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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 5mg, 10mg, 15mg and
30mg 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 or
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
• The full name of this medicine is Aripiprazole 5mg,
10mg, 15mg and 30mg 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
2. What you need to know before you take Aripiprazole
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.

Tell your doctor immediately if you suffer from muscle
stiffness or inflexibility with high fever, sweating, altered
mental status, or very rapid or irregular heartbeat.
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 symptom taking any of these medicines
together with Aripiprazole tablets, you should see your
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,
2. What you need to know before you take Aripiprazole 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
Do not take Aripiprazole tablets
contact your doctor.
• if you are allergic to aripiprazole or any of the other
ingredients of this medicine (listed in section 6).
Be sure to tell your doctor immediately if you are breastfeeding. If you are taking Aripiprazole tablets, you should
Warnings and precautions
not breast-feed.
Talk to your doctor before taking Aripiprazole tablets if
you suffer from
Driving and using machines
• High blood sugar (characterised by symptoms such
Do not drive or use any tools or machines, until you
as excessive thirst, passing of large amounts of urine,
know how Aripiprazole tablets affects you.
increase in appetite, and feeling weak) or family history
of diabetes
Aripiprazole tablets contain lactose
• S eizure
If you have been told by your doctor that you have an
• Involuntary, irregular muscle movements, especially in intolerance to some sugars, contact your doctor before
the face
taking this medicine.
• Cardiovascular diseases, family history of cardiovascular
disease, stroke or “mini” stroke, abnormal blood
3. How to take Aripiprazole tablets
• Blood clots, or family history of blood clots, as
antipsychotics have been associated with formation of Always take this medicine exactly as your doctor or
blood clots
pharmacist has told you. Check with your doctor or
• Past experience of excessive gambling
pharmacist if you are not sure.
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

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 effect of Aripiprazole
tablets is too strong or too weak, talk to your doctor or
Continued over page

T00075-01 Malta Zejtun 190x380 PIL

Try to take the Aripiprazole tablet at the same time
each day.
It does not matter whether you take it with or without
food. Always take the tablet with water and swallow it
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
than your doctor has recommended (or if someone else
has taken some of your Aripiprazole 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 tablets
Do not stop your treatment just because you feel better.
It is important that you carry on taking your Aripiprazole
tablets for as long as your doctor has told you to.

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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Aripiprazole tablets

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

Keep this medicine out of the sight and reach of

4. Possible side effects

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

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common side effects (may affect up to 1 in 10
people): 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.
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
heartbeat, 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.

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.
6. Contents of the pack and other information
What Aripiprazole tablets contain
• The active substance is aripiprazole. Each tablet
contains 5mg of aripiprazole, 10mg of aripiprazole,
15mg of aripiprazole, 30mg of aripiprazole.
• The other ingredients are lactose monohydrate, maize
starch, microcrystalline cellulose, hydroxypropyl
cellulose type EF (E463), magnesium stearate, purified
What Aripiprazole tablets look like and contents of the
Aripiprazole 5mg tablets are round, biconvex and white
5mm, engraved with “5” on one side and “ZL” on one
Aripiprazole 10mg tablets are capsule shaped, biconvex
and white 8mm x 5mm, engraved with “10” on one side
and “ZL” on one side.
Aripiprazole 15mg round, biconvex and white 7mm,
engraved with “15” on one side and “ZL” on one side.
Aripiprazole 30mg tablets round, biconvex and white
9mm, engraved with “30” on one side and “ZL” on one
Pack sizes:
Push-through blister packs: 28
Marketing Authorisation Holder
Caduceus Pharma Ltd
6th floor
94 Wigmore Street
Actavis Ltd
BLB 016
Bulebel Industrial Estate
Zejtun ZTN 3000
This leaflet was last revised in May 2016

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.

Continued top of next column


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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.