ARIPIPRAZOLO 1 mg /Ml Roztwór Doustny

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

Aripiprazolo Mylan Generics 1 mg/ml oral solution

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

1. What is Aripiprazolo Mylan Generics and what it is used for

Aripiprazolo Mylan Generics contains the active ingredient 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
flattening of emotions. People who present this condition may also feel
depressed, guilty, anxious or tense.
Aripiprazolo Mylan Generics 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 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 Mylan Generics.

2. What you need to know before taking Aripiprazolo Mylan Generics

Do not take Aripiprazolo Mylan Generics

• if you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform
your doctor immediately if you are having any thoughts or feelings of self-harm.
Talk to your doctor or pharmacist before taking Aripiprazolo Mylan Generics 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
• epilepsy (seizures) as your doctor may decide to monitor you more closely 1 of 9
• irregular, involuntary 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
• conditions that can lead to a reduction in blood pressure, such as fluid loss, reduced blood volume and use of medicines to lower blood pressure.
• increased blood pressure
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• past experience of excessive gambling
• a condition known as “Attention Deficit Hyperactivity Disorder” (with symptoms such as difficulty maintaining focus on tasks, difficulty following instructions, hyperactivity) and are taking medicines to treat this condition. During treatment If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy to the point it interferes with your normal daily activities, if you have difficulty swallowing or if you have allergy symptoms, inform your doctor.

Inform your doctor if you suffer from tremors, decreased heart rate, muscle stiffness and
balance disorders while being treated with this medicine. These are signs of a
condition known as parkinsonism.
If you are an elderly patient suffering from Alzheimer's disease, dementia (loss of memory and other
mental abilities), you or the person caring for you must inform your 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 ideation and suicidal behaviours have been reported during treatment with aripiprazole.
Inform 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. The doctor may
consider stopping treatment with aripiprazole.
Inform your doctor if you, your family members or your caregivers notice that you are developing a
urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, urge or temptation to perform 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 desire or preoccupation with sexual thoughts or feelings. Your doctor may
need to adjust your dose or discontinue your therapy.

Children and adolescents
Aripiprazolo Mylan Generics is not recommended for use in children and adolescents under the age of
13 years and for the treatment of schizophrenia in children under 15 years. Ask your doctor
or pharmacist for advice before taking Aripiprazolo Mylan Generics.

Other medicines and Aripiprazolo Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Medicines that lower blood pressure: Aripiprazolo Mylan Generics 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 Mylan Generics with other medicines may require your doctor
to change the dosage of Aripiprazolo Mylan Generics. It is important to inform your doctor in
particular if you are taking the following medicines:

• quinidine (medicine to correct heart rhythm) 2 of 9
• escitalopram, fluoxetine (antidepressant), cimetidine (used to treat stomach ulcers) or herbal remedies used to treat depression and anxiety
• ketoconazole, itraconazole (antifungal agents)
• medicines that can change the heart rhythm which can be seen in laboratory tests (such as alfuzosin, amiodarone, chloroquine)
• medicines that can alter the level of salts in the blood (such as hydrocortisone, prednisolone, furosemide)
• some medicines to treat HIV infection (such as ritonavir, indinavir, nelfinavir, efavirenz, nevirapine)
• diltiazem, carbamazepine, phenytoin, phenobarbital, primidone (anticonvulsants used to treat epilepsy)
• rifampicin and rifabutin (antibiotics used to treat tuberculosis). These medicines can increase the risk of side effects or reduce the effect of Aripiprazolo Mylan Generics. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazolo Mylan Generics.

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:

• SSRIs (e.g. paroxetine and fluoxetine) and SNRIs used for depression, OCD, panic and anxiety;
• St John's Wort ( Hypericum perforatum), used as a herbal remedy for mild depression;

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

Aripiprazolo Mylan Generics with alcohol
Alcohol should be avoided while using Aripiprazolo Mylan Generics.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The following symptoms may occur in newborns of mothers who have used Aripiprazolo Mylan
Generics in the last trimester (last three months of pregnancy): tremor, muscle stiffness 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.

Breastfeeding
If you are taking Aripiprazolo Mylan Generics, your doctor will discuss with you whether you should breastfeed,
considering the benefit you receive from therapy and the benefit to 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 vision disturbances may occur during treatment with this medicine (see
section 4). This should be taken into account in situations where full alertness is required, for example
when driving a vehicle or using machinery

This medicine contains sodium benzoate
This medicine contains 1 mg of sodium benzoate per ml.
Sodium benzoate can increase jaundice (yellowing of the skin and eyes) in newborns up to 4
weeks of age.

This medicine contains less than 1 mmol of sodium (23 mg) per ml of oral solutionthat is
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essentially sodium-free

This medicine contains propylene glycol
This medicine contains 80 mg of propylene glycol per ml of oral solution.

3. How to take Aripiprazolo Mylan Generics oral solution

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

The recommended dose for adults is 10 ml or 15 ml of solution (corresponding to 10 mg or 15
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.

Elderly
If you are elderly, your doctor may start treatment with a lower dose than the recommended one.

Patients with liver problems
Tell your doctor if you have severe liver problems, because your doctor may need to
adjust the dose of the medicine.

Use in children and adolescents
Aripiprazolo Mylan Generics can be started at a low dose with the oral solution
(liquid) form. This must be administered using the 5 ml graduated syringe provided with the
pack. The dose can be gradually increased to the recommended dose for
adolescents of 10 ml once a day.
However, your doctor may prescribe a lower or higher dose up to a maximum of 30 ml once
a day.

Measuring the dose
The dose of Aripiprazolo Mylan Generics oral solution must be measured using the
30 ml graduated measuring cup or the 5 ml graduated oral syringe included in the pack.

Open the vial and make sure the syringe is firmly inserted into the adapter (Figure 1).
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Turn the vial upside down with the syringe still inserted (Figure 2).

Pull the plunger and fill the syringe with a slightly larger amount of solution than
prescribed (Figure 3).

If any bubbles appear in the syringe, hold the vial upside down and gently push
the plunger and pull it back again. Repeat until there are no more bubbles in the syringe
(Figure 4).

Slowly push the plunger to the mark on the graduation corresponding to the amount in
milliliters (ml) prescribed by your doctor (Figure 5).
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Turn the vial upright and remove the syringe (Figure 6).
After use, wash the syringe and measuring device with water and close the vial with the plastic screw cap.
If you feel that the effect of Aripiprazolo Mylan Generics is too strong or too weak, contact your doctor or pharmacist.

Try to take Aripiprazolo Mylan Generics oral solution every day at the same time. It
doesn't matter if you take it with food or not. However, you should not dilute it with other liquids or mix it with other
foods before administering Aripiprazolo Mylan Generics oral solution.

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

If you take more Aripiprazolo Mylan Generics than you should
If you realize you have taken more Aripiprazolo Mylan Generics oral solution than your
doctor has recommended (or if someone else has taken some of your Aripiprazolo Mylan Generics
oral solution), contact your doctor immediately. If you cannot reach your doctor, go to the nearest
hospital and take the pack with you.
Patients who have taken too much aripiprazole have had the following symptoms:

• feeling sleepy or sluggish
• increased blood pressure, rapid heartbeat
• nausea or vomiting or diarrhea

In children, an overdose can cause:

• sleepiness
• temporary loss of consciousness
• movement and muscle problems throughout the body (e.g. tremor and unusual body movements).

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

If you forget to take Aripiprazolo Mylan Generics
If you forget a dose, take it as soon as you remember but do not take a double dose to make up
for the missed one.
If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Aripiprazolo Mylan Generics and immediately contact your doctor or go to the Emergency
Room of the nearest hospital if any of the following side effects occur:

Frequency not known(frequency cannot be estimated based on available data)

• changes in the levels of certain blood cells, which can be observed with a blood test and lead to having more infections than normal
• heart attack
• unusual or abnormal heartbeat, which can be observed with clinical tests
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, difficulty breathing and swallowing, itching, rash),
• ketoacidosis (ketones in the blood and urine) or coma
• suicide, suicidal thoughts or suicide attempt
• seizures
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness and sudden changes in blood pressure and heart rate
• formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can reach the lungs through blood vessels causing chest pain and difficulty breathing
• accidental inhalation of food with risk of pneumonia
• inflammation of the pancreas
• difficulty urinating (urinary retention)
• liver failure, inflammation of the liver, yellowing of the skin and the white of the eye
• muscle weakness, sensitivity or pain and especially if at the same time you have malaise or high temperature, this may be caused by an abnormal breakdown of muscles which can be life-threatening and lead to kidney problems.

Other possible side effects:

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

• uncontrollable muscle contractions, jerking or twisting movements, restlessness in the legs,
• feeling restless and unable to stay still, difficulty remaining seated,
• headache
• feeling dizzy
• drowsiness
• tremors
• fatigue
• diabetes mellitus
• nausea, vomiting, indigestion, constipation, increased saliva production
• difficulty sleeping, feeling anxious
• blurred vision.

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

• some people may experience dizziness, especially when getting up from a lying or sitting position
• you may have a rapid heartbeat or double vision
• some people may feel depressed
• alteration or increase in sexual interest
• increased levels of the hormone prolactin in the blood
• decreased blood pressure
• high blood sugar levels that can be observed with blood tests
• muscle disorder causing twisting movements (dystonia)
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)
• hiccups.

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The side effects that follow have been reported since the marketing of
Aripiprazolo Mylan Generics but the frequency with which they have occurred is not known (the
frequency cannot be estimated based on available data):

• sudden, unexplained death
• decreased heart rate
• low level of sodium in the blood
• weight loss, weight gain, loss of appetite (anorexia)
• nervousness, agitation, aggressiveness, speech disorders
• fainting, high blood pressure
• spasm of the muscles around the larynx, difficulty swallowing
• reduced platelets causing bleeding or bruising more easily than normal
• reports of abnormal liver function values, abdominal and stomach discomfort, diarrhea
• rash and sensitivity to light, unusual hair loss or thinning, excessive sweating, stiffness or cramps, muscle pain
• involuntary loss of urine
• prolonged and/or painful erection
• difficulty controlling internal body temperature or conditions of excessive heat, chest pain and swelling of the hands, ankles or feet
• increase or fluctuation of blood sugar and other changes visible with blood tests.
• 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 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 or spending,
• uncontrollable 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 withdraw.

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 transient ischemic attacks (TIA) have been reported.

Additional side effects in children and adolescents
Adolescents starting from 13 years of age 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 have been 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, uncontrolled movements of the limbs and feeling dizzy,
especially when getting up from a lying or sitting position, which have been 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 www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.
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5. How to store Aripiprazolo Mylan Generics oral solution

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 package after
“Exp.”. The expiry date refers to the last day of that month.
After first opening: use within 6 months.
Do not refrigerate or freeze. Store in the original package to protect the medicine from
light.
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 Mylan Generics oral solution contains

• The active ingredient is aripiprazole. Each ml contains 1 mg of aripiprazole. The other ingredients are disodium edetate, erythritol (E 968), hypromellose, macrogol 4000, concentrated phosphoric acid, propylene glycol (E 1520), sodium benzoate (E 211), sucralose (E 955), purified water, grape flavour.

Description of the appearance of Aripiprazolo Mylan Generics oral solution and contents of the pack
Aripiprazolo Mylan Generics 1 mg/ml oral solution is a clear, colourless liquid.
Aripiprazolo Mylan Generics is supplied in amber-coloured glass or plastic bottles with a child-resistant closure. Each bottle contains 150 ml of Aripiprazolo Mylan Generics and is placed in a cardboard box. Also, each pack contains a 5 ml syringe (graduated every 0.5 ml) and a measuring cup (graduated every 5 ml).

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer
Balkanpharma – Troyan AD
1 Krayrechna Str.
Troyan, 5600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy: Aripiprazolo Mylan Generics
Portugal: Aripiprazol Anova
United Kingdom: Aripiprazole Vale 1 mg/ml oral solution
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