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LARIAM 250MG TABLETS

Active substance(s): MEFLOQUINE / MEFLOQUINE HYDROCHLORIDE

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Genisys-No.

10173232

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10 pt

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Pantone Black

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27.10.2015

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148x594 mm

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GB

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148x38.5 mm

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26.04.16

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Package leaflet: Information for the patient

10173232 GB FY

Lariam® 250 mg 
Tablets

Mefloquine
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.

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.

- 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.

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).

What is in this leaflet

Tell your doctor, pharmacist, or nurse if
you are taking, have recently taken or
might take any other medicines including:

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

● 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

1. What Lariam is and what it is
used for
Lariam tablets contain 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.
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.
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.

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)

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.

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.

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.

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.

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.

Warnings and precautions

Lariam contains lactose

Lariam may cause serious mental
problems in some people. Tell your doctor
immediately if you experience any of the
following while taking Lariam:

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.

● 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

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.
● Take the 1st dose 10 days before you
leave: this is to make sure that Lariam is
well tolerated. Take the 2nd 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.

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 life-threatening 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 tablets
for malaria prevention
● 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

10173232_148x594mm.indd 1

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.
1

Please turn over 

26.04.2016 14:16:57

Genisys-No.

10173232

Type Size

10 pt

Printing Colour:

Pantone Black

Drawing Norm

27.10.2015

Format:

148x594 mm

make-up code

GB

Folding Format:

148x38.5 mm

COE/CMO

FY

Creator

Date

Version

26.04.16

3

Signature

Proofreader

Date

Signature

PDF Approval (only if not given in ALPIN E2E)
Name

Date

Signature

● 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.

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 – 19 kg
(approx.
11 – 43 lbs)
20 – 30 kg
(approx.
44 – 67 lbs)
31 – 45 kg
(approx.
68 – 99 lbs)

Age (approx.)
3 months –
5 years

Dose
¼ tablet

6 – 8 years

½ tablet

9 – 14 years

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:

5. How to store Lariam

Common (may affect up to 1 in 10 people):
● depression
● anxiety

● Keep this medicine out of the sight and
reach of children.
● Do not use this medicine after the expiry
date which is printed on the carton and
blister foil after (EXP). The expiry date
refers to the last day of that month.
● Do not store above 30ºC.
● Keep the blister in the outer carton in
order to protect it from moisture.
● Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

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

6. Contents of the pack and other
information
What Lariam contains
The active substance in Lariam is
mefloquine. Lariam is an anti-malarial.
Each tablet contains 250 mg of mefloquine
(as mefloquine hydrochloride).
The other ingredients in Lariam tablets are
poloxamer, microcrystalline cellulose,
lactose monohydrate, maize starch,
crospovidone, ammonium calcium
alginate, talc, and magnesium stearate.
What Lariam looks like and contents of
the pack
Appearance: The tablets are white to
off-white, cross-scored, and imprinted with
Roche on one face.
Pack size: The tablets are available in foil
strips in packs of 8.
Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
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).

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 lifethreatening 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 life-threatening 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.

10173232_148x594mm.indd 2

This leaflet was last revised in
February 2016.

2

10173232 GB FY

26.04.2016 14:16:57

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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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