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ARIPIPRAZOLE TEVA 15 MG ORODISPERSIBLE TABLETS

Active substance(s): ARIPIPRAZOLE

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ARIPIPRAZOLE
10 mg AND 15 mg
ORODISPERSIBLE TABLETS

Taking Aripiprazole Orodispersible Tablets with
some medicines may need to change your dose
of Aripiprazole Orodispersible Tablets. It is
especially important to mention the following to
your doctor:
PACKAGE LEAFLET:
• medicines to correct heart rhythm
INFORMATION FOR THE USER
• antidepressants or herbal remedy used to treat
Read all of this leaflet carefully before you start
depression and anxiety
taking this medicine because it contains
• antifungal agents
important information for you.
• certain medicines to treat HIV infection
• Keep this leaflet. You may need to read it again. • anticonvulsants used to treat epilepsy.
• If you have any further questions, ask your
Medicines that increase the level of serotonin:
doctor or pharmacist.
triptans, tramadol, tryptophan, selective
• This medicine has been prescribed for you
serotonin re-uptake inhibitors (SSRIs (such as
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same paroxetine and fluoxetine)), tricyclics (such as
clomipramine, amitriptyline), pethidine, St John’s
as yours.
Wort and venlafaxine. These medicines increase
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side the risk of side effects; if you get any unusual
effects not listed in this leaflet. See section 4. symptom taking any of these medicines together
with Aripiprazole Orodispersible Tablets, you
What is in this leaflet:
should see your doctor.
1. What Aripiprazole Orodispersible Tablets are
and what they are used for
2. What you need to know before you take
Aripiprazole Orodispersible Tablets
3. How to take Aripiprazole Orodispersible
Tablets
4. Possible side effects
5. How to store Aripiprazole Orodispersible
Tablets
6. Contents of the pack and other information

Aripiprazole Orodispersible Tablets with alcohol
Alcohol should be avoided when taking
Aripiprazole Orodispersible 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
Aripiprazole Orodispersible
1 What
Tablets are and what they are used for Orodispersible Tablets in the last trimester (last
three months of their pregnancy): shaking,
Aripiprazole Orodispersible Tablets contains the muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems and difficulty in
active substance aripiprazole and belongs to a
feeding. If your baby develops any of these
group of medicines called antipsychotics.
symptoms you may need to contact your doctor.
It is used to treat adults and adolescents aged
15 years and older who suffer from a disease
Be sure to tell your doctor immediately if you are
characterised by symptoms such as hearing,
breast-feeding.
seeing or sensing things which are not there,
If you are taking Aripiprazole Orodispersible
suspiciousness, mistaken beliefs, incoherent
Tablets, you should not breast-feed.
speech and behaviour and emotional flatness.
People with this condition may also feel
Driving and using machines
depressed, guilty, anxious or tense.
Do not drive or use any tools or machines, until

2

What you need to know before you
take Aripiprazole Orodispersible
Tablets

Do not take Aripiprazole Orodispersible 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
Orodispersible 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.
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.

you know how Aripiprazole Orodispersible
Tablets affects you.

Aripiprazole Orodispersible Tablets contains
aspartame (E951)
Aspartame is a source of phenylalanine. May be
harmful for people with phenylketonuria.

3

How to take Aripiprazole
Orodispersible 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 Orodispersible Tablets is too strong
or too weak, talk to your doctor or pharmacist.
Aripiprazole Orodispersible Tablets are for oral
use.
Try to take the orodispersible tablet at the same
time each day. It does not matter whether you
take it with or without food.

Once the tablet is outside the blister, using dry
Tell your doctor immediately if you are having any hands, place the entire orodispersible tablet on
the tongue. Tablet disintegration occurs rapidly in
thoughts or feelings about hurting yourself.
saliva. The orodispersible tablet can be taken
Suicidal thoughts and behaviours have been
with or without liquid. Alternatively, disperse the
reported during aripiprazole treatment.
tablet in water and drink the resulting
suspension.
Tell your doctor immediately if you suffer from
muscle stiffness or inflexibility with high fever,
sweating, altered mental status, or very rapid or If you take more Aripiprazole Orodispersible
Tablets than you should
irregular heart beat.
If you realise you have taken more orodispersible
tablets than your doctor has recommended (or if
Children and adolescents
someone else has taken some of your
Aripiprazole Orodispersible Tablets are not for
use in children and adolescents under 15 years. orodispersible tablets), contact your doctor right
Ask your doctor or pharmacist for advice before away. If you cannot reach your doctor, go to the
nearest hospital and take the pack with you.
taking Aripiprazole Orodispersible Tablets.
Other medicines and Aripiprazole Orodispersible
Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Blood pressure-lowering medicines: Aripiprazole
Orodispersible 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 forget to take Aripiprazole Orodispersible
Tablets
If you miss a dose, take the missed dose as soon
as you remember but do not take two doses in
one day.

822 (100110111)

If you stop taking Aripiprazole Orodispersible
Tablets
Even if you feel better, do not alter or discontinue
the daily dose of Aripiprazole Orodispersible
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 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
• double vision
• some people may feel depressed
• 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
• aggression
• 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.

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.

5

How to store Aripiprazole
Orodispersible 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.

6

Contents of the pack and other
information

What Aripiprazole Orodispersible Tablets
contains
• The active substance is aripiprazole.
Each 10 mg orodispersible tablet contains
10 mg of aripiprazole.
Each 15 mg orodispersible tablet contains
15 mg of aripiprazole.
• The other ingredients are microcrystalline
cellulose, silicified microcrystalline cellulose,
silica colloidal anhydrous, iron oxide yellow
(E172) (15 mg only), iron oxide red (E172) (10 mg
only), carmellose, crospovidone type B, xylitol
(E967), aspartame (E951), acesulfame
potassium (E950), tartaric acid, pineapple
flavour (contains nature identical flavourings,
natural flavours, maltodextrin and triacetin),
magnesium stearate.
What Aripiprazole Orodispersible Tablets look
like and contents of the pack
10 mg
Pink to light pink coloured, round, flat-faced
bevelled edge tablets with debossed “10” on one
side and plain on the other side.
15 mg
Light yellow coloured, round, flat-faced bevelled
edge tablets with debossed “15” on one side and
plain on the other side.
Aripiprazole Orodispersible Tablets are available
in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56,
56x1, 98 and 98x1 orodispersible 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 06/2015.
PL 00289/1940
PL 00289/1941

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,

10214-A

148 x 420
261288.01-GB
GO/DRUGS/727

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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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