Aripiprazole Teva Italia: detailed information

Package leaflet: Information for the user

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

Equivalent medicine
Please read this leaflet carefully before using 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 Teva Italia is and what it is used for
What you need to know before taking Aripiprazole Teva Italia
How to take Aripiprazole Teva Italia
Possible side effects
How to store Aripiprazole Teva Italia
Contents of the pack and other information

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

Aripiprazole Teva 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 years 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.
Aripiprazole Teva Italia is used to treat adults and adolescents from the age of 13 years who are
affected by a condition characterized by symptoms such as feeling "high", having excessive energy,
needing less sleep than usual, talking very quickly, having racing thoughts, and sometimes severe
irritability. In addition, Aripiprazole Teva Italia prevents the recurrence of this condition in adults who
have previously responded to treatment.

2. What you need to know before taking Aripiprazole Teva Italia

Do not take Aripiprazole Teva 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 Teva 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.
Inform your doctor immediately if you experience numbness or muscle stiffness accompanied by high
fever, sweating, altered mental state, or rapid or irregular heartbeat.
Before starting treatment with Aripiprazole Teva 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 need to monitor you more closely
involuntary and irregular muscle movements, especially of the face
cardiovascular diseases (heart and circulation problems), family history of cardiovascular diseases, stroke or transient ischaemic attack, or abnormal blood pressure
blood clots in the veins, or a family history of blood clots, as antipsychotics have been associated with blood clot formation
a history of excessive gambling.

If you notice that you are gaining weight, develop unusual movements, feel drowsiness that interferes
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 should inform the doctor if you have previously had a stroke or transient ischaemic attack.
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, urge, 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, excessive eating or spending, abnormally increased sexual desire, or preoccupation due to
an increase in sexual thoughts or sensations.
Your doctor may need to adjust your dose or discontinue treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in
ability to move and maintain 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 Aripiprazole Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Medicines that lower blood pressure: Aripiprazole Teva Italia may enhance the effect of medicines
used to lower blood pressure. Inform your doctor if you are taking a medicine to control blood
pressure.
Taking Aripiprazole Teva Italia together with certain medicines may require your doctor to adjust the
dose of Aripiprazole Teva Italia or of the other medicines. It is particularly important to inform your
doctor if you are taking 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 agents (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, primidone)
some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of adverse effects or reduce the effectiveness of Aripiprazole
Teva Italia. Consult your doctor if you experience any unusual symptoms while taking any of these
medicines together with Aripiprazole Teva Italia.
Medicines that increase serotonin levels are typically used in conditions such as depression, generalised
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; if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Teva Italia, you should consult your doctor.

Aripiprazole Teva Italia with food and alcohol
This medicine can be taken regardless of food. Alcohol consumption should be avoided.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazole Teva Italia during
the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness,
drowsiness, agitation, breathing problems, and feeding difficulties. If your baby shows any of these
symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Teva Italia, your doctor will discuss with you the possibility of
breastfeeding, taking into account the benefit you receive from the treatment and the benefit of
breastfeeding for your baby. 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.
Aripiprazole Teva Italia contains aspartame (E951)
10 mg
This medicine contains 3 mg of aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare
genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
15 mg
This medicine contains 4.5 mg of aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare
genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.

3. How to take Aripiprazole Teva 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
Treatment may be started at a lower dose, for example using an oral solution.
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 Teva Italia is too strong or too weak, consult your doctor or pharmacist.
Aripiprazole Teva Italia is for oral use.
Try to take the orodispersible tablet at the same time each day. It does not matter whether you take it with or without food.
Once the orodispersible tablet has been removed from the blister pack with dry hands, it should be placed 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 swallowed.
Even if you feel better, do not change or stop the daily dose of Aripiprazole Teva Italia without first consulting your doctor.
If you take more Aripiprazole Teva Italia than you should
If you realize that you have taken more tablets than your doctor prescribed (or if someone else has taken some of your tablets), contact your doctor immediately. If you cannot contact your doctor, go to the nearest hospital and take the pack with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:
o rapid heartbeat, agitation/aggression, speech difficulties;
o unusual movements (especially of the face or tongue), and reduced level of consciousness.
Other symptoms may include:
o acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, and drowsiness or sleepiness, slow 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 Teva Italia
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 Teva
Do not stop treatment just because you feel better. It is important that you continue taking the orodispersible tablets for as long as your doctor has instructed.
If you have any questions about how to use 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 falling asleep,
feeling of anxiety,
feeling restless and unable to stay still, difficulty remaining still,
uncontrollable contractions, spasms or sudden or twisted movements, restless legs,
tremor,
headache,
fatigue,
drowsiness,
mild dizziness,
blurred or flickering vision,
reduced number of bowel movements or difficulty with bowel movements,
indigestion,
malaise,
increased saliva production,
vomiting,
feeling of tiredness.

Uncommon side effects (may affect up to 1 in 100 people)

increased blood levels of the hormone prolactin,
high blood sugar levels,
depression,
altered or increased sexual interest,
uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
muscular disorder causing twisting movements (dystonia),
double vision,
rapid heartbeat,
drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting,
hiccups.

The following adverse reactions have been reported during post-marketing experience with oral aripiprazole, but the frequency is unknown (frequency cannot be estimated from the available data):

reduced levels of white blood cells,
low platelet levels,
allergic reactions (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,
low sodium levels in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
suicidal thoughts, suicide attempts and suicide,
aggression,
agitation,
nervousness,
neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting),
seizures,
serotonin syndrome (a reaction that may cause extreme feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorders,
eyes fixed in one position,
unexplained sudden death,
life-threatening irregular heartbeat,
heart attack,
slower 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 help),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
spasm of muscles 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,
abnormal liver function test results,
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 syndrome in newborns following exposure to the medicine 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 glucose levels, increased glycosylated 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,
- excessive and uncontrollable shopping,
- uncontrolled 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 hunger),
- tendency to wander away.

If you experience any of these behaviours, inform your doctor; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, numerous fatal cases have been reported during treatment with aripiprazole. In addition, cases of stroke or transient ischaemic attack 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 that drowsiness, uncontrollable muscle contractions or sudden movements, restlessness and fatigue have been very common (may affect more than 1 in 10 people), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable movements of limbs, and dizziness especially when rising from a lying or sitting position have been common (may affect up to 1 in 10 people).

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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 Teva Italia contains

The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
The other ingredients are microcrystalline cellulose, silicified microcrystalline cellulose, anhydrous colloidal silica, yellow iron oxide (E172) ( only in the 15 mg tablets ), red iron oxide (E172) ( only in the 10 mg tablets ), caramellose, crospovidone type B, xylitol (E967), aspartame (E951), potassium acesulfame (E950), tartaric acid, pineapple flavour (containing natural identical flavours, natural flavours, maltodextrins and triacetin), magnesium stearate.

Description of the appearance of Aripiprazolo Teva Italia and contents of the pack
10 mg
Round, pink to light pink, flat tablets with bevelled edges, marked "10" on one side and smooth on the other.
15 mg
Round, light yellow, flat tablets with bevelled edges, marked "15" on one side and smooth on the other.
Aripiprazolo Teva Italia is available in packs of 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 98 and 98 x 1 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. Piazzale Luigi Cadorna, 4 20123 – Milan, Italy
Manufacturers
Merckle GmbH Ludwig-Merckle-Straße 3, Blaubeuren 89143 - Germany
Teva Pharma B.V. Swensweg 5, Haarlem 2031 GA – The Netherlands
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.) Prilaz baruna Filipovica 25, Zagreb 10000 - Croatia
Teva Operations Poland Sp. z.o.o ul. Mogilska 80., Krakow 31-546 - Poland
TEVA Gyógyszergyár Zrt., Pallagi út 13, H-4042 Debrecen - Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
DE/H/5041/002
Belgium: Aripiprazole Instant Teva 10 mg orodispergeerbare tabletten/comprimés orodispersibles/Schmelztabletten
France: Aripiprazole Teva 10 mg comprimé orodispersible
Germany: Aripiprazol AbZ 10 mg Schmelztabletten
Italy: Aripiprazolo Teva Italia
Slovakia: Aripiprazol Teva 10mg orodispergovateľné tablety
United Kingdom: Aripiprazole 10mg Teva Orodispersible Tablets

DE/H/5041/003/DC
Belgium: Aripiprazole Instant Teva 15 mg orodispergeerbare tabletten/comprimés orodispersibles/Schmelztabletten
France: Aripiprazole Teva 15 mg comprimé orodispersible
Germany: Aripiprazol AbZ 15 mg Schmelztabletten
Italy: Aripiprazolo Teva Italia
Slovakia: Aripiprazol Teva 15mg orodispergovateľné tablety
United Kingdom: Aripiprazole 15mg Teva Orodispersible Tablets