ARIPIPRAZOLO 5 mg Coated Tablet

Зміст інструкції

1. Aripiprazolo Alter 5 mg tablets
   1. What is Aripiprazolo Alter tablets and what are they for
   2. What you need to know before taking Aripiprazolo Alter tablets
   3. How to take Aripiprazolo Alter tablets
   4. Possible side effects
   5. How to store Aripiprazolo Alter
   6. Contents of the pack and other information
2. Aripiprazolo Alter 10 mg tablets
   1. What is Aripiprazolo Alter tablets and what it is used for
   2. What you need to know before taking Aripiprazolo Alter tablets
   3. How to take Aripiprazolo Alter tablets
   4. Possible side effects
   5. How to store Aripiprazolo Alter
   6. Contents of the pack and other information
3. Aripiprazolo Alter 15 mg tablets
   1. What is Aripiprazolo Alter tablets and what it is used for
   2. What you need to know before taking Aripiprazolo Alter tablets
   3. How to take Aripiprazolo Alter tablets
   4. Possible side effects
   5. How to store Aripiprazolo Alter
   6. Contents of the pack and other information

Aripiprazolo Alter 5 mg tablets

Aripiprazolo

Generic medicine

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 Alter tablets are and what they are used for
• 2. What you need to know before you take Aripiprazolo Alter tablets
• 3. How to take Aripiprazolo Alter tablets
• 4. Possible side effects
• 5. How to store Aripiprazolo Alter tablets
• 6. Contents of the pack and other information

1. What is Aripiprazolo Alter tablets and what are they for

Aripiprazolo Alter tablets contain the active ingredient aripiprazole and belong 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, suspicion, false beliefs, incoherent speech and
behaviour and flattening of emotions. People who present this
condition may also feel depressed, guilty, anxious or tense.
Aripiprazolo Alter tablets are 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 “up”,
having excessive energy, needing much less sleep 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 Alter.

2. What you need to know before taking Aripiprazolo Alter tablets

Do not take Aripiprazolo Alter tablets

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

Warnings and precautions
Talk to your doctor before taking Aripiprazolo Alter tablets.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Immediately inform your doctor if you are experiencing any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Alter, 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 (convulsions) 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 to the point it interferes with your normal daily activities, if you have difficulty swallowing or if you experience 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 had a stroke or transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Thoughts and suicidal behaviours have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, 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, overeating or spending, unusually high sexual drive or preoccupation with sexual thoughts or sensations.
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 your ability to move and maintain balance, which can lead to falls. Be careful, especially if you are elderly or in any 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 Alter tablets
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 Alter tablets can increase the effect of medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to control your blood pressure.
Taking Aripiprazolo Alter tablets with certain medicines may mean that your doctor will need to change the dose of Aripiprazolo Alter or the other medicines.
It is particularly important to inform your doctor about the following medicines:

• Medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's Wort)
• Antifungal medicines (e.g. ketoconazole, itraconazole)
• Some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor 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 Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazolo Alter.

Medicines that increase serotonin levels are typically used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain:

• Triptans, tramadol and tryptophan used 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 Alter.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo Alter in the last trimester (last three months of pregnancy): tremor, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If the child presents any of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Alter tablets, 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 operating machinery
Dizziness and vision disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations where full vigilance is required, for example when driving a vehicle or operating machinery.

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

3. How to take Aripiprazolo Alter tablets

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

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

Use in children and adolescents
This medicine can be started at low doses using the oral solution (liquid).
The dose can be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose up to a maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Alter tablets is too strong or too weak, contact your doctor or pharmacist.

Try to take Aripiprazolo Alter tablets every day at the same time.It does not 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 Alter tablets without first consulting your doctor.

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

• Fast heartbeat, agitation/aggression, speech problems.
• Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

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

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

If you forget to take Aripiprazolo Alter tablets
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 Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazolo Alter tablets for the entire period indicated by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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, jerking or twisting movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• increased saliva production,
• 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,
• sensitivity of the eyes to light,
• fast heartbeat,
• low blood pressure when getting up, which causes dizziness, mild confusion or fainting,
• hiccups. Side effects that have been reported since the marketing of oral aripiprazole began but the frequency with which they have occurred is not known:
• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, decreased 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,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• 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,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling 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 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 via the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Alter

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. 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 Alter tablets contain
The active ingredient is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline
cellulose, hypromellose, magnesium stearate.

Description of the appearance of Aripiprazolo Alter tablets and contents of the pack
Aripiprazolo Alter 5 mg tablets are biconvex, round, white in colour, without
a score line. They are supplied in aluminium blisters packaged in cartons containing 28
tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
SPAIN:
Aripiprazol Alter 5 mg comprimidos EFG
Aripiprazol Alter 10 mg comprimidos EFG
Aripiprazol Alter 15 mg comprimidos EFG
FRANCE:
ARIPIPRAZOLE BGR 5 mg comprimé
ARIPIPRAZOLE BGR 10 mg comprimé
ARIPIPRAZOLE BGR 15 mg comprimé
ITALY:
Aripiprazolo Alter

Aripiprazolo Alter 10 mg tablets

Aripiprazolo

Generic medicine

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 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 Alter tablets are and what they are used for
• 2. What you need to know before you take Aripiprazolo Alter tablets
• 3. How to take Aripiprazolo Alter tablets
• 4. Possible side effects
• 5. How to store Aripiprazolo Alter tablets
• 6. Contents of the pack and other information

1. What is Aripiprazolo Alter tablets and what it is used for

Aripiprazolo Alter tablets contain the active ingredient aripiprazole and belong 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, suspicion, false beliefs, incoherent speech and
behaviour and flattening of emotions. People who present this
condition may also feel depressed, guilty, anxious or tense.
Aripiprazolo Alter tablets are 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 “high”,
having excessive energy, needing much less sleep than usual, talking
very quickly with “racing thoughts” and sometimes severe irritability. Furthermore, it prevents this
condition in adults who have responded to treatment with Aripiprazolo Alter.

2. What you need to know before taking Aripiprazolo Alter tablets

Do not take Aripiprazolo Alter 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 Alter tablets.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Immediately inform your doctor if you are experiencing any thoughts or feelings of self-harm.
Before treatment with Aripiprazolo Alter, 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 (convulsions) 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 your 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 (memory loss and other mental abilities), you or your caregiver must inform the doctor if you have had a stroke or transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviour have been reported during treatment with aripiprazole.
Immediately inform your doctor if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, 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 sensations.
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 lead to falls. Be careful, especially if you are elderly or in some way debilitated.

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

Other medicines and Aripiprazolo Alter tablets
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 Alter tablets can increase the effect of medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to control your blood pressure.
Taking Aripiprazolo Alter tablets with certain medicines may mean that your doctor will need to change the dose of Aripiprazolo Alter or the other medicines. It is particularly important to inform your doctor about the following medicines:

• Medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort)
• Antifungal medicines (e.g. ketoconazole, itraconazole)
• Some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor 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 Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazolo Alter.

Medicines that increase serotonin levels are typically used in conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain:

• Triptans, tramadol and tryptophan used for conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain
• Selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• Other antidepressants (e.g. venlafaxine and tryptophan) used in major depression
• Tricyclics (e.g. clomipramine and amitriptyline) used for depressive illness
• St John's Wort (Hypericum perforatum), used as a herbal remedy for mild depression
• 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 Alter.

Aripiprazolo Alter 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 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 Alter in the last trimester (last three months of pregnancy): tremor, stiffness and/or weakness of muscles, drowsiness, agitation, breathing problems, and feeding difficulties. If the child presents any of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Alter tablets, 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 operating machinery
Dizziness and vision 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 operating machinery.

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

3. How to take Aripiprazolo Alter tablets

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

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

Use in children and adolescents
This medicine can be started at low doses using the oral solution (liquid).
The dose can be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose up to a maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Alter tablets is too strong or too weak, consult your doctor or pharmacist.

Try to take Aripiprazolo Alter tablets every day at the same time.It does not 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 Alter tablets without first consulting your doctor.

If you take more Aripiprazolo Alter tablets than you should
If you should realize that you have taken more Aripiprazolo Alter tablets than your doctor has recommended (or if someone else has taken Aripiprazolo Alter tablets),
contact your doctor immediately. If you cannot reach your doctor, go to the nearest
hospital and take the package 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 rigidity 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 experience any of these symptoms.

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

If you stop taking Aripiprazolo Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Alter tablets 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, jerking or twisting movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild mental confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• increased production of saliva,
• vomiting,
• feeling tired.

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

• increase or decrease in 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),
• restless legs,
• double vision,
• sensitivity of the eyes to light,
• fast heartbeat,
• low blood pressure when standing up, which causes dizziness, mild mental confusion or fainting,
• hiccups. Side effects that have been reported since the marketing of oral aripiprazole began but the frequency with which they have occurred is not known:
• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetic condition, 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 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 rigidity),
• speech disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• 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 in hands, ankles or feet,
• in blood tests: increase or fluctuation in 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 type and frequency 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 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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Alter

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 packaging. 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 Alter tablets contain
The active ingredient is aripiprazole. Each tablet contains 10 mg of aripiprazole.
The other ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline
cellulose, hypromellose, magnesium stearate.

Description of the appearance of Aripiprazolo Alter tablets and contents of the pack
Aripiprazolo Alter 10 mg tablets are biconvex, round, white in colour, with
a score line on one side. The score line is not for breaking the tablet.
They are supplied in aluminium blisters packaged in cartons containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano

Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
SPAIN:
Aripiprazol Alter 5 mg tablets EFG
Aripiprazol Alter 10 mg tablets EFG
Aripiprazol Alter 15 mg tablets EFG
FRANCE:
ARIPIPRAZOLE BGR 5 mg tablet
ARIPIPRAZOLE BGR 10 mg tablet
ARIPIPRAZOLE BGR 15 mg tablet
ITALY:
Aripiprazolo Alter

Aripiprazolo Alter 15 mg tablets

Aripiprazolo
Generic medicine

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 Alter tablets are and what they are used for
• 2. What you need to know before you take Aripiprazolo Alter tablets
• 3. How to take Aripiprazolo Alter tablets
• 4. Possible side effects
• 5. How to store Aripiprazolo Alter tablets
• 6. Contents of the pack and other information

1. What is Aripiprazolo Alter tablets and what it is used for

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

2. What you need to know before taking Aripiprazolo Alter tablets

Do not take Aripiprazolo Alter 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 Alter tablets.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Tell your doctor immediately if you are experiencing any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Alter, 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 (convulsions) 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 drowsy to the point that it interferes with your 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 had a stroke or transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Tell your doctor immediately if you experience stiffness or rigidity with high fever, sweating, altered mental status, or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, urge or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours
such as compulsive gambling, excessive eating or spending, an unusually high sexual drive or preoccupation with sexual thoughts or feelings. Your doctor may need to adjust your dose or stop your therapy.
Aripiprazolo can cause drowsiness, low blood pressure when getting up, dizziness and changes in your ability to move and maintain balance, which can lead to falls. Be careful, especially if you are elderly or in some way debilitated.

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

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

• Medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort)
• Antifungal medicines (e.g. ketoconazole, itraconazole)
• Some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor 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 Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazolo Alter.

Medicines that increase serotonin levels are typically used in conditions
such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and
social phobia, as well as migraine and pain:

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

These medicines may increase the risk of side effects. Consult your doctor if
you experience any unusual symptoms while taking any of these
medicines together with Aripiprazolo Alter.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this
medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo
Alter in the last trimester (last three months of pregnancy): tremor, stiffness and/or weakness
of muscles, drowsiness, agitation, breathing problems and difficulty feeding. If the
child presents any of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Alter tablets, your doctor will discuss with you whether you should continue breastfeeding, 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 vision disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations where full
vigilance is required, for example when driving a vehicle or using machines.

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

3. How to take Aripiprazolo Alter tablets

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

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

Use in children and adolescents
This medicine can be started at low doses using the oral solution (liquid).
The dose can be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose up to a maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Alter tablets is too strong or too weak, consult your doctor or pharmacist.

Try to take Aripiprazolo Alter tablets every day at the same time.It does not 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 Alter tablets without first consulting your doctor.

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

• Fast heartbeat, agitation/aggression, speech problems.
• Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

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

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

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

If you stop taking Aripiprazolo Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Alter tablets for the entire period indicated by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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, jerky or twisting movements,
• 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,
• 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,
• sensitivity of the eyes to light,
• fast heartbeat,
• lowering of blood pressure when standing up, which causes dizziness, mild mental confusion or fainting,
• hiccups.

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

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of 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 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,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• 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

which then spreads, high temperature, enlarged lymph nodes, increased levels of
liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),

• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or conditions of excessive heat,
• chest pain,
• swelling in 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
administration 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 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 via the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By
reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Aripiprazolo Alter

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 packaging. 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 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 Alter tablets contain
The active ingredient is aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline
cellulose, hypromellose, magnesium stearate.

Description of the appearance of Aripiprazolo Alter tablets and contents of the pack
Aripiprazolo Alter 15 mg tablets are biconvex, round, white in colour, without
a score line.
They are supplied in aluminium blisters packaged in cartons containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
SPAIN:
Aripiprazol Alter 5 mg comprimidos EFG
Aripiprazol Alter 10 mg comprimidos EFG
Aripiprazol Alter 15 mg comprimidos EFG
FRANCE:
ARIPIPRAZOLE BGR 5 mg comprimé
ARIPIPRAZOLE BGR 10 mg comprimé
ARIPIPRAZOLE BGR 15 mg comprimé
ITALY:
Aripiprazolo Alter