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REAGILA®
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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
REAGILA contains the active ingredient cariprazine. REAGILA is used to treat adults
with schizophrenia.
For more information, see Section 1. Why am I using REAGILA? in the full CMI.
Do not use if you have ever had an allergic reaction to REAGILA 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. Women of childbearing
potential must use effective contraception during and for at least 10 weeks after
REAGILA treatment. REAGILA is not recommended for use during pregnancy.
For more information, see Section 2. What should I know before I use REAGILA®? in the full CMI.
Some medicines should not be taken with REAGILA as they may interfere with how well
it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
More instructions can be found in Section 4. How do I use REAGILA? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using REAGILA
Call your doctor straight away if you are having any thoughts or feelings about hurting
yourself or to commit suicide, OR if you have combination of confusion, drowsiness,
muscle stiffness, high fever, sweating, high blood pressure, fast heartbeat and breathing
(‘neuroleptic malignant syndrome’).
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Things you should not do
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Do not stop using this medicine suddenly.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take this medicine if you are pregnant or breastfeeding.
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Driving or using machines
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There is a minor or moderate risk that the medicine could affect the ability to drive
and use machines. Drowsiness, dizziness and vision problems may occur during treatment
with this medicine.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
Avoid alcohol when taking REAGILA.
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Looking after your medicine
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Keep your capsules in a cool dry place where the temperature stays below 30°C and
in the outer carton until it is time to take them in order to protect from light.
Do not take REAGILA after the expiry date or if the packaging is torn or shows signs
of tampering.
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For more information, see Section 5. What should I know while using [insert medicine]? in the full CMI.
The most common side effects are restlessness and Parkinsonism. Serious side effects
include severe allergic reaction, neuroleptic malignant syndrome, kidney problems,
blood clots and suicidal thoughts.
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.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
REAGILA® (Ree-ag-ee-la)
Active ingredient:
cariprazine
Consumer Medicine Information (CMI)
This leaflet provides important information about using REAGILA. 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 REAGILA.
Where to find information in this leaflet:
REAGILA contains the active ingredient cariprazine. REAGILA is an atypical antipsychotic.
REAGILA is used to treat adults with schizophrenia.
Schizophrenia is a mental illness characterised by symptoms such as hearing, seeing
or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs,
incoherent speech and behaviour and emotional flatness.
Do not use REAGILA if:
you are allergic to cariprazine, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
you are taking any of the medicines listed in Section 3. ‘What if I am taking other
medicines?’ as they may interfere with how well REAGILA® works.
Check with your doctor or pharmacist if you:
Have or have had any of these medical conditions
restlessness and inability to sit still
abnormal, involuntary movements, most commonly of the tongue or face
visual impairment
irregular heart beat or if someone else in your family has a history of irregular
heartbeat (including so called QT prolongation seen with ECG monitoring)
high or low blood pressure, cardiovascular disease
dizziness on standing up due to a drop in your blood pressure, which may cause fainting
a history of blood clots, or if someone else in your family has a history of blood
clots
a history of stroke, especially if you are elderly or know that you have other risk
factors for stroke
dementia (loss of memory and other mental abilities) especially if you are elderly
Parkinson’s disease
diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family
has diabetes)
a history of seizures (fits) or epilepsy
take any medicines for any other condition.
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. REAGILA is
not recommended for use during pregnancy and in women of childbearing potential not
using effective contraception.
Women of childbearing potential must use effective contraception during REAGILA treatment.
Even after treatment is stopped, use contraception for at least 10 weeks after your
last dose of REAGILA. This is because the medicine will stay in your body for some
time after the last dose was taken.
Ask your doctor about appropriate choices of contraception.
Like most atypical antipsychotic medicines, REAGILA is not recommended for use during
pregnancy. However, if you need to take REAGILA during your pregnancy, your doctor will discuss
with you the benefits and risks of taking it.
If your doctor decides that you should take this medicine during pregnancy, your doctor
will monitor your baby closely after birth. This is because the following symptoms
may occur in newborn babies of mothers who have used this medicine in the last trimester
(last three months) of their pregnancy.
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems,
and difficulty in feeding.
If your baby develops any of these symptoms, you should contact your doctor.
Breastfeeding is not recommended whilst you are taking this medicine, as it is not
known if this medicine can pass in to the breastmilk and affect the baby. Talk to your doctor if you are breastfeeding or intend to breastfeed.
Patients with kidney or liver problems
If you have serious kidney or liver problems REAGILA may not be appropriate for you.
Talk to your doctor.
Elderly patients
Your doctor will carefully select the appropriate dose for your needs. REAGILA should
not be used by elderly patients with dementia (loss of memory).
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 should not be taken with REAGILA as they may interfere with how well
it works.
REAGILA should not be taken with these medicines as they may increase the effect of
REAGILA and you are more likely to get side effects:
boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone,
nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole,
diltiazem, erythromycin, fluconazole, verapamil;
Avoid consuming grapefruit juice
REAGILA should not be taken with these medicines as it may reduce how well this medicine
works.
carbamazepine, phenobarbital, phenytoin, rifampicin, St. John’s wort (Hypericum perforatum),
bosentan, efavirenz, etravirine, modafinil, nafcillin.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REAGILA.
How much to take
Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended starting dose is 1.5 mg once a day by mouth. Thereafter, the dose
may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment
works for you.
The maximum dose should not exceed 6 mg once a day.
If you were taking another medicine to treat schizophrenia before starting REAGILA,
your doctor will decide whether to stop the other medicine gradually or immediately
and how to adjust the dose of REAGILA. Your doctor will also inform you how to act
if you switch from REAGILA to another medicine
When to take REAGILA
REAGILA should be taken about the same time each day with or without food.
Swallow REAGILA whole with a glass of water. Do not chew the capsule.
If you forget to use REAGILA
REAGILA should be taken regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember it. However, if it is almost time
for your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for the dose 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 take too much REAGILA
If you think that you have used too much REAGILA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking REAGILA if:
you are about to be started on any new medicines
you plan to have surgery that needs a general anaesthetic. It may affect other medicines
used during surgery.
you have signs of frequent infections such as fever, chills, sore throat or mouth
ulcers
you have hyperglycaemia (high blood sugar)
dizziness on standing up, especially when getting up from a sitting or lying position
(orthostatic hypotension) or fainting
you experience weight gain
you need to have any medical tests while you are taking REAGILA
you are about to have any blood tests as it may interfere with the results of some
tests. The following can be seen in laboratory tests:
increases in liver enzymes
increases in the level of creatine phosphokinase in the blood
abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood
Call your doctor straight away if you:
become pregnant while taking REAGILA
are having any thoughts or feelings about hurting yourself or to commit suicide. Suicidal
thoughts and behaviours are more likely at the beginning of the treatment.
have combination of confusion, drowsiness, muscle stiffness, high fever, sweating,
high blood pressure, fast heartbeat and breathing (these symptoms may be associated
with a condition called ‘neuroleptic malignant syndrome’)
Remind any doctor, dentist or pharmacist you visit that you are using REAGILA.
Things you should not do
Do not stop using this medicine suddenly.
Do not give REAGILA to a child or adolescent under the age of 18 years.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how REAGILA
affects you.
REAGILA may cause drowsiness, dizziness and vision problems in some people.
Looking after your medicine
Keep your capsules below 30°C and in the outer carton until it is time to take them
in order to protect from light.
Follow the instructions in the carton on how to take care of your medicine properly.
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.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects
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What to do
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Whole body:
a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness
of breath, itching, skin rash and sometimes a drop in blood pressure. (Rare side effect)
combination of confusion, drowsiness, muscle stiffness, high fever, sweating, high
blood pressure, fast heart beat and breathing (these symptoms may be associated with
a condition called 'neuroleptic malignant syndrome') (Side effect with frequency not
known)
Kidney-related:
inexplicable muscle pains, muscle cramps or muscle weakness. These may be signs of
muscle damage which can cause very serious kidney problems. (Rare side effect)
Bleeding-related:
symptoms related to blood clots in the veins especially in the legs (symptoms include
swelling, pain and redness in the leg), which may travel through blood vessels to
the lungs causing chest pain and difficulty in breathing. (Side effect with frequency
not known).
Mental health-related:
thoughts or feelings about hurting yourself or to commit suicide, suicide attempt.
Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
(Uncommon side effect).
Skin related:
there have been some reported cases of Stevens-Johnson Syndrome (SJS) with the use
of cariprazine, (however, the frequency is not known). SJS can be a life-threatening
skin reaction, with flu-like symptoms and widespread painful rash with blisters and
peeling skin, particularly around the mouth, nose, eyes and genitals.
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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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Less serious side effects
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Less serious side effects
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What to do
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Nervous system-related:
feeling of restlessness and inability to sit still
Parkinsonism i.e. decreased or slow movements, slowness of thought, jerks when bending
the limbs, shuffling steps, shaking, little or no facial expression, muscle stiffness,
drooling
involuntary twisting movements and strange postures
excessive teeth grinding or jaw clenching, drooling, persistent blinking, movement
problems, tongue movement disturbance
dizziness
Mental health-related:
anxiety
sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking
Eye-related:
blurred vision
Heart-related:
high blood pressure fast, irregular heartbeat
Metabolism-related:
weight increased decreased or increased appetite
Intestine-related:
nausea, vomiting, constipation
General:
tiredness
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
For eye-related side effects, your doctor will advise you to visit an ophthalmologist.
Your doctor will regularly check your weight. |
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.
This medicine is only available with a doctor's prescription.
What REAGILA contains
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Active ingredient
(main ingredient)
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cariprazine
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Other ingredients
(inactive ingredients)
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Pregelatinised maize starch
Magnesium stearate
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Do not take this medicine if you are allergic to any of these ingredients.
What REAGILA looks like
REAGILA 1.5 mg hard capsules (AUST R 325477) are white
REAGILA 3 mg hard capsules (AUST R 325478) are green and white
REAGILA 4.5 mg hard capsules (AUST R 325479) are green
REAGILA 6 mg hard capsules (AUST R 325476) are purple and white.
Who distributes REAGILA
REAGILA is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street
Sydney, NSW, 2000
Australia
This leaflet was prepared in December 2025.
