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ARIPIPRAZOLE NICHE 30 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aripiprazole Niche 5 mg, 10 mg, 15 mg and 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.
any other medicines, including medicines
obtained without a prescription.
Blood pressure-lowering medicines:
Aripiprazole Niche 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
medicines, your doctor may need to
1.What Aripiprazole Niche is and change your dose. It is especially important
to mention the following to your doctor:
what it is used for
■ Medicines to correct heart rhythm
Aripiprazole Niche tablets contains the
■ Antidepressants or herbal remedy used
active substance aripiprazole and is
to treat depression and anxiety
one of a group of medicines called
■ Antifungal agents
antipsychotics.
■ Certain medicines to treat HIV infection
It is used to treat adults and adolescents
■ Anticonvulsants used to treat epilepsy
aged 15 years and older who suffer from a
Medicines that increase the level of
disease characterised by symptoms such
serotonin: triptans, tramadol, tryptophan,
as hearing, seeing or sensing things which
SSRIs (such as paroxetine and fluoxetine),
are not there, suspiciousness, mistaken
tricyclics (such as clomipramine,
beliefs, incoherent speech and behaviour
amitriptyline), pethidine, St John’s Wort and
and emotional flatness. People with this
venlafaxine. These medicines increase the
condition may also feel depressed, guilty,
risk of side effects; if you get any unusual
anxious or tense.
symptoms taking any of these medicines
Aripiprazole Niche is used to treat adults
together with Aripiprazole Niche, you
and adolescents aged 13 years and older
who suffer from a condition with symptoms should see your doctor.
Aripiprazole Niche with food, drink and
such as feeling "high", having excessive
alcohol
amounts of energy, needing much less
sleep than usual, talking very quickly with
Aripiprazole Niche can be taken regardless
racing ideas and sometimes severe
of meals.
irritability. In adults it also prevents this
Alcohol should be avoided when taking
condition from returning in patients who
Aripiprazole Niche.
have responded to the treatment with
Pregnancy, breast-feeding and fertility
Aripiprazole Niche.
If you are pregnant or breast-feeding, think
2.What you need to know before you may be pregnant or are planning to
you take Aripiprazole Niche
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Do not take Aripiprazole Niche:
■ if you are allergic to aripiprazole or any of
The following symptoms may occur in
newborn babies of mothers that have used
the other ingredients of this medicine
aripiprazole in the last trimester (last three
(listed in section 6).
months of their pregnancy): shaking,
Warnings and precautions
muscle stiffness and/or weakness,
Talk to your doctor before taking
sleepiness, agitation, breathing problems,
Aripiprazole Niche if you suffer from:
and difficulty in feeding. If your baby
■ High blood sugar (characterised by
develops any of these symptoms you may
symptoms such as excessive thirst,
need to contact your doctor.
passing of large amounts of urine, increase
Be sure to tell your doctor immediately if
in appetite, and feeling weak) or family
you
are breast-feeding. If you are taking
history of diabetes
Aripiprazole Niche, you should not breast■ Seizure
feed.
■ Involuntary, irregular muscle movements,
Driving and using machines
especially in the face
Do not drive or use any tools or machines
■ Cardiovascular diseases, family history of
until you know how Aripiprazole Niche
cardiovascular disease, stroke or "mini"
affects you.
stroke, abnormal blood pressure
■ Blood clots, or family history of blood
Aripiprazole Niche contains lactose
clots, as antipsychotics have been
If you have been told by your doctor that
associated with formation of blood clots
you have an intolerance to some sugars,
■ Past experience of excessive gambling
contact your doctor before taking this
medicine.
If you notice you are gaining weight,
develop unusual movements, experience
3.How to take Aripiprazole Niche
somnolence that interferes with normal
Always take this medicine exactly as your
daily activities, any difficulty in swallowing
doctor or pharmacist has told you. Check
or allergic symptoms, please tell your
with your doctor or pharmacist if you are
doctor.
not sure.
If you are an elderly patient suffering from
The recommended dose for adults is 15
dementia (loss of memory and other
mg once a day. However your doctor may
mental abilities), you or your carer/relative
should tell your doctor if you have ever had prescribe a lower or higher dose to a
maximum of 30 mg once a day.
a stroke or "mini" stroke.
Use in children and adolescents
Tell your doctor immediately if you are
Aripiprazole Niche may be started at a low
having any thoughts or feelings about
dose with the oral solution (liquid) form.
hurting yourself. Suicidal thoughts and
The dose may be gradually increased to
behaviours have been reported during
the recommended dose for adolescents
aripiprazole treatment.
of 10 mg once a day. However your
Tell your doctor immediately if you suffer
doctor may prescribe a lower or higher
from muscle stiffness or inflexibility with
high fever, sweating, altered mental status, dose to a maximum of 30 mg once a day.
If you have the impression that the effects
or very rapid or irregular heart beat.
of Aripiprazole Niche is too strong or too
Children and adolescents
Aripiprazole Niche is not for use in children weak, talk to your doctor or pharmacist.
Try to take the Aripiprazole Niche tablet
and adolescents under 13 years. Ask your
at the same time each day. It does not
doctor or pharmacist for advice before
matter whether you take it with or without
taking Aripiprazole Niche.
food. Always take the tablet with water and
Other medicines and Aripiprazole Niche swallow it whole.
Tell your doctor or pharmacist if you are
Even if you feel better, do not alter or
taking, have recently taken or might take
What is in this leaflet
1. What Aripiprazole Niche is and what it is
used for
2. What you need to know before you take
Aripiprazole Niche
3. How to take Aripiprazole Niche
4. Possible side effects
5. How to store Aripiprazole Niche
6. Contents of the pack and other
information

discontinue the daily dose of Aripiprazole
Niche without first consulting your doctor.
If you take more Aripiprazole Niche
than you should
If you realise you have taken more
Aripiprazole Niche tablets than your doctor
has recommended (or if someone else has
taken some of your Aripiprazole Niche
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 Niche
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 Niche
Do not stop your treatment just because
you feel better. It is important that you
carry on taking your Aripiprazole Niche
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 experience altered or
increased sexual interest and increase
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 (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
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 Niche
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 carton and
blister foil after ‘EXP’. The expiry date
refers to the last day of that month.
This 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.

6.Contents of the pack and other
information
What Aripiprazole Niche contains
■ The active substance is aripiprazole. Each
tablet contains either 5 mg, 10 mg, 15
mg or 30 mg of aripiprazole
■ The other ingredients are:
q 5 mg tablet: lactose monohydrate,
cellulose microcrystalline ,
hydroxypropylcellulose (E462), maize
starch, magnesium stearate.
q 10 mg, 15 mg and 30 mg tablet: lactose
monohydrate, cellulose
microcrystalline, hydroxypropylcellulose
(E462), ferric oxide red (E172), maize
starch, magnesium stearate.
What Aripiprazole Niche looks like and
contents of the pack
The 5 mg tablets are white to off-white,
rounded off rectangular shaped, biconvex
tablets debossed with “A5” on one side and
plain on other side.
The 10 mg tablets are pink coloured, oval
shaped, biconvex tablets debossed with
“A10” on one side and plain on other side
The 15 mg tablets are pink coloured,
round, biconvex tablets debossed with
“A15” on one side and plain on other side
The 30 mg tablets are pink coloured, oval
shaped, biconvex tablets debossed with
“A30” on one side and plain on other side
Aripiprazole Niche tablets are available in
aluminium blister packs containing 14, 28,
49, 56 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Niche Generics Limited, 1 The Cam Centre,
Wilbury Way, Hitchin, Hertfordshire SG4
0TW, United Kingdom.
Manufacturer:
Niche Generics Limited,
Unit 5, 151 Baldoyle Industrial Estate,
Baldoyle, Dublin 13, Ireland.
This medicinal product is authorised in
the Member States of the EEA under
the following names:
The Netherlands: Aripiprazol Unichem 5
mg, 10 mg, 15 mg & 30 mg tabletten
Germany: Aripiprazol Unichem 5 mg, 10 mg
15 mg & 30 mg tabletten
This leaflet was last revised in: 04/2016

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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.

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