Aripiprazole Zentiva: detailed information

Patient Information Leaflet: Information for the User

Aripiprazole Zentiva 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg 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 others, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazole Zentiva 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 disorder
characterized by symptoms such as hearing, seeing, or perceiving things that are not present,
suspiciousness, false beliefs, disorganized speech and behaviour, and blunted emotions.
People with this condition may also feel depressed, guilty, anxious, or tense.
Aripiprazole Zentiva is used to treat adults and adolescents from the age of 13 who are affected by a
condition characterized by symptoms such as feeling euphoric, having excessive energy, needing
much less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe
irritability. In addition, it prevents recurrence of this condition in adults who have responded to
treatment with Aripiprazole Zentiva.

2. What you need to know before taking Aripiprazole Zentiva

Do not take Aripiprazole 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 Aripiprazole Zentiva.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Contact your doctor immediately if you experience any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Zentiva, 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
seizures, for which 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 that interferes 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).
Contact 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 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 may harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, binge eating, excessive spending, abnormally increased sexual drive, or preoccupation due to increased thoughts or sexual 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 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 Aripiprazole Zentiva
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: Aripiprazole Zentiva 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 Aripiprazole Zentiva with certain medicines may require your doctor to adjust the dose of Aripiprazole Zentiva 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, 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 Aripiprazole Zentiva. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Zentiva.
Medicines that increase serotonin levels are typically used for 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 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 Aripiprazole Zentiva.

Aripiprazole Zentiva 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 used Aripiprazole Zentiva during the third trimester (last three months of pregnancy): tremors, 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 Aripiprazole Zentiva, 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 vision 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.

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

Aripiprazole 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 Aripiprazole Zentiva

Take this medicine exactly as instructed 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 Aripiprazole Zentiva is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Zentiva at the same time every day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole.
Even if you feel better, do not change or stop the daily dose of Aripiprazole Zentiva without first consulting your doctor.
Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for dividing the tablet.
If you take more Aripiprazole Zentiva than you should
If you realize that you have taken more Aripiprazole Zentiva than your doctor has prescribed (or if someone else has taken Aripiprazole 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 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, 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 Aripiprazole Zentiva
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 Aripiprazole Zentiva
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Zentiva for the entire duration prescribed by your doctor.
If you have any questions about using 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 sit still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible urge to keep moving),
uncontrollable muscle contractions, spasms or twisting movements,
tremors,
headache,
tiredness,
drowsiness,
mild confusion,
trembling and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
feeling unwell,
increased saliva production 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,
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 when standing up, causing dizziness, mild confusion or fainting,
hiccupping.

The following side effects have been reported since the start of oral aripiprazole marketing, but their frequency is not known (frequency cannot be estimated from the 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 sensation, 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 level of consciousness, sudden changes in blood pressure and heart rate, 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 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 may travel through blood vessels to the lungs causing chest pain and breathing difficulties (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 muscles 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,
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 presents with flu-like symptoms and a skin rash on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzymes found in blood tests, and increase in a type of white blood cells (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 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: increased or fluctuating blood sugar levels, increased glycosylated haemoglobin,
inability to resist an impulse, drive or temptation to perform an action that could 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 the patient or others, for example, increased sexual drive
- excessive and uncontrollable spending
- 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 off. 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, there have been reports of increased fatal cases during treatment with aripiprazole. In addition, cases of stroke or "mini" strokes 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 spasms, 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, uncontrolled limb movements 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 indicated in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aripiprazole 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 outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 Aripiprazole Zentiva contains
The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of
aripiprazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate.

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

Marketing Authorization 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)
Italy

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 280 86 420 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +35924417136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2778 0890
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS.
Tel: +372 52 70308 Tlf: +47 219 66 203
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva, k.s. Zentiva Polska Sp. z o.o.
Tel: +34 931 815 250 Tel: +48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351 210601360
[email protected] [email protected]

Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 0650 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39-02-38598801 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS.
Τηλ: +357 240 30 144 Tel: +46 840 838 822
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Zentiva, k.s. Zentiva, k.s.
Tel: +371 67893939 Tel: +44 (0) 800 090 2408
[email protected] [email protected]

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

Package leaflet: information for the user

Aripiprazole Zentiva 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazole Zentiva contains the active substance aripiprazole and belongs to a group of
medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older who have a disorder characterised by symptoms such as hearing, seeing or perceiving things that are not present, suspiciousness, false beliefs, disorganised speech and behaviour, and blunted emotions.
People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Zentiva is also used to treat adults and adolescents aged 13 years and older who have a condition characterised by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it is used to prevent this condition in adults who have responded to treatment with Aripiprazole Zentiva orodispersible tablets.

2. What you should know before taking Aripiprazole Zentiva

Do not take Aripiprazole 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 Aripiprazole Zentiva.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Contact your doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Zentiva, inform your doctor if you have

high blood sugar levels (characterized by symptoms such as excessive thirst, excessive urination, 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 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 that you are gaining weight, develop unusual movements, feel drowsy to the extent that it interferes 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).
Contact your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviour have been reported during treatment with aripiprazole.
Contact 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 known as impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sexual desire, or preoccupation due to increased thoughts or sexual 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 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 Aripiprazole Zentiva
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: Aripiprazole Zentiva 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 Aripiprazole Zentiva with certain medicines may require your doctor to adjust the dose of Aripiprazole Zentiva 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)
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 effectiveness of Aripiprazole Zentiva. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Zentiva.
Medicines that increase serotonin levels are typically used for 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 for major depression
tricyclics (e.g., clomipramine and amitriptiline) 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 Aripiprazole Zentiva.
Aripiprazole Zentiva 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 may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns of mothers who have taken Aripiprazole Zentiva during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing problems, and feeding difficulties. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Zentiva, 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 (see section 4) may occur during treatment with this medicine. This should be taken into account when full alertness is required, for example when driving a vehicle or operating machinery.
Aripiprazole Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Aripiprazole 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 Aripiprazole Zentiva

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 Aripiprazole Zentiva is too strong or too weak, consult your doctor or pharmacist.

Try to take Aripiprazole Zentiva 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 tablet. To take the single dose, open the packaging and peel back the aluminium foil from the blister to reveal 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 Aripiprazole Zentiva without first consulting your doctor.

Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended to divide the tablet.

If you take more Aripiprazole Zentiva than you should
If you realize you have taken more Aripiprazole Zentiva than your doctor has prescribed (or if someone else has taken it), 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 difficulties.
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, sensation of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.

If you forget to take Aripiprazole Zentiva
If you forget to take a dose, take it as soon as you remember, but do not take two doses on the same day.

If you stop taking Aripiprazole Zentiva
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Zentiva orodispersible tablets for the full duration prescribed by your doctor.

If you have any questions about the use of 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 sit still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, spasms or twisting movements,
tremors,
headache,
tiredness,
drowsiness,
mild confusion,
trembling and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
feeling unwell,
increased production of saliva 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,
change or increase in sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscular 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, mild confusion or fainting,
hiccups.

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

low levels of white blood cells,
low levels of platelets,
allergic reaction (e.g. swelling of mouth, tongue, face and throat, itching sensation, 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 of aggressiveness,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced level of consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizures,
serotonin syndrome (a reaction that may cause extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
potentially life-threatening 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),
spasm of muscles 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,
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 presents with flu-like symptoms and a skin rash on the face that then 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 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 controlling body temperature or conditions of excessive heat,
chest pain,
swelling of hands, ankles or feet,
in blood tests: increased or fluctuating blood sugar levels, increased glycated haemoglobin,
inability to resist an impulse, drive or temptation to perform an action that could be harmful to oneself or others, which may include:
- strong urge to gamble 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 uncontrolled spending,
- 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 off. 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, increased numbers of fatal cases have been reported during treatment with aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.
Additional side effects in children and adolescents
Adolescents from the age of 13 years have experienced side effects similar in frequency and type to those in adults, except for drowsiness, uncontrollable muscle contractions or spasms, restlessness and tiredness, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled limb movements and dizziness, especially when rising from a lying or sitting position, which have been 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 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 Aripiprazole Zentiva

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 carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aripiprazole Zentiva contains
The active substance is aripiprazole. Each orodispersible tablet contains 10 mg/15 mg/30 mg of
aripiprazole.
The other components are monohydrate lactose, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, anhydrous colloidal silica, sodium croscarmellose, acesulfame potassium,
mango flavour, magnesium stearate.

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

Marketing Authorization 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 Authorization Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 280 86 420 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +35924417136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2778 0890
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +47 219 66 203
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva, k.s. Zentiva Polska Sp. z o.o.
Tel: +34 931 815 250 Tel: + 48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360
[email protected] [email protected]

Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS. Zentiva, a.s.
Sími: +354 539 0650 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39-02-38598801 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +357 240 30 144 Tel: +46 840 838 822
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Zentiva, k.s. Zentiva, k.s.
Tel: +371 67893939 Tel: +44 (0) 800 090 2408
[email protected] [email protected]

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