Package leaflet: Information for the user

Aripiprazole Alter 5 mg tablets

Aripiprazole
Generic medicine
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

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

Contents of this leaflet

What Aripiprazole Alter tablets are and what they are used for
What you need to know before taking Aripiprazole Alter tablets
How to take Aripiprazole Alter tablets
Possible side effects
How to store Aripiprazole Alter tablets
Contents of the pack and other information

1. What Aripiprazole Alter tablets are and what they are used for

Aripiprazole Alter tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics. They are 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 blunting of emotions. People with this condition may also feel depressed, guilty, anxious or tense.

Aripiprazole Alter tablets are used to treat adults and adolescents aged 13 years and older who have a condition characterised by symptoms such as feeling "high", having excessive energy, needing much less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents recurrence of this condition in adults who have responded to treatment with Aripiprazole Alter.

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

Do not take Aripiprazole 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 Aripiprazole Alter tablets.
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 Alter, inform your doctor if you have:

high blood sugar levels (characterised by symptoms such as excessive thirst, production of 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 circulatory diseases), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities
a history of 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, feel drowsiness that interferes with your normal daily activities, have difficulty swallowing, or experience allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (memory loss and decline in other mental abilities), you or your caregiver should inform your doctor if you have previously 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 status, or a very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as gambling addiction, excessive eating, excessive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in your ability to move and maintain balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and Aripiprazole Alter tablets
Inform 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 Alter tablets 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 Alter tablets with certain medicines may require your doctor to adjust the dose of Aripiprazole Alter or of the other medicines.
It is especially 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 used 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 Aripiprazole Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Alter.

Medicines that increase serotonin levels are typically used for 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 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 Alter.
Aripiprazole Alter 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, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have used Aripiprazole Alter during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Alter tablets, your doctor will discuss with you whether you should breastfeed, considering the benefit of the treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.
Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.
Aripiprazole Alter tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Aripiprazole Alter 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 low dose using the oral solution (liquid). The dose may then 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 Alter tablets is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Alter tablets at the same time each 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 Alter tablets without first consulting your doctor.
If you take more Aripiprazole Alter tablets than you should
If you realize you have taken more Aripiprazole Alter tablets than prescribed by your doctor (or if someone else has taken them), 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 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 rigidity and drowsiness or sedation, slow breathing, feeling 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 Alter tablets
If you forget a dose, take it as soon as you remember, but do not take a double dose on the same day.
If you stop taking Aripiprazole Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Alter 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 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 sit still,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, jerking movements or twisting,
tremors,
headache,
tiredness,
drowsiness,
mild confusion,
trembling and blurred vision,
reduced number of bowel movements or difficulty defecating,
indigestion,
feeling unwell,
increased saliva production,
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,
light sensitivity of the eyes,
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 start of oral aripiprazole marketing, but their frequency is unknown:

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 attempts and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
epileptic seizures,
serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasms around the larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test results,
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, skin rash starting on the face and spreading, high temperature, swollen lymph nodes, increased liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia),
abnormal breakdown of muscle tissue which may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns 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 glycated haemoglobin,
inability to resist an impulse, drive or temptation to carry out 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 oneself or others, e.g., increased sexual drive,
- excessive and uncontrollable shopping,
- uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger),
- tendency to wander away.

Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during treatment with aripiprazole. In addition, cases of stroke or "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 tiredness, which were very common (more than 1 in 10 patients), and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable 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 effects, 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 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 Aripiprazole Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. 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 Alter tablets contain
The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other components are monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, hypromellose, magnesium stearate.

Description of the appearance of Aripiprazole Alter tablets and package contents
Aripiprazole Alter 5 mg tablets are biconvex, round, white in colour, without a break line. They are supplied in aluminum blisters packed in cartons containing 28 tablets.

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

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
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

Package leaflet: Information for the user

Aripiprazole Alter 10 mg tablets

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

Contents of this leaflet

What Aripiprazole Alter tablets are and what they are used for
What you need to know before taking Aripiprazole Alter tablets
How to take Aripiprazole Alter tablets
Possible side effects
How to store Aripiprazole Alter tablets
Contents of the pack and other information

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

Aripiprazolo Alter 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 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.
Aripiprazolo Alter tablets are used to treat adults and adolescents from the age of 13 affected by a condition characterized by symptoms such as feeling "overly excited", having excessive energy, needing much less sleep than usual, talking 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 Alter.

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

Do not take Aripiprazole 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 Aripiprazole Alter tablets.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Alter, 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 (convulsions), 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 interfering with normal daily activities, have difficulty swallowing, or develop allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness, 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 drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the 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 Alter tablets
Inform 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 Alter 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 Alter tablets with certain medicines may require your doctor to adjust the dose of Aripiprazole Alter 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)
Some medicines used 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 adverse effects or reduce the effect of Aripiprazole Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole 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 adverse effects. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Alter.
Aripiprazole Alter with food, drinks and alcohol
This medicine may be taken regardless of meals. Alcohol should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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 used Aripiprazole Alter during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the baby shows any of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazole Alter tablets, your doctor will discuss with you whether you should breastfeed, considering the benefit of the treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.
Driving and using machines
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.
Aripiprazole Alter tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Aripiprazole Alter 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 initiated at a low dose using the oral solution (liquid).
The dose may then 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 Alter tablets is too strong or too weak, talk to your doctor or pharmacist.
Try to take Aripiprazole Alter tablets 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 Alter tablets without first consulting your doctor.
If you take more Aripiprazole Alter tablets than you should
If you realize you have taken more Aripiprazole Alter tablets than prescribed by your doctor (or if someone else has taken Aripiprazole 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 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 rigidity and drowsiness or sedation, slowed breathing, feeling 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 Alter tablets
If you miss a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aripiprazole Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Alter tablets for the entire duration prescribed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to sit still,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, jerky movements or twisting,
tremors,
headache,
tiredness,
drowsiness,
mild confusion,
trembling and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
feeling unwell,
increased saliva production,
vomiting,
feeling of fatigue.

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

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

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

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 attempts and suicide,
feeling of aggressiveness,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
epileptic seizures,
serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasms around the larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test results,
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 starting on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzymes found in blood tests, and an increase in a type of white blood cell (eosinophilia),
abnormal breakdown of muscle tissue which may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns 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 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 excessively despite serious personal or family consequences,
- altered or increased sexual interest and behaviour causing significant concern to oneself or others, e.g. increased sex 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 away.

Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, 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 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

5. How to store Aripiprazole Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

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

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

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

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

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
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

Package leaflet: Information for the user

Aripiprazole Alter 15 mg tablets

Aripiprazole
Generic medicinal product
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet

What Aripiprazole Alter tablets are and what they are used for
What you need to know before taking Aripiprazole Alter tablets
How to take Aripiprazole Alter tablets
Possible side effects
How to store Aripiprazole Alter tablets
Contents of the pack and other information

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

Aripiprazolo Alter 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 characterised 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 with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazolo Alter tablets are used to treat adults and adolescents from the age of 13 who are affected by a condition characterised by symptoms such as feeling "high", having excessive energy, needing much less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents this condition in adults who have responded to treatment with Aripiprazolo Alter.

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

Do not take Aripiprazole 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 Aripiprazole Alter tablets.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Alter, 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 (fits), for which your doctor may decide to monitor you more closely
involuntary, irregular muscle movements, especially of the face
cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities
a history of 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, developing unusual movements, feeling drowsy to the extent that it interferes with your normal daily activities, having difficulty swallowing, or experiencing 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 transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviour have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or a 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 pathological gambling, binge eating, compulsive spending, abnormally increased sex drive, or preoccupation due to increased sexual thoughts or sensations. Your doctor may consider it necessary to adjust the dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in your ability to move and maintain balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and Aripiprazole Alter tablets
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 Alter 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 Aripiprazole Alter tablets with certain medicines may mean that your doctor needs to adjust the dose of Aripiprazole Alter or of the other medicines. It is especially 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, a protease inhibitor 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 Alter. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Alter.

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 amitriptyline) used for depressive illness
St. John's wort (Hypericum perforatum), used as a herbal remedy for mild depression
Painkillers (e.g., tramadol and meperidine) 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 Alter.
Aripiprazole Alter with food, drinks, and alcohol
This medicine can be taken regardless of food. 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 Alter during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Alter tablets, your doctor will discuss with you whether you should breastfeed, considering the benefit of the treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.
Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations where full alertness is required, such as when driving a vehicle or operating machinery.
Aripiprazole Alter tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Aripiprazole Alter 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 initiated at low doses 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 Alter tablets is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Alter tablets 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 Alter tablets without first consulting your doctor.
If you take more Aripiprazole Alter tablets than you should
If you realize that you have taken more Aripiprazole Alter tablets than prescribed by your doctor (or if someone else has taken them), 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 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 rigidity and drowsiness or sedation, slowed breathing, feeling 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 Alter 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 Alter tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Alter tablets for the entire duration indicated by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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 sit still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible urge to keep moving),
uncontrollable muscle contractions, jerky movements or twisting movements,
tremors,
headache,
tiredness,
drowsiness,
mild confusion,
trembling and blurred vision,
reduced number of bowel movements or difficulty defecating,
indigestion,
feeling unwell,
increased saliva production,
vomiting,
feeling of fatigue.

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

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

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

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,
a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizures,
serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
sudden unexplained death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, seek medical advice immediately),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasms around the larynx,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,
yellowing of the skin and whites of the eyes,
cases of abnormal liver function test results,
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, which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and an increase in a type of white blood cell (eosinophilia),
abnormal breakdown of muscle tissue which may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal symptoms in newborns 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 glycated haemoglobin,
inability to resist an impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
- strong urge to gamble excessively despite serious personal or family consequences,
- altered or increased sexual interest and behaviour causing significant concern to you or others, for example, increased sexual drive,
- excessive and uncontrollable shopping,
- uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger),
- tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during treatment with aripiprazole. In addition, cases of stroke or "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 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 contractions, 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 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 Aripiprazole Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. 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 Aripiprazolo Alter tablets contain
The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, hypromellose, magnesium stearate.

Description of the appearance of Aripiprazolo Alter tablets and contents of the package
Aripiprazolo Alter 15 mg tablets are biconvex, round, white, without a score line.
They are supplied in aluminum blisters packed into cartons containing 14 or 28 tablets.
It is possible that not all pack sizes are marketed.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
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