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ARIPIPRAZOLE 15MG TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE / ARIPIPRAZOLE

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T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: Information for the user

Aripiprazole 5mg, 10mg, 15mg and
30mg Tablets
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.
• The full name of this medicine is Aripiprazole 5mg, 10mg,
15mg and 30mg Tablets but within the leaflet it will be
referred to as Aripiprazole tablets.

Blood pressure-lowering medicines: Aripiprazole 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.

What is in this leaflet
1. What Aripiprazole tablets are and what they are used for
2. What you need to know before you take Aripiprazole tablets
3. How to take Aripiprazole tablets
4. Possible side effects
5. How to store Aripiprazole tablets
6. Contents of the pack and other information

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 tablets, you should see your doctor.

1. What Aripiprazole tablets are and what they are used for

Aripiprazole tablets with food, drink and alcohol
Aripiprazole tablets can be taken regardless of meals.
Alcohol should be avoided.

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 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 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 Aripiprazole
tablets.
2. What you need to know before you take Aripiprazole
tablets

Taking Aripiprazole tablets with some medicines may need
to change your dose of Aripiprazole 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

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 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 breastfeeding. If you are taking Aripiprazole tablets, you should not
breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how
Aripiprazole tablets affects you.
Aripiprazole tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.

Do not take Aripiprazole 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 Aripiprazole 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 heartbeat.
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 Aripiprazole 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.

3. H
 ow to take Aripiprazole 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 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
tablets 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 tablets without first consulting your
doctor.
If you take more Aripiprazole tablets 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.
The following symptoms may occur: feeling unusually tired
or sleepy, increased blood pressure, rapid heart beat, feeling
or being sick and diarrhoea. Serious signs and symptoms in
children may include tiredness, fainting and abnormal body
movements (called extrapyramidal symptoms).

Continued top of next column

Continued over page

Aripiprazole 5mg, 10mg, 15mg & 30mg 28 Tablets PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0285

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
24.11.16
18.04.17
S.Anson

Date sent:
06.12.16
Date received: 07.12.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Malta Zejtun

Colours

Non Printing Colours

1. Black

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2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

T00075-01 Malta Zejtun 190x380 PIL

If you forget to take Aripiprazole tablets
If you miss a dose, take the missed dose as soon as you
remember but do not take two doses in one day. Do not take a
double dose to make up for a forgotten dose.
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.
Stop taking this medicine and contact your doctor
immediatly if you experience any of the following serious
side effects:
Common side effects (may affect up to 1 in 10 people)
• feeling more thirsty or hungrier then usual, need to urinate
more often, feeling confused, weak, tired or your breath may
smell fruity, these are signs of diabetes.
Unknown frequency (cannot be estimated from the available
data)
• severe itching of the skin (with raised lumps) or swelling of
the face, lips, tongue and/or throat, which may cause difficulty
in swallowing or breathing (angioedema).
• life-threatening irregular heartbeat.
• seizure.
• sudden unexplained death.
• abnormal bruising, bleeding, or signs of infection such as
a sore throat and high temperature (can indicate reduced
number of white blood cells or platelets).
• thoughts of suicide or suicide attempt and suicide.
• swelling, pain, and redness in the leg indicating a blood clot
in the veins, which may travel through blood vessels to the
lungs causing chest pain and difficulty in breathing.
• yellowing of the skin and white part of eyes (jaundice), dark
urine, nausea, diarrhoea, tiredness, flu like symptoms, swollen
abdomen, bleeding easily or confusion (can be symptoms of
liver inflammation or liver failure).
• fever, muscle stiffness, muscle pains, vomiting, sweating, dark
urine, or a lowered level of consciousness (a disorder called
“Neuroleptic Malignant Syndrome”).
• prolonged and/or painful erection.
• inflammation of the pancreas.
• abnormal muscle breakdown which can lead to kidney
problems.
• serotonin syndrome (a reaction which may cause feelings of
great happiness, drowsiness, clumsiness, restlessness, feeling
of being drunk, fever, sweating or rigid muscles).
• heart attack.
The following side effects could happen:
Common side effects (may affect up to 1 in 10 people)
• 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 (frequency cannot be estimated from the
available data):
• 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,
• excessive gambling,
• feeling aggressive,

• agitation,
• nervousness,
• speech disorder,
• slower heart beat,
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung
infection),
• spasm of the muscles around the voice box,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• reports of abnormal liver tests values,
• skin rash,
• sensitivity to light,
• baldness,
• excessive sweating,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty in passing urine,
• withdrawal symptoms in newborn babies in case of exposure
during pregnancy,
• 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, pharmacist or
nurse. 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. H
 ow to store Aripiprazole 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. The expiry date refers to the
last day of that month.
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. C
 ontents of the pack and other information
What Aripiprazole tablets contain
• The active substance is aripiprazole. Each tablet contains 5mg
of aripiprazole, 10mg of aripiprazole, 15mg of aripiprazole,
30mg of aripiprazole.
• The other ingredients are lactose monohydrate, maize starch,
microcrystalline cellulose, hydroxypropyl cellulose type EF
(E463), magnesium stearate, purified water.
What Aripiprazole tablets look like and contents of the pack
Aripiprazole 5mg tablets are round, biconvex and white 5mm,
engraved with “5” on one side and “ZL” on one side.
Aripiprazole 10mg tablets are capsule shaped, biconvex and
white 8mm x 5mm, engraved with “10” on one side and “ZL” on
one side.
Aripiprazole 15mg round, biconvex and white 7mm, engraved
with “15” on one side and “ZL” on one side.
Aripiprazole 30mg tablets round, biconvex and white 9mm,
engraved with “30” on one side and “ZL” on one side.
Pack sizes:
Push-through blister packs: 28
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Actavis Ltd
BLB 016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in April 2017

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column

BBBA0285

Aripiprazole 5mg, 10mg, 15mg & 30mg 28 Tablets PIL - UK
approved for print/date

Proof Round

8

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0285

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
24.11.16
18.04.17
S.Anson

Date sent:
06.12.16
Date received: 07.12.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Malta Zejtun

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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