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ARIPIPRAZOLE ASPIRE 10 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user

Aripiprazole 5mg tablets
Aripiprazole 10mg tablets
Aripiprazole 15mg tablets
Aripiprazole 30mg tablets
Aripiprazole
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 tablets contain 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
characterized 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 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
• 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 is not for use in children and adolescents
under 13 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.
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
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.
Aripiprazole contains maltose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.

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 15mg once
a day. However, your doctor may prescribe a lower or
higher dose to a maximum of 30mg 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 10mg once a day. However, your
doctor may prescribe a lower or higher dose to a
maximum of 30mg 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 tablets
Do not stop your treatment just because you feel
better. It is important that you carry on taking your
Aripiprazole tablets 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.

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):
• uncontrollable twitching or jerking movements;
• headache, tiredness;
• nausea, vomiting;
• an uncomfortable feeling in the stomach,
constipation;
• increased production of saliva;
• light-headedness, trouble sleeping;
• restlessness, feeling anxious, sleepiness;
• shaking and blurred vision.
Uncommon side effects
(may affect up to 1 in 100 people):
• some people may feel dizzy, especially when getting
up from a lying or sitting position,
• or may experience a fast heart rate or
double vision;
• some people may feel depressed;
• some people may have altered or increased
sexual interest and increased blood levels of the
hormone prolactin;
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):
• changes in the levels of some blood cells;
• unusual heart beat, sudden unexplained death,
heart attack;
• allergic reaction (e.g. swelling in the mouth, tongue,
face and throat, itching, rash);
• high blood sugar, onset or worsening of diabetes,
ketoacidosis (ketones in the blood and urine) or
coma, low sodium level in the blood;
• weight gain, weight loss, anorexia;
• aggression, nervousness, agitation, feeling anxious,
excessive gambling;
• thoughts of suicide, suicide attempt and suicide;
• speech disorder, seizure;
• 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;
• fainting, high blood pressure;
• 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);
• spasm of the muscles around the voice box,
accidental inhalation of food with risk of pneumonia,
difficulty in swallowing;
• inflammation of the pancreas;
• liver failure, inflammation of the liver, yellowing of
the skin and white part of eyes, 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, weakness;
• involuntary loss of urine, difficulty in passing urine;
• prolonged and/or painful erection;
• difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands,
ankles or feet.
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 (may affect more 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
(may affect up to 1 in 10 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 (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
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 blister and on the carton after EXP.
The expiry date refers to the last day of that month.
Store in the original package in order to protect
from moisture.
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 tablet of
5, 10, 15, 30mg containing 5, 10, 15, 30mg of
aripiprazole respectively.
• The other ingredients for 5mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, indigo carmine (E132) and
magnesium stearate.
• The other ingredients for 10, 30mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, iron oxide red (E172) and
magnesium stearate.
• The other ingredients for 15mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, iron oxide yellow (E172)
and magnesium stearate.
What Aripiprazole looks like and
contents of the pack
Aripiprazole 5mg tablets are blue, round and biconvex
tablets of 6.1mm in diameter, engraved with ‘5’ on
one side.
Aripiprazole 10mg tablets are pink, round and
biconvex tablets of 8.1mm in diameter, engraved
with ‘10’ on one side.
Aripiprazole 15mg tablets are yellow, round and
biconvex tablets of 10.1mm in diameter, engraved
with ‘15’ on one side.
Aripiprazole 30mg tablets are pink, oval and biconvex
tablets of 17.1mm in length, 8.1mm in width,
engraved with ‘30’ on one side.
They are supplied in PA/Alu/PVC-Aluminium foil
perforated blisters packed in cardboard box containing
14, 28, 49, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspire Pharma Limited
Bellamy House, Winton Road, Petersfield,
Hampshire, GU32 3HA
United Kingdom
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5,
Rodopi 69300, Greece
or
Pharmathen S.A.
6, Dervenakion, Pallini 15351,
Attiki, Greece
This leaflet was last revised in May 2016.

1010288-P1.7

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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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