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Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the

Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 30 mg tablets

Read all of this leaflet carefully before you start
using 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

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
3. How to take Aripiprazole
4. Possible side effects
5. How to store Aripiprazole
6. Contents of the pack and other information.

What Aripiprazole is and what it is used for

Aripiprazole 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.

What you need to know before you take

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 before taking Aripiprazole 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

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
Children and adolescents
Do not use this medicine 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
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.

Taking Aripiprazole with some medicines may need
to change your dose of Aripiprazole. 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, you
should see your doctor.
Aripiprazole with food, drink and alcohol
Aripiprazole can be taken regardless of meals.
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 for advice before taking this medicine.
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.
Be sure to tell your doctor immediately if you are
If you are taking Aripiprazole, you should not breastfeed.
Driving and using machines
Do not drive or use any tools or machines, until you
know how Aripiprazole affects you.
Aripiprazole contains lactose monohydrate. If
you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

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 15 mg once
a day. However your doctor may prescribe a lower or
higher dose to a maximum of 30 mg once a day.
Use in children and adolescents
This medicinal product 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.
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 tablet at the same time
each day. It does not matter whether you take it with
or without food. Always take the tablet with water and
swallow it whole.
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 tablets
than your doctor has recommended (or if someone
else has taken some of your Aripiprazole tablets),
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
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
Do not stop your treatment just because you feel
better. It is important that you carry on taking your
Aripiprazole 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 or pharmacist.

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 movements,
• 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,


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,

The following side effects have been reported since
the marketing of 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,



Combination of fever, muscle stiffness, faster
breathing, sweating, reduced consciousness and
sudden changes in blood pressure and heart
rate, fainting (neuroleptic malignant syndrome),


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,


Accidental inhalation of food with risk of
pneumonia (lung infection),

Spasm of the muscles around the voice box,

Inflammation of the pancreas,

Difficulty swallowing,


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,


Excessive sweating,

Abnormal muscle breakdown which can lead to
kidney problems,

Muscle pain,


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
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 or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the national reporting system
listed in Yellow Card Scheme Website: By reporting side
effects you can help provide more information on the
safety of this medicine.

How to store Aripiprazole

Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date which is
stated on the label, carton and bottle after EXP. The
expiry date refers to the last day of that month.
The medicinal product does not require any special
storage conditions.
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.

Contents of the pack and other information

What Aripiprazole contains

The active substance is aripiprazole.
Each tablet contains 5 mg of aripiprazole.
Each tablet contains 10 mg of aripiprazole.
Each tablet contains 15 mg of aripiprazole.
Each tablet contains 30 mg of aripiprazole.
The other ingredients are lactose monohydrate,
microcrystalline cellulose, maize starch, indigo
carmine aluminium lake (E132) (for 5 mg
strength only), hydroxypropyl cellulose, silica
colloidal anhydrous, magnesium stearate.

What Aripiprazole looks like and contents of the
Aripiprazole 5 mg tablets
Blue colored, modified rectangular shaped, uncoated
tablets debossed with ‘62’ on one side and ‘H’ on
other side. The size is 8 mm x 4.5 mm.
Aripiprazole 10 mg tablets
White colored, modified rectangular shaped, uncoated
tablets debossed with ‘63’ on one side and ‘H’ on
other side. The size is 8 mm x 4.5 mm.
Aripiprazole 15 mg tablets
White colored, round shaped (diameter 7 mm),
uncoated tablets debossed with ‘64’ on one side and
‘H’ on other side.
Aripiprazole 30 mg tablets
White colored, round shaped (diameter 9 mm),
uncoated tablets debossed with ‘66’ on one side and
‘H’ on other side.
Aripiprazole tablets are available in Polyamide/
Aluminium/ PVC/ Aluminium foil blister pack and
HDPE bottle with polypropylene closure containing
silica gel as dessicant.
Pack sizes:
Blister packs: 14, 28, 30, 49, 56 and 98 tablets
HDPE bottle packs: 30, 100, 250 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 06/2016.

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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.