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Active substance(s): ARIPIPRAZOLE

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T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: Information for the user

Aripiprazole 10mg and 15mg
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 10mg
and 15mg Orodispersible Tablets but within the
leaflet it will be referred to as Aripiprazole tablets.
What is in this leaflet
1. What Aripiprazole tablets are and what they are
used for
2. What you need to know before you take
Aripiprazole tablets
3. How to take Aripiprazole tablets
4. Possible side effects
5. How to store Aripiprazole tablets
6. Contents of the pack and other information
1. What Aripiprazole tablets are and what they are
used for
Aripiprazole tablets contain 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 are 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.
2. 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.

Continued top of next column

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
• 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 symptoms 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 Aripiprazole tablets 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 you.
Aripiprazole tablets contain aspartame
Patients who cannot take phenylalanine should
note that Aripiprazole orodispersible tablets contain
aspartame, which is a source of phenylalanine.
May be harmful for people with phenylketonuria.
3. 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.
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T00075-01 Malta Zejtun 190x380 PIL

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
If you realise you have taken more Aripiprazole
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.
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.
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.

In elderly patients with dementia, more fatal cases have
been reported while taking aripiprazole. In
addition, cases of stroke or “mini” stroke have been
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 the Yellow Card Scheme Website:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Aripiprazole tablets
Keep this medicine out of the sight and reach of

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

Do not use this medicine after the expiry date which is
stated on the blister and on the carton.

4. Possible side effects

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.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common side effects (may affect up to 1 in 10
Uncontrollable twitching or jerking movements,
headache, tiredness, nausea, vomiting, an
uncomfortable feeling in the stomach, constipation,
increased production of saliva, light-headedness,
trouble sleeping, restlessness, feeling anxious,
sleepiness, shaking and blurred vision.
Uncommon side effects (may affect up to
1 in 100 people)
Some people may feel dizzy, especially when getting
up from a lying or sitting position, or may experience a
fast heart rate or double vision. Some people may feel
depressed. Some people may experience altered or
increased sexual interest and increased blood levels of
the hormone prolactin. Hiccups.
The following side effects have been reported since the
marketing of aripiprazole but the frequency for them
to occur is not known (frequency cannot be estimated
from the available data):
Changes in the levels of some blood cells; unusual
heart beat, sudden unexplained death, heart attack;
allergic reaction (e.g. swelling in the mouth, tongue,
face and throat, itching, rash); high blood sugar, onset
or worsening of diabetes, ketoacidosis (ketones in
the blood and urine) or coma, low sodium level in the
blood; weight gain, weight loss, anorexia; aggression,
nervousness, agitation, feeling anxious, excessive
gambling; thoughts of suicide, suicide attempt and
suicide; speech disorder, seizure, serotonin syndrome
(a reaction which may cause feelings of great happiness,
drowsiness, clumsiness, restlessness, feeling of being
drunk, fever, sweating or rigid muscles), combination
of fever, muscle stiffness, faster breathing, sweating,
reduced consciousness and sudden changes in blood
pressure and heart rate; fainting, high blood pressure,
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 (if you notice any
of these symptoms, seek medical advice immediately);
spasm of the muscles around the voice box, accidental
inhalation of food with risk of pneumonia, difficulty in
swallowing; inflammation of the pancreas; liver failure,
inflammation of the liver, yellowing of the skin and
white part of eyes, reports of abnormal liver test values,
abdominal and stomach discomfort, diarrhoea; skin rash
and sensitivity to light, unusual hair loss or thinning,
excessive sweating; stiffness or cramps, muscle pain,
weakness; involuntary loss of urine, difficulty in passing
urine; prolonged and/or painful erection; difficulty
controlling core body temperature or overheating,
chest pain, and swelling of hands, ankles or feet.
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6. Contents of the pack and other information
What Aripiprazole tablets contain
• The active substance is aripiprazole. Each
orodispersible tablet contains 10mg, 15mg
of aripiprazole
• The other ingredients are:
Silicified microcrystalline cellulose, Aspartame (E951),
Vanilla flavour (501469 TP0551), Magnesium stearate,
Croscarmellose sodium (E468). Yellow iron oxide
(E172) for 15mg orodispersible.
What Aripirazole tablets look like and contents of
the pack
Orodispersible tablet 10mg
Round and white, 7mm with “1” debossed on one side
and “ZT” on the other.
Orodispersible tablet 15mg
Round and yellow mottled, 8mm with “2” 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
Actavis Ltd.
Bulebel Industrial Estate
Zejtun ZTN 3000
This leaflet was last revised in May 2016


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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.