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LARIAM 250MG TABLETS

Active substance(s): MEFLOQUINE / MEFLOQUINE HYDROCHLORIDE / MEFLOQUINE / MEFLOQUINE HYDROCHLORIDE / MEFLOQUINE / MEFLOQUINE HYDROCHLORIDE

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Genisys-No.

10175003

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

10 pt

Drawing Norm

NP9344

make-up code

GB

Creator

Name

11.08.10

Date

Version

18.05.16

2

97.4.3524

Signature

Date

Signature

PDF Approval (only if not given in ALPIN E2E)
Date
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Package leaflet:
Information for the patient

Lariam® 250 mg
Tablets

Mefloquine
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.
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 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.

2. What you need to know before
you take Lariam

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
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
1
10175003_NP9344.indd 1

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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).
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
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.
Pregnancy and breast-feeding
Pregnant women should not normally take
these tablets.
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.
●● 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.
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.
Please turn over
10175003 GB

18.05.2016 08:32:34

Genisys-No.

10175003

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

10 pt

Drawing Norm

NP9344

make-up code

GB

Creator

11.08.10

Date

Version

18.05.16

2

Name

97.4.3524

Signature

Date

Signature

PDF Approval (only if not given in ALPIN E2E)
Date
Signature

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
Age
Dose
(approx.)
5 – 20 kg
3 months
¼ tablet
(approx. 11 – 44 lbs) – 5 years
>20 – 30 kg
6 – 8 years ½ tablet
(approx. >44 – 66 lbs)
>30 – 45 kg
9 – 14 years ¾ tablet
(approx. >66 – 99 lbs)
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
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.
●● 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
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●● 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

●● 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.

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).
This leaflet was last revised in May 2016.

10175003 GB

18.05.2016 08:32:34

Expand Transcript

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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