ARIPIPRAZOLO 1 mg /Ml Oral Solution

Зміст інструкції

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

Aripiprazolo Aurobindo Italia 1 mg/ml oral solution

Generic medicine

Read this leaflet carefully before using 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 Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Aripiprazolo Aurobindo Italia
• 3. How to take Aripiprazolo Aurobindo Italia
• 4. Possible side effects
• 5. How to store Aripiprazolo Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Aripiprazolo Aurobindo Italia and what it is used for

Aripiprazolo Aurobindo Italia oral solution 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 suffer from a
disease 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,
guilty, anxious or tense.
Aripiprazolo Aurobindo Italia oral solution is 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, not needing to sleep compared to 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 Aurobindo Italia oral solution.

2. What you need to know before taking Aripiprazolo Aurobindo Italia

Do not take Aripiprazolo Aurobindo Italia:

• 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 Aurobindo Italia oral solution.
Suicidal thoughts have been reported during treatment with aripiprazole. Tell your
doctor immediately if you have thoughts or feelings of harming yourself.
Before starting treatment with Aripiprazolo Aurobindo Italia oral solution, 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 tired) or a family history of diabetes
• Seizures (convulsions) as your doctor may want to monitor you more closely
• Irregular, involuntary muscle movements, especially of the face
• Cardiovascular disorders (heart and circulation diseases), a family history of cardiovascular disorders, stroke or “mini” stroke, abnormal blood pressure
• Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation
• Past experience with excessive gambling

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy that
interferes with normal daily activities, if you have difficulty swallowing or if you have allergic
symptoms, tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or
your caregiver/a family member should inform the doctor if you have had a stroke or a “mini” stroke in
the past.
Tell your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and suicidal behaviour 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 or your family/caregiver notices that you are developing impulses
or urges to behave in ways that are unusual for you and that you are unable to resist the impulse,
compulsion or temptation to perform certain activities that could harm yourself or others.
These are called impulse control disorders and can include behaviours such as
gambling addiction, excessive eating or spending, an abnormally high sexual drive or preoccupation with increased sexual thoughts or sensations.
Your doctor may need to adjust the dose or stop therapy.

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

Other medicines and Aripiprazolo Aurobindo Italia oral solution
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 Aurobindo Italia oral solution
can increase the effect of medicines used to lower blood pressure. Tell your
doctor if you are taking a medicine to control your blood pressure.
Taking Aripiprazolo Aurobindo Italia oral solution with other medicines may mean that your
doctor may need to change the dose of Aripiprazolo Aurobindo Italia oral solution or
the other medicines. It is important to tell your doctor especially if you are taking the following
medicines:

• Medicines that correct heart rhythm (such as quinidine, amiodarone, flecainide)
• Antidepressants or herbs used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St John's Wort)
• Antifungal agents (such as ketoconazole, itraconazole)
• Some medicines for the treatment of HIV infection (such as efavirenz, nevirapine, protease inhibitors e.g. indinavir, ritonavir)
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• Some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines can increase the risk of side effects or reduce the effect of
Aripiprazolo Aurobindo Italia oral solution; if you experience any unusual symptoms while
taking one of these medicines together with Aripiprazolo Aurobindo Italia oral solution,
you should consult your doctor.
Medicines that increase the level of serotonin are usually used in conditions that
include depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and
social phobia as well as migraine and pain:

• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain
• SSRIs (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• Other antidepressants (such as venlafaxine and tryptophan) used in major depression
• tricyclics (such as clomipramine and amitriptyline) used for depressive illness
• St John's Wort (Hypericum perforatum) used as a herbal remedy for mild depression
• Painkillers (such as tramadol and pethidine) used for pain relief
• Triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines can increase the risk of side effects; if you experience any
unusual symptoms while taking one of these medicines together with Aripiprazolo
Aurobindo Italia oral solution, you should consult your doctor.

Aripiprazolo Aurobindo Italiaoral solutionwith food, drinks and alcohol
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.
Avoid using alcohol.

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
Aurobindo Italia oral solution in the last trimester (last three months of pregnancy): tremor,
muscle rigidity and/or 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 Aurobindo Italia oral solution, your doctor will discuss with you
the possibility of breastfeeding considering the benefits of therapy for you and the benefits
of breastfeeding for the baby. You should not do both. Discuss with your doctor the
best way to feed your baby while taking this medicine.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where total
alertness is required, e.g. when driving a car or using machines.

Aripiprazolo Aurobindo Italiaoral solutioncontains fructose, sucrose and para-
hydroxybenzoates
Each ml of Aripiprazolo Aurobindo Italia oral solution contains 200 mg of fructose and 400 mg of
sucrose. If you have been diagnosed with an intolerance to certain sugars, contact your doctor
before taking this medicine.
Para-hydroxybenzoates may cause allergic reactions (including delayed reactions).
This medicine contains 0.3 mg of benzyl alcohol per each ml of oral solution and may
cause allergic reactions. This medicine may be harmful to teeth.
This medicine contains 53 mg of propylene glycol per each ml of oral solution.

3. How to take Aripiprazolo Aurobindo Italia

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

The recommended dose for adults is 15 ml of oral solution (equivalent to 15 mg of aripiprazole)
once a day. However, your doctor may prescribe you a lower or higher dose up to a
maximum of 30 mg (i.e. 30 ml) once a day.

Use in children and adolescents
Therecommended dose for adolescents is 10 ml of solution (equivalent to 10 mg of aripiprazole)
once a day. However, your doctor may prescribe a lower or higher dosage up to
a maximum of 30 ml (i.e. 30 mg) once a day.
The dose of Aripiprazolo Aurobindo Italia oral solution must be measured using the calibrated measuring cylinder
or the calibrated 2 ml dropper provided in the package.
If you feel that the effect of Aripiprazolo Aurobindo Italia oral solution is too strong or
too weak, consult your doctor or pharmacist.

Try to take Aripiprazolo Aurobindo Italiaoral solutionevery day at the same time.
It does not matter if you take it with food or not. However, you must not dilute it with other liquids or mix
Aripiprazolo Aurobindo Italia oral solution with other foods before administration.

Even if you feel well, do not change or stop the daily dose of Aripiprazolo Aurobindo
Italia oral solution without first consulting your doctor.

If you take more Aripiprazolo Aurobindo Italiaoral solutionthan you should
If you realize that you have taken more Aripiprazolo Aurobindo Italia oral solution than
recommended by your doctor (or if someone else has taken your oral solution), 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 excessive doses of aripiprazole have experienced the following symptoms:

• Rapid heartbeat, agitation/aggressiveness, problems with speech.
• 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, slow breathing, choking, high or low blood pressure, irregular heartbeat

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

If you forget to take Aripiprazolo Aurobindo Italia oral solution
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 Aurobindo Italia oral solution
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Aurobindo Italia oral solution for the duration prescribed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• diabetes mellitus
• difficulty sleeping,
• feeling anxious,
• restlessness and inability to stay still, difficulty sitting still
• uncontrollable contractions, jerky or twisting movements, restless legs,
• trembling,
• headache,
• fatigue
• drowsiness
• feeling lightheaded,
• blurred and trembling vision
• reduced number or difficulty with bowel movements
• indigestion
• nausea
• excess saliva in the mouth compared to usual
• vomiting
• feeling tired

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

• increased levels of the hormone prolactin in the blood,
• excess sugar in the blood,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorders that cause spasms (dystonia),
• double vision,
• fast heartbeat,
• low blood pressure when standing up causing dizziness, lightheadedness or fainting,
• hiccups.

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

• low levels of white blood cells,
• low levels of platelets
• allergic reaction (swelling in 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,
• insufficient 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 consciousness and sudden changes in blood pressure and heart rate; fainting (malignant neuroleptic syndrome)
• seizures
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity)
• speech disorders,
• life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through 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 vocal cords,
• 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,
• sensitivity to light,
• hair loss,
• excessive sweating,
• abnormal breakdown of muscles that can lead to 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 overheating,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar, increased glycated hemoglobin.
• Inability to resist the 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 personal or family consequences
• altered or significantly increased sexual interest and behavior concerning for you or others, for example, increased sexual drive
• compulsive shopping
• compulsive eating (eating large amounts of food in a short period of time) or binge eating (eating more food than normal and more than needed to satisfy hunger)
• tendency to wander.

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

Additional side effects in children and adolescents
Adolescents starting at 13 years of age have had side effects similar in frequency and
type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, 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, uncontrolled 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, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Aripiprazolo Aurobindo Italia

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 carton and the bottle after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Use within 6 months of first opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aripiprazolo Aurobindo Italia contains

• The active ingredient is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other ingredients are: glycerol, propylene glycol, sucrose, fructose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, orange flavour containing flavourings, propylene glycol, benzyl alcohol, hydrochloric acid, concentrated sodium hydroxide, purified water.

Description of the appearance of Aripiprazolo Aurobindo Italiaand contents of the pack
Aripiprazolo Aurobindo Italia is a clear solution, from colourless to pale yellow, available in
child-resistant polypropylene bottles containing 50 ml, 150 ml or 480 ml per
bottle.
Each pack contains one bottle and both a polypropylene calibrated measuring cup and a polypropylene
calibrated dropper.
The dropper is graduated for dosages of 0.5 ml and 1 ml, and then every 0.5 ml up to 2 ml.
The measuring cup is graduated for dosages of 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and a maximum volume of 30
ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Génériques
26 avenue Tony Garnier
Lyon – France, 69007
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France: Aripiprazole Arrow 1 mg/ml oral solution
Germany: Aripiprazol PUREN 1 mg/ml solution for oral use
Italy: Aripiprazolo Aurobindo Italia
Portugal: Aripiprazol Aurovitas
Spain: Aripiprazol Aurobindo 1 mg/ml oral solution EFG
Netherlands: Aripiprazol Aurobindo 1 mg/ml, drink