Abilify: detailed information

Package leaflet: Information for the user

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

aripiprazole
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What ABILIFY is and what it is used for
What you need to know before taking ABILIFY
How to take ABILIFY
Possible side effects
How to store ABILIFY
Contents of the pack and other information

1. What ABILIFY is and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents from the age of 15 years who have a disorder characterized by symptoms such as hearing, seeing, or perceiving things that are not present, suspiciousness, false beliefs, disorganized speech and behavior, and blunted emotions.
People with this condition may also feel depressed, guilty, anxious, or tense.
ABILIFY is used to treat adults and adolescents from the age of 13 years who have a condition characterized by symptoms such as feeling "high", having excessive energy, needing much less sleep than usual, talking very rapidly 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 should know before taking ABILIFY

Do not take ABILIFY

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

Warnings and precautions
Talk to your doctor before taking ABILIFY.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your
doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with ABILIFY, inform your doctor if you have:

high blood sugar levels (characterized by symptoms such as excessive thirst, production of large

amounts of urine, increased appetite, and feeling weak) 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 circulatory diseases), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities;
a history of blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation;
a history of excessive gambling.

If you notice that you are gaining weight, develop unusual movements, feel drowsy to the point of interfering with normal daily activities, have difficulty swallowing, or experience allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform your doctor if you have ever had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as compulsive gambling, eating, or spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in your ability to move and maintain balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. 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 those obtained without a prescription.
Medicines that lower blood pressure: ABILIFY may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking a medicine to control your blood pressure.
Taking ABILIFY together with certain medicines may require your doctor to adjust the dose of ABILIFY or of the other medicines. It is particularly important to inform your doctor about the following medicines:

medicines used 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 used 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 effectiveness of ABILIFY; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with ABILIFY.
Medicines that increase serotonin levels 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;
painkillers (e.g., tramadol and pethidine), used to relieve pain;
triptans (e.g., sumatriptan and zolmitriptan), used to treat 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 regardless of food intake.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have used ABILIFY during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking ABILIFY, your doctor will discuss with you whether you should breastfeed, considering the benefit of the treatment for you and the benefit of breastfeeding for the baby. One choice 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 requiring full alertness, such as driving a vehicle or operating machinery.

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

3. How to take ABILIFY

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be started at a low dose using the oral solution (liquid).
The dose may be gradually increased up to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
Try to take ABILIFY at the same time every day. It does not matter whether 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 your daily dose of ABILIFY without first consulting your doctor.
If you take more ABILIFY than you should
If you realize that you have taken more ABILIFY than prescribed by your doctor (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 pack 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 stiffness and drowsiness or sedation, slow breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or hospital immediately if you experience 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 doses on 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 duration prescribed by your doctor.
If you have any questions about how to use this medicine, consult 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 remain still, difficulty staying seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, jerky movements or twisting,
tremors,
headache,
tiredness,
drowsiness,
feeling of light-headedness,
agitation and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
nausea,
increased saliva production compared to usual,
vomiting,
feeling of fatigue.

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

increase or decrease in blood levels of the hormone prolactin,
high blood sugar levels,
depression,
altered or increased sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restlessness in the legs,
double vision,
sensitivity of the eyes to light,
rapid heartbeat,
drop in blood pressure upon standing, causing dizziness, light-headedness or fainting,
hiccup.

The following side effects have been reported since the start of oral aripiprazole marketing, but their frequency is unknown:

low white blood cell count,
low platelet count,
allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma,
high blood sugar levels,
low sodium levels in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
suicidal thoughts, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizures,
serotonin syndrome (a reaction that may cause a feeling of extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
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 breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasm around the larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test results,
rash,
skin sensitivity to light,
hair loss,
excessive sweating,
severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a facial rash that spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and increase in a type of white blood cells (eosinophilia),
abnormal breakdown of muscle tissue that may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns if exposed 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: increased or fluctuating blood sugar levels, increased glycated haemoglobin,
inability to resist the impulse, urge or temptation to carry out an action that may be harmful to oneself or others, which may include:
- strong urge to gamble excessively despite serious personal or family consequences,
- altered or increased sexual interest and behaviour causing significant concern to oneself 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 hunger),
tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

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

Additional side effects in children and adolescents

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the blister and the carton after "Exp." or "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What ABILIFY contains

The active substance 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 components are: monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose and magnesium stearate.
Tablet coating of ABILIFY 5 mg tablets: indigo carmine aluminium 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 pack contents
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 are available in divisible blisters for single doses, packed 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
The Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

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

Danmark Malta
Otsuka Pharma Scandinavia AB Otsuka Pharmaceutical Netherlands B.V.
Tlf: +46 (0) 8 545 286 60 Tel: +31 (0) 20 85 46 555

Deutschland Nederland
Otsuka Pharma GmbH Otsuka Pharmaceutical Netherlands B.V.
Tel: +49 (0) 69 1700 860 Tel: +31 (0) 20 85 46 555

Eesti Norge
Otsuka Pharmaceutical Netherlands B.V. Otsuka Pharma Scandinavia AB
Tel: +31 (0) 20 85 46 555 Tlf: +46 (0) 8 545 286 60

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

España Polska
Otsuka Pharmaceutical, S.A. Otsuka Pharmaceutical Netherlands B.V.
Tel: +34 93 550 01 00 Tel: +31 (0) 20 85 46 555

France Portugal
Otsuka Pharmaceutical France SAS Lundbeck Portugal Lda
Tél: +33 (0)1 47 08 00 00 Tel: +351 (0) 21 00 45 900

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

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

Ísland Slovenská republika
Vistor hf. Otsuka Pharmaceutical Netherlands B.V.
Sími: +354 (0) 535 7000 Tel: +31 (0) 20 85 46 555

Italia Suomi/Finland
Otsuka Pharmaceutical Italy S.r.l. Otsuka Pharma Scandinavia AB
Tel: +39 (0) 2 0063 2710 Puh/Tel: +46 (0) 8 545 286 60

Κύπρος Sverige
Otsuka Pharmaceutical Netherlands B.V. Otsuka Pharma Scandinavia AB
Tel: +31 (0) 20 85 46 555 Tel: +46 (0) 8 545 286 60

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

Further 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/ .

Instructions for the user: package leaflet

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

aripiprazole
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What ABILIFY is and what it is used for
What you need to know before taking ABILIFY
How to take ABILIFY
Possible side effects
How to store ABILIFY
Contents of the pack and other information

1. What ABILIFY is and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called
antipsychotics. It is used to treat adults and adolescents from the age of 15 who are affected by a
condition characterized by symptoms such as hearing, seeing, or perceiving things that are not present,
suspiciousness, false beliefs, disorganized speech and behavior, and blunting of emotions.
People with this condition may also feel depressed, guilty, anxious, or tense.
ABILIFY is also used to treat adults and adolescents from the age of 13 who are affected by a
condition characterized by symptoms such as feeling "high", having excessive energy, needing much
less sleep than usual, speaking very rapidly 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking ABILIFY.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your doctor immediately if you experience any self-harming thoughts or feelings.
Before starting treatment with ABILIFY, inform your doctor if you have:

high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) 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 circulatory diseases), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities;
blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
a history of excessive gambling.

If you notice weight gain, develop unusual movements, experience drowsiness interfering with normal daily activities, have difficulty swallowing, or develop allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform your doctor if you have ever had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as pathological gambling, binge eating, compulsive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or feelings.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

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

Other medicines and ABILIFY
Inform 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 may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Taking ABILIFY together with certain medicines may require your doctor to adjust the dose of ABILIFY or of 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);
certain medicines used 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);
certain 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.
Medicines that increase serotonin levels 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;
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 regardless of meals.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have taken ABILIFY during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking ABILIFY, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for the baby. One choice 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 when 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 to you if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.

ABILIFY contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be started at a low dose using the oral solution (liquid).
The dose may be gradually increased up to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
Try to take ABILIFY at the same time each day. It does not matter whether you take it with or without food.
Do not open the blister pack until you are ready to take the dose. To take the tablet, open the packaging and peel back the aluminum foil to expose the tablet. Do not push the tablet through the foil, as this may damage it. Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid.
Alternatively, the tablet may be dispersed in water and the resulting suspension drunk.
Even if you feel better, do not change or stop your daily dose of ABILIFY without first consulting your doctor.
If you take more ABILIFY than you should
If you realize you have taken more ABILIFY than prescribed (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 an overdose of 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 stiffness and drowsiness or sedation, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or hospital immediately if you experience 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 doses on 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 full duration prescribed by your doctor.
If you have any questions about how to use 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 remain still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, jerky movements or twisting movements,
tremors,
headache,
tiredness,
drowsiness,
feeling lightheaded,
agitation and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
nausea,
increased production of saliva compared to usual,
vomiting,
feeling of fatigue.

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

increased or decreased levels of the hormone prolactin in the blood,
high blood sugar levels,
depression,
change or increase in sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restlessness in the legs,
double vision,
sensitivity of the eyes to light,
rapid heartbeat,
drop in blood pressure when standing up, causing dizziness, lightheadedness or fainting,
hiccups.

The following side effects have been reported since the start of oral aripiprazole marketing, but their frequency is unknown:

low white blood cell count,
low platelet count,
allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma,
high blood sugar levels,
low sodium levels in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
suicidal thoughts, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,
a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome),
seizures,
serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
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 breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasms around the larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test results,
rash,
skin sensitivity to light,
hair loss,
excessive sweating,
severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia),
abnormal breakdown of muscle tissue which may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns following exposure during pregnancy,
prolonged and/or painful erection,
difficulty regulating internal body temperature or conditions of excessive heat,
chest pain,
swelling of the hands, ankles or feet,
in blood tests: increased or fluctuating blood sugar levels, increased glycated haemoglobin,
inability to resist the impulse, urge or temptation to carry out an action that could 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 behaviour causing significant concern to you or others, for example increased sexual drive,
- excessive and uncontrollable shopping,
- uncontrolled eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger),
- tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

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

Additional side effects in children and adolescents

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to 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 stated on the blister pack and carton after "Exp" or "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What ABILIFY contains

The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole. Each orodispersible tablet contains 30 mg of aripiprazole.
The other components 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 orodispersible tablets: red iron oxide (E 172)
Coating of ABILIFY 15 mg orodispersible tablets: yellow iron oxide (E 172)
Coating of ABILIFY 30 mg orodispersible tablets: red iron oxide (E 172)

Description of the appearance of ABILIFY and contents of the pack
ABILIFY 10 mg orodispersible tablets are round and pink, engraved with ‘"A" over "640"’ on one side and ‘10’ on the other side.
ABILIFY 15 mg orodispersible tablets are round and yellow, engraved with ‘"A" over "641"’ on one side and ‘15’ on the other side.
ABILIFY 30 mg orodispersible tablets are round and pink, engraved with ‘"A" over "643"’ on one side and ‘30’ on the other side.
ABILIFY orodispersible tablets are available in divisible blisters for single doses, packed in cartons containing 14 × 1, 28 × 1 or 49 × 1 orodispersible tablets.
Not all pack sizes may be marketed.