Aripiprazole Laboratori Alter

Package leaflet: Information for the user

Aripiprazole Laboratori Alter 10 mg orodispersible tablets

aripiprazole
Generic medicine
Please 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazole Laboratori Alter orodispersible tablets contain the active substance
aripiprazole and belong to a group of medicines called antipsychotics. It is used for the
treatment of adults and adolescents from the age of 15 years who have a disorder
characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, disorganized speech and behavior, and blunted emotions.
Individuals with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Laboratori Alter orodispersible tablets are used for the treatment of adults and
adolescents from the age of 13 years who have 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 this condition in adults who have responded to treatment
with Aripiprazole Laboratori Alter.

2. What you should know before taking Aripiprazole Laboratori Alter orodispersible tablets

orodispersible
Do not take Aripiprazole Laboratori Alter orodispersible 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 Aripiprazole Laboratori Alter orodispersible 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 Laboratori 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 ischemic 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, unusual movements, drowsiness interfering with normal daily activities, difficulty swallowing, or 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 ischemic attack (TIA).
Contact your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Contact 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, binge eating, excessive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise frail.
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 Laboratori Alter orodispersible 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 Laboratori Alter orodispersible tablets may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Taking Aripiprazole Laboratori Alter orodispersible tablets with certain medicines may require your doctor to adjust the dose of Aripiprazole Laboratori 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 for 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. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Laboratori 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 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 Laboratori Alter.
Aripiprazole Laboratori 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, 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 Laboratori Alter during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Laboratori Alter orodispersible tablets, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.
Driving and using machines
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.
Aripiprazole Laboratori Alter contains aspartame
Aripiprazole Laboratori Alter 10 mg orodispersible tablets: this medicine contains 2 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Aripiprazole Laboratori Alter orodispersible tablets

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be initiated at a low dose using the oral solution (liquid). The dose may be gradually increased up to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of Aripiprazole Laboratori Alter orodispersible tablets is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Laboratori Alter orodispersible tablets at the same time each day. It does not matter whether you take it with or without food.
Do not open the blister pack until you are ready to take the dose. To take a single tablet, open the packaging and peel back the aluminum foil from the blister to expose the tablet. Do not push the tablet through the foil, as this may damage it.
Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid.
Alternatively, the tablet may be dispersed in water and the resulting suspension swallowed.
Even if you feel better, do not change or stop the daily dose of Aripiprazole Laboratori Alter without first consulting your doctor.
If you take more Aripiprazole Laboratori Alter orodispersible tablets than you should
If you realize that you have taken more Aripiprazole Laboratori Alter orodispersible 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 take the packaging with you.
Patients who have taken an overdose of aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

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

Contact your doctor or go to hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole Laboratori Alter orodispersible tablets
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aripiprazole Laboratori Alter orodispersible tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Laboratori Alter orodispersible tablets for the entire duration prescribed by your doctor. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to sit still,
• 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 production of saliva,
• 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 increased 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 when standing up, causing dizziness, mild confusion or fainting,
• hiccups.

The following side effects have been reported since the start of marketing of oral aripiprazole, 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, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• unexplained sudden death,
• potentially fatal irregular heartbeat,
• heart attack,
• slow 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, Drug Reaction with Eosinophilia and Systemic Symptoms). DRESS initially presents with flu-like symptoms and a skin rash on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and 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 carry out an action that may be harmful to oneself or others, which may include:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example, increased sexual drive,
  • excessive and 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, 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 type and frequency to those in adults, except for drowsiness, uncontrollable muscle contractions or spasms, restlessness and tiredness, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled limb movements, and dizziness, especially when rising from a lying or sitting position, which have been common (more than 1 in 100 patients).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Aripiprazole Laboratori Alter orodispersible tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Laboratori Alter contains
The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of
aripiprazole.
The other components are maltose, microcrystalline cellulose, anhydrous colloidal silica,
crospovidone, aspartame, ethyl vanillin flavour, iron oxide red (E172), magnesium stearate.
Description of the appearance of Aripiprazolo Laboratori Alter and package contents
Aripiprazolo Laboratori Alter 10 mg orodispersible tablets are pink-coloured, round, flat,
without a score line.
They are supplied in aluminium blisters packed in cartons containing 14 or 28 orodispersible 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 (EEA) Member States under the following names:
SPAIN:
Aripiprazol Alter 10 mg comprimidos bucodispersables EFG
Aripiprazol Alter 15 mg comprimidos bucodispersables EFG
FRANCE:
ARIPIPRAZOLE BGR 10 mg comprimé orodispersible
ARIPIPRAZOLE BGR 15 mg comprimé orodispersible
ITALY:
Aripiprazolo Laboratori Alter

Package leaflet: information for the user

Aripiprazole Laboratori Alter 15 mg orodispersible tablets

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

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

Contents of this leaflet:

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

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

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

2. What you should know before taking Aripiprazole Laboratori Alter orodispersible tablets

Do not take Aripiprazole Laboratori Alter orodispersible tablets

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

Warnings and precautions
Talk to your doctor before taking Aripiprazole Laboratori Alter orodispersible tablets.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you are experiencing any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazole Laboratori 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 ischemic attack (TIA), or blood pressure abnormalities
• blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation
• previous experience of excessive gambling.

If you notice that you are gaining weight, developing unusual movements, feeling drowsy to the point of interfering with 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 ischemic 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 accompanied by 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 called impulse control disorders and may include behaviours such as gambling addiction, compulsive eating, excessive spending, abnormally increased sex drive, or preoccupation due to an increase in sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor coordination 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 Laboratori Alter orodispersible 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 Laboratori Alter orodispersible 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 Laboratori Alter orodispersible tablets with certain medicines may require your doctor to adjust the dose of Aripiprazole Laboratori 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 for 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. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Laboratori 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
• Analgesics (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 Laboratori Alter.

Aripiprazole Laboratori Alter with food, drinks and alcohol
This medicine may be taken regardless of food intake. Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazole Laboratori Alter during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Laboratori Alter orodispersible 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 when full alertness is required, for example when driving a vehicle or operating machinery.

Aripiprazole Laboratori Alter contains aspartame
Aripiprazole Laboratori Alter 15 mg orodispersible tablets: this medicine contains 3 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly metabolize it.

3. How to take Aripiprazole Laboratori Alter orodispersible tablets

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may
prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be initiated at a low dose using the oral solution (liquid). The dose may be gradually increased up to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of Aripiprazole Laboratori Alter orodispersible tablets is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Laboratori Alter orodispersible tablets at the same time each day. It does not matter whether you take it with or without food.
Do not open the blister pack until you are ready to take the dose. To take the single tablet, open the packaging and remove the aluminium foil from the blister to expose the tablet. Do not push the tablet through the foil, as this may damage it.
Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquids.
Alternatively, the tablet may be dispersed in water and the resulting suspension swallowed.
Even if you feel better, do not change or stop your daily dose of Aripiprazole Laboratori Alter without first consulting your doctor.
If you take more Aripiprazole Laboratori Alter orodispersible tablets than you should
If you realize that you have taken more Aripiprazole Laboratori Alter orodispersible 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 take the packaging with you.
Patients who have taken an overdose of aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

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

Contact your doctor or go to hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole Laboratori Alter orodispersible tablets
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aripiprazole Laboratori Alter orodispersible tablets
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Laboratori Alter orodispersible tablets for the entire duration prescribed by your doctor. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
• uncontrolled muscle contractions, jerking 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 production of saliva,
• vomiting,
• feeling tired.

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 increased interest in sex,
• uncontrolled 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 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 attempt and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• unexplained sudden death,
• potentially fatal irregular heartbeat,
• heart attack,
• slow 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 spasm 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,
• 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 rash on the face which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles 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 severe personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to self or others, for example, 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, increased cases of death 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, uncontrolled muscle contractions or spasms, restlessness and tiredness, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled movements of limbs, 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 Laboratori Alter orodispersible tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Laboratori Alter contains
The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of
aripiprazole.
The other components are maltose, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
crospovidone, aspartame, ethyl vanillin flavour, red iron oxide (E172), magnesium
stearate.
Description of the appearance of Aripiprazolo Laboratori Alter and contents of the pack
Aripiprazolo Laboratori Alter 15 mg orodispersible tablets are biconvex, round and
yellow in colour, without a score line.
They are supplied in aluminium blisters packed in cartons containing 14 or 28 orodispersible
tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area countries under
the following names:
SPAIN:
Aripiprazol Alter 10 mg bucodispersable tablets EFG
Aripiprazol Alter 15 mg bucodispersable tablets EFG
FRANCE:
ARIPIPRAZOLE BGR 10 mg orodispersible tablet
ARIPIPRAZOLE BGR 15 mg orodispersible tablet
ITALY:
Aripiprazolo Laboratori Alter