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ARIPIPRAZOLE 1MG/ML ORAL SOLUTION

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 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

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
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.

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 carton.

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 patients.
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 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.

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.

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).

(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).

(4)

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

(5)

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

(6)

Continued top of next column

Continued over page

Aripirazole 1mg/ml 150ml Oral Solution PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

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BBBA1706
Dimensions:
160 x 400
Min Body Text Size: 8pt
Supplier:
Actavis Troyan

S.Anson
16.01.18
18.01.18
S.Anson

Balkanpharma

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
16.01.18
Date received: 17.01.18

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

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Details

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Version 2
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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
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.
The following symptoms may occur: feeling unusually
tired or sleepy, increased blood pressure, rapid heartbeat,
feeling or being sick and diarrhoea. Serious signs and
symptoms in children may include tiredness, fainting
and abnormal body movements (called extrapyramidal
symptoms).
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. Do not
take a double dose to make up for a forgotten dose.
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.
Stop taking this medicine and contact your doctor
immediately if you experience any of the following
serious side effects:
Common side effects (may affect up to 1 in 10 people):
• feeling more thirsty or hungrier then usual, need
to urinate more often, feeling confused, weak, tired
or your breath may smell fruity, these are signs of
diabetes.
Unknown frequency (cannot be estimated from the
available data):
• severe itching of the skin (with raised lumps) or
swelling of the face, lips, tongue and/or throat, which
may cause difficulty in swallowing or breathing
(angio-oedema).
• abnormal bruising, bleeding or signs of infection such
as a sore throat and high temperature (can indicate
reduced number of white blood cells or platelets).
• thoughts of suicide or suicide attempt.
• swelling, pain and redness in the leg indicating a blood
clot in the veins, which may travel through blood
vessels to the lungs causing chest pain and difficulty in
breathing.
• yellowing of the skin and white part of eyes (jaundice),
dark urine, nausea, diarrhoea, tiredness, flu like
symptoms, swollen abdomen, bleeding easily or
confusion (can be symptoms of liver inflammation or
liver failure).
• fever, muscle stiffness, muscle pains, vomiting,
sweating, dark urine or a lowered level of
consciousness (a disorder called “Neuroleptic Malignant
Syndrome”).
• prolonged and/or painful erection.
The following side effects could happen:
Common side effects (may affect up to 1 in 10 people):
• 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 side effects (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 heartbeat
• 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 (frequency cannot be estimated
from the available data):
• 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
• suicide

• excessive gambling
• feeling aggressive
• agitation
• nervousness
• 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 heartbeat
• heart attack
• slower heartbeat
• 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
• 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
• difficulty controlling core body temperature or
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.
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:
www.mhra.gov.uk/yellowcard
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. Do not refrigerate or
freeze. 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) and 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
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma Troyan AD
1, Krayrechna Str
Troyan
5600
Bulgaria
This leaflet was revised in January 2018

Continued top of next column

BBBA1706

Actavis, Barnstaple, EX32 8NS, UK

Aripirazole 1mg/ml 150ml Oral Solution PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

2

BBBA1706
Dimensions:
160 x 400
Min Body Text Size: 8pt
Supplier:
Actavis Troyan

S.Anson
16.01.18
18.01.18
S.Anson

Balkanpharma

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
16.01.18
Date received: 17.01.18

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

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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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