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ARPOYA 15 MG TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE / 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 tablets are and what they are
used for
2. What you need to know before you take
ARPOYA tablets
3. How to take ARPOYA tablets
4. Possible side effects
5. How to store ARPOYA tablets
6. Contents of the pack and other information
1. What ARPOYA tablets are and what they
are used for
ARPOYA tablets contain the active substance
aripiprazole and belong 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.
ARPOYA tablets are 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 tablets.
2. What you need to know before you take
ARPOYA tablets
Do not take ARPOYA tablets
• 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 tablets 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
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 ARPOYA tablets
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: ARPOYA tablets
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 ARPOYA tablets with some medicines may
need to change your dose of ARPOYA tablets. 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
ARPOYA tablets, you should see your doctor.
ARPOYA tablets with food, drink and alcohol
ARPOYA tablets can be taken regardless of meals.
Alcohol should be avoided .
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 tablets
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 tablets, you should not
breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you
know how ARPOYA tablets affect you.
ARPOYA tablets contain maltose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take ARPOYA tablets
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 medicine 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 effects of your
ARPOYA tablets are too strong or too weak, talk to
your doctor or pharmacist.
Try to take your ARPOYA tablets 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 tablets
without first consulting your doctor.
If you take more ARPOYA tablets 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
your doctor, go to the nearest hospital and take the
pack with you.
If you forget to take your ARPOYA
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 ARPOYA tablets
Do not stop your treatment just because you feel
better. It is important that you carry on taking your
ARPOYA 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):
• 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 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 heart beat,
• 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:
• 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,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, faster
breathing, sweating, reduced consciousness and
sudden changes in blood pressure and heart
rate, fainting (neuroleptic malignant syndrome),
• 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 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,
• 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,
• 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,
• 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,
• prolonged and/or painful erection,
• 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 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: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 ARPOYA tablets
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 ARPOYA tablets contain
• 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 tablets look 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, 56 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 12/2016

Expand Transcript

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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