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ARIPIPRAZOLE 30 MG TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE / ARIPIPRAZOLE

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4. Possible side effects

GB 724-7661-APIL
Package leaflet: Information for the user

Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 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 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 is one of 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.
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.

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.
Pregnancy and breast-feeding
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.

2. What you need to know before you
take Aripiprazole

Driving and using machines
Do not drive or use any tools or machines, until
you know how Aripiprazole affects you.

Do not take Aripiprazole
• if you are allergic to aripiprazole or any of the
other ingredients of this medicine (listed in
section 6).

Aripiprazole contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.

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

3. How to take Aripiprazole

If you notice you are gaining weight, develop
unusual movements, experience somnolence
(sleepiness or drowsiness) 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. 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, including medicines obtained
without a prescription.

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
Aripiprazole 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 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.

Like all medicines, this medicine can cau
effects, although not everybody gets them

Common side effects (may affect up to 1
people):
• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep sti
difficulty sitting still,
• uncontrollable twitching, jerking or wr
movements, restless legs,
• trembling,
• headache,
• tiredness,
• sleepiness,
• light-headedness,
• shaking and blurred vision,
• decreased number of or difficulty mak
bowel movements,
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.

Uncommon side effects (may affect up to
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, t
and limbs (tardive dyskinesia),
• muscle disorder causing twisting
movements (dystonia),
• double vision,
• fast heart beat,
• a fall in blood pressure on standing up
causes dizziness, light-headedness or
fainting,
• hiccups.

The following side effects have been repo
since the marketing of oral aripiprazole b
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 m
tongue, face and throat, itching, hives
• onset or worsening of diabetes, ketoa
(ketones in the blood and urine) or com
• high blood sugar,
• not enough sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, suicide attempt an
suicide,
• excessive gambling,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness
breathing, sweating, reduced consciou
and sudden changes in blood pressure
heart rate, fainting (neuroleptic malign
syndrome),
• seizure,
• serotonin syndrome (a reaction which
cause feelings of great happiness,
drowsiness, clumsiness, restlessness,
feeling of being drunk, fever, sweating
rigid muscles),
• speech disorder,
• sudden unexplained death,
• life-threatening irregular heart beat,
• heart attack,
• slower heart beat,
• blood clots in the veins especially in th
(symptoms include swelling, pain and
redness in the leg), which may travel t
blood vessels to the lungs causing che
pain and difficulty in breathing (if you
any of these symptoms, seek medical
immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk
pneumonia (lung infection),
• spasm of the muscles around the voic
• 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
• reports of abnormal liver tests values,
• skin rash,
• sensitivity to light,
• baldness,
• excessive sweating,
• abnormal muscle breakdown which ca
to kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence
• difficulty in passing urine,
• withdrawal symptoms in newborn bab
case of exposure during pregnancy,
• prolonged and/or painful erection,

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 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
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.
Aripiprazole 5 mg tablet contains 5 mg of
aripiprazole.
Aripiprazole 10 mg tablet contains 10 mg of
aripiprazole.
Aripiprazole 15 mg tablet contains 15 mg of
aripiprazole.
Aripiprazole 30 mg tablet contains 30 mg of
aripiprazole.
• The other ingredients are lactose
monohydrate, maize starch, microcrystalline
cellulose, hydroxypropylcellulose,
crospovidone type A, silica, colloidal
anhydrous and magnesium stearate.
The 5 mg tablets also contain indigo carmine
aluminium lake (E132).
The 10 mg and 30 mg tablets also contain iron
oxide red (E172).
The 15 mg tablets also contain iron oxide yellow
(E172).
What Aripiprazole looks like and contents of
the pack
Aripiprazole 5 mg tablets are blue colour,
modified rectangular shaped, uncoated, mottled
tablets debossed with ‘250’ on one side and
plain on other side.
Aripiprazole 10 mg tablets are pink colour,
modified rectangular shaped, uncoated, mottled
tablets debossed with ‘252’ on one side and
plain on other side.
Aripiprazole 15 mg tablets are yellow colour,
round shaped, bevelled edge, uncoated, mottled
tablets debossed with ‘253’ on one side and
plain on other side.
Aripiprazole 30 mg tablets are pink colour,
round shaped, bevelled edge, uncoated, mottled
tablets debossed with ‘L255’ on one side and
plain on other side.
The tablets are supplied in blisters packed in
cartons containing 28 tablets.
Marketing Authorisation Holder
Sovereign Medical, Sovereign House, Miles Gray
Road, Basildon, Essex SS14 3FR, United
Kingdom
Manufacturer
Waymade Plc, Sovereign House, Miles Gray
Road, Basildon, Essex SS14 3FR, United
Kingdom
This leaflet was last revised in June 2016
PL 06464/3078
PL 06464/3079
PL 06464/3080
PL 06464/3081

Aripiprazole 5 mg Tablets
Aripiprazole 10 mg Tablets
Aripiprazole 15 mg Tablets
Aripiprazole 30 mg Tablets

To request a copy of this leaflet in Braille, large
print or audio format, contact the licence holder
at the above address or telephone: 01268
535200 / e-mail: info@waymade.co.uk

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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