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ARPOYA 5 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user
Arpoya 5 mg tablets
Arpoya 10 mg tablets
Arpoya 15 mg tablets
Arpoya 30 mg 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 Arpoya is and what it is used for
2. What you need to know before you take Arpoya
3. How to take Arpoya
4. Possible side effects
5 How to store Arpoya
6. Contents of the pack and other information
1. What Arpoya is and what it is used for
Arpoya 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
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.
Arpoya 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 Arpoya.
2. What you need to know before you take
Arpoya
Do not take Arpoya
• 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 Arpoya 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
Arpoya is not for use in children and adolescents

under 13 years. Ask your doctor or pharmacist for
advice before taking Arpoya.

your doctor, go to the nearest hospital and take the
pack with you.

Other medicines and Arpoya
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

If you forget to take Arpoya
If you miss a dose, take the missed dose as soon
as you remember but do not take two doses in one
day.

Blood pressure-lowering medicines: Arpoya 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 have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects

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.

Taking Arpoya with some medicines may need to
change your dose of Arpoya. 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

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

5. How to store Arpoya

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
Arpoya, you should see your doctor.
Arpoya with food, drink and alcohol
Arpoya can be taken regardless of meals.
Alcohol should be avoided when taking Arpoya.
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 Arpoya 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 Arpoya, you should not
breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you
know how Arpoya affects you.
Arpoya 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 Arpoya
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
Arpoya 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 Arpoya
is too strong or too weak, talk to your doctor or
pharmacist.
Try to take the Arpoya 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 Arpoya without first
consulting your doctor.
If you take more Arpoya than you should
If you realise you have taken more Arpoya tablets
than your doctor has recommended (or if someone
else has taken some of your Arpoya tablets),
contact your doctor right away. If you cannot reach

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;
The following side effects have been reported since
the marketing of Arpoya 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;
• 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).

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.
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 Arpoya contains
• The active substance is aripiprazole. Each tablet
of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of
aripiprazole respectively.
• The other ingredients for 5 mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, indigo carmine (E132) and
magnesium stearate.
• The other ingredients for 10, 30 mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, iron oxide red (E172) and
magnesium stearate.
• The other ingredients for 15 mg are maltose,
microcrystalline cellulose, pregelatinised starch,
croscarmellose sodium, iron oxide yellow (E172)
and magnesium stearate.
What Arpoya looks like and contents of the
pack
Arpoya 5 mg tablets are blue, round and biconvex
tablets of 6.1mm in diameter, engraved with ‘5’ on
one side.
Arpoya 10 mg tablets are pink, round and biconvex
tablets of 8.1mm in diameter, engraved with ‘10’ on
one side.
Arpoya 15 mg tablets are yellow, round and
biconvex tablets of 10.1mm in diameter, engraved
with ‘15’ on one side.
Arpoya 30 mg 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 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex.
RH11 7XA
United Kingdom
This leaflet was last revised in 05/2015.

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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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