ARIPIPRAZOLO 5 mg Tabletka

Treść ulotki

1. Aripiprazolo Zentiva 5 mg tablets
   1. What is Aripiprazolo Zentiva and what it is used for
   2. What you need to know before you take Aripiprazolo Zentiva
   3. How to take Aripiprazolo Zentiva
   4. Possible side effects
   5. How to store Aripiprazolo Zentiva
   6. Package contents and other information
2. Aripiprazolo Zentiva 10 mg orodispersible tablets
3. aripiprazole
   1. What is Aripiprazolo Zentiva and what it is used for
   2. What you need to know before you take Aripiprazolo Zentiva
   3. How to take Aripiprazolo Zentiva
   4. Possible side effects
   5. How to store Aripiprazolo Zentiva
   6. Contents of the pack and other information

Aripiprazolo Zentiva 5 mg tablets

Aripiprazolo Zentiva 10 mg tablets
Aripiprazolo Zentiva 15 mg tablets
Aripiprazolo Zentiva 30 mg tablets
aripiprazolo

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 pass it on to others, even if they have the same symptoms as you, 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 Aripiprazolo Zentiva is and what it is used for
• 2. What you need to know before you take Aripiprazolo Zentiva
• 3. How to take Aripiprazolo Zentiva
• 4. Possible side effects
• 5. How to store Aripiprazolo Zentiva
• 6. Contents of the pack and other information

1. What is Aripiprazolo Zentiva and what it is used for

Aripiprazolo Zentiva 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 suffer from an
illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and flattening of the
emotions. People who present this condition may also feel depressed, guilty,
anxious or tense.
Aripiprazolo Zentiva is used for the treatment of adults and adolescents starting from 13 years of age who
suffer from a condition characterized by symptoms such as feeling euphoric, having excessive
energy, needing to sleep much less than usual, talking very quickly with “flight of
ideas” and sometimes severe irritability. In addition, it prevents this condition in adults who have
responded to treatment with Aripiprazolo Zentiva.

2. What you need to know before you take Aripiprazolo Zentiva

Do not take Aripiprazolo Zentiva

• 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 Aripiprazolo Zentiva.
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 Aripiprazolo Zentiva, tell your doctor if you suffer from

• 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
• seizures for which 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 that
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.
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 very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregiver 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. Such
phenomena are called impulse control disorders and may include behaviours
such as gambling addiction, excessive eating or spending, unusually high sexual desire or preoccupation with increased sexual thoughts or feelings.
Your doctor may need to adjust the dose or stop your therapy.
Aripiprazolo can cause drowsiness, low blood pressure when getting up,
dizziness and changes in the ability to move and maintain balance, which can
cause falls. Be careful, especially if you are elderly or somehow 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 Aripiprazolo Zentiva
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: Aripiprazolo Zentiva may 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 Aripiprazolo Zentiva with some medicines may mean that your doctor will need to
change the dose of Aripiprazolo Zentiva or the other medicines. It is particularly important
to tell your doctor about the following medicines:

• mMedicines 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 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
Aripiprazolo Zentiva, consult your doctor if you experience any unusual symptoms while
taking any of these medicines together with Aripiprazolo Zentiva.
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 for 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
Aripiprazolo Zentiva.

Aripiprazolo Zentiva 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 may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo Zentiva
in the last trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness,
drowsiness, agitation, breathing problems, and difficulty feeding. If the child presents one
of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Zentiva, 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 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 cases where full alertness is required, for example
when driving a vehicle or using machinery.

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

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

3. How to take Aripiprazolo Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
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
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 dosage up to a
maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Zentiva is too strong or too weak, contact your
doctor or pharmacist.

Try to take Aripiprazolo Zentiva every day at the same time.It doesn't matter if you take it
with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better,do not change or stop the daily dose of Aripiprazolo Zentiva
without first consulting your doctor.
Aripiprazolo Zentiva 10 mg, 30 mg tablets: The score line is not intended to divide the
tablet.

If you take more Aripiprazolo Zentiva than you should
If you should realise that you have taken more Aripiprazolo Zentiva than your doctor has recommended
(or if someone else has taken Aripiprazolo Zentiva), 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:

• fast 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 Aripiprazolo Zentiva
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 Aripiprazolo Zentiva
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Zentiva for the entire period indicated by your doctor.
If you have any questions 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 everyone 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, spasms or convulsions,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild mental confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• 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,
• involuntary movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heartbeat,
• lowering of blood pressure when getting up, which causes dizziness, mild mental confusion or fainting,
• hiccups.

The following side effects have been reported since aripiprazole oral was marketed but the frequency with which they have occurred is not known (frequency cannot be estimated from available data):

• 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,
• suicidal thoughts, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced state of 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 disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• irregular heartbeat potentially life-threatening,
• 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 (seek immediate medical advice if you notice any of these symptoms),
• 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 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,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or conditions of excessive heat,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increase or fluctuation of blood sugar levels, increased glycated hemoglobin,
• inability to resist an impulse, urge 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 "mini" strokes 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 spasms, restlessness and fatigue which were very common (more than 1 in 10) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, involuntary movements of the limbs and dizziness, 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system indicated in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Zentiva

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 package after
EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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 Aripiprazolo Zentiva contains
The active ingredient is aripiprazole. Each tablet contains 5 mg/ 10 mg/ 15 mg / 30 mg of
aripiprazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose, magnesium stearate.

Description of the appearance of Aripiprazolo Zentiva and package contents
Aripiprazolo Zentiva 5 mg tablets are white to almost white in colour, round,
flat with bevelled edges, uncoated, with "5" imprinted on one side and plain on the other, with a diameter of
approximately 6 mm.
Aripiprazolo Zentiva 10 mg tablets are white to almost white in colour, round,
uncoated, with "10" imprinted on one side and a score line on the other, with a diameter of approximately 8
mm.
Aripiprazolo Zentiva 15 mg tablets are white to almost white in colour, round,
flat with bevelled edges, uncoated, with "15" imprinted on one side and plain on the other, with a diameter
of approximately 8.8 mm.
Aripiprazolo Zentiva 30 mg tablets are white to almost white in colour, uncoated,
capsule-shaped, with "30" imprinted on one side and a score line on the other, with dimensions of
approximately 15.5 x 8 mm.
Pack sizes: 14, 28, 49, 56, or 98 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr.50, sector 3.
Bucharest, code 032266
Romania
LAMP SAN PROSPERO SPA
VIA DELLA PACE 25/A
SAN PROSPERO (MO)
41030
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2778 0890
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS.
Tlf: +47 219 66 203
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Sverige
Zentiva Denmark ApS.
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

Aripiprazolo Zentiva 10 mg orodispersible tablets

Aripiprazolo Zentiva 15 mg orodispersible tablets
Aripiprazolo Zentiva 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 Aripiprazolo Zentiva is and what it is used for
• 2. What you need to know before you take Aripiprazolo Zentiva
• 3. How to take Aripiprazolo Zentiva
• 4. Possible side effects
• 5. How to store Aripiprazolo Zentiva
• 6. Contents of the pack and other information

1. What is Aripiprazolo Zentiva and what it is used for

Aripiprazolo Zentiva contains the active ingredient 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 suffer from an
illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and flattening of the
emotions. People who present this condition may also feel depressed, guilty,
anxious or tense.
Aripiprazolo Zentiva is used for the treatment of adults and adolescents starting from 13 years of age who
suffer from a condition characterized by symptoms such as feeling euphoric, having excessive
energy, needing to sleep much less than usual, talking very quickly with “flight of
ideas” and sometimes severe irritability. Furthermore, it prevents this condition in adults who have
responded to treatment with Aripiprazolo Zentiva orally disintegrating tablets.

2. What you need to know before you take Aripiprazolo Zentiva

Do not take Aripiprazolo Zentiva

• 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 Aripiprazolo Zentiva.
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 Aripiprazolo Zentiva, tell your doctor if you suffer from

• high blood sugar levels (characterised by symptoms such as excessive thirst, producing large amounts of urine, increased appetite and feeling of weakness) or a family history of diabetes
• seizures for which 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
• a 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 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
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.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or rigidity of muscles with high
fever, sweating, altered mental state or very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregiver 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 sexual thoughts or feelings.
Your doctor may need to adjust the dose or stop your therapy.
Aripiprazolo may cause drowsiness, low blood pressure when getting up
from a sitting or lying position, dizziness and changes in the ability to move and maintain balance, which may
cause 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 Aripiprazolo Zentiva
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: Aripiprazolo Zentiva may 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 Aripiprazolo Zentiva with some medicines may mean that your doctor will need to
change the dose of Aripiprazolo Zentiva or the other medicines. It is particularly important
to tell 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
Aripiprazolo Zentiva, consult your doctor if you experience any unusual symptoms while
taking any of these medicines together with Aripiprazolo Zentiva.
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 for 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
Aripiprazolo Zentiva.

Aripiprazolo Zentiva with food, beverages 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 Aripiprazolo Zentiva
in the last trimester (last three months of pregnancy): tremor, rigidity and/or weakness of muscles,
drowsiness, agitation, breathing problems, and difficulty feeding. If the baby presents any of
these symptoms, you may need to contact your doctor.
If you are taking Aripiprazolo Zentiva, your doctor will discuss with you whether you should breastfeed, considering the
benefit of the therapy 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 where full alertness is required, for example
when driving a vehicle or using machinery.

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

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

3. How to take Aripiprazolo Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
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
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 dosage up to a
maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Zentiva is too strong or too weak, contact your
doctor or pharmacist.

Try to take Aripiprazolo Zentiva every day at the same time.It doesn't matter if you take it
with or without food.
Do not open the blister until you are ready to administer. To take the single
tablet, open the package 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, 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 Aripiprazolo Zentiva
without first consulting your doctor.
Aripiprazolo Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not designed
to divide the tablet.

If you take more Aripiprazolo Zentiva than you should
If you should realize that you have taken more Aripiprazolo Zentiva than your doctor has recommended
(or if someone else has taken Aripiprazolo Zentiva), 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/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 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 Aripiprazolo Zentiva
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 Aripiprazolo Zentiva
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Zentiva orodispersible tablets for the entire period indicated by your doctor.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, spasms or convulsions,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild mental confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• 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,
• decreased or increased 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 heartbeat,
• low blood pressure when standing up, which causes dizziness, mild mental confusion or fainting,
• hiccups.

The following side effects have been reported since aripiprazole oral was launched but the frequency with which they have occurred is not known (frequency cannot be estimated from the available data):

• low levels of white blood cells,
• low platelet levels,
• 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,
• suicidal thoughts, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant 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 disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• irregular heartbeat potentially life-threatening,
• 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 the 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, swollen 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 if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or conditions of excessive heat,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increase or fluctuation of blood sugar levels, increased glycated hemoglobin,
• inability to resist an impulse, urge or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble despite serious personal or family consequences
• altered or increased sexual interest and behaviour that causes significant distress to you or others, for example an increased sexual drive
• excessive and uncontrollable shopping
• binge 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 behaviours; they will advise you on how to manage or reduce the symptoms.

More fatal cases have been reported in elderly patients with dementia taking aripiprazole. In addition, cases of stroke or "mini" strokes 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 spasms, restlessness and fatigue which were very common (more than 1 in 10 patients) 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system indicated in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Zentiva

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 carton after
EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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. Contents of the pack and other information

What Aripiprazolo Zentiva contains
The active ingredient is aripiprazole. Each orally disintegrating tablet contains 10 mg/15 mg/30 mg of
aripiprazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose, potassium acesulfame, mango
flavour, magnesium stearate.

Description of the appearance of Aripiprazolo Zentiva
and contents of the pack
Aripiprazolo Zentiva 10 mg orally disintegrating tablets are from white to almost white in colour, round, with
"10" imprinted on one side and a score line on the other, with a diameter of approximately 7
mm.
Aripiprazolo Zentiva 15 mg orally disintegrating tablets are from white to almost white in colour, round, flat with
bevelled edges, with "15" imprinted on one side and plain on the other, with a diameter of approximately 8
mm.
Aripiprazolo Zentiva 30 mg orally disintegrating tablets are from white to almost white in colour, round, with
"30" imprinted on one side and a score line on the other, with a diameter of approximately
10.2 mm.
Packs: 14, 28 or 49 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr.50, sector 3.
Bucharest, code 032266
Romania
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2778 0890
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS.
Sími: +354 539 0650
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .