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ARIPIPRAZOLE TEVA 15MG TABLETS

Active substance(s): ARIPIPRAZOLE

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TEVA UK Ref:

231-30-12345-E LEA ARIPIPRAZOLE 5mg/10mg/15mg/30mg TABS TUK

FOLD
LINE.

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

Tablets

Keep this medicine out of the sight and
reach of children.

10 mg
Pink to light pink coloured, oblong
tablets with debossed “10” on one side
and breakline on the other side.
The tablet can be divided into equal
doses.

Blister
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.

Pink to light pink coloured, round,
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
biconvex tablets with debossed “30” on
Shelf life after first opening: 6 months.
one side and breakline on the other
side.
Do not throw away any medicines via
The tablet can be divided into equal
wastewater or household waste. Ask
doses.
your pharmacist how to throw away
medicines you no longer use. These
Aripiprazole 5 mg Tablets are available
measures will help protect the
in packs of 7, 7x1, 14, 14x1, 15, 28, 28x1,
environment.
30, 49, 56, 56x1, 60, 98, 98x1 and 100
tablets.

6 Contents of the pack and other
information

What Aripiprazole Tablets contain


The active substance is aripiprazole.
Each 5 mg tablet contains 5 mg of
aripiprazole.
Each 10 mg tablet contains 10 mg of
aripiprazole.
Each 15 mg tablet contains 15 mg of
aripiprazole.
Each 20 mg tablet contains 20 mg of
aripiprazole.
Each 30 mg tablet contains 30 mg of
aripiprazole.

The other ingredients are lactose
monohydrate, microcrystalline
cellulose, maize starch, iron oxide
yellow (E172) (5 mg + 15 mg only), iron
oxide red (E172) (10 mg + 30 mg only),
hydroxypropylcellulose, croscarmellose
sodium, magnesium stearate.
What Aripiprazole Tablets look like and
contents of the pack

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

ARIPIPRAZOLE
5 mg, 10 mg, 15 mg, 20 mg
AND 30 mg TABLETS
Package leaflet:
Information for the user

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 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 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









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,
Aripiprazole Tablets contain the active
substance aripiprazole and belongs to a altered mental status, or very rapid or
irregular heart beat.
group of medicines called
antipsychotics.
Children and adolescents
It is used to treat adults and
Aripiprazole Tablets is not for use in
adolescents aged 15 years and older
who suffer from a disease characterised children and adolescents under 15
years. Ask your doctor or pharmacist
by symptoms such as hearing, seeing
for advice before taking Aripiprazole
or sensing things which are not there,
Tablets.
suspiciousness, mistaken beliefs,
incoherent speech and behaviour and
Other medicines and Aripiprazole
emotional flatness. People with this
Tablets
condition may also feel depressed,
Tell your doctor or pharmacist if you are
guilty, anxious or tense.
taking, have recently taken or might
take any other medicines.

and what they are used for

Aripiprazole 10 mg Tablets are available
in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30,
49, 56, 56x1, 60, 98, 98x1 and 100 tablets.
Aripiprazole 15 mg Tablets are available
in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30,
49, 56, 56x1, 60, 98, 98x1 and 100 tablets.
Aripiprazole 20 mg Tablets are available
in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30,
49, 56, 56x1, 98 and 98x1 tablets.
Aripiprazole 30 mg Tablets are available
in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30,
49, 56, 56x1, 60, 98, 98x1 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22
9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3,
Blaubeuren, 89143, Germany
This leaflet was last revised in 11/2015

PL 00289/1910
PL 00289/1911
5 mg
Light yellow coloured, round, flat-faced PL 00289/1912
PL 00289/1913
bevelled edge tablets with debossed
“5” on one side and plain on the other PL 00289/1914
side.

10 December 2015

12345-E

320 x 323

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 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

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

Peel Here To Open

Pharma code TBC
First bar is 105mm from top edge.

15 mg
Light yellow coloured, round, flat-faced
bevelled edge tablets with debossed
“15” on one side and breakline on the
other side.
The tablet can be divided into equal
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg) doses.
Do not use this medicine after the
20 mg
expiry date which is stated on the label
White to off white or pale cream
and on the carton. The expiry date
coloured, capsule-shaped, biconvex
refers to the last day of that month.
tablets with debossed “20” on one side
and breakline on the other side.
Blister + HDPE bottle (5 mg, 10 mg,
The tablet can be divided into equal
15 mg, 30 mg)
doses.
This medicine does not require any
special storage conditions.
30 mg

3

Top of page cut-off to middle of registration mark = 44 mm

5 How to store Aripiprazole

Version:

TEVA UK Ref:

231-30-12345-E LEA ARIPIPRAZOLE 5mg/10mg/15mg/30mg TABS TUK

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

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, selective serotonin
re-uptake inhibitors (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.

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
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,
e.g. with an oral solution. 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 Tablets is too
strong or too weak, talk to your doctor
or pharmacist.

Aripiprazole Tablets with alcohol
Alcohol should be avoided when taking
Aripiprazole Tablets are for oral use.
Aripiprazole Tablets.
Pregnancy and breast-feeding
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 contains lactose
If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicine.

Try to take the tablet at the same time
each day. It does not matter whether
you take it with or without food.
5 mg only: Always take the tablet with
water and swallow it whole.
10 mg/15 mg/20 mg/30 mg only: Always
take the tablet with water. The tablet can
be divided into equal doses.
If you take more Aripiprazole Tablets
than you should
If you realise you have taken more
tablets than your doctor has
recommended (or if someone else has
taken some of your 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
Even if you feel better, do not alter or
discontinue the daily dose of
Aripiprazole Tablets without first
consulting your doctor.
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.

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LINE.

Version:

3

10 December 2015

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

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
• 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
• Nervousness, agitation, feeling
anxious
• Excessive gambling
• Thoughts of suicide, suicide attempt
and suicide
• Agression
• 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)
• Neuroleptic malignant syndrome (a
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
Drug withdrawal syndrome in
newborn babies
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
Adolescents 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.

TEVA UK Ref:

231-30-12345-E LEA ARIPIPRAZOLE 5/10/15/20/30mg TABS TUK < ZAG

Version:

1

27 November 2015

BLACK

ARIPIPRAZOLE
5 mg, 10 mg, 15 mg,
20 mg AND 30 mg TABLETS
Package leaflet:
Information for the user

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 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 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.

2

What you need to know before
you take Aripiprazole Tablets

• 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,
selective serotonin re-uptake inhibitors
(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 alcohol
Alcohol should be avoided when taking
Aripiprazole Tablets.
Pregnancy and breast-feeding
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 contains lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.

Do not take Aripiprazole Tablets
How to take Aripiprazole Tablets
• if you are allergic to aripiprazole or any of 3
the other ingredients of this medicine
Always take this medicine exactly as your
(listed in section 6).
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
Warnings and precautions
not sure.
Talk to your doctor 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.

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.

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.

Aripiprazole Tablets are for oral use.

from muscle stiffness or inflexibility with
high fever, sweating, altered mental status,
or very rapid or irregular heart beat.

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.

Use in children and adolescents
Treatment may be started at a low dose, e.g.
with an oral solution. 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 Tablets is too strong or too
weak, talk to your doctor or pharmacist.

Try to take the tablet at the same time each
day. It does not matter whether you take it
with or without food.
5 mg only: Always take the tablet with water
and swallow it whole.
If you are an elderly patient suffering from
10 mg/15 mg/20 mg/30 mg only: Always
dementia (loss of memory and other mental take the tablet with water. The tablet can be
abilities), you or your carer/relative should
divided into equal doses.
tell your doctor if you have ever had a
If you take more Aripiprazole Tablets than
stroke or “mini” stroke.
you should
Tell your doctor immediately if you are
If you realise you have taken more tablets
having any thoughts or feelings about
than your doctor has recommended (or if
hurting yourself. Suicidal thoughts and
someone else has taken some of your
behaviours have been reported during
tablets), contact your doctor right away. If
aripiprazole treatment.
you cannot reach your doctor, go to the
nearest hospital and take the pack with you.
Tell your doctor immediately if you suffer

Children and adolescents
Aripiprazole Tablets is not for use in children
and adolescents under 15 years. Ask your
doctor or pharmacist for advice before
taking Aripiprazole Tablets.
Other medicines and Aripiprazole Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
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 stop taking Aripiprazole Tablets
Even if you feel better, do not alter or
discontinue the daily dose of Aripiprazole
Tablets without first consulting your doctor.
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
Taking Aripiprazole Tablets with some
movements
medicines may need to change your dose of
• Headache, tiredness
Aripiprazole Tablets. It is especially
important to mention the following to your • Nausea, vomiting, an uncomfortable
feeling in the stomach, constipation
doctor:
• Increased production of saliva
• medicines to correct heart rhythm

TEVA UK Ref:

231-30-12345-E LEA ARIPIPRAZOLE 5/10/15/20/30mg TABS TUK < ZAG

• 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
• 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
• Nervousness, agitation, feeling anxious
• Excessive gambling
• Thoughts of suicide, suicide attempt and
suicide
• Agression
• 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)
• Neuroleptic malignant syndrome (a
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
• Drug withdrawal syndrome in newborn
babies
• 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.

5

Version:

1

27 November 2015

How to store Aripiprazole Tablets

Keep this medicine out of the sight and
reach of children.
Blister
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.
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
Do not use this medicine after the expiry
date which is stated on the label and on the
carton. The expiry date refers to the last day
of that month.
Blister + HDPE bottle (5 mg, 10 mg, 15 mg,
30 mg)
This medicine does not require any special
storage conditions.
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
Shelf life after first opening: 6 months.
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 5 mg tablet contains 5 mg of
aripiprazole.
Each 10 mg tablet contains 10 mg of
aripiprazole.
Each 15 mg tablet contains 15 mg of
aripiprazole.
Each 20 mg tablet contains 20 mg of
aripiprazole.
Each 30 mg tablet contains 30 mg of
aripiprazole.
The other ingredients are lactose
monohydrate, microcrystalline cellulose,
maize starch, iron oxide yellow (E172) (5 mg
+ 15 mg only), iron oxide red (E172) (10 mg
+ 30 mg only), hydroxypropylcellulose,
croscarmellose sodium, magnesium
stearate.
What Aripiprazole Tablets look like and
contents of the pack
5 mg
Light yellow coloured, round, flat-faced
bevelled edge tablets with debossed “5” on
one side and plain on the other side.
10 mg
Pink to light pink coloured, oblong tablets
with debossed “10” on one side and
breakline on the other side.
The tablet can be divided into equal doses.
15 mg
Light yellow coloured, round, flat-faced
bevelled edge tablets with debossed “15”
on one side and breakline on the other side.
The tablet can be divided into equal doses.
20 mg
White to off white or pale cream coloured,
capsule-shaped, biconvex tablets with
debossed “20” on one side and breakline
on the other side.
The tablet can be divided into equal doses.
30 mg
Pink to light pink coloured, round, biconvex
tablets with debossed “30” on one side and
breakline on the other side.
The tablet can be divided into equal doses.
Aripiprazole 5 mg Tablets are available in
packs of 7, 7x1, 14, 14x1, 15, 28, 28x1, 30, 49,
56, 56x1, 60, 98, 98x1 and 100 tablets.

In elderly patients with dementia, more fatal Aripiprazole 10 mg Tablets are available in
cases have been reported while taking
packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56,
aripiprazole. In addition, cases of stroke or
56x1, 60, 98, 98x1 and 100 tablets.
“mini” stroke have been reported.
Aripiprazole 15 mg Tablets are available in
Additional side effects in children and
packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56,
adolescents
56x1, 60, 98, 98x1 and 100 tablets.
Adolescents experienced side effects that
Aripiprazole 20 mg Tablets are available in
were similar in frequency and type to those
packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56,
in adults except that sleepiness,
56x1, 98 and 98x1 tablets.
uncontrollable twitching or jerking
Aripiprazole 30 mg Tablets are available in
movements, restlessness, and tiredness
were very common (may affect more than 1 packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56,
56x1, 60, 98, 98x1 and 100 tablets.
in 10 people) and upper abdominal pain,
dry mouth, increased heart rate, weight
Not all pack sizes may be marketed.
gain, increased appetite, muscle twitching,
uncontrolled movements of the limbs, and Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG,
feeling dizzy, especially when getting up
UK
from a lying or sitting position, were
common (may affect up to 1 in 10 people).
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3,
Reporting of side effects
Blaubeuren, 89143, Germany
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:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.

This leaflet was last revised in 11/2015
PL 00289/1910
PL 00289/1911
PL 00289/1912
PL 00289/1913
PL 00289/1914

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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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