ARIPIPRAZOLO 10 mg Ородисперсная Таблетка

Содержание инструкции

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

Aripiprazolo Laboratori Alter 10 mg orodispersible tablets

aripiprazolo

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

orodispersible
Do not take Aripiprazolo 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 Aripiprazolo Laboratori Alter orodispersible tablets.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Laboratori Alter, tell your doctor if you suffer from

• high blood sugar levels (characterised by symptoms such as excessive thirst, frequent urination, increased appetite and feeling weak) or a family history of diabetes
• seizures (convulsions) for which your doctor may decide to monitor you more closely
• involuntary, irregular muscle movements, especially of the face
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• a previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy
that interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic
symptoms, tell your doctor.
If you are an elderly patient with dementia (memory loss and other mental abilities),
you or the person caring for you must inform the doctor if you have had a stroke or transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Ideation and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or rigidity of muscles with high fever, sweating, altered mental status or very fast or irregular heartbeat.
Tell your doctor if you, your family members or those who care for you 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, urge or temptation to carry out certain activities that may
harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as gambling addiction,
excessive eating or spending, unusually high sexual drive or preoccupation
with increased sexual thoughts or feelings.
Your doctor may need to adjust the dose or stop your therapy.
Aripiprazole can cause drowsiness, low blood pressure when getting up, dizziness and changes in the ability to move and stay balanced, which can
cause falls. Be careful, especially if you are elderly or in some way debilitated.

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

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

• Medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort)
• Antifungal medicines (e.g. ketoconazole, itraconazole)
• Some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor such as indinavir, ritonavir)
• Anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital)
• Some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects. Consult your doctor if
you experience any unusual symptoms while taking any of these medicines
together with Aripiprazolo Laboratori Alter.
The medicines that increase the level of serotonin 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
• Pain relievers (e.g. tramadol and pethidine) used to relieve pain
• Triptans (e.g. sumatriptan and zolmitriptan) used for the treatment of migraine.

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo
Laboratori Alter in the last trimester (last three months of pregnancy): tremor, rigidity and/or
muscle weakness, drowsiness, agitation, breathing problems, and difficulty
feeding. If the baby presents any of these symptoms, it may be necessary to contact the
doctor.
If you are taking Aripiprazolo Laboratori Alter orodispersible tablets, your doctor will discuss
with you whether you should breastfeed, considering the benefit of therapy for you and the benefit
of breastfeeding for the baby. One excludes the other. If you are taking this
medicine, discuss with your doctor the best way to feed your baby.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where full alertness is required, for
example when driving a vehicle or operating machinery.

Aripiprazolo Laboratori Alter contains aspartame
Aripiprazolo Laboratori Alter 10 mg orodispersible tablets: this medicine contains 2
mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to you if you have phenylketonuria
(PKU),a rare genetic disorder in which there is an accumulation of phenylalanine because the body cannot
process it correctly.

3. How to take Aripiprazolo Laboratori Alter orodispersible tablets

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

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

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

Try to take Aripiprazolo Laboratori Alter orodispersible tablets every day at the same time.It does not matter if you take it with or without food.
Do not open the blister until you are ready to administer. To take the single tablet, open the package and remove the aluminum from the blister to reveal the tablet. Do not push the tablet through the aluminum as this could damage it.
Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on your tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet can be taken with or without liquids.
Alternatively, disperse the tablet in water and drink the resulting suspension.

Even if you feel better, do not change or stop the daily dose of Aripiprazolo Laboratori Alter without first consulting your doctor.

If you take more Aripiprazolo Laboratori Alter orodispersible tablets than you should
If you should realize that you have taken more Aripiprazolo Laboratori Alter orodispersible tablets than your doctor has recommended (or if someone else has taken Aripiprazolo Laboratori Alter orodispersible tablets), contact your doctor immediately.
If you cannot reach your doctor, go to the nearest hospital and take the package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
• uncontrollable muscle contractions, jerky movements or contortions,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild mental confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• increased saliva production,
• vomiting,
• feeling tired.

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

• increase or decrease in prolactin hormone levels in the blood,
• high blood sugar levels,
• depression,
• alteration or increase in sexual interest,
• involuntary 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,
• fast heartbeat,
• lowering of blood pressure when getting up, which causes dizziness, mild mental confusion or fainting,
• hiccups. Side effects that have been reported since aripiprazole oral began to be marketed but the frequency with which they have occurred is not known:
• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• speech disorders,
• eyeballs fixed in a single position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or conditions of excessive heat,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increase or fluctuation in blood sugar levels, increased glycated hemoglobin,
• inability to resist an impulse, urge or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example, an increase in sexual drive
• excessive and uncontrollable shopping
• uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)
• tendency to wander.

Inform your doctor if you experience any of these behaviors; they will explain how to manage or
reduce the symptoms.
In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole. In addition, cases of stroke or “mini” strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in type and frequency to those of adults, except for drowsiness, uncontrollable muscle contractions or spasms, restlessness and fatigue which were very common (more than 1 in 10) and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, involuntary movements of the limbs and feeling dizzy, especially when getting up from a lying or sitting position, which were common (more than 1 in 100).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Laboratori Alter orodispersible tablets

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

6. Contents of the pack and other information

What Aripiprazolo Laboratori Alter contains
The active ingredient is aripiprazole. Each orodispersible tablet contains 10 mg of
aripiprazole.
The other ingredients are maltose, microcrystalline cellulose, anhydrous colloidal silica,
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 10 mg orodispersible tablets are pink, round,
flat, without a score line.
They are supplied in aluminium blisters packaged in cartons containing 14 or 28 orodispersible
tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
SPAIN:
Aripiprazol Alter 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

Aripiprazolo Laboratori Alter 15 mg orodispersible tablets

aripiprazolo

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before you take Aripiprazolo Laboratori Alter orodispersible tablets

orodispersible
Do not take Aripiprazolo 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 Aripiprazolo Laboratori Alter orodispersible tablets.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Laboratori Alter, tell your doctor if you suffer from

• high blood sugar levels (characterised by symptoms such as excessive thirst, frequent urination, increased appetite and feeling weak) or a family history of diabetes
• seizures (convulsions) for which your doctor may decide to monitor you more closely
• involuntary, irregular muscle movements, especially of the face
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• a previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy
that interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic
symptoms, tell your doctor.
If you are an elderly patient suffering from dementia (memory loss and other mental abilities),
you or the person caring for you must inform the doctor if you have had a stroke or a transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregivers 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, urge or temptation to carry out certain activities that may
harm yourself or others. These phenomena are called impulse control disorders and may include behaviours
such as gambling addiction, excessive eating or spending, unusually high sexual drive or preoccupation with sexual thoughts or sensations.
Your doctor may need to adjust your dose or stop your therapy.
Aripiprazole can cause drowsiness, low blood pressure when getting up, dizziness and changes in the ability to move and maintain balance, which can
cause falls. Be careful, especially if you are elderly or debilitated in any way.

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

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

• Medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort)
• Antifungal medicines (e.g. ketoconazole, itraconazole)
• Some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor such as indinavir, ritonavir)
• Anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital)
• Some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects. Consult your doctor if
you experience any unusual symptoms while taking any of these medicines
together with Aripiprazolo 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
• Pain relievers (e.g. tramadol and pethidine) used to relieve pain
• Triptans (e.g. sumatriptan and zolmitriptan) used for the treatment of migraine.

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo
Laboratori Alter in the last trimester (last three months of pregnancy): tremor, stiffness and/or
muscle weakness, drowsiness, agitation, breathing problems, and difficulty
feeding. If the baby presents any of these symptoms, it may be necessary to contact the
doctor.
If you are taking Aripiprazolo Laboratori Alter orodispersible tablets, your doctor will discuss
with you whether you should breastfeed, considering the benefit of therapy for you and the benefit of
breastfeeding for the baby. One excludes the other. If you are taking this medicine,
discuss with your doctor the best way to feed your baby.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where full alertness is required, for
example when driving a vehicle or operating machinery.

Aripiprazolo Laboratori Alter contains aspartame
.
Aripiprazolo Laboratori Alter 15 mg orodispersible tablets: this medicine contains 3
mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria
(PKU),a rare genetic disorder in which there is an accumulation of phenylalanine because the body cannot
process it correctly.

3. How to take Aripiprazolo Laboratori Alter orodispersible tablets

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

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

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

Try to take Aripiprazolo Laboratori Alter orodispersible tablets every day at the same time.It does not matter if you take it with or without food.
Do not open the blister until you are ready to administer. To take the single tablet, open the package and remove the aluminum from the blister to reveal the tablet. Do not push the tablet through the aluminum as this could damage it.
Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on your tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet can be taken with or without liquids.
Alternatively, disperse the tablet in water and drink the resulting suspension.

Even if you feel better, do not change or stop the daily dose of Aripiprazolo Laboratori Alter without first consulting your doctor.

If you take more Aripiprazolo Laboratori Alter orodispersible tablets than you should
If you should realize that you have taken more Aripiprazolo Laboratori Alter orodispersible tablets than your doctor has recommended (or if someone else has taken Aripiprazolo Laboratori Alter orodispersible tablets), contact your doctor immediately.
If you cannot reach your doctor, go to the nearest hospital and take the package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
• uncontrollable muscle contractions, jerking or twisting movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• mild mental confusion,
• trembling and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• feeling unwell,
• increased production of saliva,
• vomiting,
• feeling tired.

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

• increase or decrease in prolactin hormone levels in the blood,
• high blood sugar levels,
• depression,
• alteration or increase in sexual interest,
• involuntary 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,
• fast heartbeat,
• low blood pressure when getting up, which causes dizziness, mild mental confusion or fainting,
• hiccups. Side effects that have been reported since aripiprazole oral began to be marketed but the frequency with which they have occurred is not known:
• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• speech disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or conditions of excessive heat,
• chest pain,
• swelling in hands, ankles or feet,
• in blood tests: increase or fluctuation in blood sugar levels, increased glycated hemoglobin,
• inability to resist an impulse, urge or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example, an increase in sexual drive
• excessive and uncontrollable shopping
• uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)
• tendency to wander.

Tell your doctor if you experience any of these behaviors; they will explain how to manage or
reduce the symptoms.
In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole. In addition, cases of stroke or “mini” strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in type and frequency
to those of adults, except for drowsiness, uncontrollable muscle contractions or
spasms, restlessness and fatigue which were very common (more than 1 in 10) and
for upper abdominal pain, dry mouth, increased heart rate,
weight gain, increased appetite, muscle contraction, involuntary movements
of the limbs and feeling dizzy, especially when getting up from a lying or sitting position,
which were common (more than 1 in 100).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system via the national
reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Aripiprazolo Laboratori Alter orodispersible tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the packaging.
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 in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aripiprazolo Laboratori Alter contains
The active ingredient is aripiprazole. Each orally disintegrating tablet contains 10 mg of
aripiprazole.
The other ingredients are maltose, microcrystalline cellulose, anhydrous colloidal silica,
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 orally disintegrating tablets are biconvex, round and
yellow in colour, without a score line.
They are supplied in aluminium blisters packaged in cartons containing 14 or 28 orally disintegrating
tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
SPAIN:
Aripiprazol Alter 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