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ARIPIPRAZOLE TEVA 20 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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TEVA UK Ref:

231-30-18631-E LEA ARIPIPRAZOLE 5/10/15/20/30mg TABS TUK < ZAG

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 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.

2

What you need to know before
you take Aripiprazole Tablets

Version:

1

17 November 2014

• 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.
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
• if you are allergic to aripiprazole or any of 3 How to take Aripiprazole Tablets
the other ingredients of this medicine
Always take this medicine exactly as your
(listed in section 6).
doctor or pharmacist has told you. Check
Warnings and precautions
with your doctor or pharmacist if you are
Talk to your doctor before taking
not sure.
Aripiprazole Tablets if you suffer from
• high blood sugar (characterised by
The recommended dose for adults is 15 mg
symptoms such as excessive thirst,
once a day. However your doctor may
passing of large amounts of urine,
prescribe a lower or higher dose to a
increase in appetite, and feeling weak) or maximum of 30 mg once a day.
family history of diabetes
Use in children and adolescents
• seizure
• involuntary, irregular muscle movements, Treatment may be started at a low dose, e.g.
with an oral solution. The dose may be
especially in the face
• cardiovascular diseases, family history of gradually increased to the recommended
dose for adolescents of 10 mg once a day.
cardiovascular disease, stroke or “mini”
However your doctor may prescribe a lower
stroke, abnormal blood pressure
or higher dose to a maximum of 30 mg
• blood clots, or family history of blood
once a day.
clots, as antipsychotics have been
associated with formation of blood clots
If you have the impression that the effect of
• past experience of excessive gambling.
Aripiprazole Tablets is too strong or too
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.

weak, talk to your doctor or pharmacist.
Aripiprazole Tablets is for oral use.

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:
If you are an elderly patient suffering from
Always take the tablet with water and
dementia (loss of memory and other mental swallow it whole.
abilities), you or your carer/relative should
10 mg, 15 mg, 20 mg and 30 mg only:
tell your doctor if you have ever had a
Always take the tablet with water. The tablet
stroke or “mini” stroke.
can be divided into equal doses.
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.

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
Children and adolescents
Aripiprazole Tablets is not for use in children soon as you remember but do not take two
doses in one day.
and adolescents under 15 years. Ask your
doctor or pharmacist for advice before
If you stop taking Aripiprazole Tablets
taking Aripiprazole Tablets.
Even if you feel better, do not alter or
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.

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.

Taking Aripiprazole Tablets with some
medicines may need to change your dose of Common side effects (may affect up to
1 in 10 people)
Aripiprazole Tablets. It is especially
important to mention the following to your • Uncontrollable twitching or jerking
movements
doctor:

TEVA UK Ref:

231-30-18631-E LEA ARIPIPRAZOLE 5/10/15/20/30mg TABS TUK < ZAG

• 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
• Some people may feel depressed.
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
• 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

17 November 2014

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.

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 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

Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3,
In elderly patients with dementia, more fatal Blaubeuren 89143, Germany
cases have been reported while taking
This leaflet was last revised in 11/2014
aripiprazole. In addition, cases of stroke or
“mini” stroke have been reported.
PL 00289/1915
PL 00289/1916
Additional side effects in children and
PL 00289/1917
adolescents
PL 00289/1918
Adolescents experienced side effects that
were similar in frequency and type to those PL 00289/1919
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.

18631-E

500 x 155

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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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