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Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user
Aripiprazole 20mg and 30mg Orodispersible Tablets

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.
The full name of this medicine is Aripiprazole 20mg and 30mg Orodispersible Tablets
but within the leaflet it will be referred to as Aripiprazole tablets.

What is in this leaflet


What Aripiprazole tablets are and what they are used for
What you need to know before you take Aripiprazole tablets
How to take Aripiprazole tablets
Possible side effects
How to store Aripiprazole tablets
Contents of the pack and other information

What Aripiprazole tablets are and what they are used for

Aripiprazole tablets contains the active substance aripiprazole and belongs to a group of
medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older who suffer from a disease
characterised by symptoms such as hearing, seeing or sensing things which are not there,
suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole tablets is used to treat adults and adolescents aged 13 years and older who suffer
from a condition with symptoms such as feeling "high", having excessive amounts of energy,
needing much less sleep than usual, talking very quickly with racing ideas and sometimes
severe irritability. In adults it also prevents this condition from returning in patients who have
responded to the treatment with Aripiprazole tablets.


What you need to know before you take Aripiprazole tablets

Do not take Aripiprazole tablets
if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Aripiprazole tablets if you suffer from:
- High blood sugar (characterised by symptoms such as excessive thirst, passing of large
amounts of urine, increase in appetite, and feeling weak) or family history of diabetes
- Seizure
- Involuntary, irregular muscle movements, especially in the face


Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke,
abnormal blood pressure
Blood clots, or family history of blood clots, as antipsychotics have been associated with
formation of blood clots
Past experience of excessive gambling

If you notice you are gaining weight, develop unusual movements, experience somnolence
that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms,
please tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental
abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or
“mini” stroke.
Tell your doctor immediately if you are having any thoughts or feelings about hurting
yourself. Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high
fever, sweating, altered mental status, or very rapid or irregular heart beat.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if
it is safe and effective in these patients..
Other medicines and Aripiprazole tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Blood pressure-lowering medicines: Aripiprazole tablets may increase the effect of
medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine
to keep your blood pressure under control.
Taking Aripiprazole tablets with some medicines may need to change your dose of
Aripiprazole tablets. It is especially important to mention the following to your doctor:
- Medicines to correct heart rhythm
- Antidepressants or herbal remedy used to treat depression and anxiety
- Antifungal agents
- Certain medicines to treat HIV infection
- Anticonvulsants used to treat epilepsy
Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as
paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St
John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any
unusual symptom taking any of these medicines together with Aripiprazole tablets, you
should see your doctor.
Aripiprazole tablets with food, drink and alcohol
Aripiprazole tablets can be taken regardless of meals.
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used /…/ 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 may need to contact your doctor.
Be sure to tell your doctor immediately if you are breast-feeding.
If you are taking Aripiprazole tablets, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how Aripiprazole tablets affects
Aripiprazole tablets contains aspartame
Patients who cannot take phenylalanine should note that Aripiprazole tablets orodispersible
tablets contain aspartame, which is a source of phenylalanine. May be harmful for people
with phenylketonuria.


How to take Aripiprazole tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose for adults is 15mg once a day. However your doctor may prescribe
a lower or higher dose to a maximum of 30mg once a day.
Use in children and adolescents
This medicinal product may be started at a low dose with the oral solution (liquid) form. The
dose may be gradually increased to the recommended dose for adolescents of 10mg once a
day. However your doctor may prescribe a lower or higher dose to a maximum of 30mg once
a day.
If you have the impression that the effects of your Aripiprazole orodispersible tablets are too
strong or too weak, talk to your doctor or pharmacist.
Try to take the Aripiprazole orodispersible tablet at the same time each day. It does not
matter whether you take it with or without food.
Immediately upon opening the blister, using dry hands, remove the tablet and place the entire
orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The
orodispersible tablet can be taken with or without liquid. Alternatively, disperse the tablet in
water and drink the resulting suspension.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole tablets
without first consulting your doctor.
If you take more Aripiprazole tablets than you should
If you realise you have taken more Aripiprazole tablets orodispersible tablets than your doctor
has recommended (or if someone else has taken some of your Aripiprazole orodispersible
tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest
hospital and take the pack with you.
The following symptoms may occur: feeling unusually tired or sleepy, increased blood
pressure, rapid heart beat, feeling or being sick and diarrhoea. Serious signs and symptoms in

children may include tiredness, fainting and abnormal body movements (called
extrapyramidal symptoms).
If you forget to take Aripiprazole tablets
If you miss a dose, take the missed dose as soon as you remember but do not take two doses
in one day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aripiprazole orodispersible tablets
Do not stop your treatment just because you feel better. It is important that you carry on
taking Aripiprazole orodispersible tablets for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or


Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately if you
experience any of the following serious side effects:
Common side effects (may affect up to 1 in 10 people):
- feeling more thirsty or hungrier then usual, need to urinate more often, feeling
confused, weak, tired or your breath may smell fruity, these are signs of diabetes.
Unknown frequency (cannot be estimated from the available data):
- severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue
and/or throat, which may cause difficulty in swallowing or breathing (angioedema).
- abnormal bruising, bleeding, or signs of infection such as a sore throat and high
temperature (can indicate reduced number of white blood cells or platelets).
- thoughts of suicide or suicide attempt.
- Swelling, pain, and redness in the leg indicating a blood clot in the veins, which
may travel through blood vessels to the lungs causing chest pain and difficulty in
- yellowing of the skin and white part of eyes (jaundice), dark urine, nausea,
diarrhoea, tiredness, flu like symptoms, swollen abdomen, bleeding easily or
confusion (can be symptoms of liver inflammation or liver failure).
- fever, muscle stiffness, muscle pains, vomiting, sweating, dark urine, or a lowered
level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”).
- prolonged and/or painful erection.
The following side effects could happen:
Common side effects (may affect up to 1 in 10 people):
difficulty sleeping
feeling anxious
feeling restlessness and unable to keep still, difficulty sitting still
uncontrollable twitching or jerking movements, restless legs


light headedness
shaking and blurred vision
decreased number of or difficulty making bowel movements
feeling sick
more saliva in mouth than normal
feeling tired

Uncommon side effects (may affect up to 1 in 100 people):
increased blood levels of the hormone prolactin
too much sugar in the blood
altered or increased sexual interest
uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
muscle disorder causing twisting movements (dystonia)
double vision
fast heart beat
a fall in blood pressure on standing up which causes dizziness, light-headedness or
The following side effects have been reported since the marketing of oral aripiprazole but the
frequency for them to occur is not known (frequency cannot be estimated from the available


worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma
high blood sugar
not enough sodium in the blood
loss of appetite (anorexia)
weight loss
weight gain
excessive gambling
feeling aggressive
serotonin syndrome (a reaction which may cause feelings of great happiness,
drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid
speech disorder
sudden unexplained death
life-threatening irregular heart beat
heart attack
slower heart beat
high blood pressure
accidental inhalation of food with risk of pneumonia (lung infection)
spasm of the muscles around the voice box
inflammation of the pancreas
difficulty swallowing
abdominal discomfort


stomach discomfort
reports of abnormal liver tests values
skin rash
sensitivity to light
excessive sweating
abnormal muscle breakdown which can lead to kidney problems
muscle pain
involuntary loss of urine (incontinence)
difficulty in passing urine
withdrawal symptoms in newborn babies in case of exposure during pregnancy
difficulty controlling core body temperature or overheating
chest pain
swelling of hands, ankles or feet
in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin

In elderly patients with dementia, more fatal cases have been reported while taking
aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and older experienced side effects that were similar in frequency
and type to those in adults except that sleepiness, uncontrollable twitching or jerking
movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and
upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite,
muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when
getting up from a lying or sitting position, were common (greater than 1 in 100 patients).
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
Yellow Card Scheme Website:
By reporting side effects you can help provide more information on the safety of this


How to store Aripiprazole tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton.
The expiry date refers to the last day of that month.

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


Contents of the pack and other information

What Aripiprazole tablets contains
- The active substance is aripiprazole Each orodispersible contains 20mg, 30mg of


The other ingredients are Silicified microcrystalline cellulose, Aspartame (E951), Vanilla
flavour (501469 TP0551), Magnesium stearate, Croscarmellose sodium (E468),
Yellow iron oxide (E172) 30mg orodispersible,

What Aripirazole tablets looks like and contents of the pack

Orodispersible tablet 20 mg
Round and white,9 mm with "3" debossed on one side and "ZT" on the other.
Orodispersible tablet 30 mg
Round and yellow mottled,10.5 mm with "4" debossed on one side and "ZT" on the other.
Pack sizes:
Push-through blisters packed in cartons containing 28 orodispersible tablets.

Marketing Authorisation Holder
Caduceus Pharma Ltd
6th Floor
94 Wigmore Street
United Kingdom
Actavis Ltd.
Bulebel Industrial Estate
Zejtun ZTN 3000

This leaflet was last revised in February 2017

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Further information

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