ABILIFY 5 мг Таблетка

Сергей Ильясов

Сергей Ильясов — опытный врач-невролог и квалифицированный психиатр, предоставляющий онлайн-консультации для взрослых и подростков. Сочетая глубокую неврологическую экспертизу с современным психиатрическим подходом, он обеспечивает комплексную диагностику и эффективное лечение широкого спектра состояний, затрагивающих как физическое, так и психическое здоровье.

Доктор помогает пациентам в таких случаях:

Хронические головные боли (мигрень, головная боль напряжения), боли в спине, невропатические боли, головокружения, онемение конечностей, нарушения координации.
Тревожные расстройства (панические атаки, генерализованное тревожное расстройство), депрессия (в том числе атипичная и резистентная), нарушения сна (бессонница, сонливость, кошмары), стресс, выгорание.
Хронические болевые синдромы и психосоматические симптомы (например, синдром раздражённого кишечника на нервной почве, вегетососудистая дистония).
Поведенческие нарушения и трудности с концентрацией внимания у подростков (включая СДВГ, расстройства аутистического спектра), нервные тики.
Нарушения памяти, фобии, обсессивно-компульсивное расстройство (ОКР), эмоциональные качели, а также поддержка при посттравматическом стрессовом расстройстве (ПТСР).

Благодаря двойной специализации в неврологии и психиатрии, Сергей Ильясов предлагает интегрированную и доказательную помощь при сложных состояниях, требующих междисциплинарного подхода. Его консультации направлены на точную диагностику, разработку индивидуального плана лечения (включая фармакотерапию и психотерапевтические методики) и долгосрочную поддержку, адаптированную к уникальным потребностям каждого пациента.

Запишитесь на онлайн-консультацию с доктором Сергеем Ильясовым, чтобы получить квалифицированную помощь и улучшить своё самочувствие уже сегодня.

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Инструкция по применению ABILIFY

Содержание инструкции

ABILIFY 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets
ABILIFY 10 mg orodispersible tablets, 15 mg orodispersible tablets, 30 mg orodispersible tablets
ABILIFY 1 mg/mL oral solution
ABILIFY 7.5 mg/mL injectable solution

ABILIFY 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets

aripiprazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ABILIFY is and what it is used for
2. What you need to know before you take ABILIFY
3. How to take ABILIFY
4. Possible side effects
5. How to store ABILIFY
6. Contents of the pack and other information

1. What is ABILIFY and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called
antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who are affected
by an illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and blunted emotions.
People who present with this condition may also feel depressed, guilty, anxious or
tense.
ABILIFY is used for the treatment of adults and adolescents starting from 13 years of age who are affected by
a condition characterized by symptoms such as feeling “revved up”, having excessive energy, needing
to sleep much less than usual, talking very quickly with “racing thoughts” and
sometimes severe irritability. In addition, it prevents this condition in adults who have responded to
treatment with ABILIFY.

2. What you need to know before you take ABILIFY

Do not take ABILIFY

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 ABILIFY.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Tell your
doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with ABILIFY, tell your doctor if you suffer from:

high blood sugar levels (characterised by symptoms such as excessive thirst, production

of large amounts of urine, increased appetite and feeling of weakness) or a family history of
diabetes;

epilepsy (seizures) as your doctor may decide to monitor you more closely;
involuntary, irregular muscle movements, especially of the face;
cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities;
blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which
interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic
reactions, tell your doctor.
If you are an elderly patient suffering from dementia (memory loss and other mental abilities), you or
your caregiver must inform the doctor if you have ever had a stroke or a transient ischaemic attack (TIA).
Tell your doctor immediately if you are thinking about harming yourself.
Ideation and suicidal behaviours have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever,
sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregivers notice that you are developing a
urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, urge or temptation to carry out certain activities that may harm yourself or others. These
phenomena are called impulse control disorders and may include behaviours such as
gambling addiction, excessive eating or spending, unusually high sexual drive or preoccupation with increased sexual thoughts or sensations.
Your doctor may need to adjust your dose or stop your therapy.
Aripiprazole can cause drowsiness, low blood pressure when getting up,
dizziness and changes in the ability to move and maintain balance, which can lead to
falls. Be careful, especially if you are elderly or in some way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 13 years. It is not known if it is safe
and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: ABILIFY can increase the effect of medicines
used to lower blood pressure. Tell your doctor if you are taking medicine to control
your blood pressure.
Taking ABILIFY together with certain medicines may mean that your doctor will need to change
the dose of ABILIFY or the other medicines. It is particularly important to inform your doctor about the
following medicines:

medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide);
antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort);
antifungal medicines (e.g. ketoconazole, itraconazole);
some medicines to treat HIV infection (e.g. efavirenz, nevirapine, protease inhibitors such as indinavir and ritonavir);
anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of ABILIFY;
consult your doctor if you experience any unusual symptoms while taking any of these
medicines together with ABILIFY.
The medicines that increase the level of serotonin are typically used in conditions such as
depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia,
as well as migraine and pain:

triptans, tramadol and tryptophan, used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain;
selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine), used for depression, OCD, panic and anxiety;
other antidepressants (e.g. venlafaxine and tryptophan), used in major depression;
tricyclics (e.g. clomipramine and amitriptyline), used for depressive illness;
St John's wort ( Hypericum perforatum), used as a herbal remedy for mild depression;
pain relievers (e.g. tramadol and pethidine), used to relieve pain;
triptans (e.g. sumatriptan and zolmitriptan), used for the treatment of migraine.

These medicines may increase the risk of side effects; consult your doctor if you experience
any unusual symptoms while taking any of these medicines together with
ABILIFY.

ABILIFY with food, drink and alcohol
This medicine can be taken independently of food.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used ABILIFY in the last
trimester (last three months of pregnancy): tremor, rigidity and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If the baby presents any of these
symptoms, it may be necessary to contact the doctor.
If you are taking ABILIFY, your doctor will discuss with you whether you should breastfeed, considering the benefit
of therapy for you and the benefit of breastfeeding for the baby. One excludes the other. If you
are taking this medicine, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in situations where full alertness is required, for
example when driving a vehicle or using machines.

ABILIFY contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take ABILIFY

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents
This medicine can be started at low doses using the oral solution (liquid).
The dose can 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, up to a maximum of 30 mg once a day.
If you feel that the effect of ABILIFY is too strong or too weak, contact your doctor or pharmacist.

Try to take ABILIFY every day at the same time. It does not matter if you take it with or without food. Always take the tablet with water, swallowing it whole.

Even if you feel better, do not change or stop the daily dose of ABILIFY without first consulting your doctor.

If you take more ABILIFY than you should
If you should realize that you have taken more ABILIFY than your doctor has recommended (or if someone else has taken ABILIFY), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and bring the package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

rapid heartbeat, agitation/aggressiveness, speech problems;
unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
muscle stiffness and drowsiness or sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or hospital immediately if you have any of these symptoms.

If you forget to take ABILIFY
If you forget a dose, take it as soon as you remember, but do not take two in the same day.

If you stop taking ABILIFY
Do not stop treatment just because you feel better. It is important to continue taking ABILIFY for the entire period indicated by your doctor.
If you have any doubts about 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):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to stay still, difficulty remaining seated,
akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
uncontrollable muscle contractions, jerky or twitching movements,
tremor,
headache,
fatigue,
drowsiness,
feeling lightheaded,
agitation and blurred vision,
reduced number of bowel movements or difficulty evacuating,
indigestion,
nausea,
increased saliva production compared to usual,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increase or decrease in the levels of the hormone prolactin in the blood,
high blood sugar levels,
depression,
alteration or increase in sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heart rate,
lowering of blood pressure when getting up, which causes dizziness, lightheadedness or fainting,
hiccups.

The following side effects have been reported since aripiprazole oral began to be marketed, but the frequency with which they have occurred is not known:

low levels of white blood cells,
low levels of platelets,
allergic reaction (e.g. swelling of 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 levels,
low sodium levels in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, attempted suicide and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced awareness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
seizures,
serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorder,
eyeballs fixed in one position,
sudden unexplained death,
life-threatening irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel to the lungs causing chest pain and difficulty 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 larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and the whites of the eyes,
cases of abnormal liver function test values,
skin rash,
skin sensitivity to light,
hair loss,
excessive sweating,
serious allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
abnormal breakdown of muscles that can cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns in case of exposure during pregnancy,
prolonged and/or painful erection,
difficulty controlling internal body temperature or conditions of excessive heat,
chest pain,
swelling of the hands, ankles or feet,
in blood tests: increase or fluctuation in blood sugar levels, increased glycated hemoglobin,
inability to resist the urge, impulse or temptation to perform an action that may be harmful to you or others, which may include:

strong urge to gamble excessively despite serious personal or family consequences,
altered or increased sexual interest and behavior that causes significant concern to you or others, for example increased sexual drive,
excessive and uncontrollable shopping,
uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite),

tendency to withdraw. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole. In addition, cases of stroke or transient ischemic attack have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in frequency and type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue, which were very common (more than 1 in 10) and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable limb movements and dizziness, especially when rising from a lying or sitting position, which were common (more than 1 in 100).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ABILIFY

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 the box after
“Scad.” or “EXP”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ABILIFY contains

The active ingredient is aripiprazole. Each tablet contains 5 mg of aripiprazole. Each tablet contains 10 mg of aripiprazole. Each tablet contains 15 mg of aripiprazole. Each tablet contains 30 mg of aripiprazole.
The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose and magnesium stearate. Tablet coating ABILIFY 5 mg tablets: aluminium indigotine lake (E 132) ABILIFY 10 mg tablets: red iron oxide (E 172) ABILIFY 15 mg tablets: yellow iron oxide (E 172) ABILIFY 30 mg tablets: red iron oxide (E 172)

Description of the appearance of ABILIFY and contents of the pack
ABILIFY 5 mg tablets are rectangular and blue, engraved with ‘A-007’ and ‘5’ on one side.
ABILIFY 10 mg tablets are rectangular and pink, engraved with ‘A-008’ and ‘10’ on one side.
ABILIFY 15 mg tablets are round and yellow engraved, with ‘A-009’ and ‘15’ on one side.
ABILIFY 30 mg tablets are round and pink, engraved with ‘A-011’ and ‘30’ on one side.
ABILIFY tablets is available in divisible blister packs in cartons containing 14 × 1,
28 × 1, 49 × 1, 56 × 1 or 98 × 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Lietuva
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

България
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Luxembourg/Luxemburg
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Česká republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Magyarország
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Danmark
Otsuka Pharma Scandinavia AB
Tlf: +46 (0) 8 545 286 60

Malta
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Deutschland
Otsuka Pharma GmbH
Tel: +49 (0) 69 1700 860

Nederland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Eesti
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Norge
Otsuka Pharma Scandinavia AB
Tlf: +46 (0) 8 545 286 60

Ελλάδα
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Österreich
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

España
Otsuka Pharmaceutical, S.A.
Tel: +34 93 550 01 00

Polska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

Portugal
Lundbeck Portugal Lda
Tel: +351 (0) 21 00 45 900

Hrvatska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

România
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Ireland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Slovenija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Ísland
Vistor hf.
Sími: +354 (0) 535 7000

Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0) 2 0063 2710

Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46 (0) 8 545 286 60

Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60

Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

United Kingdom (Northern Ireland)
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .

ABILIFY 10 mg orodispersible tablets, 15 mg orodispersible tablets, 30 mg orodispersible tablets

aripiprazole

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ABILIFY is and what it is used for
2. What you need to know before you take ABILIFY
3. How to take ABILIFY
4. Possible side effects
5. How to store ABILIFY
6. Contents of the pack and other information

1. What is ABILIFY and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called
antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who are affected
by an illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and blunted emotions.
People who present with this condition may also feel depressed, guilty, anxious or
tense.
ABILIFY is used for the treatment of adults and adolescents starting from 13 years of age who are affected by
a condition characterized by symptoms such as feeling “revved up”, having excessive energy, needing
to sleep much less than usual, talking very quickly with “racing thoughts” and
sometimes severe irritability. Furthermore, it prevents this condition in adults who have responded to
treatment with ABILIFY.

2. What you need to know before taking ABILIFY

Do not take ABILIFY

if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

high blood sugar levels (characterised by symptoms such as excessive thirst, producing large amounts of urine, increased appetite and feeling weak) or a family history of

diabetes;

epilepsy (convulsions) as your doctor may decide to monitor you more closely;
involuntary, irregular muscle movements, especially of the face;
cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities;
blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy which
interferes with normal daily activities, if you have difficulty swallowing or if you have allergic
symptoms, tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or
the person caring for you must inform the doctor if you have ever had a stroke or a transient
ischaemic attack (TIA).
Tell your doctor immediately if you are thinking about harming yourself.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever,
sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregivers notice that you are developing an
urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, the
urge or the temptation to carry out certain activities that may harm yourself or others. These
phenomena are called impulse control disorders and can include behaviours such as
gambling addiction, excessive eating or spending, unusually high sexual drive or preoccupation with
increased sexual thoughts or feelings.
Your doctor may need to adjust the dose or stop your therapy.
Aripiprazole can cause drowsiness, low blood pressure when getting up,
dizziness and changes in the ability to move and maintain balance, which can lead to
falls. Be careful, especially if you are elderly or in some way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 13 years. It is not known whether it is safe
and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: ABILIFY can increase the effect of medicines
used to lower blood pressure. Tell your doctor if you are taking a medicine to control
your blood pressure.
Taking ABILIFY together with certain medicines may mean that your doctor will need to change
the dose of ABILIFY or the other medicines. It is particularly important to inform your doctor about
the following medicines:

medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide);
antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort);
antifungal medicines (e.g. ketoconazole, itraconazole);
some medicines to treat HIV infection (e.g. efavirenz, nevirapine, protease inhibitors such as indinavir and ritonavir);
anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of ABILIFY;
consult your doctor if you experience any unusual symptoms while taking any of these
medicines together with ABILIFY.
The medicines that increase the level of serotonin are typically used in conditions such as
depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia,
as well as migraine and pain:

triptans, tramadol and tryptophan, used in conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain;
selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine), used for depression, OCD, panic and anxiety;
other antidepressants (e.g. venlafaxine and tryptophan), used in major depression;
tricyclics (e.g. clomipramine and amitriptyline), used for depressive illness;
St John's wort ( Hypericum perforatum), used as a herbal remedy for mild depression;
painkillers (e.g. tramadol and pethidine), used to relieve pain;
triptans (e.g. sumatriptan and zolmitriptan), used for the treatment of migraine.

These medicines may increase the risk of side effects; consult your doctor if you experience
any unusual symptoms while taking any of these medicines together with
ABILIFY.

ABILIFY with food, drinks and alcohol
This medicine can be taken independently of food.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used ABILIFY in the last
trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If the baby presents any of these
symptoms, it may be necessary to contact the doctor.
If you are taking ABILIFY, your doctor will discuss with you whether you should breastfeed, considering the benefit
of therapy for you and the benefit of breastfeeding for the baby. One excludes the other. If you are
taking this medicine, discuss with your doctor the best way to feed your baby.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where full alertness is required, for
example when driving a vehicle or operating machinery.

ABILIFY contains aspartame
ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg of aspartame per
tablet.
ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg of aspartame per
tablet.
ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg of aspartame per
tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria,a rare
genetic disorder that causes phenylalanine to build up because the body cannot break it down
correctly.

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

ABILIFY contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take ABILIFY

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

The recommended dose for adults is 15 mg once a day. However, your doctor may
prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents
This medicine may be started at low doses using the oral solution (liquid).
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, up to
a maximum of 30 mg once a day.
If you feel that the effect of ABILIFY is too strong or too weak, contact your doctor or
pharmacist.

Try to take ABILIFY every day at the same time. It does not matter if you take it with or without
food.
Do not open the blister pack until you are ready to administer. To take the single
tablet, open the packaging and remove the aluminum from the blister to reveal the tablet. Do not
push the tablet through the aluminum as this could damage it. Immediately
after opening the blister pack, with dry hands, remove the orodispersible tablet and place it whole
on your tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet can be taken with or without liquids.
Alternatively, disperse the tablet in water and drink the resulting suspension.

Even if you feel better, do not change or stop the daily dose of ABILIFY without first
consulting your doctor.

If you take more ABILIFY than you should
If you should realize that you have taken more ABILIFY than your doctor has recommended (or if
someone else has taken ABILIFY), contact your doctor immediately. If you cannot reach
your doctor, go to the nearest hospital and take the packaging with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

rapid heartbeat, agitation/aggression, speech problems;
unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
muscle rigidity and drowsiness or sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, heart rhythm changes.

Contact your doctor or hospital immediately if you have any of these symptoms.

If you forget to take ABILIFY
If you forget a dose, take it as soon as you remember, but do not take two in the same
day.

If you stop taking ABILIFY
Do not stop treatment just because you feel better. It is important to continue taking
ABILIFY for the entire period indicated by your doctor.
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):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to stay still, difficulty remaining seated,
akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
uncontrollable muscle contractions, jerky or twitching movements,
tremor,
headache,
fatigue,
drowsiness,
feeling lightheaded,
agitation and blurred vision,
reduced number of bowel movements or difficulty evacuating,
indigestion,
nausea,
increased saliva production compared to usual,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increase or decrease in prolactin hormone levels in the blood,
high blood sugar levels,
depression,
alteration or increase in sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heart rate,
lowering of blood pressure when getting up, which causes dizziness, lightheadedness or fainting,
hiccups.

The following side effects have been reported since aripiprazole oral began to be marketed, but the frequency with which they have occurred is not known:

low levels of white blood cells,
low levels of platelets,
allergic reaction (e.g. swelling of 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 levels,
low sodium level in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, attempted suicide and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
seizures,
serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
speech disorder,
eyeballs fixed in one position,
sudden unexplained death,
life-threatening irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty 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 larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhea,
abdominal discomfort,
stomach discomfort,
liver failure,
liver inflammation,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test values,
skin rash,
skin sensitivity to light,
hair loss,
excessive sweating,
severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
abnormal breakdown of muscles that can cause kidney problems,
muscle pain,
rigidity,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns if exposed during pregnancy,
prolonged and/or painful erection,
difficulty controlling body temperature or conditions of excessive heat,
chest pain,
swelling of the hands, ankles or feet,
in blood tests: increase or fluctuation of blood sugar levels, increased glycated hemoglobin,
inability to resist the urge, impulse or temptation to perform an action that may be harmful to you or others, which may include:

strong urge to gamble excessively despite serious personal or family consequences,
altered or increased sexual interest and behavior that causes significant concern to you or others, for example an increase in sexual drive,
excessive and uncontrollable shopping,
uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite),
tendency to wander. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole. In addition, cases of stroke or transient ischemic attack have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in frequency and type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue, which were very common (more than 1 in 10) and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable movements of the limbs and feeling dizzy, especially when getting up from a lying or sitting position, which were common (more than 1 in 100).

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ABILIFY

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 the box after
“Scad.” or “EXP”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ABILIFY contains

The active ingredient is aripiprazole. Each orally disintegrating tablet contains 10 mg of aripiprazole. Each orally disintegrating tablet contains 15 mg of aripiprazole. Each orally disintegrating tablet contains 30 mg of aripiprazole.
Other ingredients are: calcium silicate, sodium croscarmellose, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, potassium acesulfame, vanilla flavour (contains lactose), tartaric acid, magnesium stearate. Coating of ABILIFY 10 mg orally disintegrating tablets: red iron oxide (E 172) ABILIFY 15 mg orally disintegrating tablets: yellow iron oxide (E 172) ABILIFY 30 mg orally disintegrating tablets: red iron oxide (E 172)

Description of ABILIFY and package contents
ABILIFY 10 mg orally disintegrating tablets are round and pink, engraved with ‘"A" on "640"’ on one
side and ‘10’ on the other side.
ABILIFY 15 mg orally disintegrating tablets are round and yellow, engraved with ‘"A" on "641"’ on one
side and ‘15’ on the other side.
ABILIFY 30 mg orally disintegrating tablets are round and pink, engraved with ‘"A" on "643"’ on one
side and ‘30’ on the other side.
ABILIFY orally disintegrating tablets are available in divisible blister packs for unit dose in
cartons containing 14 × 1, 28 × 1 or 49 × 1 orally disintegrating tablets.
Not all pack sizes may be marketed.