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ARIPIPRAZOLE 10 MG ORODISPERSIBLE TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE / ARIPIPRAZOLE

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T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: Information for the user

Aripiprazole 10mg and 15mg
Orodispersible Tablets
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• K
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist
or nurse.
• T his 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
• T he full name of this medicine is Aripiprazole 10mg and 15mg
Orodispersible Tablets but within the
leaflet it will be referred to as Aripiprazole tablets.
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
1. What Aripiprazole tablets are and what they are
used for
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.

• M
 edicines to correct heart rhythm
• A
 ntidepressants or herbal remedy used to treat
depression and anxiety
• A
 ntifungal agents
• C
 ertain medicines to treat HIV infection
• A
 nticonvulsants 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 symptoms taking any of these medicines
together with Aripiprazole tablets, you should see your doctor.
Aripiprazole tablets with food, drink and alcohol
Aripiprazole 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 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
breast-feeding. 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 aspartame
Patients who cannot take phenylalanine should note that
Aripiprazole orodispersible tablets contain aspartame, which is a
source of phenylalanine.
May be harmful for people with phenylketonuria.
3. How to take Aripiprazole tablets

2. What you need to know before you 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.

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

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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Aripiprazole
tablets if you suffer from:
• H
 igh 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
• S eizure
• Involuntary, irregular muscle movements, especially in the face
• C
 ardiovascular diseases, family history of cardiovascular
disease, stroke or “mini” stroke, abnormal blood pressure
• B
 lood clots, or family history of blood clots, as antipsychotics
have been associated with formation of blood clots
• P
 ast experience of excessive gambling

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 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.

Immediately upon opening the blister, using dry hands,
remove the tablet and place the entire orodispersible tablet
on the tongue. Tablet disintegration occurs rapidly in saliva.
The orodispersible tablet can be taken with or without liquid.
Alternatively, disperse the tablet in water and drink the resulting
suspension.

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.

If you have the impression that the effects of your Aripiprazole
orodispersible tablets are too strong or too weak, talk to your
doctor or pharmacist.
Try to take the Aripiprazole orodispersible tablet at the same
time each day. It does not matter whether you take it with or
without food.

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 orodispersible
tablets than your doctor has recommended (or if someone else
has taken some of your Aripiprazole orodispersible tablets),
contact your doctor right away. If you cannot reach your doctor,
go to the nearest hospital and take the pack with you.

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.

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).

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.

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.

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.

If you stop taking Aripiprazole orodispersible tablets
Do not stop your treatment just because you feel better. It is
important that you carry on taking Aripiprazole orodispersible
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, pharmacist or nurse.

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:
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T00075-01 Malta Zejtun 190x380 PIL

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
immediately 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):
• s evere 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).
• a bnormal bruising, bleeding, or signs of infection such as a sore
throat and high temperature (can indicate reduced number of
white blood cells or platelets).
• t houghts of suicide or suicide attempt.
• s welling, 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.
• y ellowing 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”).
• p
 rolonged and/or painful erection.
The following side effects could happen:
Common side effects (may affect up to 1 in 10 people):
• d
 ifficulty sleeping
• feeling anxious
• feeling restlessness and unable to keep still, difficulty sitting
still
• u
 ncontrollable twitching or jerking movements, restless legs
• t rembling
• h
 eadache
• t iredness
• s leepiness
• light headedness
• s haking and blurred vision
• d
 ecreased number of or difficulty making bowel movements
• indigestion
• feeling sick
• m
 ore saliva in mouth than normal
• v omiting
• feeling tired
Uncommon side effects (may affect up to 1 in 100 people):
• increased blood levels of the hormone prolactin
• t oo much sugar in the blood
• d
 epression
• a ltered or increased sexual interest
• u
 ncontrollable movements of mouth, tongue and limbs
(tardive dyskinesia)
• m
 uscle disorder causing twisting movements (dystonia)
• d
 ouble vision
• f ast heart beat
• a fall in blood pressure on standing up which causes dizziness,
light-headedness or fainting
• h
 iccups
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):
• w
 orsening of diabetes, ketoacidosis (ketones in the blood and
urine) or coma
• h
 igh blood sugar
• n
 ot enough sodium in the blood
• loss of appetite (anorexia)
• w
 eight loss
• w
 eight gain
• s uicide
• e xcessive gambling
• feeling aggressive
• a gitation
• n
 ervousness
• s eizure
• s erotonin syndrome (a reaction which may cause feelings of
great happiness, drowsiness, clumsiness, restlessness, feeling of
being drunk, fever, sweating or rigid muscles)
• s peech disorder
• s udden unexplained death
• life-threatening irregular heart beat
• h
 eart attack
• s lower heart beat
• h
 igh blood pressure
• f ainting
• a ccidental inhalation of food with risk of pneumonia (lung
infection)
• s pasm of the muscles around the voice box
• inflammation of the pancreas
• d
 ifficulty swallowing
• d
 iarrhoea
• a bdominal discomfort
• s tomach discomfort
• r eports of abnormal liver tests values
• s kin rash
• s ensitivity to light
• b
 aldness
• e xcessive sweating
• a bnormal muscle breakdown which can lead to kidney
problems
Continued top of next column











m
 uscle pain
s tiffness
involuntary loss of urine (incontinence)
d
 ifficulty in passing urine
w
 ithdrawal symptoms in newborn babies in case of exposure
during pregnancy
d
 ifficulty controlling core body temperature or overheating
c hest pain
s welling 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
Website: 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 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. Contents of the pack and other information
What Aripiprazole tablets contain
• T he active substance is aripiprazole. Each orodispersible tablet
contains 10mg, 15mg of aripiprazole
• T he other ingredients are:
Silicified microcrystalline cellulose, Aspartame (E951), Vanilla
flavour (501469 TP0551), Magnesium stearate, Croscarmellose
sodium (E468). Yellow iron oxide (E172) for 15mg
orodispersible.
What Aripirazole tablets look like and contents of the pack
Orodispersible tablet 10mg
Round and white, 7mm with “1” debossed on one side and “ZT” on
the other.
Orodispersible tablet 15mg
Round and yellow mottled, 8mm with “2” debossed on one side
and “ZT” on the other.
Pack sizes:
Blisters:
• P
 ush-through blisters packed in cartons containing
28 orodispersible tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, Ex32 8NS, UK
Manufacturer
Actavis Ltd.
BLB016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in February 2017

Actavis, Barnstaple, EX32 8NS, UK

BBBA0279

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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