ARIPIPRAZOLO 1 mg /Ml Roztwór Doustny

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1. ARIPIPRAZOLO DOC 1 mg/ml oral solution
   1. What is ARIPIPRAZOLO DOC and what it is used for
   2. What you need to know before you take ARIPIPRAZOLO DOC
   3. How to take ARIPIPRAZOLO DOC
   4. Possible side effects
   5. How to store ARIPIPRAZOLO DOC
   6. Contents of the pack and other information

ARIPIPRAZOLO DOC 1 mg/ml oral solution

Equivalent Medicinal Product

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 DOC is and what it is used for
• 2. What you need to know before you take ARIPIPRAZOLO DOC
• 3. How to take ARIPIPRAZOLO DOC
• 4. Possible side effects
• 5. How to store ARIPIPRAZOLO DOC
• 6. Contents of the pack and other information

1. What is ARIPIPRAZOLO DOC and what it is used for

ARIPIPRAZOLO DOC contains the active substance aripiprazole and belongs to a group of medicines
called antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who are
affected by an illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and emotional blunting. People who present this
condition may also feel depressed, guilty, anxious or tense.
ARIPIPRAZOLO DOC is used for the treatment of adults and adolescents starting from 13 years of age who
are affected by a condition characterized by symptoms such as feeling “revved up”, having excessive
energy, not needing to sleep as much as 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 DOC.

2. What you need to know before you take ARIPIPRAZOLO DOC

Do not take ARIPIPRAZOLO DOC

• 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 or pharmacist before taking ARIPIPRAZOLO DOC.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Inform
your doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with ARIPIPRAZOLO DOC, tell your doctor if you suffer from

• high blood sugar levels (characterised by symptoms such as excessive thirst, producing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes;
• epilepsy (seizures) as your doctor may decide to monitor you more closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities;
• blood clots or a family history of blood clots, as antipsychotics have been associated

with the formation of blood clots;

• a previous experience of excessive gambling. If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, tell your doctor.

If you are an elderly patient suffering from dementia (loss of memory 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. Suicidal thoughts and behaviours have been reported during treatment with
aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your 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 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 maintain balance, which can lead to falls. Be
careful, especially if you are elderly or in some way debilitated.

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

Other medicines and ARIPIPRAZOLO DOC
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 DOC 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 DOC together with certain medicines may mean that your doctor will need
to change the dose of ARIPIPRAZOLO DOC 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 or reduce the effect of ARIPIPRAZOLO DOC. Consult your doctor if you experience any unusual symptoms while taking one

of these medicines together with ARIPIPRAZOLO DOC.
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 in 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 one of these medicines together with ARIPIPRAZOLO DOC.

ARIPIPRAZOLO DOC with food and drink
This medicine can be taken independently of food. However, the oral solution should not
be diluted with other liquids or mixed with food before administration.
Alcohol should be avoided.

Pregnancy and breastfeeding
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 DOC
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 you may need to contact your doctor.
If you are taking ARIPIPRAZOLO DOC, your doctor will discuss with you whether you should continue breastfeeding, considering the
benefit you receive from the therapy and the benefit for the baby from breastfeeding. One 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 cases where full vigilance is required, for example when
driving a vehicle or using machines.

ARIPIPRAZOLO DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially it is
‘sodium-free’.

ARIPIPRAZOLO DOC contains propylene glycol
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended
by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
Propylene glycol in this medicine may have the same effects as drinking alcohol and may
increase the likelihood of side effects.
Use this medicine only if recommended by your doctor. The doctor may perform further checks during the
therapy.

3. How to take ARIPIPRAZOLO DOC

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 ml of solution (corresponding to 15 mg of aripiprazole)
once a day.However, your doctor may prescribe a lower or higher dose up to a maximum
of 30 mg (i.e. 30 mL) once a day.

Use in children and adolescents
The recommended dose for adolescents is 10 mL of solution (corresponding to 10 mg of
aripiprazole) once a day.However, your doctor may prescribe a lower or higher dose up to
a maximum of 30 mL (i.e. 30 mg) once a day.
The dose of ARIPIPRAZOLO DOC must be measured using the calibrated measuring cup or the calibrated 4 ml syringe
included in the package.
If you feel that the effect of ARIPIPRAZOLO DOC is too strong or too weak, consult your
doctor or pharmacist.

Try to take ARIPIPRAZOLO DOC every day at the same time.It does not matter if you take it with
food or not. However, you must not dilute with other liquids or mix with other foods ARIPIPRAZOLO DOC
oral solution before administration.

Even if you feel well, do not change or stop the daily dose of ARIPIPRAZOLO DOC without first
consulting your doctor.

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

• 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 sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, heart rhythm changes.

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

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

4. Possible side effects

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

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

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

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

• increased levels of the hormone prolactin in the blood,
• high blood sugar levels,
• depression,
• altered or increased sexual interest,
• involuntary movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heart rate,
• low blood pressure when standing up, which causes dizziness, lightheadedness or fainting,
• hiccups.

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

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g. swelling of 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 level of sodium 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 awareness and sudden changes in pressure and heart rate, fainting (malignant neuroleptic syndrome),
• convulsions,
• 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 (seek immediate medical advice if you notice any of these symptoms),
• 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,
• liver inflammation,
• 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,
• serious 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 in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling internal body temperature or conditions of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: fluctuation of blood sugar levels, increased glycated hemoglobin,
• inability to resist the urge, drive 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 increased sexual drive,
• excessive and uncontrollable shopping or 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 your appetite),
• tendency to wander. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole.
In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in frequency and type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and fatigue which were very common (more than 1 in 10) and for pain in the upper abdomen, 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 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 DOC

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 bottle and the carton after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original container to protect the medicine from light.
Use within 6 months of first opening.
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 DOC contains

• The active ingredient is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other ingredients present in the solution are: butylated hydroxyanisole (E320), orange aroma, phosphoric acid, propylene glycol, sucralose, sodium hydroxide and purified water

Description of the appearance of ARIPIPRAZOLO DOC and contents of the pack
ARIPIPRAZOLO DOC is a clear liquid, from colorless to light yellow, supplied in amber-colored PET bottles
containing 150 ml per bottle.
Each bottle is closed with a white plastic (HD polyethylene) child-resistant screw cap with a
white polypropylene adapter.
a 30 ml measuring cup.
The syringe body is made of PP and the plunger is made of HDPE and is graduated for dosing of 0.5 ml and then every
0.5 ml up to 2 ml.
The measuring cup is made of PP and is graduated for dosing of 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and a
maximum volume of 30 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano (Italy).

Manufacturer:
Chanelle Medical - Dublin Road, Loughrea, Co. Galway - Ireland.

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Malta Aripiprazole DOC
Italy ARIPIPRAZOLO DOC