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Active substance(s): ARIPIPRAZOLE

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Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 30 mg tablets

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
• Keep this leaflet. You may need to read it
• If you have any further questions, ask your
doctor or pharmacist.
• 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.

What is in this leaflet
1. What Aripiprazole is and what it is used for
2. What you need to know before you take
3. How to take Aripiprazole
4. Possible side effects
5. How to store Aripiprazole
6. Contents of the pack and other information

1. What Aripiprazole is and
what it is used for

Aripiprazole is one of 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.

2. What you need to know
before you take Aripiprazole

Do not take Aripiprazole:
• 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 before taking Aripiprazole 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
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
Aripiprazole is not for use in children and
adolescents under 15 years. Ask your doctor
or pharmacist for advice before taking

Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

Blood pressure-lowering medicines:
Aripiprazole 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
Taking Aripiprazole with some medicines may
need to change your dose of Aripiprazole. 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,
you should see your doctor.

Aripiprazole with food, drink and alcohol
Aripiprazole can be taken regardless of meals.

Alcohol should be avoided when taking
Pregnancy and breast-feeding
You should not take Aripiprazole if you
are pregnant unless you have discussed this
with your doctor.
Be sure to tell your doctor immediately if you
are pregnant, think you may be pregnant, or if
you are planning to become pregnant.
The following symptoms may occur in
newborn babies, of mothers that have used
aripiprazole 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
Be sure to tell your doctor immediately
if you are breast-feeding.
If you are taking Aripiprazole, you should not

Driving and using machines
Do not drive or use any tools or machines,
until you know how Aripiprazole affects you.

Aripiprazole contains lactose
If you have been told by your doctor that you

have an intolerance to some sugars, contact
your doctor before taking this medicinal

3. How to take Aripiprazole

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
15 mg once a day. However your doctor
may prescribe a lower or higher dose to a
maximum of 30 mg once a day.

Use in children and adolescents
Treatment may be started at a low dose with
aripiprazole oral solution (liquid) form. The
dose may be gradually increased to the
recommended dose for adolescents of
10 mg once a day. However your doctor
may prescribe a lower or higher dose to a
maximum of 30 mg once a day.
If you have the impression that the effect of
Aripiprazole is too strong or too weak, talk to
your doctor or pharmacist.
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 whole.
Even if you feel better, do not alter or
discontinue the daily dose of Aripiprazole
without first consulting your doctor.
If you take more Aripiprazole than you
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
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 have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects

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.
Some people may feel depressed.
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; 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.
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 aged 15 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
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 packaging after
EXP. The expiry date refers to the last day of
that month.
This medicine does not require any special
storage conditions.
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 contains
• The active substance is aripiprazole. Each

tablet contains 5 mg, 10 mg, 15 mg or
30 mg aripiprazole.
• The other ingredients are lactose
monohydrate, microcrystalline cellulose
(E460), maize starch, hydroxypropylcellulose
(E463), red iron oxide (E172) – only in
10 mg and 30 mg tablets, yellow iron oxide
(E172) – only in 15 mg tablets, indigo
carmine (E132) – only in 5 mg tablets and
magnesium stearate (E470b). See section 2
“Aripiprazole contains lactose”.
What Aripiprazole looks like and
contents of the pack
5 mg tablets: Blue, round tablets with
bevelled edges and with possible darker and
lighter spots.
10 mg tablets: Light pink, rectangular tablets
with possible darker and lighter spots and
engraved with A10 on one side.
15 mg tablets: Light yellow to brownish
yellow, round, slightly biconvex tablets with
bevelled edges and with possible darker and
lighter spots and engraved with A15 on one
30 mg tablets: Light pink, round, biconvex
tablets with bevelled edges and with possible
darker and lighter spots and engraved with
A30 on one side.

Aripiprazole is available in boxes containing
14, 28, 30, 50, 56, 60, 84, 90, 98 or 100
tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation Holder
Consilient Health Ltd., 5th floor, Beaux Lane
House, Mercer Street Lower, Dublin 2,
KRKA, d. d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto,
This leaflet was last revised in 10/2014.


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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.