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ARIPIPRAZOLE 5 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 30 mg tablets
aripiprazole
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
t Keep this leaflet. You may need to read it
again.
t If you have any further questions, ask your
doctor or pharmacist.
t 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.
t 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
Aripiprazole
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 tablets contain the active
substance aripiprazole and belong 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.

2. What you need to know before
you take Aripiprazole
Do not take Aripiprazole:
t 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
tablets if you suffer from
t 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
t seizure
t involuntary, irregular muscle movements,
especially in the face
t cardiovascular diseases, family history of
cardiovascular disease, stroke or “mini”
stroke, abnormal blood pressure
t blood clots, or family history of blood clots,
as antipsychotics have been associated
with formation of blood clots
t past experience of excessive gambling

Suicidal thoughts and behaviours have been
reported during aripiprazole treatment.

t

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.

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.

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.

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.

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.

Children and adolescents
Do not use this medicine in children and
adolescents under 15 years of age. It is not
known if it is safe and effective in these
patients.
Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including medicines
obtained without a prescription.

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:
t Medicines to correct heart rhythm
t Antidepressants or herbal remedy used to
treat depression and anxiety
t Antifungal agents

t

Certain medicines to treat HIV infection
Anticonvulsants used to treat epilepsy

Aripiprazole with food, drink and alcohol
Aripiprazole tablets can be taken regardless
of meals.
Alcohol should be avoided.
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
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 affect
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
product.

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.

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If you have the impression that the effects of
your Aripiprazole tablets are too strong or too
weak, talk to your doctor or pharmacist.
Try to take your Aripiprazole tablets 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
tablets without first consulting your doctor.
If you take more Aripiprazole 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
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.
If you stop taking Aripiprazole
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.

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):
t diabetes mellitus,
t difficulty sleeping,
t feeling anxious,
t feeling restless and unable to keep still,
difficulty sitting still,
t uncontrollable twitching, jerking or writhing
movements, restless legs,
t trembling,
t headache,
t tiredness,
t sleepiness,
t light-headedness,
t shaking and blurred vision,
t decreased number of or difficulty making
bowel movements,
t indigestion,
t feeling sick,
t more saliva in mouth than normal,
t vomiting,
t feeling tired.

Uncommon side effects (may affect up to
1 in 100 people):
t increased blood levels of the hormone
prolactin,
t too much sugar in the blood,
t depression,
t altered or increased sexual interest,
t uncontrollable movements of mouth, tongue
and limbs (tardive dyskinesia),
t muscle disorder causing twisting
movements (dystonia),
t double vision,
t fast heart beat,
t a fall in blood pressure on standing up
which causes dizziness, light-headedness or
fainting,
t hiccups.
The following side effects have been reported
since the marketing of oral aripiprazole but
the frequency for them to occur is not known:
t low levels of white blood cells,
t low levels of blood platelets,
t allergic reaction (e.g. swelling in the mouth,
tongue, face and throat, itching, hives),
t onset or worsening of diabetes, ketoacidosis
(ketones in the blood and urine) or coma,
t high blood sugar,
t not enough sodium in the blood,
t loss of appetite (anorexia),
t weight loss,
t weight gain,
t thoughts of suicide, suicide attempt and
suicide,

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excessive gambling,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness,
faster breathing, sweating, reduced
consciousness and sudden changes in
blood pressure and heart rate, fainting
(neuroleptic malignant syndrome),
seizure,
serotonin syndrome (a reaction which may
cause feelings of great happiness,
drowsiness, clumsiness, restlessness,
feeling of being drunk, fever, sweating or
rigid muscles),
speech disorder,
sudden unexplained death,
life-threatening irregular heart beat,
heart attack,
slower heart beat,
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),
high blood pressure,
fainting,
accidental inhalation of food with risk of
pneumonia (lung infection),
spasm of the muscles around the voice box,
inflammation of the pancreas,

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difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and white part of eyes,
reports of abnormal liver tests values,
skin rash,
sensitivity to light,
baldness,
excessive sweating,
abnormal muscle breakdown which can
lead to kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty in passing urine,
withdrawal symptoms in newborn babies in
case of exposure during pregnancy,
prolonged and/or painful erection,
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 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 (may affect more
than 1 in 10 people) 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 (may
affect up to 1 in 10 people).
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:
https://yellowcard.mhra.gov.uk.
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
t The active substance is aripiprazole. Each
tablet contains 5 mg, 10 mg, 15 mg or
30 mg aripiprazole.
t 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
side.
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
Manufacturer
Marketing Authorisation Holder
Consilient Health Ltd., 5th floor, Beaux Lane
House, Mercer Street Lower, Dublin 2,
Ireland
Manufacturer
KRKA, d. d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto,
Slovenia
This leaflet was last revised in 07/2016
P0499

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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.

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