Aripiprazole Mylan Generics

Patient Information Leaflet

Aripiprazole Mylan Generics 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazolo Mylan Generics contains the active substance aripiprazole and belongs to a group of
medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older
who have a disorder characterised by symptoms such as hearing, seeing or perceiving things that are
not present, suspiciousness, false beliefs, disorganised speech and behaviour, and emotional
flatness. People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazolo Mylan Generics is used to treat adults and adolescents aged 13 years and older who
have a condition characterised by symptoms such as feeling "over-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 Aripiprazolo Mylan Generics.

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

Do not take Aripiprazole 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 experiencing any self-harming thoughts or feelings.
Talk to your doctor or pharmacist before taking Aripiprazole Mylan Generics if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of 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 problems), family history of cardiovascular disease, stroke or transient ischemic attack (TIA), or blood pressure abnormalities
• conditions that may lead to low blood pressure, such as fluid loss, reduced blood volume, or use of medicines to lower blood pressure
• increased blood pressure
• blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation
• a past history of excessive gambling
• a condition known as “Attention Deficit Hyperactivity Disorder” (ADHD) (with symptoms such as difficulty focusing on tasks, difficulty following instructions, hyperactivity), and you are taking medicines to treat this condition. If you notice that you are gaining weight, developing unusual movements, feeling drowsy to the point that it interferes with your daily activities, having difficulty swallowing, or experiencing allergy symptoms, inform your doctor.

Inform your doctor if you experience tremors, slowed heart rate, muscle stiffness, and
balance disorders while taking this medicine. These are signs of a
condition known as parkinsonism.
If you are an elderly patient with Alzheimer's disease or 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 ischemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness accompanied by high fever, sweating, altered mental state, or very rapid or irregular heartbeat. Your
doctor may consider stopping treatment with aripiprazole.
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 could harm yourself or others. These
phenomena are called impulse control disorders and may include behaviours such as gambling addiction, binge eating, excessive spending, unusually high sex drive, or preoccupation with increased sexual thoughts or sensations. Your doctor may
consider adjusting your dose or discontinuing your treatment.
Children and adolescents
Aripiprazole Mylan Generics is not recommended for use in children and adolescents under
13 years of age, and for the treatment of schizophrenia in children under 15 years of age. Consult your doctor
or pharmacist before taking Aripiprazole Mylan Generics.
Other medicines and Aripiprazole Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Medicines that lower blood pressure: Aripiprazole Mylan Generics may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking a
medicine to control your blood pressure.
Taking Aripiprazole Mylan Generics with other medicines may require your doctor
to adjust the dosage of Aripiprazole Mylan Generics. It is important to inform your doctor, in
particular, if you are taking the following medicines:

• quinidine (a medicine used to correct heart rhythm)
• escitalopram, fluoxetine (antidepressants), cimetidine (used to treat stomach ulcers), or herbal remedies used to treat depression and anxiety
• ketoconazole, itraconazole (antifungal agents)
• medicines that may affect heart rhythm, as seen in laboratory tests (such as alfuzosin, amiodarone, chloroquine)
• medicines that may alter the levels of salts in the blood (such as hydrocortisone, prednisolone, furosemide)
• some medicines used 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 may increase the risk of side effects or reduce the effectiveness of Aripiprazole Mylan Generics. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Mylan Generics.

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:

• 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 may increase the risk of side effects; if you experience any unusual
symptoms while taking any of these medicines together with Aripiprazole Mylan Generics,
you should consult your doctor.
Aripiprazole Mylan Generics and alcohol
Alcohol should be avoided during treatment with Aripiprazole Mylan Generics.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
The following symptoms may occur in newborns of mothers who have used Aripiprazole Mylan
Generics during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing problems, and feeding difficulties. If the baby
shows any of these symptoms, you may need to contact your doctor.
Breastfeeding
If you are taking Aripiprazole Mylan Generics, 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 may occur during treatment with this medicine (see
section 4). This should be taken into account when full alertness is required, for example
when driving a vehicle or operating machinery.
This medicine contains sodium benzoate
This medicine contains 1 mg of sodium benzoate per ml.
Sodium benzoate may 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 solution, i.e.
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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 Aripiprazole Mylan Generics oral solution

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 10 ml or 15 ml of solution (corresponding to 10 mg or 15
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.
Elderly patients
If you are elderly, your doctor may start treatment with a lower dose than the recommended one.
Patients with liver problems
Inform your doctor if you have severe liver problems, as your doctor may need to adjust the dose of this medicine.
Use in children and adolescents
Aripiprazole Mylan Generics may be started at a low dose using the oral solution (liquid) form.
This should be administered using the 5 ml graduated oral syringe supplied with the pack. The dose may be gradually increased up to the recommended dose for adolescents of 10 ml once daily.
However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 ml once daily.
Measuring the dose
The dose of Aripiprazole Mylan Generics oral solution must be measured using the 30 ml measuring cup or the 5 ml graduated oral syringe provided in the package.

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

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

If air bubbles appear in the syringe, keep the bottle upside down and gently push the plunger forward, then pull it back again. Repeat until no more air bubbles remain in the syringe (Figure 4).

Slowly push the plunger down to the mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 5).
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Turn the bottle upright and remove the syringe (Figure 6).
After use, wash the syringe and measuring device with water and close the bottle with the plastic screw cap.
If you feel that the effect of Aripiprazole Mylan Generics is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Mylan Generics oral solution at the same time each 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 other foods before administration.
Even if you feel well, do not change or stop the daily dose of Aripiprazole Mylan Generics without first consulting your doctor.
If you take more Aripiprazole Mylan Generics than you should
If you realize you have taken more Aripiprazole Mylan Generics oral solution than prescribed (or if someone else has taken some of your Aripiprazole Mylan Generics oral solution), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the packaging with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

• feeling drowsy or sluggish
• increased blood pressure, rapid heartbeat
• nausea, vomiting, or diarrhoea

In children, overdose may cause:

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

Contact your doctor or hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole 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 dose.
If you have any further 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 will experience them.
Stop taking Aripiprazole Mylan Generics and contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data)

• changes in levels of certain blood cells, which may be observed in blood tests and may lead to more frequent infections than normal
• heart attack
• unusual or irregular heartbeat, which may be detected during clinical examinations
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, difficulty breathing or swallowing, itching, rash)
• ketoacidosis (ketones in blood and urine) or coma
• suicide, suicidal thoughts or attempted suicide
• seizures
• serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness)
• a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate
• formation of blood clots in 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 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 whites of the eyes
• muscle weakness, tenderness or pain, particularly if accompanied by feeling unwell or having a high temperature; this may be due to abnormal breakdown of muscle tissue, 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, jerky movements or twisting movements, restlessness in the legs
• feeling restless and unable to stay still, difficulty remaining seated
• headache
• feeling of light-headedness
• drowsiness
• tremors
• fatigue
• diabetes mellitus
• nausea, vomiting, indigestion, constipation, increased salivation
• difficulty sleeping, feeling anxious
• blurred vision

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

• some people may experience dizziness, especially when standing up from lying or sitting positions
• may experience rapid heartbeat or double vision
• some people may feel depressed
• altered or increased interest in sex
• increased levels of the hormone prolactin in the blood
• low blood pressure
• high blood sugar levels, which may be detected in blood tests
• a muscle disorder causing twisting movements (dystonia)
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)
• hiccups

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The following side effects have been reported since the start of marketing of Aripiprazole Mylan Generics, but their frequency is unknown (frequency cannot be estimated from the available data):

• unexplained sudden death
• slow heartbeat
• low sodium levels in the blood
• weight loss, weight gain, loss of appetite (anorexia)
• nervousness, agitation, aggression, speech disorders
• fainting, high blood pressure
• muscle spasms around the larynx, difficulty swallowing
• reduced platelet count leading to easier bleeding or bruising than normal
• abnormal liver function test results, abdominal and stomach discomfort, diarrhoea
• skin rash and light sensitivity, unusual hair loss or thinning, excessive sweating, stiffness or cramps, muscle pain
• involuntary loss of urine
• prolonged and/or painful erection
• difficulty regulating internal body temperature or conditions of excessive heat, chest pain, swelling of the hands, ankles or feet
• increased or fluctuating blood sugar levels and other changes detectable in blood tests
• inability to resist the impulse, urge or temptation to carry out an action that could be harmful to oneself or others, which may include:
• a 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, there have been reports of increased fatal cases during treatment with aripiprazole. In addition, cases of stroke or transient ischaemic attacks (TIAs) 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 those in adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contractions, uncontrolled limb movements and dizziness, especially when rising from a lying or sitting position, which have been 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 may also report side effects directly via 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 Aripiprazole Mylan Generics oral solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and outer carton 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 packaging to protect the medicine from light.
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 Aripiprazole Mylan Generics oral solution contains

• The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole. The other components 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 Aripiprazole Mylan Generics oral solution and contents of the
pack
Aripiprazole Mylan Generics 1 mg/ml oral solution is a clear, colourless liquid.
Aripiprazole Mylan Generics is supplied in amber glass or plastic bottles with a child-resistant closure. Each bottle contains 150 ml of Aripiprazole Mylan Generics and is packed in a cardboard box. Each pack also contains a 5 ml syringe (graduated every 0.5 ml) and a dosing cup (graduated every 5 ml).
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturer
Balkanpharma – Troyan AD
1 Krayrechna Str.
Troyan, 5600
Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Italy: Aripiprazolo Mylan Generics
Portugal: Aripiprazol Anova
United Kingdom: Aripiprazole Vale 1 mg/ml oral solution
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