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231-30-18631-H LEA ARIPIPRAZOLE 5/10/15/20/30mg TABS TUK < ZAG
Dimensions Changed:
500 mm
155 mm
Foil Width:

• antifungal agents
5 mg, 10 mg, 15 mg, 20 mg and 30 mg • certain medicines to treat HIV infection
• anticonvulsants used to treat epilepsy.
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
- 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


What Aripiprazole Tablets are and
what they are used for

Aripiprazole Tablets contains 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.


What you need to know before
you take Aripiprazole Tablets

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 food and alcohol
Aripiprazole Tablets can be taken regardless
of meals. Alcohol should be avoided.
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.


How to take Aripiprazole Tablets

Do not take Aripiprazole Tablets
• if you are allergic to aripiprazole or any of Always take this medicine exactly as your
the other ingredients of this medicine (listed doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
in section 6).
not sure.
Warnings and precautions
The recommended dose for adults is 15 mg
Talk to your doctor before taking
once a day. However your doctor may
Aripiprazole Tablets if you suffer from
prescribe a lower or higher dose to a
• high blood sugar (characterised by
maximum of 30 mg once a day.
symptoms such as excessive thirst,
passing of large amounts of urine,
Use in children and adolescents
increase in appetite, and feeling weak) or Treatment may be started at a low dose,
family history of diabetes
e.g. with an oral solution. The dose may be
• seizure
gradually increased to the recommended
• involuntary, irregular muscle movements, dose for adolescents of 10 mg once a day.
especially in the face
However your doctor may prescribe a lower
• cardiovascular diseases, family history of or higher dose to a maximum of 30 mg
cardiovascular disease, stroke or “mini”
once a day.
stroke, abnormal blood pressure
If you have the impression that the effect of
• blood clots, or family history of blood
Aripiprazole Tablets is too strong or too
clots, as antipsychotics have been
weak, talk to your doctor or pharmacist.
associated with formation of blood clots
• past experience of excessive gambling.
Aripiprazole Tablets is for oral use.
If you notice you are gaining weight,
Try to take the tablet at the same time each
develop unusual movements, experience
day. It does not matter whether you take it
somnolence that interferes with normal
with or without food.
daily activities, any difficulty in swallowing
or allergic symptoms, please tell your doctor. 5 mg only:
Always take the tablet with water and
If you are an elderly patient suffering from
swallow it whole.
dementia (loss of memory and other mental
10 mg, 15 mg, 20 mg and 30 mg only:
abilities), you or your carer/relative should
Always take the tablet with water. The tablet
tell your doctor if you have ever had a
can be divided into equal doses.
stroke or “mini” stroke.
Even if you feel better, do not alter or
Tell your doctor immediately if you are
discontinue the daily dose of Aripiprazole
having any thoughts or feelings about
Tablets without first consulting your doctor.
hurting yourself. Suicidal thoughts and
behaviours have been reported during
If you take more Aripiprazole Tablets than
aripiprazole treatment.
you should
If you realise you have taken more tablets
Tell your doctor immediately if you suffer
than your doctor has recommended (or if
from muscle stiffness or inflexibility with
someone else has taken some of your
high fever, sweating, altered mental status,
tablets), contact your doctor right away. If
or very rapid or irregular heart beat.
you cannot reach your doctor, go to the
nearest hospital and take the pack with you.
Children and adolescents
Do not use this medicine in children and
If you forget to take Aripiprazole Tablets
adolescents under 15 years of age. It is not
If you miss a dose, take the missed dose as
known if it is safe and effective in these
soon as you remember but do not take two
doses in one day.
Other medicines and Aripiprazole Tablets
If you stop taking Aripiprazole Tablets
Tell your doctor or pharmacist if you are
Do not stop your treatment just because
taking, have recently taken or might take
you feel better. It is important that you carry
any other medicines.
on taking your tablets for as long as your
doctor has told you to.
Blood pressure-lowering medicines:
Aripiprazole Tablets may increase the effect
If you have any further questions on the use of
of medicines used to lower the blood
this medicine, ask your doctor or pharmacist.
pressure. Be sure to tell your doctor if you
take a medicine to keep your blood
4 Possible side effects
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 doctor:
• medicines to correct heart rhythm
• antidepressants or herbal remedy used to
treat depression and anxiety


Like all medicines, this medicine can cause
side effects, although not everybody gets
Common side effects (may affect up to 1 in
10 people)
• diabetes mellitus
• difficulty sleeping

Version 3.4


Colours Used:



09 August 2016

• feeling anxious
• feeling restless and unable to keep still,
difficulty sitting still
• uncontrollable twitching, jerking or
writhing movements, restless legs
• trembling
• headache
• tiredness
• sleepiness
• light-headedness
• shaking and blurred vision
• decrease number of or difficulty making
bowel movements
• indigestion
• feeling sick
• more saliva in mouth than normal
• vomiting
• feeling tired
Uncommon side effects (may affect up to
1 in 100 people)
• increased blood levels of the hormone
• too much sugar in the blood
• depression
• altered or increased sexual interest
• uncontrollable movements of mouth,
tongue and limbs (tardive dyskinesia)
• muscle disorder causing twisting
movements (dystonia)
• double vision
• fast heart beat
• a fall in blood pressure on standing up
which causes dizziness, light-headedness
or fainting
• hiccups
The following side effects have been
reported since the marketing of oral
aripiprazole but the frequency for them to
occur is not known (frequency cannot be
estimated from the available data)
• low levels of white blood cells
• low levels of blood platelets
• allergic reaction (e.g. swelling in the mouth,
tongue, face and throat, itching, hives)
• onset or worsening of diabetes,
ketoacidosis (ketones in the blood and
urine) or coma
• not enough sodium in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• thoughts of suicide, suicide attempt and
• excessive gambling
• feeling aggressive
• agitation
• nervousness
• neuroleptic malignant syndrome
(combination of fever, muscle stiffness,
faster breathing, sweating, reduced
consciousness and sudden changes in
blood pressure and heart rate)
• 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
• 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
• 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

Additional side effects in children and
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:
By reporting side effects you can help
provide more information on the safety of
this medicine.


How to store Aripiprazole Tablets

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 blister and on
the carton. 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.


Contents of the pack and other

What Aripiprazole Tablets contain
• The active substance is aripiprazole.
Each 5 mg tablet contains 5 mg of
Each 10 mg tablet contains 10 mg of
Each 15 mg tablet contains 15 mg of
Each 20 mg tablet contains 20 mg of
Each 30 mg tablet contains 30 mg of
• 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
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 Tablets are available in packs of 7,
7x1, 14, 28, 28x1, 49, 56, 56x1 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Merckle GmbH, Ludwig-Merckle-Straße 3,
Blaubeuren 89143, Germany
This leaflet was last revised in 08/2016

PL 00289/1915
In elderly patients with dementia, more fatal PL 00289/1916
PL 00289/1917
cases have been reported while taking
PL 00289/1918
aripiprazole. In addition, cases of stroke or
PL 00289/1919
“mini” stroke have been reported.


500 x 155

Page 1 of 2


Teva Pharmaceuticals Europe B.V

Signed by
Michael Silvester


Meaning of Signature
Regulatory Affairs Approval

Version 3.4


Server Date
12-Aug-2016 03:34:21 PM

Page 2 of 2

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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.