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ARIPIPRAZOLE VALE 1 MG/ML ORAL SOLUTION

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the patient

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

1. What Aripiprazole is and what it is used for
Aripiprazole contains the active substance
aripiprazole, which 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 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.

2. What you need to know before you take
Aripiprazole
Do not take Aripiprazole:
• 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 or pharmacist before taking
Aripiprazole if you suffer from or have ever suffered
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
• seizures
• involuntary, irregular muscle movements,
especially in the face
• heart diseases, family history of heart disease,
heart failure, abnormal heart rhythm, stroke or
“mini” stroke
• conditions which would lead to reduced blood
pressure such as loss of fluid, reduced blood
volume and use of blood pressure lowering
medicines
• increased 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
• a condition known as Attention-deficit
hyperactivity disorder (ADHD) (with symptoms
such as difficulty in maintaining focus on one task,
struggle to follow instructions, hyperactive) and
are taking medicines to treat this condition.
During treatment
If you notice you are gaining weight, develop
unusual movements, experience sleepiness that
interferes with normal daily activities, any difficulty
in swallowing or allergic symptoms, please tell your
doctor.
Tell your doctor if you suffer from shaking, decreased
heart rate, muscle stiffness and balance disorders
while on treatment with this medicine. These may
be signs of a condition known as parkinsonism.
If you are an elderly patient suffering from
Alzheimer’s disease, 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. Your doctor may consider
stopping your treatment with aripiprazole.
Children and adolescents
Aripiprazole is not recommended for use in children
and adolescents under 13 years and for treating
schizophrenia in children under 15 years. Ask your
doctor or pharmacist for advice before taking
Aripiprazole.

Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Blood pressure-lowering medicines:
Aripiprazole 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.
If you are taking Aripiprazole with some other
medicines, you may need to change your dose of
Aripiprazole. It is especially important to mention
the following to your doctor:
• quinidine (medicines to correct heart rhythm)
• escitalopram, fluoxetine (antidepressant),
cimetidine (used to treat stomach ulcers) or herbal
remedy used to treat depression and anxiety
• ketoconazole, itraconazole (antifungal agents)
• medicines that may cause changes in hearth
rhythm which may be seen in tests (such as
alfuzosin, amiodarone, chloroquine)
• medicines that may alter the level of blood salts
(such as hydrocortisone, prednisolone,
furosemide)
• certain medicines to treat HIV infection (such as
ritonavir, indinavir, nelfinavir, efavirenz, nevirapine)
• diltiazem, carbamazepine, phenytoin,
phenobarbital, primidone (anticonvulsants
used to treat epilepsy)
• rifampicin and rifabutin (antibiotic used to
treat tuberculosis).
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 symptoms
taking any of these medicines together with
Aripiprazole, you should see your doctor.
Aripiprazole with alcohol
Alcohol should be avoided when taking Aripiprazole.
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 or pharmacist for advice before taking this
medicine.
Pregnancy
The following symptoms may occur in newborn
babies, of mothers that have used Aripiprazole 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.
Breast-feeding
Be sure to tell your doctor immediately if you are
breast-feeding. If you are taking Aripiprazole, you
should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines until you
know how Aripiprazole affects you.

3. How to take Aripiprazole
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 10 ml or
15 ml solution (corresponding to 10 mg or 15 mg
aripiprazole) once a day. However your doctor may
prescribe a lower or higher dose to a maximum of
30 ml (i.e. 30 mg) once a day.
Elderly
If you are elderly your doctor may start your
treatment with a dose lower than the
recommended dose.
Patients with liver problems
Tell your doctor if you are suffering from severe liver
problems as your doctor may need to adjust the
dose of your medicine.
Use in children and adolescents
Aripiprazole may be started at a low dose with the
oral solution (liquid) form. This should be given
using the 5 ml graduated oral syringe supplied in
the carton. The dose may be gradually increased to
the recommended dose for adolescents of 10 ml
once a day.
However your doctor may prescribe a lower or
higher dose to a maximum of 30 ml once a day.
Measuring dose
The dose of Aripiprazole oral solution
must be measured using the graduated
30 ml cup or the 5 ml graduated oral
syringe supplied in the carton.
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 millilitres (ml) prescribed by
your doctor (Figure 5).
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 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 without first
consulting your doctor.
If you take more Aripiprazole 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. Signs and symptoms of
overdose may include unusual tiredness, increased
blood pressure, feeling sleepy, fast heart rate, feeling
sick (nausea), diarrhoea and being sick (vomiting).
If you forget to take Aripiprazole
If you miss a dose, take the missed dose as soon as
you remember but do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Aripiprazole and contact your doctor
immediately or go to your nearest hospital
emergency room if you have any of the following:
Not known (frequency cannot be estimated from
the available data):
- changes in the levels of some blood cells, which
can be seen on a blood test and lead to getting
more infections than normal
- heart attack
- unusual heart beat or abnormal heart rhythm
which may be seen in tests
- allergic reaction (e.g. swelling in the mouth,
tongue, face and throat, difficulty in breathing
and swallowing, itching, rash)
- ketoacidosis (ketones in the blood and urine) or
coma
- suicide, thoughts of suicide, suicide attempt
- seizures
- 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
- 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
- accidental inhalation of food with risk of
pneumonia
- inflammation of the pancreas
- difficulty in passing urine (urinary retention)
- liver failure, inflammation of the liver,
yellowing of the skin and white part of eyes
- muscle weakness, tenderness or pain and
particularly, if at the same time, you feel unwell or
have a high temperature it may be caused by an
abnormal muscle breakdown which can be
life-threatening and lead to kidney problems.
Other possible side effects:
Common (may affect up to 1 in 10 people):
- uncontrollable twitching, jerking or writhing
movements, restless legs
- feeling restless and unable to keep still, difficulty
sitting still
- headache
- light-headedness
- sleepiness
- shaking
- tiredness
- diabetes mellitus
- feeling sick (nausea), being sick (vomiting),
indigestion, constipation, increased production
of saliva
- trouble sleeping, feeling anxious
- blurred vision.
Uncommon (may affect up to 1 in 100 people):
- some people may feel dizzy, especially when
getting up from a lying or sitting position
- may experience a fast heart rate or double vision
- some people may feel depressed
- increased or altered sexual interest

- increased levels of the hormone prolactin
- decreased blood pressure
- high blood sugar which may be seen in blood
tests
- muscle disorder causing twisting movements
(dystonia)
- uncontrollable movements of the mouth tongue
and limbs (tardive dyskinesia)
- hiccups.
The following side effects have been reported since
the marketing of Aripiprazole but the frequency for
them to occur is not known (frequency cannot be
estimated from the available data):
- sudden unexplained death
- decreased heart rate
- low sodium level in the blood
- weight gain, weight loss, loss of appetite
(anorexia)
- nervousness, agitation, aggression, feeling
anxious, excessive gambling, speech disorder
- fainting, high blood pressure
- spasm of the muscles around the voice box,
difficulty in swallowing
- reduction in blood platelets resulting in bleeding
or bruising more easily than normal
- 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
- involuntary loss of urine
- prolonged and/or painful erection
- difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands,
ankles or feet
- increased or fluctuating blood sugar and other
changes which may be seen in blood tests.
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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
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
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 after EXP.
The expiry date refers to the last day of that month.
After first opening: Use within 6 months.
This medicine does not require any special
temperature storage conditions. Store in the
original package 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 contains
The active substance is aripiprazole.
Each ml contains 1 mg of aripiprazole.
The other ingredients are disodium edetate;
erythritol (E 968); hypromellose; macrogol 4000;
phosphoric acid, concentrated; propylene glycol
(E 1520); sodium benzoate (E 211); sucralose (E 955);
water, purified, grape flavour.
What Aripiprazole looks like and contents
of the pack
Aripiprazole 1 mg/ml oral solution is a clear,
colourless liquid.
Aripiprazole is supplied in amber glass or plastic
bottles with child-resistant caps. Each bottle
contains 150 ml of Aripiprazole, and is placed in a
cardboard carton. Each carton also contains a 5 ml
syringe (graduated at every 0.5 ml) and a 30 ml
measuring cup (graduated at every 5 ml).
Marketing Authorisation Holder
Vale Pharmaceuticals Ltd., 1B Gurtnafleur Business
Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland.
Manufacturer
Balkanpharma – Troyan AD, 1 Krayrechna Str.,
Troyan, 5600, Bulgaria.
This leaflet was last revised in 07/2016

887344

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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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