LARIAM®contains the active ingredient mefloquine

Consumer Medicine Information

LARIAM® Published by MIMS/myDr December 2013 1

What is in this leaflet

This leaflet answers some commonquestions about LARIAM tablets.

It does not contain all the availableinformation.

It does not take the place of talking toyour doctor or pharmacist.

All medicines have risks andbenefits. Your doctor has weighedthe risks of you taking LARIAMtablets against the benefits expectedfor you.

If you have any concerns abouttaking this medicine, ask yourdoctor or pharmacist.

Keep this leaflet with the medicine.You may need to read it again.

What LARIAM is usedfor

LARIAM is used to prevent and treatmalaria.

LARIAM contains the activeingredient mefloquine. LARIAMbelongs to a group of medicinescalled quinolones (pronounced kwin-o-lones).

LARIAM works by killing theparasites that may cause or havecaused malaria.

Where and how you cancontract malaria

Malaria is an infectious disease thatis widespread in tropical andsubtropical areas of Africa, LatinAmerica, Asia and countries aroundthe Pacific. There are different formsof malaria, each of them caused by aspecific parasite transmitted tohumans by the bite of the Anophelesmosquito.

Precautions against malaria

The best protection against malaria isto avoid mosquito bites. Themosquito that causes malaria mainlybites between dusk and dawn.Therefore the followingprecautionary measures arerecommended:

• during this period, wear light-coloured clothing that covers asmuch of your skin as possible

• apply mosquito repellent to youruncovered skin and to yourclothes

• when sleeping in rooms that arenot protected against mosquitoes,use an effective mosquito net welltucked under the mattress

• additional protection is providedby smoke spirals, insect spraysand candles.

Symptoms of malaria

The symptoms of malaria may oftenbe mild. However, malaria should besuspected if, after one week in amalarial area, you suffer unexplainedfever with or without othersymptoms such as headache, achinglimbs, weakness, shaking, chills, andsometimes diarrhoea, vomiting andcough. These symptoms can easily beconfused with influenza.

If these symptoms are due to themost dangerous form of malariacaused by the falciparum parasite,and they are not treated in time,severe organ damage, loss ofconsciousness and death can occurwithin a short period. The lessdangerous forms of malaria, whichare not life threatening, can break outmonths or even years after the end ofa stay in a malarial area.

Diagnosis and treatment ofmalaria

Early diagnosis is critical forsuccessful treatment. Anyonesuspected of having malaria shouldseek medical attention promptly andrequest that a blood sample be takenand examined microscopically formalaria parasites.

Most tourists and business travellerswill normally be able to receivemedical attention. However, if this isnot readily available, anti-malarialdrug treatment can be self-administered 'stand-by treatment').

Consult your doctor about the need tocarry 'stand-by treatment' on yourtrip. Medical advice should still besought after self-administered drugtreatment.

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There are many different types ofmedicines used for the treatment andprevention of malaria.

Your doctor may have prescribedLARIAM for another purpose.

Ask your doctor if you have anyquestions about why LARIAM hasbeen prescribed for you.LARIAM is not addictive.

This medicine is available only witha doctor's prescription.

Before you takeLARIAM

When you must not takeLARIAM

Do not take LARIAM:

1. if you have had an allergicreaction to LARIAM or relatedcompounds quinine, quinidine

2. if you have kidney disease3. if you have severe liver disease4. as a preventative medicine if

you have depression or have ahistory of psychiatric disorders,such as depression or anxietySome people who take LARIAMmay have sudden serious mentalproblems. Symptoms of seriousmental problems may include;

• severe anxiety• hallucinations• depression• feeling restless• unusual behaviour• feeling confused5. as a preventative medicine if

you have a history of seizures(epilepsy or convulsions)

6. if you have had an allergicreaction to any of theingredients listed at the end ofthis leafletSome of the symptoms of anallergic reaction may include;

• shortness of breath• wheezing or difficult breathing

• swelling of the face, lips, tongueor other parts of the body

• rash, itching or hives on the skin7. if the package is torn or shows

signs of tampering8. if the expiry date (EXP) printed

on the pack has passed.If you take this medicine after theexpiry date has passed, it may notwork as well.

If you are not sure if you should betaking LARIAM, talk to yourdoctor.

Do not give LARIAM to childrenunder 14 years of age, unlessadvised to do so by the child'sdoctor.Safety and effectiveness in childrenhave not been established.

Before you start to takeLARIAM

Tell your doctor if:

1. you have or have had anyhealth problems, especially thefollowing:

• psychiatric disordersparticularly mood disturbances(e.g. anxiety, depression)

• heart conditions such asirregular heartbeat

• epilepsy (fits or seizures) orconvulsions

• liver problems• malaria2. you have recently had a

vaccination3. you are planning to travel to

areas where LARIAM may notbe an effective treatment (i.eareas where there is anincreased risk of drugresistance such as South-EastAsia )Contact your doctor or travelhealth clinic before travelling forcurrent advice on treatment andprecautionary measures.

4. you are pregnant or plan tobecome pregnant.If there is a need to takeLARIAM during your pregnancy,your doctor will discuss with youthe risks and benefits of using it.

5. you are breast feeding or intendto breast feedLARIAM passes into breast milkand may affect your baby,therefore your doctor will discussthe risks and benefits of takingLARIAM if you arebreastfeeding.

6. you are allergic to any othermedicines, foods, dyes orpreservatives.

If you have not told your doctorabout any of the above, do sobefore starting LARIAM.

Taking other medicines

Tell your doctor if you are takingany other medicines including anythat you buy without aprescription from your pharmacy,supermarket or health food shop.

Especially tell your doctor if you aretaking (or have taken recently):

• halofantrine, a medicine used totreat malaria which is availableoverseas in some countries.

• quinine, a medicine used to treatcramps or malaria

• quinidine, a medicine used totreat a heart problem called atrialfibrillation

• ketoconazole, an antifungalmedicine used to treat infections

These medicines must not be takenwith LARIAM or after LARIAM hasbeen taken. It may cause seriousheart problems.

Other medicines may interfere withLARIAM. These include:

• chloroquine, a medicine used totreat or prevent malaria

• rifampicin, a medicine used totreat infections

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• medicines used to treat fits,seizures or convulsions (epilepsy)such as valproic acid,carbamazepine, phenobarbital andphenytoin

• medicines used to treat or preventirregular heartbeat

• medicines used to treat highblood pressure, including groupsof medicines called beta-blockersand calcium channel blockers

• medicines used to lower blood-sugar (treat diabetes)

• medicines used to prevent bloodclots

• some medicines used to treatdepression and other mentaldisorders, including a groupcalled tricyclic antidepressants

• some antihistamines andmedicines used to prevent orrelieve the symptoms of allergy,including promethazine andtrimeprazine

• a group of medicines known asphenothiazines, used to treatmental problems, includingprochlorperazine,chlorpromazine, trifluoperazineand fluphenazine

• typhoid vaccines. You should notbe vaccinated against typhoidwith a "live" vaccine while takingLARIAM. Live typhoidvaccinations should be completedat least three days before the firstdose of LARIAM. Ask yourdoctor or pharmacist if you arenot sure if your vaccine is "live".

These medicines may be affected byLARIAM, or may affect how well itworks. You may need to takedifferent amounts of your medicine,or you may need to take differentmedicines. Your doctor will adviseyou.

Your doctor and pharmacist havemore information on medicines to becareful with or avoid while takingLARIAM.

Ask your doctor or pharmacist if youare not sure about this list.

How to take LARIAM

Follow all directions given to youby your doctor and pharmacistcarefully.They may differ from theinformation contained in this leaflet.

How much LARIAM to take

Take LARIAM exactly as yourdoctor has prescribed.Your doctor will tell you how manyLARIAM tablets to take and howoften to take them.

Treatment of malariaThe first dose of LARIAM is 3tablets. This is followed by a seconddose of 1 or 2 tablets, 6 - 8 hourslater. The total dose of LARIAM is 4to 5 tablets.

Prevention of malariaThe dose is 1 tablet of LARIAMonce weekly, always on the sameday. Take the first tablet one weekbefore you arrive in the malarial area.Take 1 tablet each week that you arein a malarial area. Continue to take 1tablet per week for two weeks afteryou have left the malarial area.

How to take LARIAM

Swallow tablets whole with a fullglass of water.

When to take LARIAM

It does not matter if you takeLARIAM before or after food.

How long to take LARIAM

Continue taking LARIAM for aslong as your doctor tells you to.The length of therapy will depend onwhether LARIAM is used for thetreatment or prevention of malaria.

LARIAM can be taken for up tothree months for prevention ofmalaria.

If you stay in a malarial area formore than three months, your doctorwill tell you what to do to preventmalaria.

If you forget to take LARIAM

If you forget to take the seconddose of LARIAM for the treatmentof malaria, take it as soon as youremember and contact yourdoctor.

Do not take a double dose to makeup for one you have missed.If you are not sure what to do, askyour doctor or pharmacist.

For the prevention of malaria, youmust take 1 tablet of LARIAMonce weekly, always on the sameday. If you forget to take a dose,take it as soon as you rememberand then go back to taking it asyou would normally once a week.

If you think you may have troubleremembering your dose, ask yourpharmacist for some hints.

If you take too much(overdose)

If you think that you or anyoneelse may have taken too muchLARIAM, immediately telephoneyour doctor or PoisonsInformation Centre (telephone 1311 26) for advice, or go to Accidentand Emergency at your nearesthospital. Do this even if there areno signs of discomfort orpoisoning.You may need urgent medicalattention.

Keep telephone numbers for theseplaces handy.

If you are not sure what to do,contact your doctor or pharmacist.

While you are takingLARIAM

Things you must do

Tell all doctors, dentists andpharmacists who are treating youthat you are taking LARIAM.

LARIAM® Published by MIMS/myDr December 2013 4

Tell your doctor immediately ifyou become pregnant while takingLARIAM.Women of child-bearing potentialshould use effective contraceptionwhile taking LARIAM and for atleast three months after taking thelast dose.

Tell your doctor if, for any reason,you have not taken your medicineexactly as prescribed.Otherwise, your doctor may thinkthat it was not effective and changeyour treatment unnecessarily.

If you are taking LARIAM for thetreatment of malaria, tell yourdoctor if you feel it is not helpingyour condition.

Be sure to keep all of yourappointments with your doctor sothat your progress can be checked.

Things you must not do

Do not stop taking LARIAM orchange the dose without firstchecking with your doctor.

Do not let yourself run out ofLARIAM over the weekend or onholidays.

Do not give LARIAM to anyoneelse even if they have the samecondition as you.

Do not use LARIAM to treat othercomplaints unless your doctor saysto.

Do not take any other medicineswhether they require aprescription or not without firsttelling your doctor or consulting apharmacist.

Things to be careful of

Be careful driving or operatingmachinery until you know howLARIAM affects you.LARIAM may cause dizziness,drowsiness or loss of balance in somepeople. These effects may occur forsome time after stopping LARIAMtreatment.

Make sure you know how you reactto LARIAM before you drive a car,operate machinery, or do anythingthat could be dangerous if you aredizzy or light-headed. Do not drive ifyou experience these side effects. Ifyou drink alcohol these symptomsmay be worse.

Side Effects

Tell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingLARIAM.LARIAM helps most people but itmay have unwanted side effects in afew people.

All medicines can have side effects.Sometimes they are serious, most ofthe time they are not. You may needmedical treatment if you get some ofthe side effects.

When LARIAM is used for treatmentof malaria, side effects may occurmore often than when it is used forprevention of malaria.

If you are taking LARIAM for thetreatment of malaria, you may not beable to distinguish between thesymptoms of malaria and the sideeffects of LARIAM.

Ask your doctor or pharmacist toanswer any questions you may have.

Tell your doctor if you notice anyof the following and they worryyou:

• dizziness, vertigo (a sense ofspinning) or loss of balance; thesemay occur after LARIAM hasbeen stopped

• aching muscles, cramps, muscletenderness or weakness, notcaused by exercise

• headache• fever, sweating or chills• nausea (feeling sick) or vomiting• diarrhoea, pain in the stomach• fatigue, tiredness or drowsiness• loss of appetite

• tinnitus (buzzing, hissing,whistling, ringing or otherpersistent noise in the ears)

• hair loss• itchingThese are the more common orgeneral mild side effects.

Tell your doctor immediately or goto Accident and Emergency atyour nearest hospital if youexperience any of the following:

• insomnia (inability to sleep) orabnormal or strange dreams;these may occur after LARIAMhas been stopped

• change in mood, for example,depression, restlessness,confusion, agitation, aggression,feeling anxious or nervous,hallucinations, suicidal thoughtsor panic attacks; these may occurafter LARIAM has been stopped

• seizure (fit) or convulsion.• irregular or racing heartbeat,

chest pain• loss of consciousness• shaking or tremors• difficulty breathing, shortness of

breath, chest tightness, coughingor wheezing

• tingling or numbness in the handsor feet

• severe skin rash, blisters orbleeding in the lips, eyes, mouth,nose or genitals

• sudden tiredness, dizziness orsudden shortness of breath

• yellowing of the skin or the eyes• problems with your eyes such as

blurred vision or eye pain.These are serious side effects. Youmay need urgent medical attention.Serious side effects are rare.

This is not a complete list of allpossible side effects. Others mayoccur in some people and there maybe some side effects not yet known.

Tell your doctor if you noticeanything else that is making youfeel unwell, even if it is not on thislist.

LARIAM® Published by MIMS/myDr December 2013 5

Ask your doctor or pharmacist ifyou do not understand anything inthis list.Do not be alarmed by this list ofpossible side effects. You may notexperience any of them.

After taking LARIAM

Storage

Keep your tablets in the blisterpack until it is time to take them.If you take the tablets out of theblister pack they will not keep well.

Keep LARIAM in a cool dry placewhere the temperature stays below30°C.

Do not store LARIAM or anyother medicine, in a bathroom ornear a sink.

Do not leave it in the car or onwindow sills.Heat and dampness can destroy somemedicines.

Keep LARIAM where childrencannot reach it.A locked cupboard at least one-and-a-half metres above the ground is agood place to store medicines.

Disposal

If your doctor tells you to stoptaking LARIAM, or the tabletshave passed their expiry date, askyour pharmacist what to do withany tablets that are left over.

Product Description

LARIAM is available as pack of 8tablets (250 mg).

What LARIAM looks like

The tablets are white, round, andmarked with "RO", "C", "HE" and animprinted hexagon on one side. Theyare cross-scored so that they can beeasily broken into halves or intoquarters.

Ingredients

Active ingredient - mefloquine

• each LARIAM tablet contains250 mg mefloquine asmefloquine hydrochloride.

Inactive ingredients

• microcrystalline cellulose• lactose• maize starch• crospovidone• ammonium calcium alginate• talc• magnesium stearate• poloxamer 3800.LARIAM does not contain sucrose,tartrazine or any other azo dyes.

Manufacturer

LARIAM is distributed by:Roche Products Pty LimitedABN 70 000 132 8654 - 10 Inman RoadDee Why NSW 2099Customer enquiries: 1800 233 950

Please check with your pharmacistfor the latest Consumer MedicineInformation.

Australian Registration Number:AUST R 43321

This leaflet was prepared on 16September 2013.