicidal thoughts
▪ self-endangering behaviour
▪ losing touch with reality (psychosis)
▪ feelings of mistrust towards others (paranoia)
▪ panic attacks
▪ unusual behaviour
▪ feeling confused
▪ seeing or hearing things that are not there (hallucinations)
▪ aggression
▪ agitation
▪ feeling restless
▪ unusual changes in your mood
▪ disturbance in attention
Please seek medical help immediately if you experience serious mental problems
while taking Lariam. Lariam should be stopped immediately and replaced with
another medicine to prevent malaria.
If you develop any of the following potentially serious symptoms, you should STOP
taking this medicine and also consult a doctor immediately.
Not known (frequency cannot be estimated from the available data):
▪ a mild to serious potential life-threatening allergic reaction (anaphylaxis) to Lariam or
any of its ingredients with symptoms such as difficulty in breathing, swollen tongue,
itching and severe rash
▪ severe changes in texture and appearance of the skin, especially serious blistering and
peeling that affects the mouth eyes and genitals (Stevens Johnson syndrome)
▪ fits (seizures or convulsions)
▪ heart problems e.g. severe changes in heartbeat, including pounding, racing or skipped
beats (palpitations)
▪ inflammation of the lungs, also known as pneumonitis. This is a serious, potentially lifethreatening allergic reaction in the lungs which may cause fever, chills, cough, shortness
of breath or chest pain.
▪ severe liver problems which might be demonstrated by a transient increase in your liver
enzymes shown by blood tests or other symptoms such as tender, firm or possibly
enlarged liver, jaundice (yellowing of skin/ eyes), dark urine, light coloured stools and
generalised itchiness
Other possible side effects
Very common (may affect more than 1 in 10 people):
▪ sleeping problems (sleepiness, unable to sleep, bad dreams)
Common (may affect up to 1 in 10 people):
▪ dizziness
▪ headache
▪ problems with your vision
▪ loss of balance (vertigo)
▪ feeling sick (nausea), being sick (vomiting)
▪ diarrhoea
▪ stomach ache (abdominal pain)
▪ itching
Not known (frequency cannot be estimated from the available data):
▪ abnormal blood test results showing a decrease or an increase in white blood cells, a
decrease in red blood cells or platelets. Symptoms may include painful mouth or throat
ulcers, fever, chills, bruises on the skin, nosebleeds, bleeding in the stomach or vaginal
bleeding.














kidney problems, failure or infection, causing impairment, cessation , infection, or blood
in the urine. Symptoms may include abnormal blood tests (increased blood creatinine),
feeling dehydrated, fatigue, swelling (oedema), shortness of breath, feeling or being
sick, loss of appetite, or headache
decreased appetite
fainting
neuropathy with signs of e.g. “pins and needles”, weakness, new or worsening
clumsiness or unsteadiness on your feet, or shaking of the hands and fingers
forgetfulness (sometimes lasting for more than 3 months)
difficulties in talking
difficulties with sense of smell and taste, eye movement, facial sensation and
expression, hearing, balance, tasting, tongue movement, head-turning, and raising your
shoulders
cataract, dazzled in the evenings or other vision disturbances, blurred vision
changes to your hearing including ringing in the ears or difficulty in hearing (sometimes
prolonged), everyday sounds seeming too loud
changes to blood pressure or heart rate
hot flushes
breathlessness, cough
pancreas problems; symptoms may include stomach pain, nausea, vomiting, changes to
blood pressure or heart rates and breathlessness
indigestion
rash
hair loss
sweating
muscle weakness
muscle cramps
joint pains
muscle pains
oedema
chest pain
tiredness
fever or chills

Whilst taking this medicine, if you experience these or any other symptoms that concern
you, tell your doctor.
Some side effects may occur after you have stopped taking Lariam. In a small number of
patients it has been shown that depression, dizziness or vertigo and loss of balance may
persist for months or longer, even after you have stopped taking Lariam.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Lariam







Do not use after the expiry date printed on the carton label or blister strip. The expiry
date refers to the last day of that month.
Store in the original package to protect from moisture. Do not store above 35°C.
Keep all medicines out of the sight and reach of children.
If the tablets become discoloured or show signs of any deterioration, you should seek
the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
Each tablet contains 250mg of the active ingredient mefloquine (as the hydrochloride) in a
white round tablet, cross scored and marked ‘Roche’ and logo on one side and plain on the
reverse.
Lariam 250mg Tablets also contain the following inactive ingredients:
Microcrystalline cellulose, lactose anhydrous, maize starch, ammonium-calcium alginate,
polaxamer (polyoxyethylene-polyoxypropylene copolymer), talc and magnesium stearate.
Lariam 250mg Tablets are available in blister packs of 8 tablets.
POM

PL NO: 17805/0369

This product is manufactured by F. Hoffmann-La Roche A.G., Grenzacherstrasse 124, CH4070, Basle Switzerland and procured from within the EU by the Product Licence holder
Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford, Herts WD24
4EW and repackaged by O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 04.04.2016.
Lariam is a registered Trade Mark of Roche Products Limited, UK
You can get more information on Lariam from your doctor, pharmacist or nurse.
It is essential that you follow the recommendations given for taking the tablets.
Other preventative actions you should take
If you are taking Lariam to prevent malaria, you should also take steps to avoid mosquito
bites. Some information on how to avoid bites is given below. This is important as no
medicine can be 100% guaranteed to protect you against malaria.
▪ Make sure you sleep in a room that is screened against mosquitoes or has full air
conditioning, or that you use a mosquito net (preferably one that has been treated with
an insect repellent) over the bed.
▪ Use insect repellents; ointments, lotions and sprays, to deter mosquitoes.
▪ In the evening, cover arms and legs with light-coloured, long-sleeved clothes and
trousers, and use an insect repellent. Anklets are also available which have been treated
with repellent.
▪ Vaporising electric “mats”, mosquito coils or tablets can be used at night-time around
exposed areas of the body (ankles and feet).
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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