ARIPIPRAZOLE DOC GENERICI

Package leaflet: Information for the patient

ARIPIPRAZOLE DOC 1 mg/ml oral solution

Generic Medicine
Please read 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ARIPIPRAZOLO DOC is 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 to treat adults and adolescents from the age of 15 who suffer from 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. People with this condition may also feel depressed, guilty, anxious, or tense.
ARIPIPRAZOLO DOC is also used to treat adults and adolescents from the age of 13 who suffer from a condition characterized by symptoms such as feeling "high", having excessive energy, needing less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents this condition in adults who have responded to treatment with ARIPIPRAZOLO DOC.

2. What you need to know before taking ARIPIPRAZOLO DOC

Do not take ARIPIPRAZOLO DOC

• 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 or pharmacist before taking ARIPIPRAZOLO DOC.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your
doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with ARIPIPRAZOLO DOC, inform your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;

• epilepsy (seizures), as your doctor may decide to monitor you more closely;

• involuntary, irregular muscle movements, especially of the face;

• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities;

• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;

• a history of excessive gambling. If you notice that you are gaining weight, develop unusual movements, feel drowsy to the point that it interferes with your 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 should inform your doctor if you have previously had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself. Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that may harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as gambling addiction, binge eating, excessive spending, abnormally increased sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and ARIPIPRAZOLO DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: ARIPIPRAZOLO DOC may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Taking ARIPIPRAZOLO DOC together with certain medicines may require your doctor to adjust the dose of ARIPIPRAZOLO DOC or of the other medicines. It is particularly important to inform your doctor about the following medicines:

• medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide);

• antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St. John’s wort);

• antifungal medicines (e.g. ketoconazole, itraconazole);

• some medicines used 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);

• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin). These medicines may increase the risk of side effects or reduce the effectiveness of ARIPIPRAZOLO DOC. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with ARIPIPRAZOLO DOC.
  Medicines that increase serotonin levels are typically used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;

• selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;

• other antidepressants (e.g. venlafaxine and tryptophan) used for major depression;

• tricyclics (e.g. clomipramine and amitriptyline) used for depressive illness;

• St. John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression;

• painkillers (e.g. tramadol and pethidine) used to relieve pain;

• triptans (e.g. sumatriptan and zolmitriptan) used to treat 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 DOC.

ARIPIPRAZOLO DOC with food and drink
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 should be avoided.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have used ARIPIPRAZOLO DOC during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking ARIPIPRAZOLO DOC, your doctor will discuss with you whether you should breastfeed, considering the benefit you receive from the treatment and the benefit to the baby from breastfeeding. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.
Driving and using machines
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account when full alertness is required, for example when driving a vehicle or operating machinery.
ARIPIPRAZOLO DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.
ARIPIPRAZOLO DOC contains propylene glycol
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
Propylene glycol in this medicine may produce effects similar to those of alcohol and may increase the likelihood of side effects.
Use this medicine only if recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take ARIPIPRAZOLE DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mL of 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 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 DOC must be measured using the calibrated oral dosing syringe or the 4 mL calibrated dosing cup provided in the package.
If you feel that the effect of ARIPIPRAZOLE DOC is too strong or too weak, consult your
doctor or pharmacist.
Try to take ARIPIPRAZOLE DOC at the same time each day. It does not matter whether you take it
with or without food. However, do not dilute or mix ARIPIPRAZOLE DOC oral solution with other liquids or foods before administration.
Even if you feel well, do not change or stop the daily dose of ARIPIPRAZOLE DOC without first
consulting your doctor.
If you take more ARIPIPRAZOLE DOC than you should
If you realize that you have taken more ARIPIPRAZOLE DOC than prescribed by your
doctor (or if someone else has taken ARIPIPRAZOLE DOC), 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 an overdose of aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

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

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

4. Possible side effects

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

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

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to remain still, difficulty staying seated,
• akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
• uncontrollable muscle contractions, jerky movements or twisting,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling of light-headedness,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• 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,
• change or increase in sexual interest,
• uncontrollable 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,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, light-headedness or fainting,
• hiccups.

The following side effects have been reported since the start of marketing of oral aripiprazole, but their frequency is unknown:

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• unexplained sudden death,
• potentially fatal irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• muscle spasm around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• cases of abnormal liver function test results,
• 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 presents with flu-like symptoms and a skin rash on the face that then spreads, high fever, swollen lymph nodes, increased liver enzyme levels found in blood tests, and increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscle tissue which may cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns following 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: fluctuations in blood sugar levels, increased glycated haemoglobin,
• inability to resist the impulse, urge or temptation to perform an action that may be harmful to oneself or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example increased sexual drive,
  • excessive and uncontrollable shopping or spending,
  • uncontrolled eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger),
  • tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

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

Additional side effects in children and adolescents
Adolescents aged 13 years and older have experienced side effects similar in frequency and type to those in adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue, which were very common (more than 1 in 10 patients), and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled limb movements and dizziness, especially when rising from a lying or sitting position, which were common (more than 1 in 100 patients).

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

5. How to store ARIPIPRAZOLE 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 bottle to protect the medicine from light.
Use within 6 months of first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARIPIPRAZOLO DOC contains

• The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other components present in the solution are: butylated hydroxyanisole (E320), orange flavour, 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, colourless to pale yellow liquid supplied in amber-coloured PET bottles containing 150 ml per bottle.
Each bottle is closed with a white plastic screw cap (HD polyethylene) with a child-resistant closure and a white polypropylene adapter.
Each carton contains one bottle, one leaflet, measuring devices: a 4 ml syringe and a 30 ml measuring cup.
The syringe barrel is made of PP and the plunger is made of HDPE, graduated for dosing at 0.5 ml increments up to 2 ml.
The measuring cup is made of PP and is graduated for dosing at 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, with 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