Aripiprazole Aurobindo Italia: detailed information

Patient Information Leaflet: Information for the User

Aripiprazole Aurobindo Italia 1 mg/ml oral solution

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because 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:

What Aripiprazole Aurobindo Italia is and what it is used for
What you need to know before taking Aripiprazole Aurobindo Italia
How to take Aripiprazole Aurobindo Italia
Possible side effects
How to store Aripiprazole Aurobindo Italia
Contents of the pack and other information

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

Aripiprazole Aurobindo Italia oral solution contains the active substance aripiprazole and belongs to
a group of medicines called antipsychotics.
It is used to treat adults and adolescents from the age of 15 who are affected by a disorder
characterized by symptoms such as hearing, seeing, or perceiving things that are not present,
suspiciousness, false beliefs, disorganized speech and behavior, and flattening of emotions.
Individuals affected by this condition may also feel depressed, guilty, anxious, or tense.
Aripiprazole Aurobindo Italia oral solution is used to treat adults and adolescents from the age of 13
who are affected by a condition characterized by symptoms such as feeling "overly excited", having
excessive energy, needing less sleep than usual, speaking very rapidly with "racing thoughts", and
sometimes severe irritability. In addition, it prevents recurrence of this condition in adults who have
responded to treatment with Aripiprazole Aurobindo Italia oral solution.

2. What you should know before taking Aripiprazole Aurobindo Italia

Do not take Aripiprazole Aurobindo Italia:

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 Aurobindo Italia oral solution.
Suicidal thoughts have been reported during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.
Before starting treatment with Aripiprazole Aurobindo Italia oral solution, inform your doctor if you suffer from:

High blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling of fatigue) or a family history of diabetes
Seizures (epilepsy), as your doctor may wish to monitor you more closely
Irregular, involuntary muscle movements, especially of the face
Cardiovascular disorders (heart and circulatory diseases), family history of cardiovascular disorders, stroke or "mini" strokes, abnormal blood pressure
Blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation
Past experience with excessive gambling

If you notice that you are gaining weight, develop unusual movements, feel drowsiness interfering with normal daily activities, have difficulty swallowing, or experience allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver/family member should inform the doctor if you have previously had a stroke or a "mini" stroke.
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and suicidal behaviour have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges 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 are called impulse control disorders and may include behaviours such as compulsive gambling, eating or spending, abnormally increased sex drive, or preoccupation with an increase in sexual thoughts or feelings.
Your doctor may need to adjust your dose or discontinue treatment.

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 Aurobindo Italia oral solution
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 Aurobindo Italia oral solution 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 Aurobindo Italia oral solution together with other medicines may mean that your doctor needs to change the dosage of Aripiprazole Aurobindo Italia oral solution or of the other medicines. It is particularly important to inform your doctor if you are taking the following medicines:

Medicines that regulate heart rhythm (such as quinidine, amiodarone, flecainide)
Antidepressants or herbal remedies 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 may increase the risk of adverse effects or reduce the effectiveness of Aripiprazole Aurobindo Italia oral solution; if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Aurobindo Italia oral solution, you must consult your doctor.
Medicines that increase serotonin levels are usually used in conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

triptans, tramadol, and tryptophan used for conditions including depression, generalized 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 amitriptiline) 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 may increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Aurobindo Italia oral solution, you must consult your doctor.

Aripiprazole Aurobindo Italia oral solution with food, drinks and alcohol
This medicine can be taken regardless of food intake. However, the oral solution must not be diluted with other liquids or mixed with food before administration.
Alcohol consumption 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 Aurobindo Italia oral solution 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 Aurobindo Italia oral solution, your doctor will discuss with you the possibility of breastfeeding, considering the benefits of the treatment for you and the benefits of breastfeeding for your 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 situations requiring full alertness, e.g. when driving a car or operating machinery.

Aripiprazole Aurobindo Italia oral solution contains fructose, sucrose and para-hydroxybenzoates
Each ml of Aripiprazole Aurobindo Italia oral solution contains 200 mg of fructose and 400 mg of sucrose. If your doctor has diagnosed you 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 Aripiprazole Aurobindo Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 ml of oral solution (equivalent to 15 mg of aripiprazole)
once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg (i.e. 30 ml) once daily.
Use in children and adolescents
The recommended dose for adolescents is 10 ml of oral solution (equivalent to 10 mg of aripiprazole)
once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 ml (i.e. 30 mg) once daily.
The dose of Aripiprazole Aurobindo Italia oral solution must be measured using the calibrated oral dosing syringe or the 2 ml calibrated dropper provided in the package.
If you feel that the effect of Aripiprazole Aurobindo Italia oral solution is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Aurobindo Italia oral solution at the same time every day.
It does not matter whether you take it with food or not. However, do not dilute it with other liquids or mix it with food before administration.
Even if you feel well, do not change or stop the daily dose of Aripiprazole Aurobindo Italia oral solution without first consulting your doctor.
If you take more Aripiprazole Aurobindo Italia oral solution than you should
If you realize that you have taken more Aripiprazole Aurobindo Italia oral solution than your doctor prescribed (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 packaging with you.
Patients who have taken excessive doses of aripiprazole have experienced the following symptoms:

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

Other possible symptoms include:

Acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating,
Muscle rigidity and drowsiness, slow breathing, suffocation, high or low blood pressure, irregular heartbeat.

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

4. Possible side effects

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

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

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

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
uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)
muscle disorders causing spasms (dystonia)
double vision
rapid heartbeat
drop in blood pressure upon standing, causing dizziness, lightheadedness, 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 (swelling of the mouth, tongue, face, and throat, itching, rash)
onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma
high blood sugar levels
low sodium levels in the blood
loss of appetite (anorexia)
weight loss
weight gain
suicidal thoughts, suicide attempts, and suicide
feeling aggressive
agitation
nervousness
a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate; fainting (neuroleptic malignant syndrome)
seizures
serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness)
speech disorders
life-threatening 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 experience 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 vocal cords
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 (jaundice)
cases of abnormal liver function tests
skin rash
sensitivity to light
hair loss
excessive sweating
abnormal breakdown of muscle tissue which may lead to kidney problems
muscle pain
stiffness
involuntary loss of urine (incontinence)
difficulty urinating
withdrawal symptoms in newborns following 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 levels, increased glycated haemoglobin

Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to yourself or others, which may include:

strong urge to gamble excessively despite personal or family consequences
significantly increased or altered sexual interest and behaviour causing concern to yourself or others, for example increased sexual drive
uncontrollable compulsive shopping
uncontrolled eating (eating large amounts of food in a short period of time) or compulsive overeating (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 discuss how to manage or reduce the symptoms.

In elderly patients with dementia, increased numbers of 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 adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness, and fatigue, which were very common (affecting more than 1 in 10 people), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contractions, uncontrollable limb movements, and dizziness—especially when rising from a lying or sitting position—which were common (affecting more than 1 in 100 people).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
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 Aripiprazole Aurobindo Italia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Use within 6 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Aurobindo Italia contains

The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.
The other components 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 Italia and contents of the pack
Aripiprazolo Aurobindo Italia is a clear solution, colourless to pale yellow, available in bottles with child-resistant closure made of polypropylene containing 50 ml, 150 ml or 480 ml per bottle.
Each package contains one bottle, one polypropylene graduated oral dosing cup and one polypropylene calibrated dropper.
The dropper is graduated for doses of 0.5 ml and 1 ml, then every 0.5 ml up to 2 ml.
The dosing cup is graduated for doses 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 European Economic Area countries under the following names:
France: Aripiprazole Arrow 1 mg/ml oral solution
Germany: Aripiprazol PUREN 1 mg/ml Lösung zum Einnehmen
Italy: Aripiprazolo Aurobindo Italia
Portugal: Aripiprazol Aurovitas
Spain: Aripiprazol Aurobindo 1 mg/ml oral solution EFG
Netherlands: Aripiprazol Aurobindo 1 mg/ml, drink