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Package leaflet: Information for the user
Aripiprazole 10 mg Orodispersible Tablets
Aripiprazole 15 mg Orodispersible 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.
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 contains 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.
2. What you need to know before you take Aripiprazole
Do not take Aripiprazole
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 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
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
Aripiprazole is not for use in children and adolescents under 15 years. Ask your doctor or pharmacist for
advice before taking Aripiprazole.
Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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
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, selective serotonin
re-uptake inhibitors [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 alcohol
Alcohol should be avoided when taking Aripiprazole.
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.
Driving and using machines
Do not drive or use any tools or machines, until you know how Aripiprazole affects you.
3. How to take Aripiprazole
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 an 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
Aripiprazole is for oral use
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.

an uncomfortable feeling in the stomach,
increased production of saliva,
trouble sleeping,
feeling anxious,
shaking and
blurred vision.

Uncommon side effects (may affect up to 1 in 100 people):
dizziness, especially when getting up from a lying or sitting position,
fast heart rate.
double vision
some people may feel depressed
Increased 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 heartbeat,
sudden unexplained death,
heart attack,
allergic reaction (for example 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,
feeling anxious,
excessive gambling,
thoughts of suicide,
suicide attempt and suicide,
speech disorder,
serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Neuroleptic malignant syndrome (a combination of fever, muscle stiffness, faster breathing,
sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
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,
skin rash and sensitivity to light,
unusual hair loss or thinning,
excessive sweating,
stiffness or cramps,
muscle pain,
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 (may affect more than 1 in 10 people) 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
(may affect up to 1 in 10 people).
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 Website: 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.
This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater. 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.
Each orodispersible tablet contains 10 mg of aripiprazole.
Each orodispersible tablet contains 15 mg of aripiprazole.


The other ingredients are mannitol, crospovidone (type B), colloidal anhydrous silica, hydroxypropyl
cellulose, microcrystalline cellulose, acesulfame potassium, vanilla flavour (including nature
identical flavourings, natural flavours, maize maltodextrin, modified corn starch, triacetin), tartaric
acid, magnesium stearate.

Do not remove the orodispersible tablet from the blister until ready to administer. 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.

What Aripiprazole looks like and contents of the pack

Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole without first consulting
your doctor.

Aripiprazole 15 mg orodispersible tablets are white to off white, round uncoated tablets debossed with
“15” on one side and plain on other side with an approx. diameter of 7.9mm.

If you take more Aripiprazole 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 tablets), contact your doctor right away. If you
cannot reach your doctor, go to the nearest hospital and take the pack with you.

Aripiprazole orodispersible tablets are supplied in blisters packed in cartons containing 10, 14, 28, 30, 49,
56 or 60 tablets.

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 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,

Aripiprazole 10 mg orodispersible tablets are white to off white, round uncoated tablets debossed with
“10” on one side and plain on other side with an approx. diameter of 7.1mm.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way
West Sussex
RH11 7XA
United Kingdom
This leaflet was last revised in 07/2015.


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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.