Aripiprazole Doc Generici

Package leaflet: Information for the user

ARIPIPRAZOLO DOC Generici 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

Generic medicine
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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ARIPIPRAZOLO DOC Generici tablets are and what they are used for
2. What you need to know before taking ARIPIPRAZOLO DOC Generici tablets
3. How to take ARIPIPRAZOLO DOC Generici tablets
4. Possible side effects
5. How to store ARIPIPRAZOLO DOC Generici tablets
6. Contents of the pack and other information

1. What ARIPIPRAZOLO DOC Generici tablets are and what they are used for

ARIPIPRAZOLO DOC Generici tablets contain the active substance aripiprazole and
belong 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, incoherent speech and behavior, and blunted emotions. People with this condition may also feel depressed, guilty, anxious or tense.
ARIPIPRAZOLO DOC Generici 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, not needing to sleep as much as usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents the recurrence of this condition in adults who have responded to treatment with ARIPIPRAZOLO DOC Generici.

2. What you need to know before taking ARIPIPRAZOLE DOC Generics tablets

Do not take ARIPIPRAZOLE DOC Generics tablets

• 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 DOC Generics tablets if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling tired) or a family history of diabetes
• seizures
• irregular, involuntary muscle movements, especially of the face
• cardiovascular disorders, family history of cardiovascular disorders, stroke or "mini" strokes, abnormal blood pressure
• blood clots or family history of blood clots, since antipsychotics have been associated with blood clot formation
• past experience of excessive gambling

If you notice that you are gaining weight, develop unusual movements, feel drowsy to the point 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 a "mini" stroke.
Inform your doctor immediately if you are thinking about or feel like 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.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. The safety and efficacy of this medicine have not been established in these patients.

Other medicines and ARIPIPRAZOLE DOC Generics tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
Medicines that lower blood pressure: ARIPIPRAZOLE DOC Generics tablets may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control blood pressure.
Taking ARIPIPRAZOLE DOC Generics tablets with other medicines may require a dose adjustment of ARIPIPRAZOLE DOC Generics tablets. It is important to inform your doctor, in particular, if you are taking the following medicines:

• Medicines that regulate the heart rhythm
• Antidepressants or herbal remedies used to treat depression and anxiety
• Antifungal agents
• Some medicines used to treat HIV infection
• Anticonvulsants used to treat epilepsy

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, Selective Serotonin Reuptake Inhibitors (SSRIs) (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St. John’s wort (hypericum), and venlafaxine.
These medicines increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with ARIPIPRAZOLE DOC Generics, you should consult your doctor.

ARIPIPRAZOLE DOC Generics tablets with food, drinks and alcohol
ARIPIPRAZOLE DOC Generics tablets can be taken regardless of food intake.
Alcohol use should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns whose mothers have taken aripiprazole tablets 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.
Inform your doctor immediately if you are breastfeeding.
If you are taking ARIPIPRAZOLE DOC Generics tablets, you must not breastfeed.

Driving and using machines
Do not drive or operate tools or machinery until you know how ARIPIPRAZOLE DOC Generics tablets affect you.

ARIPIPRAZOLE DOC Generics tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ARIPIPRAZOLO DOC Generici tablets

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 lower dose using the oral solution
(liquid). The dose may then be gradually increased 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 ARIPIPRAZOLO DOC Generici is too strong or too weak,
talk to your doctor or pharmacist.
Try to take your ARIPIPRAZOLO DOC Generici tablet 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 well , do not change or stop the daily dose of ARIPIPRAZOLO DOC
Generici without first consulting your doctor.
If you take more ARIPIPRAZOLO DOC Generici tablets than you should
If you realize you have taken more ARIPIPRAZOLO DOC Generici tablets than your doctor
recommended (or if someone else has taken some of your tablets), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the packaging with you.
If you forget to take your dose of ARIPIPRAZOLO DOC Generici tablets
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 ARIPIPRAZOLO DOC Generici tablets
Do not stop treatment just because you feel better. It is important that you continue taking your
ARIPIPRAZOLO DOC Generici tablets for as long as your doctor has prescribed.
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 will experience them.
Common side effects (may affect up to 1 in 10 people): uncontrollable contractions or jerking movements, headache, tiredness, nausea, vomiting, an unpleasant sensation in the stomach, constipation, increased saliva production, feeling lightheaded, difficulty sleeping, restlessness, feeling anxious, drowsiness, agitation, and blurred vision.
Uncommon side effects (may affect up to 1 in 100 people): some people may experience dizziness, especially when getting up from a lying or sitting position, or a rapid heartbeat or double vision. Some people may feel depressed. In some individuals, there may be changes or increased interest in sexual activity and increased levels of the hormone prolactin in the blood.
The following side effects have been reported since aripiprazole was first marketed, but their frequency is unknown (frequency cannot be estimated from the available data):
Changes in levels of certain blood cells; irregular heartbeat, unexplained sudden death, heart attack; allergic reaction (e.g. swelling of the mouth, tongue, face, and throat, itching, rash); high blood sugar levels, onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low sodium levels in the blood; weight gain, weight loss, anorexia; aggression; nervousness, agitation, anxiety, excessive gambling; suicidal thoughts, suicide attempt, and suicide; speech disorders, seizures, serotonin syndrome (a reaction that may cause feelings of extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate; fainting; high blood pressure; blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you experience any of these symptoms, seek immediate medical advice); muscle spasms around the vocal cords, accidental inhalation of food with risk of pneumonia, difficulty swallowing; inflammation of the pancreas; liver failure, liver inflammation, yellowing of the skin and whites of the eyes, cases of abnormal liver function test results; abdominal discomfort and stomach discomfort, diarrhoea; rash and light sensitivity, unusual hair loss or brittle hair, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; 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 elderly patients with dementia, there have been more reported cases of death while 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 older have experienced side effects similar in frequency and type to those in adults, except for somnolence, uncontrollable muscle contractions or jerking 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, 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, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIPIPRAZOLE DOC Generics tablets

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 on the carton. 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ARIPIPRAZOLO DOC Generici tablets contain
Tablets 5 mg

• The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate.

Tablets 10 mg

• The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, red iron oxide (E 132).

Tablets 15 mg

• The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, yellow iron oxide (E 132).

Tablets 20 mg

• The active substance is aripiprazole. Each tablet contains 20 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate.

Description of the appearance of ARIPIPRAZOLO DOC Generici tablets and contents of the
pack
ARIPIPRAZOLO DOC Generici 5 mg tablets are white and round, with "ARZ" engraved on one side and "5" on the other side. They are supplied in perforated blisters packed in cartons containing 28 tablets.
ARIPIPRAZOLO DOC Generici 10 mg tablets are pink and oblong (with possible black specks), with "ARZ" and "10" engraved on one side. They are supplied in perforated blisters packed in cartons containing 28 tablets.
ARIPIPRAZOLO DOC Generici 15 mg tablets are yellow and round (with possible black specks), with "ARZ" and "15" engraved on one side. They are supplied in perforated blisters packed in cartons containing 28 tablets.
ARIPIPRAZOLO DOC Generici 20 mg tablets are white and round, with "ARZ" and "20" engraved on one side. They are supplied in perforated blisters packed in cartons containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

Manufacturers
Synthon Hispania S.L., C/Castelló, 1, Polígono Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain
Synthon s.r.o., Brnĕnská 32 /čp. 597, 678 01 Blansko, Czech Republic

This medicinal product is authorized in the European Economic Area countries under the
following names:
Netherlands: Aripiprazole DOC Generici
Italy: ARIPIPRAZOLO DOC Generici

Package leaflet: Information for the user

ARIPIPRAZOLE DOC Generics 10 mg orodispersible tablets, 15 mg orodispersible tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ARIPIPRAZOLE DOC Generics orodispersible tablets are and what they are used for
2. What you need to know before taking ARIPIPRAZOLE DOC Generics orodispersible tablets
3. How to take ARIPIPRAZOLE DOC Generics orodispersible tablets
4. Possible side effects
5. How to store ARIPIPRAZOLE DOC Generics orodispersible tablets
6. Package contents and other information

1. What ARIPIPRAZOLO DOC Generici orodispersible tablets are and what they are used for

ARIPIPRAZOLO DOC Generici orodispersible tablets contain the active substance
aripiprazole and belong 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 blunted emotions.
People with this condition may also feel depressed, guilty, anxious or tense.
ARIPIPRAZOLO DOC Generici is 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, not needing as much sleep as usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents the recurrence of this condition in adults who have responded to treatment with ARIPIPRAZOLO DOC Generici.

2. What you should know before taking ARIPIPRAZOLO DOC Generici orodispersible tablets

orodispersible
Do not take ARIPIPRAZOLO DOC Generici orodispersible tablets

• 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 DOC Generici orodispersible tablets if you suffer from:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling of fatigue) or family history of diabetes
• seizures
• involuntary, irregular muscle movements, especially of the face
• cardiovascular disorders, family history of cardiovascular disorders, stroke or "mini" strokes, abnormal blood pressure
• blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation
• previous experience of excessive gambling

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsiness that interferes with normal daily activities, if you have difficulty swallowing, or if you 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 previously had a stroke or a "mini" stroke.
Inform your doctor immediately if you are thinking about or feel like harming yourself.
Suicidal thoughts and behaviors have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. The safety and efficacy of this medicine have not been established in these patients.

Other medicines and ARIPIPRAZOLO DOC Generici orodispersible tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.

Medicines that lower blood pressure: ARIPIPRAZOLO DOC Generici orodispersible tablets 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 ARIPIPRAZOLO DOC Generici orodispersible tablets together with other medicines may require adjusting the dose of ARIPIPRAZOLO DOC Generici orodispersible. It is important to inform your doctor, especially if you are taking the following medicines:

• Medicines that regulate heart rhythm
• Antidepressants or herbal remedies used to treat depression and anxiety
• Antifungal agents
• Some medicines used to treat HIV infection
• Anticonvulsants used to treat epilepsy

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, Selective Serotonin Reuptake Inhibitors (SSRIs) (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), meperidine, St. John’s wort (Hypericum perforatum), and venlafaxine.
These medicines increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with ARIPIPRAZOLO DOC Generici, you should consult your doctor.

ARIPIPRAZOLO DOC Generici orodispersible tablets with food, drink, and alcohol
ARIPIPRAZOLO DOC Generici orodispersible tablets can be taken regardless of food intake.
Alcohol consumption should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns whose mothers have taken aripiprazole orodispersible tablets 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.
Inform your doctor immediately if you are breastfeeding.
If you are taking ARIPIPRAZOLO DOC Generici orodispersible tablets, you must not breastfeed.

Driving and using machines
Do not drive or operate tools or machinery until you know how ARIPIPRAZOLO DOC Generici orodispersible tablets affect you.

ARIPIPRAZOLO DOC Generici orodispersible tablets contain aspartame.
Patients who cannot tolerate phenylalanine should be aware that ARIPIPRAZOLO DOC Generici orodispersible tablets contain aspartame, a source of phenylalanine. This may be harmful if you have phenylketonuria.

ARIPIPRAZOLO DOC Generici orodispersible tablets contain lactose and glucose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine. This product may be harmful to teeth.

3. How to take ARIPIPRAZOLE DOC Generici orodispersible tablets

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 lower 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 DOC Generici is too strong or too weak,
consult your doctor or pharmacist.
Try to take your ARIPIPRAZOLE DOC Generici orodispersible tablet at the same time each day.
It does not matter whether you take it with or without food.
[For regular blister]
Do not open the blister until you are ready to administer the tablet. With dry hands, remove the
orodispersible tablet and place it whole on the tongue immediately after opening the blister.
The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without
liquid.
Alternatively, disperse the tablet in water and drink the resulting suspension.
[For peel-off blister]
Do not open the blister until you are ready to administer the tablet. To take a single tablet, open the
package and tear off a blister containing one tablet using the perforated lines. Peel back the foil on
the blister to expose the tablet. Do not push the tablet through the aluminium as this may damage it.
With dry hands, remove the tablet and place it whole on the tongue immediately after opening the
blister. The orodispersible tablet may be taken with or without liquid.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Even if you feel well, do not change or stop your daily dose of ARIPIPRAZOLE DOC Generici
without first consulting your doctor.
If you take more ARIPIPRAZOLE DOC Generici orodispersible tablets than you should
If you realize you have taken more orodispersible tablets of ARIPIPRAZOLE DOC Generici than
recommended by your doctor (or if someone else has taken some of your orodispersible tablets of
ARIPIPRAZOLE DOC Generici), contact your doctor immediately.
If you cannot reach your doctor, go to the nearest hospital and take the packaging with you.
If you forget to take your dose of ARIPIPRAZOLE DOC Generici orodispersible tablets
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 DOC Generici orodispersible tablets
Do not stop treatment just because you feel better. It is important that you continue taking your
ARIPIPRAZOLE DOC Generici tablets for as long as your doctor has prescribed.
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 everyone experiences them.
Common side effects (may affect up to 1 in 10 people): involuntary contractions or jerky movements, headache, fatigue, nausea, vomiting, stomach discomfort, constipation, increased saliva production, feeling lightheaded, difficulty sleeping, restlessness, anxiety, drowsiness, agitation, and blurred vision.
Uncommon side effects (may affect up to 1 in 100 people): some people may experience dizziness, especially when getting up from a lying or sitting position, or a rapid heartbeat or double vision. Some people may feel depressed. In some people, there may be a change in sexual interest and increased levels of the hormone prolactin in the blood.

The following side effects have been reported since the launch of aripiprazole, but their frequency is unknown (the frequency cannot be estimated from the available data):
Changes in levels of certain blood cells; irregular heartbeat, unexplained sudden death, heart attack; allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, rash); high blood sugar levels, onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low sodium levels in the blood; weight gain, weight loss, anorexia; aggression; nervousness, agitation, anxiety, excessive gambling; suicidal thoughts, suicide attempts and suicide; speech disorders, seizures, serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate; fainting; high blood pressure; blood clots in the veins, particularly 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 experience any of these symptoms, seek immediate medical advice); muscle spasms around the vocal cords, accidental inhalation of food with risk of pneumonia, difficulty swallowing; inflammation of the pancreas; liver failure, liver inflammation, yellowing of the skin and whites of the eyes, cases of abnormal liver function test results; abdominal discomfort and stomach discomfort, diarrhoea; rash and light sensitivity, unusual hair loss or brittle hair, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; 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 elderly patients with dementia, an increased number of fatal cases has 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 aged 13 years and older have experienced side effects similar in frequency and type to those in adults, except for drowsiness, involuntary 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, 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, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIPIPRAZOLE DOC Generics orodispersible tablets

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. 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. Package contents and other information

What ARIPIPRAZOLO DOC Generici orodispersible tablets contain
Orodispersible tablets 10 mg

• The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
• The other ingredients are monohydrate lactose, magnesium stearate, anhydrous colloidal silica, sodium croscarmellose, crospovidone, microcrystalline cellulose, red iron oxide (E172); vanilla flavouring powder (containing glucose), aspartame (E951), potassium acesulfame, tartaric acid.

Orodispersible tablets 15 mg

• The active substance is aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
• The other ingredients are monohydrate lactose, magnesium stearate, anhydrous colloidal silica, sodium croscarmellose, crospovidone, microcrystalline cellulose, yellow iron oxide (E172); vanilla flavouring powder (containing glucose), aspartame (E951), potassium acesulfame, tartaric acid.

Description of the appearance of ARIPIPRAZOLO DOC Generici orodispersible tablets and
pack contents
ARIPIPRAZOLO DOC Generici 10 mg orodispersible tablets are pink, round (with possible black specks), with "AD10" engraved on one side. They are available in blisters packed in cartons containing 28 orodispersible tablets.
ARIPIPRAZOLO DOC Generici 15 mg orodispersible tablets are yellow, round (with possible black specks), with "AD15" engraved on one side. They are available in blisters packed in cartons containing 28 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

Manufacturers
Synthon Hispania S.L., C/Castelló, 1, Polígono Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain
Synthon s.r.o, Brnĕnská 32 /čp. 597, 678 01 Blansko, Czech Republic

This medicinal product is authorized in the European Economic Area countries under the
following names:
Netherlands: Aripiprazole DOC Generici
Italy: ARIPIPRAZOLO DOC Generici