Aripiprazole Mylan Italia: detailed information

Package leaflet: information for the patient

Aripiprazole Mylan Italia 10 mg orodispersible tablets, 15 mg orodispersible tablets

aripiprazole
equivalent 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Aripiprazolo Mylan Italia 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 blunted emotions. People with this condition may also feel depressed, guilty, anxious, or tense.
Aripiprazolo Mylan Italia is also 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 the recurrence of this condition in adults who have responded to treatment with Aripiprazolo Mylan Italia.

2. What you should know before taking Aripiprazole Mylan Italia

Do not take Aripiprazole Mylan 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 Mylan Italia.
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 Aripiprazole Mylan Italia, 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 tired) 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, or blood pressure abnormalities;
a history of blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
a previous history of excessive gambling.

If you notice that you are gaining weight, developing unusual movements, feeling drowsy to the point that it
interferes with your normal daily activities, having difficulty swallowing, or experiencing 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 a "mini" stroke.
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviour have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness accompanied by high
fever, sweating, altered mental status, or a 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 could harm yourself or others. These phenomena are known as impulse
control disorders and may include behaviours such as gambling addiction, binge eating, compulsive
spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or
sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your 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 Mylan Italia
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 Mylan Italia 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 Aripiprazole Mylan Italia together with certain medicines may require your doctor to adjust the dose
of Aripiprazole Mylan Italia or of the other medicines. It is especially important to inform your doctor about
the following medicines:

medicines used 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, and a protease inhibitor such as indinavir, ritonavir);
anticonvulsants used to treat epilepsy (e.g., carbamazepine, phenytoin, phenobarbital);
some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of adverse effects or reduce the effect of Aripiprazole Mylan Italia;
consult your doctor if you experience any unusual symptoms while taking any of these medicines together
with Aripiprazole Mylan Italia.
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:

trazodone, tramadol, and tryptophan 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) used for depression, OCD, panic, and anxiety;
other antidepressants (e.g., venlafaxine and tryptophan) used in 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 adverse effects; consult your doctor if you experience any unusual
symptoms while taking any of these medicines together with Aripiprazole Mylan Italia.

Aripiprazole Mylan Italia with food, drinks and alcohol
Aripiprazole Mylan Italia can be taken regardless of food intake.
When taking Aripiprazole Mylan Italia, you should avoid consuming alcohol.

Pregnancy, breast-feeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breast-feeding,
please consult your doctor before taking this medicine.
Pregnancy
The following symptoms may occur in newborns of mothers who have used Aripiprazole Mylan Italia 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.
Breast-feeding
If you are taking Aripiprazole Mylan Italia, your doctor will discuss with you whether you should breast-feed,
considering the benefit you receive from the treatment and the benefit to the baby from breast-feeding. 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.

Aripiprazole Mylan Italia contains aspartame
Aripiprazole Mylan Italia 10 mg contains 2 mg of aspartame per orodispersible tablet.
Aripiprazole Mylan Italia 15 mg contains 3 mg of aspartame per orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic
disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

Aripiprazole Mylan Italia contains sucrose
If your doctor has told you that you are intolerant to certain sugars, contact him before taking this medicine.
May be harmful to teeth.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Aripiprazole Mylan Italia

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 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
Aripiprazole Mylan Italia may be started at a lower dose using the oral solution (liquid). The dose may be gradually increased up to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of Aripiprazole Mylan Italia is too strong or too weak, consult your doctor or pharmacist.
Try to take the Aripiprazole Mylan Italia orodispersible tablet at the same time each day. It does not matter whether you take it with food or not.
Do not open the blister pack until you are ready to take the dose. To take a single tablet, open the packaging and peel back the aluminum foil from the blister to reveal the tablet. Do not push the tablet through the foil, as this may damage it. Immediately after opening the blister, with dry hands, remove the orodispersible tablet and place it whole on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid.
Alternatively, the tablet may be dispersed in water and the resulting suspension drunk.
Even if you feel well, do not change or stop the daily dose of Aripiprazole Mylan Italia without first consulting your doctor.
If you take more Aripiprazole Mylan Italia than you should
If you realize you have taken more Aripiprazole Mylan Italia orodispersible tablets than your doctor has recommended (or if someone else has taken some of your Aripiprazole Mylan Italia orodispersible tablets), 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:

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 lethargy, slowed breathing, feeling 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 Mylan Italia
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 Mylan Italia
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Mylan Italia for the full duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to sit still, difficulty remaining seated,
uncontrollable muscle contractions, jerky movements or twisting motions, restlessness in the legs,
tremors,
headache,
tiredness,
drowsiness,
feeling lightheaded,
agitation and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
feeling unwell,
increased saliva production,
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),
a muscular disorder causing twisting movements (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 oral aripiprazole marketing, 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 attempts and suicide,
feeling aggressive,
agitation,
nervousness,
a combination of fever, muscle rigidity, 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,
unexplained sudden death,
potentially fatal irregular heartbeat,
heart attack,
slowed heartbeat,
blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (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 muscles 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 tests,
skin rash,
sensitivity to light,
hair loss,
excessive sweating,
abnormal breakdown of muscles 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 regulating 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 carry out an action that could 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 behaviour causing significant concern to you or others, for example increased sexual drive,
- uncontrolled excessive 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 "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 tiredness, 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 contraction, 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, pharmacist or nurse. You can 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.

5. How to store Aripiprazole Mylan Italia

This medicine does not require any special storage conditions.
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 blister and on the carton after "Exp.".
The expiry date refers to the last day of that month.
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 Mylan Italia contains

The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
The other components are microcrystalline cellulose, aspartame (E951), xylitol, acesulfame potassium, pregelatinized starch, sodium croscarmellose, crospovidone, tartaric acid, anhydrous colloidal silica, vanilla flavour (containing vanillin and sucrose), magnesium stearate and red iron oxide (E172).
The active substance is aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
The other components are microcrystalline cellulose, aspartame (E951), xylitol, acesulfame potassium, pregelatinized starch, sodium croscarmellose, crospovidone, tartaric acid, anhydrous colloidal silica, vanilla flavour (containing vanillin and sucrose), magnesium stearate and yellow iron oxide (E172).

Description of the appearance of Aripiprazolo Mylan Italia and the contents of the pack
Aripiprazolo Mylan Italia 10 mg orodispersible tablets are flat, round, light pink tablets (approximately 7 mm in diameter).
Aripiprazolo Mylan Italia 15 mg orodispersible tablets are flat, round, light yellow tablets (approximately 8 mm in diameter).
Aripiprazolo Mylan Italia is available in packs of 28 tablets.

Marketing Authorization Holder
MYLAN S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710-089 Sintra, Portugal
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Aripiprazol generics
Italy: Aripiprazolo Mylan Italia