Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Largactil?
Largactil contains the active ingredient chlorpromazine hydrochloride, one of a group
of medicines called phenothiazines. Largactil is used to treat several conditions
and may be used either for a short time or for a long time.
Ask your doctor if you have any questions about why Largactil has been prescribed
for you. Largactil is available only with a doctor's prescription. For more information,
see Section
1. Why am I using Largactil? in the full CMI.
2. What should I know before I use Largactil?
Do not use if you have ever had an allergic reaction to Largactil or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use Largactil? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Largactil?
Your doctor or pharmacist will tell you how many tablets or how much syrup you will
need to take each day. This depends on your condition and whether or not you are taking
any other medicines.
5. What should I know while using Largactil?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Largactil.
If you become pregnant while taking Largactil, tell your doctor or pharmacist.
You should avoid very cold or very hot environments.
You should avoid exposure to strong sunlight while you are taking Largactil.
Call your doctor straight away if you notice any worm-like movements of the tongue,
or other uncontrolled movements of the tongue, mouth, cheeks or jaw.
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Things you should not do
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Do not take Largactil to treat any other complaints unless your doctor or pharmacist
tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Largactil
affects you.
Largactil may cause drowsiness in some people.
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Drinking alcohol
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Be careful when drinking alcohol while taking Largactil. Combining Largactil and alcohol
can make you more sleepy, dizzy or light headed.
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Looking after your medicine
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Follow the instructions in the carton on how to take care of your medicine properly.
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6. Are there any side effects?
Less serious side effects include dizziness or light headedness, headache, nausea,
dry mouth, drowsiness or tiredness, weight gain, constipation, nasal congestion, agitation,
skin discolouration, blurred vision, difficulty urinating and impotence.
Serious side effects include sore throat, fever or any sign of infection, breathing
difficulty, seizures or fits, unwanted muscle movements of the mouth, tongue, jaw,
cheeks or arms and legs, uncontrolled bleeding or bruising more easily than usual.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
chlorpromazine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Largactil. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Largactil.
Where to find information in this leaflet:
1. Why am I using Largactil?
Largactil contains the active ingredient chlorpromazine hydrochloride, one of a group of medicines called phenothiazines. Largactil is used to treat several
conditions and may be used either for a short time or for a long time. Largactil is used to treat various problems such as severe depression or behavioural
disturbances. Largactil can also be used to treat nausea, vomiting, severe pain and
unstoppable hiccups.
Your doctor may have prescribed Largactil for another reason. Ask your doctor if you
have any questions about why Largactil has been prescribed for you.
2. What should I know before I use Largactil?
Warnings
Do not use Largactil if:
you have ever had an allergic reaction to Largactil or any of the ingredients listed
at the end of the CMI. Always check the ingredients to make sure you can use this
medicine.
you have taken any other 'phenothiazine' medicine before, which caused your face,
lips, tongue, throat, hands or feet to swell up, or made it hard for you to breathe.
If you have had an allergic reaction to a phenothiazine before, you may be allergic
to Largactil.
If you experience an allergic reaction, seek medical help right away.
you have circulatory, blood or bone marrow problems, high blood pressure, liver problems,
depression of the central nervous system and phaeochromocytoma (a rare tumour of the
adrenal gland which sits near the kidney).
the packaging is torn or shows signs of tampering or if the tablet, syrup or ampoule
doesn't look quite right.
Check with your doctor or pharmacist if you:
take any medicines for any other condition
have any other medical conditions especially the following:
asthma
chronic respiratory disorders
kidney or liver disease
heart disease
blood clots
decreased parathyroid activity
low blood calcium levels
Parkinson's disease
prostate problems
epilepsy - fits and seizures
glaucoma - high pressure in the eye
muscle weakness (myasthenia gravis)
diabetes
dementia
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Use in children
Do not use in children less than 1 year of age.
Because of the risk of choking, the tablets should be avoided in children who have
difficulty swallowing tablets.
Pregnancy and breastfeeding
Use of Largactil is not recommended during pregnancy.
Check with your doctor or pharmacist if you are a woman of childbearing age and not
using effective contraception, or if you are pregnant or intend to become pregnant.
Babies exposed to antipsychotic medicines including Largactil during the third trimester
of pregnancy are at risk of experiencing breathing problems, difficulty in feeding,
spasms, restlessness, involuntary movements and/or withdrawal symptoms following delivery.
Use of Largactil is not recommended during breastfeeding.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Your doctor or pharmacist will discuss the possible risks and benefits of using Largactil
during pregnancy and during breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Largactil and affect how it works. These include:
benztropine and levodopa - drugs used to treat Parkinson's disease
antimicrobials – used to treat infections
antacid - used to treat stomach upsets
lithium - used to treat mood disorders
barbiturates - a group of drugs used as sedatives
tricyclic antidepressants
benzodiazepines - a group of drugs used to treat anxiety and muscle spasms
other antipsychotics
medicines that are CYP1A2 inhibitors e.g. ciprofloxacin, fluvoxamine, oral contraceptives,
vemurafenib
medicines used to treat a fast or irregular heart beat e.g. amiodarone, quinidine,
disopyramide
medicines that can slow your heart beat e.g. diltiazem, verapamil, propranolol
medicines that can reduce potassium levels in the blood e.g. diuretics, laxatives
other medicines that can affect your heart rate e.g. methadone, pentamidine
anaesthetics
opioids - a group of pain killing drugs
antidiabetic agents - a group of drugs used to treat diabetes
amphetamines
anticoagulants
anticholinergics
guanethidine
clonidine
thiazides - diuretics (fluid tablets)
MAOI - a group of drugs used to treat depression
adrenaline
suxamethonium, atropine and organophosphorous insecticides
anticonvulsants - a group of drugs used to treat epilepsy e.g. phenytoin, valproic
acid
prochlorperazine - a drug used to treat nausea and vomiting
desferrioxamine - a drug used to treat iron poisoning
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Largactil.
4. How do I use Largactil?
How much to take
Follow the instructions provided and use Largactil until your doctor tells you to
stop.
Your doctor or pharmacist will tell you how many tablets or how much syrup you will
need to take each day. This depends on your condition and whether or not you are taking
any other medicines.
Follow all directions given to you by your doctor and pharmacist carefully.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
When to take Largactil
Take Largactil at about the same time each day.
Continue taking Largactil until your doctor or pharmacist tells you to stop. Do not
stop using it unless your doctor or pharmacist tells you to, even if you feel better.
Taking your tablets or syrup at the same time each day will have the best effect.
It will also help you remember when to take the tablets or syrup.
How to take Largactil
Swallow the prescribed dose of Largactil tablets whole with a full glass of water.
Do not chew the tablets.
Swallow the prescribed dose of Largactil syrup and follow with a glass of water.
Largactil may be given as an injection into a muscle or as a slow injection into a
vein. Largactil injections should only be given by a doctor, nurse or other trained
person.
If you forget to use Largactil
If you miss a dose, simply continue to take Largactil as advised by your doctor or
pharmacist. You do not need to make up for the missed dose.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist. If you have trouble
remembering to take your medicine, ask your pharmacist for some hints.
If you use too much Largactil
If you think that you have used too much Largactil, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. If you take too much Largactil, you may experience:
drowsiness
low body temperature
low blood pressure
twisting your limbs
stiffness
shaking
unusual heart beats
muscle twitching
difficulty in swallowing and breathing
convulsions
loss of consciousness leading to coma
5. What should I know while using Largactil?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking Largactil.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking Largactil.
If you become pregnant while taking Largactil, tell your doctor or pharmacist.
You should avoid very cold or very hot environments. Largactil may make it difficult
for your body to regulate its temperature.
You should avoid exposure to strong sunlight while you are taking Largactil. Do not
use a sunlamp or tanning bed or booth.
Largactil may cause your skin to be much more sensitive to sunlight than it is normally.
Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If
your skin does appear to be burning, tell your doctor. If exposure to strong sunlight
is unavoidable, suitable clothing, including a hat, should be worn. A sunscreen with
a high level of protection should also be used.
All mentions of suicide must be taken seriously. Tell your doctor or a mental health
professional immediately if you have any suicidal thoughts or other mental/mood changes.
Call your doctor straight away if you:
notice any worm-like movements of the tongue, or other uncontrolled movements of the
tongue, mouth, cheeks or jaw which may progress to the arms and legs.
These are symptoms of a condition called tardive dyskinesia, which may develop in
people taking phenothiazine medicines, including Largactil.
This condition is more likely to occur during long term treatment with Largactil,
especially in elderly women. In very rare cases, this may be permanent. However, if
detected early, these symptoms are usually reversible.
Things you should not do
Do not give Largactil to anyone else, even if they have the same condition as you.
Do not take Largactil to treat any other complaints unless your doctor or pharmacist
tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Largactil
affects you.
Largactil may cause drowsiness, dizziness, and blurred vision in some people. Make
sure you know how you react to Largactil before you drive a car, operate machinery,
or do anything else that could be dangerous if you are dizzy or light-headed. If this
occurs, do not drive. If you drink alcohol, dizziness or light-headedness may be worse.
If Largactil makes you feel light-headed, dizzy or faint, be careful when getting
up from a sitting or lying position. Getting up slowly may help.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while taking Largactil. Combining Largactil and alcohol
can make you more sleepy, dizzy or light headed. Your doctor may suggest you avoid
alcohol while you are being treated with Largactil.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store tablets below 30°C.
Store syrup below 25°C. Protect from light.
Store ampoules below 25°C. Protect from light.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age, you may have an increased chance of getting side
effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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General
dizziness or light headedness
headache
nausea
dry mouth
drowsiness or tiredness
weight gain
constipation
nasal congestion
weakness
Nervous System related
agitation
confusion
Skin related
skin problems or discolouration
Eye related
blurred vision
Genito-urinary related
difficulty in urinating
impotence
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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General
sore throat, fever or any sign of infection
hypersensitivity, fever, rash, facial swelling, swollen lymph nodes (which could be
symptoms relating to raised levels of infection fighting cells (these could be symptoms
relating to eosinophilia)
Allergic reaction
breathing difficulty, rash, itching, shortness of breath, swelling of throat, face,
lips or tongue, clammy skin, palpitations, fainting
Nervous system related
seizures or fits
unwanted muscle movements of the mouth, tongue, jaw, cheeks or arms and legs.
hardness or rigidity of the muscles.
high fever, muscle cramps or stiffness, severe headache, fast heartbeat, hallucinations,
or are sweating a lot (symptoms relating to Neuroleptic malignant syndrome)
involuntary movement of tongue, face, mouth or jaw (symptoms relating to Tardive Dyskinesia)
high fever, muscle cramps or stiffness, dizziness, severe headache, fast heartbeat,
confusion, agitation, hallucinations or if you are sweating a lot (symptoms relating
to neuroleptic malignant syndrome)
Heart related
fast heartbeat
alteration of the heart rhythm (electrical activity of the heart).
very fast, uneven or forceful heartbeat (palpitations), weakness, fainting (symptoms
relating to QT prolongation)
Bleeding related
uncontrolled bleeding or bruising more easily than usual
Liver related
yellowing of the skin and/or eyes (jaundice) and urine becomes darker in color
Blood related
bleeding and bruising (thrombocytopenic purpura)
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Largactil contains
Tablets
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Active ingredient
(main ingredient)
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chlorpromazine hydrochloride 25mg, or 100mg (active ingredient)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
maize starch
colloidal anhydrous silica
magnesium stearate
hypromellose
macrogol 200
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Potential allergens
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Contains sugars as lactose
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Syrup
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Active ingredient
(main ingredient)
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chlorpromazine hydrochloride 25mg/5mL (active ingredient)
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Other ingredients
(inactive ingredients)
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sucrose
caramel
citric acid
polysorbate 20
peppermint oil
spearmint oil
sodium citrate dihydrate
ascorbic acid
sodium sulphite
sodium metabisulphite
sodium benzoate
fruit cup essence
purified water
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Potential allergens
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Contains sugars
Contains benzoates
Contains sulfites
Contains sodium
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Ampoules
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Active ingredient
(main ingredient)
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chlorpromazine hydrochloride 50mg/2mL (active ingredient)
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Other ingredients
(inactive ingredients)
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sodium sulfite
sodium metabisulphite
sodium chloride
sodium citrate dihydrate
water for injections
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Potential allergens
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Contains sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What Largactil looks like
Largactil tablets are white film coated tablets with embossing on one side:
25mg tablet: LG / 25
100mg tablet: LG / 100
Tablets are available in blister packs of 100.
Largactil syrup is a dark orange syrupy liquid with the odour of spearmint / peppermint,
and is slightly fruity. Syrup is available in an amber glass 100mL bottle with a childproof
cap.
Largactil for injection is a clear liquid in a 2mL glass ampoule, in a pack of 10
ampoules.
Who distributes Largactil
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Free Call Australia: 1800 899 005
Largactil® is a registered trademark.
Australian Registration Numbers:
25mg tablet AUST R 51618
100mg tablet AUST R 51619
25mg/5mL syrup AUST R 118128
50mg/2mL ampoule AUST R 27511
This leaflet was prepared in October 2023.