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ARIPIPRAZOLE TEVA 10 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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ZINC Ref:

EAS1763a LEA ARIPIPRAZOLE 5, 10, 15, 20 & 30MG TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
380 mm
190 mm
N/A
N/A

Version:

Colours Used:

2

31 October 2017
BLACK
PANTONE® GREEN C
Template

ARIPIPRAZOLE 5 mg, 10 mg, 15 mg, 20 mg
and 30 mg TABLETS

especially important to mention the following to your
doctor:
• medicines to correct heart rhythm
Package leaflet: Information for the user
• antidepressants or herbal remedy used to treat
depression and anxiety
Read all of this leaflet carefully before you start taking

antifungal agents
this medicine because it contains important
• certain medicines to treat HIV infection
information for you.
• anticonvulsants used to treat epilepsy.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or Medicines that increase the level of serotonin: triptans,
tramadol, tryptophan, selective serotonin re-uptake
pharmacist.
inhibitors (SSRIs (such as paroxetine and fluoxetine)),
- This medicine has been prescribed for you only. Do
tricyclics (such as clomipramine, amitriptyline), pethidine,
not pass it on to others. It may harm them, even if
St John’s Wort and venlafaxine. These medicines increase
their signs of illness are the same as yours.
the risk of side effects; if you get any unusual symptom
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not taking any of these medicines together with Aripiprazole
Tablets, you should see your doctor.
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.
Aripiprazole 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 Tablets.

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).

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.

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
Warnings and precautions
the recommended dose for adolescents of 10 mg once
Talk to your doctor before taking Aripiprazole Tablets if
a day. However your doctor may prescribe a lower or
you suffer from
higher dose to a maximum of 30 mg once a day.
• high blood sugar (characterised by symptoms such as
If you have the impression that the effect of
excessive thirst, passing of large amounts of urine,
Aripiprazole Tablets is too strong or too weak, talk to
increase in appetite, and feeling weak) or family
your doctor or pharmacist.
history of diabetes
Aripiprazole Tablets are for oral use.
• seizure
• involuntary, irregular muscle movements, especially
Try to take the tablet at the same time each day. It does
in the face
not matter whether you take it with or without food.
• cardiovascular diseases, family history of
5 mg only:
cardiovascular disease, stroke or “mini” stroke,
Always take the tablet with water and swallow it whole.
abnormal blood pressure
10 mg, 15 mg, 20 mg and 30 mg only:
• blood clots, or family history of blood clots, as
Always take the tablet with water. The tablet can be
antipsychotics have been associated with formation
divided into equal doses.
of blood clots
Even if you feel better, do not alter or discontinue the
• past experience of excessive gambling.
daily dose of Aripiprazole Tablets without first
If you notice you are gaining weight, develop unusual
consulting your doctor.
movements, experience somnolence that interferes
with normal daily activities, any difficulty in swallowing If you take more Aripiprazole Tablets than you should
If you realise you have taken more tablets than your
or allergic symptoms, please tell your doctor.
doctor has recommended (or if someone else has taken
If you are an elderly patient suffering from dementia
some of your tablets), contact your doctor right away. If
(loss of memory and other mental abilities), you or your you cannot reach your doctor, go to the nearest hospital
carer/relative should tell your doctor if you have ever
and take the pack with you.
had a stroke or “mini” stroke.
If you forget to take Aripiprazole Tablets
Tell your doctor immediately if you are having any
If you miss a dose, take the missed dose as soon as you
thoughts or feelings about hurting yourself. Suicidal
remember but do not take two doses in one day.
thoughts and behaviours have been reported during
If you stop taking Aripiprazole Tablets
aripiprazole treatment.
Do not stop your treatment just because you feel better.
Tell your doctor immediately if you suffer from muscle It is important that you carry on taking your tablets for
stiffness or inflexibility with high fever, sweating,
as long as your doctor has told you to.
altered mental status, or very rapid or irregular heart
If you have any further questions on the use of this
beat.
medicine, ask your doctor or pharmacist.
Children and adolescents
Do not use this medicine in children and adolescents
4 Possible side effects
under 13 years of age. It is not known if it is safe and
Like all medicines, this medicine can cause side effects,
effective in these patients.
although not everybody gets them.
Other medicines and Aripiprazole Tablets
Common side effects (may affect up to 1 in 10 people)
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• diabetes mellitus
Blood pressure-lowering medicines: Aripiprazole Tablets • difficulty sleeping
may increase the effect of medicines used to lower the • feeling anxious
blood pressure. Be sure to tell your doctor if you take a • feeling restless and unable to keep still, difficulty
sitting still
medicine to keep your blood pressure under control.
• uncontrollable twitching, jerking or writhing
Taking Aripiprazole Tablets with some medicines may
movements, restless legs
need to change your dose of Aripiprazole Tablets. It is

EAS1763a LEA ARIPIPRAZOLE 5, 10, 15, 20 & 30MG TAB TUK
ZINC Ref:

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:














No
380 mm
190 mm
N/A
N/A

Colours Used:

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

Version:

2

31 October 2017
BLACK
PANTONE® GREEN C
Template

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 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
Uncommon side effects (may affect up to 1 in 100 people) pharmacist. This includes any possible side effects not
• increased blood levels of the hormone prolactin
listed in this leaflet. You can also report side effects
• too much sugar in the blood
directly via the Yellow Card Scheme at:
• depression
www.mhra.gov.uk/yellowcard, or search for MHRA
• altered or increased sexual interest
Yellow Card in the Google Play or Apple App Store.
• uncontrollable movements of mouth, tongue and
By reporting side effects you can help provide more
limbs (tardive dyskinesia)
information on the safety of this medicine.
• muscle disorder causing twisting movements (dystonia)
• double vision
5 How to store Aripiprazole Tablets
• fast heart beat
• a fall in blood pressure on standing up which causes Keep this medicine out of the sight and reach of
dizziness, light-headedness or fainting
children.
• hiccups
Do not use this medicine after the expiry date which is
The following side effects have been reported since the stated on the blister and on the carton. The expiry date
marketing of oral aripiprazole but the frequency for
refers to the last day of that month.
them to occur is not known (frequency cannot be
This medicine does not require any special storage
estimated from the available data)
conditions.
• low levels of white blood cells
Do not throw away any medicines via wastewater or
• low levels of blood platelets
household waste. Ask your pharmacist how to throw
• allergic reaction (e.g. swelling in the mouth, tongue,
away medicines you no longer use. These measures
face and throat, itching, hives)
will help protect the environment.
• onset or worsening of diabetes, ketoacidosis (ketones
in the blood and urine) or coma
6 Contents of the pack and other information
• not enough sodium in the blood
• loss of appetite (anorexia)
What Aripiprazole Tablets contain
• weight loss
• The active substance is aripiprazole.
• weight gain
Each 5 mg tablet contains 5 mg of aripiprazole.
• thoughts of suicide, suicide attempt and suicide
Each 10 mg tablet contains 10 mg of aripiprazole.
• excessive gambling
Each 15 mg tablet contains 15 mg of aripiprazole.
• feeling aggressive
Each 20 mg tablet contains 20 mg of aripiprazole.
• agitation
Each 30 mg tablet contains 30 mg of aripiprazole.
• nervousness
• neuroleptic malignant syndrome (combination of
• The other ingredients are lactose monohydrate,
fever, muscle stiffness, faster breathing, sweating,
microcrystalline cellulose, maize starch, iron oxide
reduced consciousness and sudden changes in blood
yellow (E172) (5 mg + 15 mg only), iron oxide red
pressure and heart rate, fainting)
(E172) (10 mg + 30 mg only), hydroxypropylcellulose,
• seizure
croscarmellose sodium, magnesium stearate.
• serotonin syndrome (a reaction which may cause
What Aripiprazole Tablets look like and contents of the
feelings of great happiness, drowsiness, clumsiness, pack
restlessness, feeling of being drunk, fever, sweating
5 mg
or rigid muscles)
Light yellow coloured, round, flat-faced bevelled edge
• speech disorder
tablets with debossed “5” on one side and plain on the
• sudden unexplained death
other side.
• life-threatening irregular heart beat
• heart attack
10 mg
• slower heart beat
Pink to light pink coloured, oblong tablets with debossed
• blood clots in the veins especially in the legs
“10” on one side and breakline on the other side.
(symptoms include swelling, pain and redness in the The tablet can be divided into equal doses.
leg), which may travel through blood vessels to the
15 mg
lungs causing chest pain and difficulty in breathing (if Light yellow coloured, round, flat-faced bevelled edged
you notice any of these symptoms, seek medical
tablets with debossed “15” on one side and breakline
advice immediately)
on the other side.
• high blood pressure
The tablet can be divided into equal doses.
• fainting
20 mg
• accidental inhalation of food with risk of pneumonia
White to off white or pale cream coloured,
(lung infection)
capsule-shaped, biconvex tablets with debossed “20”
• spasm of the muscles around the voice box
on one side and breakline on the other side
• inflammation of the pancreas
The tablet can be divided into equal doses.
• difficulty swallowing
• diarrhoea
30 mg
• abdominal discomfort
Pink to light pink coloured, round, biconvex tablets with
• stomach discomfort
debossed “30” on one side and breakline on the other
• liver failure
side.
• inflammation of the liver
The tablet can be divided into equal doses.
• yellowing of the skin and white part of eyes
Aripiprazole Tablets are available in packs of 7, 7x1, 14,
• reports of abnormal liver tests values
28, 28x1, 49, 56, 56x1 and 98 tablets.
• skin rash
Not all pack sizes may be marketed.
• sensitivity to light
• baldness
Marketing Authorisation Holder
• excessive sweating
TEVA UK Limited, Eastbourne, BN22 9AG, UK
• abnormal muscle breakdown which can lead to
Manufacturer
kidney problems
• muscle pain
Actavis Ltd. BLB016 Bulebel Industrial Estate,
• stiffness
Zejtun ZTN 3000, Malta
• involuntary loss of urine (incontinence)
This leaflet was last revised in 10/2017
• difficulty in passing urine
PL 00289/1915
• withdrawal symptoms in newborn babies in case of
PL 00289/1916
exposure during pregnancy
PL 00289/1917
• prolonged and/or painful erection
PL 00289/1918
• difficulty controlling core body temperature or
PL 00289/1919
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.
EAS1763a

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