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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.
– 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 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
1. WHAT ARIPIPRAZOLE ORAL
SOLUTION IS AND WHAT IT IS
USED FOR
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.
Aripiprazole Oral Solution is 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 Oral Solution.
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.
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
Aripiprazole Oral Solution is not for use in
children and adolescents under 13 years.
It is not known if it is safe and effective in
these patients. 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 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.
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
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.
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.
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.
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.
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
dilute with other liquids or mix with other
food prior to taking Aripiprazole Oral
Solution.
Even if you feel better, do not alter or
discontinue the daily dose of Aripiprazole
Oral Solution without first consulting
your doctor.
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.

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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.

temperature or overheating
• chest pain
• swelling of hands, ankles or feet
• in blood tests: fluctuating blood sugar,
increased glycosylated haemoglobin.

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

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Common: 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.
Uncommon: may affect up to 1 in 100
people
• increased blood levels of the hormone
prolactin
• too much sugar in the blood
• depression
• altered or increased sexual interest
• uncontrollable movements of mouth,
tongue and limbs (tardive dyskinesia)
• muscle disorder causing twisting
movements (dystonia)
• double vision
• fast heart beat
• a fall in blood pressure on standing up
which causes dizziness,
light-headedness or fainting
• hiccups.
The following side effects have been
reported since the marketing of oral
aripiprazole but the frequency for them
to occur is not known:
• 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
• high blood sugar
• 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
• combination of fever, muscle stiffness,
faster breathing, sweating, reduced
consciousness and sudden changes in
blood pressure and heart rate, fainting
(neuroleptic malignant syndrome)
• 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
• 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

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 (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).
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:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. HOW TO STORE ARIPIPRAZOLE
ORAL SOLUTION
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 bottle and on
the carton. The expiry date refers to the
last day of that month.
This medicine does not require any
special storage conditions.
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
Aripiprazole Wockhardt
1mg/ml Oral Solution

Reference
number
29831/0640

This is a service provided by the Royal
National Institute of Blind People.
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
This leaflet was last revised in 08/2016

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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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