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ARIPIPRAZOLE TEVA 10 MG ORODISPERSIBLE TABLETS

Active substance(s): ARIPIPRAZOLE

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ARIPIPRAZOLE
10 mg AND 15 mg
ORODISPERSIBLE TABLETS

Be sure to tell your doctor if you take a medicine
to keep your blood pressure under control.

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

Aripiprazole Orodispersible 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.
Aripiprazole Orodispersible Tablets are used to
treat adults and adolescents aged 13 years and
older who suffer from a condition with symptoms
such as feeling “high”, having excessive
amounts of energy, needing much less sleep than
usual, talking very quickly with racing ideas and
sometimes severe irritability. In adults it also
prevents this condition from returning in patients
who have responded to the treatment with
Aripiprazole Orodispersible Tablets.

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.
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, altered mental status, or very rapid or
irregular heart beat.
Children and adolescents
Do not use this medicine in children and
adolescents under 13 years of age. It is not
known if it is safe and effective in these patients.

The following symptoms may occur in newborn
babies, of mothers that have used Aripiprazole
Orodispersible 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 Orodispersible
Tablets, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until
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
hands, place the entire orodispersible tablet on
the tongue. Tablet disintegration occurs rapidly in
saliva. The orodispersible tablet can be taken
with or without liquid. Alternatively, disperse the
tablet in water and drink the resulting suspension.
Even if you feel better, do not alter or discontinue
the daily dose of Aripiprazole Orodispersible
Tablets without first consulting your doctor.
If you take more Aripiprazole Orodispersible
Tablets than you should
If you realise you have taken more orodispersible
tablets than your doctor has recommended (or if
someone else has taken some of your
orodispersible 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 Orodispersible
Tablets
If you miss a dose, take the missed dose as soon
as you remember but do not take two doses in
Other medicines and Aripiprazole Orodispersible
one day.
Tablets
If you stop taking Aripiprazole Orodispersible
Tell your doctor or pharmacist if you are taking,
Tablets
have recently taken or might take any other
Do not stop your treatment just because you feel
medicines.
better. It is important that you carry on taking
Blood pressure-lowering medicines: Aripiprazole
your orodispersible tablets for as long as your
Orodispersible Tablets may increase the effect of
doctor has told you to.
medicines used to lower the blood pressure.

REG0162593

Version 6.2

Approved

Page 1 of 4

Pharma code 387

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)
• diabetes mellitus
• difficulty sleeping
• 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
• decreased number of or difficulty making
bowel movements
• indigestion
• feeling sick
• more saliva in mouth than normal
• vomiting
• feeling tired.











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 13 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
Uncommon side effects (may affect up to 1 in 100 position, were common (may affect up to 1 in 10
people)
people).
• increased blood levels of the hormone
Reporting of side effects
prolactin
If you get any side effects, talk to your doctor or
• too much sugar in the blood
pharmacist. This includes any possible side
• depression
effects not listed in this leaflet. You can also
• altered or increased sexual interest
report side effects directly via the Yellow Card
• uncontrollable movements of mouth, tongue
Scheme at: www.mhra.gov.uk/yellowcard, or
and limbs (tardive dyskinesia)
• muscle disorder causing twisting movements search for MHRA Yellow Card in the Google Play
or Apple App Store.
(dystonia)
• double vision
By reporting side effects you can help provide
• fast heart beat
more information on the safety of this medicine.
• a fall in blood pressure on standing up which
causes dizziness, light-headedness or fainting
5 How to store Aripiprazole
• hiccups.
Orodispersible Tablets
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
suicide
• 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,
fainting)
• 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

REG0162593

Version 6.2

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 edged tablets with debossed “10” on
one side and plain on the other side.
15 mg
Light yellow coloured, round, flat-faced bevelled
edged 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 08/2017.
PL 00289/1940
PL 00289/1941

Approved

EAS1393a
261288.05-GB
GO/DRUGS/727

Page 2 of 4

+ Expand Transcript

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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