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Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user

Aripiprazole 1mg/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,
pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• The full name of this medicine is Aripiprazole 1mg/ml
Oral Solution but within the leaflet it will be referred to
as Aripiprazole Oral Solution.
What is in this leaflet
1. What Aripiprazole Oral Solution is and what it is used
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

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
Alcohol should be avoided.
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 breastfeeding. 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.

1. What Aripiprazole Oral Solution is and what it is
used for

3. How to take Aripiprazole Oral Solution

Aripiprazole Oral Solution contains the active substance
aripiprazole and belongs to a group of medicines called
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, pharmacist or nurse 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 heartbeat.
Children and adolescents
Do not use in children and adolescents under 13 years
of age. It is not known if it is safe and effective in these
Other medicines and Aripiprazole Oral Solution
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
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
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.
Continued top of next column

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 15ml solution
(corresponding to 15mg aripiprazole) once a day.
However your doctor may prescribe a lower or higher
dose to a maximum of 30mg (i.e. 30ml) 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 10mg once a day. However your doctor
may prescribe a lower or higher dose to a maximum of
30mg once a day.
Measuring dose:
- Doses up to 5ml should be measured using the 5ml
syringe supplied in the carton.
- Doses of 10ml and more should be measured using
the measuring cup or the 5ml syringe supplied in the
Open the bottle and make sure
that the syringe is firmly inserted
into the adaptor (Figure 1).

Turn the bottle upside down
with the syringe still in place
(Figure 2).

Pull the plunger down and fill
the syringe with a quantity of
solution slightly beyond the
prescribed dose (Figure 3).


If any bubbles appear in the
syringe, keep the bottle upside
down and slightly push in the
plunger and pull it back again.
Repeat until there are no
bubbles in the syringe (Figure 4).


Push the plunger in slowly to the
graduation mark corresponding
to the quantity in milliliters (ml)
prescribed by your doctor
(Figure 5).


Continued over page

Turn the bottle the right way up
and remove the syringe
(Figure 6).


Wash the syringe and the cup with water after use and
close the bottle with the plastic screw cap.
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
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.
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.
If you stop taking Aripiprazole Oral Solution
Do not stop your treatment just because you feel better.
It is important that you carry on taking Aripiprazole Oral
Solution for as long as your doctor has told you to.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
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
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.
Uncommon side effects (may affect up to 1 in 100
• 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
• 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,
Continued top of next column


• 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 temperature or
• 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 (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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme Website:
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. This medicinal
product does not require any special storage conditions.
Use within 6 months after first opening. Store in the
original bottle in order to protect from light.
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
1mg of aripiprazole.
The other ingredients are:
Propylene glycol (E1520)
Macrogol 4000
Phosphoric acid
Hypromellose 2910
Erythritol (E968)
Sucralose (E955)
Sodium benzoate (E211)
Disodium edetate
N&A Flavour for grape 26436:
Flavouring ingredients
Propylene glycol (E1520)
Water, purified
What Aripiprazole Oral Solution looks like and contents
of the pack
Aripiprazole 1mg/ml Oral Solution is a clear, colourless
liquid supplied in amber coloured glass bottles
containing 150ml per bottle.
Each bottle is closed with white plastic (polyethylene
HD) “Child proof” screw cap with a white polypropylene
adaptor (plug).
Each carton contains 1 bottle, a leaflet and measuring
devices, a 5ml oral syringe and a 30ml measuring cup.
The syringe body is made of PP and the plunger is made
of HDPE and is graduated for dosing of 0.5ml and then
every 0.5ml up to 5ml.
The measuring cup is made of PP and is graduated for
dosing of 5ml, 10ml, 15ml, 20ml, 25ml and maximum
volume of 30ml.
Marketing Authorisation Holder
Caduceus Pharma Ltd
6th Floor
94 Wigmore Street
Balkanpharma Troyan AD
1, Krayrechna Str
This leaflet was revised in May 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.