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ARIPIPRAZOLE WOCKHARDT 1MG/ML ORAL SOLUTION

Active substance(s): ARIPIPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Aripiprazole 1 mg/ml Oral Solution
Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.

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.

– 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.

Taking Aripiprazole Oral Solution with
some medicines may need to change
your dose of Aripiprazole Oral Solution. 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
• Antifungal agents
• Certain medicines to treat HIV infection
• Anticonvulsants used to treat epilepsy

What is in this leaflet
1. What Aripiprazole Oral Solution is and
what it is used for
2. What you need to know before you
take Aripiprazole Oral Solution
3. How to take Aripiprazole Oral Solution
4. Possible side effects
5. How to store Aripiprazole Oral Solution
6. Contents of the pack and other
information

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Aripiprazole Oral Solution 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
ORAL SOLUTION
Do not take Aripiprazole Oral Solution
• 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 Oral Solution 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.

Aripiprazole Oral Solution with food,
drink and alcohol
Aripiprazole Oral Solution can be taken
regardless of meals. However, the oral
solution should not be diluted with other
liquids or mixed with any food prior to
administration.
Alcohol should be avoided when taking
Aripiprazole Oral Solution.
Pregnancy, breast-feeding and fertility
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 Oral Solution 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 Oral
Solution, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines
until you know how Aripiprazole Oral
Solution affects you.
Aripiprazole Oral Solution contains
fructose, sucrose and
parahydroxybenzoates
Each ml of Aripiprazole Oral Solution
contains 200 mg of fructose and 400 mg
of sucrose. If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicine. This medicine may
be harmful to the teeth.
Parahydroxybenzoates may cause allergic
reactions (possibly delayed).
3. HOW TO TAKE ARIPIPRAZOLE
ORAL SOLUTION
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

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.

The recommended dose for adults is
15 ml solution (corresponding to
15 mg aripiprazole) once a day.
However your doctor may prescribe a
lower or higher dose to a maximum of
30 mg (i.e. 30 ml) once a day.

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.

Use in children and adolescents
Aripiprazole Oral Solution may be started
at a low dose with the oral solution
(liquid) form. 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.

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
Aripiprazole Oral Solution is not for use in
children and adolescents under 13 years.
Ask your doctor or pharmacist for advice
before taking Aripiprazole Oral Solution.
Other medicines and Aripiprazole Oral
Solution
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Blood pressure-lowering medicines:
Aripiprazole Oral Solution may increase

The dose of Aripiprazole Oral Solution
must be measured using the calibrated
cup or the 2 ml calibrated dropper
supplied in the carton.
If you have the impression that the effect
of Aripiprazole Oral Solution is too strong
or too weak, talk to your doctor or
pharmacist.
Try to take the Aripiprazole Oral
Solution at the same time each day. It
does not matter whether you take it with
or without food. However, you should not
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1. WHAT ARIPIPRAZOLE ORAL
SOLUTION IS AND WHAT IT IS
USED FOR

Medicines that increase the level of
serotonin: triptans, tramadol, tryptophan,
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 Oral
Solution, you should see your doctor.

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Aripiprazole 1mg/ml oral solution - 150ml bottle
Wockhardt UK
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Some people may feel depressed.
Some people may experience altered or
increased sexual interest.
The following side effects have been
reported since the marketing of
Aripiprazole Oral Solution 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 heart beat, 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), 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; 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.
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

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Do not use this medicine after the expiry
date which is stated on the bottle and on
the carton. The expiry date refers to the
last day of that month.

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Keep this medicine out of the sight and
reach of children.

Use within 6 months after first opening.
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 Oral Solution
contains
• The active substance is aripiprazole.
Each ml contains 1 mg of aripiprazole.
• The other ingredients are disodium
edetate, fructose, glycerol, succinic
acid, methyl parahydroxybenzoate
(E218), propylene glycol, propyl
parahydroxybenzoate (E216), sodium
chloride, sucrose, sucralose, purified
water, and natural orange extract.
What Aripiprazole Oral Solution looks
like and contents of the pack
Aripiprazole 1 mg/ml Oral Solution is a
clear, colourless to light yellow liquid
(oral solution) supplied in PET bottles
with polypropylene child-resistant
closure containing 150 ml per bottle.
Each carton contains one bottle and both
a calibrated polypropylene measuring
cup and a calibrated polypropylene
low-density polyethylene dropper.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other sources of information:
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following
information:
Product name
number
Aripiprazole Wockhardt
1mg/ml Oral Solution

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This medicine does not require any
special storage conditions.

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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 or double
vision.

5. HOW TO STORE ARIPIPRAZOLE
ORAL SOLUTION

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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.

By reporting side effects you can help
provide more information on the safety
of this medicine.

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Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

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4. POSSIBLE SIDE EFFECTS

Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie;
e-mail: medsafety@hpra.ie

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If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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If you forget to take Aripiprazole Oral
Solution
If you miss a dose, take the missed dose
as soon as you remember but do not take
two doses in one day.

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 national reporting
systems listed below:

Reference

29831/0640

This is a service provided by the Royal
National Institute of Blind People.

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If you take more Aripiprazole Oral
Solution than you should
If you realise you have taken more
Aripiprazole Oral Solution than your
doctor has recommended (or if someone
else has taken some of your Aripiprazole
Oral Solution), contact your doctor right
away. If you cannot reach your doctor, go
to the nearest hospital and take the pack
with you.

For the Republic of Ireland please call
+44 1978 669272.
This medicinal product is authorised in
the Member States of the EEA under
the following names:
Ireland, United Kingdom: Aripiprazole
Wockhardt 1 mg/ml Oral Solution
Portugal: Aripiprazole Wockhardt

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Even if you feel better, do not alter or
discontinue the daily dose of Aripiprazole
Oral Solution without first consulting
your doctor.

except that sleepiness, uncontrollable
twitching or jerking movements,
restlessness, and tiredness were very
common (greater than 1 in 10 patients)
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 (greater than 1 in 100 patients).

This leaflet was last revised in 09/2015

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dilute with other liquids or mix with other
food prior to taking Aripiprazole Oral
Solution.

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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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