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Active substance(s): ARIPIPRAZOLE

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Aripiprazole (Front)


140x540 mm (Drawing 231)

Feb, 7- 2017

Package leaflet: Information for the user
Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 30 mg 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
What Aripiprazole is and what it is used for
What you need to know before you take Aripiprazole
How to take Aripiprazole

Possible side effects
How to store Aripiprazole


Contents of the pack and other information

What Aripiprazole is and what it is used for
Aripiprazole contains the active substance aripiprazole and belongs to a group of medicines called
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 tablets.
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 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

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 tablets are not for use in children and adolescents under 13 years. Ask your doctor or
pharmacist for advice before taking Aripiprazole tablets.
Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
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.
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

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 Aripiprazol tablets, you should see your doctor.
Aripiprazole with food, drink and alcohol
Aripiprazole tablets can be taken regardless of meals.
Alcohol should be avoided when taking aripiprazole.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or if you 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 affect you.
Aripiprazole tablets 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.
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 tablets 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 tablets is too strong or too weak, talk to your
doctor or pharmacist.
Try to take the Aripiprazol tablets 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 Aripiprazol tablets without first
consulting your doctor.

Aripiprazole (Back)

Aripiprazole 15 mg tablets: The score line is not intended for breaking the tablet
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.
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
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
Increased blood levels of the hormone prolactin.
The following side effects have been reported since the marketing of Aripiprazole tablets 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; 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 the Yellow Card Scheme, website By reporting side effects you can help provide more information on the
safety of this medicine.
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.
This medicine 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.
Contents of the pack and other information
What Aripiprazole tablets contains

The active substance is aripiprazole.
Aripiprazole 5 mg tablets: Each tablet contains 5 mg of aripiprazole.
Aripiprazole 10 mg tablets: Each tablet contains 10 mg of aripiprazole.
Aripiprazole 15 mg tablets: Each tablet contains 15 mg of aripiprazole.
Aripiprazole 30 mg tablets: Each tablet contains 30 mg of aripiprazole.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose,
hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
What Aripiprazole tablets looks like and contents of the pack
Aripiprazole 5 mg tablets: Round plane pale pink tablet
Aripiprazole 10 mg tablets: Round biconvex pale pink tablet
Aripiprazole 15 mg tablets: Round biconvex pale pink tablet, scored in one side
Aripiprazole 30 mg tablets: Round biconvex pale pink tablet
The product is packed in an Aluminium-Aluminium blister in cartons of 14, 28, 49, 56, 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gran Vía Carlos III, 98, 7th floor, 08028 Barcelona
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
This leaflet was last revised in Februrary 2017


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.