Patient Information Leaflet

Aripiprazole Teva 5 mg tablets, 10 mg tablets, 15 mg tablets

Generic medicine
Please 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Aripiprazole Teva 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, incoherent speech and behaviour, and flattening of emotions.
People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Teva is used to treat adults and adolescents aged 13 years and older who have a condition characterised by symptoms such as feeling "high", having excessive energy, needing less sleep than usual, speaking very rapidly and having racing thoughts, and sometimes severe irritability. In addition, Aripiprazole Teva prevents the recurrence of this condition in adults who previously responded to treatment.

2. What you should know before taking Aripiprazole Teva

Do not take Aripiprazole Teva

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.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your
doctor immediately if you experience any self-harming thoughts or feelings.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever,
sweating, altered mental status, or rapid or irregular heartbeat.
Before starting treatment with Aripiprazole Teva, inform your doctor if you have

high blood sugar levels (characterized by symptoms such as excessive thirst, passing 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 disorders (heart and circulatory diseases), family history of cardiovascular disorders, 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 weight gain, 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 your doctor if you have previously had a stroke or a "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, 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 pathological gambling, binge eating, excessive spending, abnormally high sex drive, or preoccupation due to increased sexual thoughts or feelings.
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
This medicine must not be used 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
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 may increase 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 Teva together with certain medicines may require your doctor to adjust your dose of Aripiprazole Teva or of the other medicines. It is especially important to inform your doctor if you are taking any of 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);
certain 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);
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Teva. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Teva.
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:

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 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 increase the risk of side effects; if you experience any unusual symptoms while taking any of these medicines with Aripiprazole Teva, you should consult your doctor.
Aripiprazole Teva with food and alcohol
This medicine can be taken regardless of meals. You should avoid alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns whose mothers have used Aripiprazole Teva 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, 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 in situations requiring full alertness, such as driving a vehicle or operating machinery.
Aripiprazole Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Aripiprazole Teva

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 is too strong or too weak, consult your
doctor or pharmacist.
Aripiprazole Teva is for oral use.
Try to take the tablet at the same time each day. It does not matter whether you take it
with or without food.
for 5 mg tablets only
Always take the tablet with water and swallow it whole.
for 10/15 mg tablets only
Always take the tablet with water. The tablet may be divided into equal parts.
Even if you feel better, do not change or stop the daily dose of Aripiprazole Teva without
first consulting your doctor.
If you take more Aripiprazole Teva than you should
If you realize you have taken more tablets than prescribed by your doctor (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 packaging with you.
Patients who have taken an overdose of aripiprazole have experienced the following symptoms:

rapid heartbeat, agitation/aggression, speech problems;
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 sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole Teva
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
tablets for as long as your doctor has recommended.
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,
sleep disorders,
feeling of anxiety,
feeling restless and unable to remain still, difficulty sitting still,
akathisia (an unpleasant sensation of inner restlessness and an irresistible urge to keep moving),
uncontrollable contractions, spasms or twisting movements,
tremor,
headache,
fatigue,
drowsiness,
feeling of lightheadedness,
nervousness and blurred vision,
reduced number of bowel movements or difficulty with bowel movements,
indigestion,
feeling unwell,
increased salivation compared to normal,
vomiting,
feeling of tiredness.

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

increased or decreased 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),
muscle disorders causing twisting movements (dystonia),
restlessness in the legs,
double vision,
sensitivity of the eyes to light,
rapid heartbeat,
drop in blood pressure upon sudden change from lying or sitting to standing position, causing dizziness, lightheadedness or fainting,
hiccups.

The following adverse reactions have been reported after marketing of oral aripiprazole, but their frequency is not known (frequency cannot be estimated from the available data)

low levels of white blood cells in the blood,
low levels of platelets in the blood,
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 levels of sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
suicidal thoughts, suicide attempts and suicide,
feeling aggressive,
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 happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
speech disorder,
eyes fixed in one position,
unexplained sudden death,
life-threatening 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 difficulty breathing (if you experience any of these symptoms, seek immediate medical help),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasm 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,
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 rash on the face that spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests and increase in a type of white blood cells (eosinophilia),
abnormal muscle breakdown that may lead to kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
withdrawal syndrome in newborns if exposed to the drug 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 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.

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, 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 from 13 years of age onwards have experienced side effects similar in frequency and type 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, uncontrolled limb movements, 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

Keep this medicine out of the sight and reach of children.
Blister
Do not use this medicine after the expiry date stated on the blister and on the packaging.
The expiry date refers to the last day of the month.
HDPE bottle (5/10/15 mg)
Do not use this medicine after the expiry date stated on the label and on the packaging.
The expiry date refers to the last day of the month.
Blister + HDPE bottle (5/10/15 mg)
This medicine does not require any special storage conditions.
HDPE bottle (5/10/15 mg)
Validity after first opening: 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Teva contains

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole. Each tablet contains 10 mg of aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are monohydrate lactose, microcrystalline cellulose, maize starch, yellow iron oxide (E172) ( only in the 5 mg and 15 mg tablets ), red iron oxide (E172) ( only in the 10 mg tablets ), hydroxypropylcellulose, sodium croscarmellose, magnesium stearate.

Description of the appearance of Aripiprazolo Teva and contents of the pack
5 mg
Light yellow, round, flat tablets with bevelled edges, marked with "5" on one side and smooth on the other.
10 mg
Oblong, pink to light pink tablets, marked with "10" on one side and a score line on the other.
The tablet can be divided into equal doses.
15 mg
Light yellow, round, flat tablets with bevelled edges, marked with "15" on one side and a score line on the other.
The tablet can be divided into equal doses.
5 mg
Aripiprazolo Teva is available in packs of 7, 7 x 1, 14, 14 x 1, 15, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1, and 100 tablets.
10 mg
Aripiprazolo Teva is available in packs of 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1, and 100 tablets.
15 mg
Aripiprazolo Teva is available in packs of 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy
Manufacturer
Merckle GmbH Ludwig-Merckle-Straße 3, Blaubeuren 89143 - Germany
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
Actavis Ltd. BLB 015-016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta
PharmaPath S.A., 28is Oktovriou 1, Agia Varvara, 123 51, Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
DE/H/5039/001
Belgium: Aripiprazole Teva 5 mg tabletten/comprimés/Tabletten
Croatia: Aripiprazol Pliva 5 mg tablete
Denmark: Aripiprazole Teva
Germany: Aripiprazol AbZ 5 mg Tabletten
Ireland: Aripiprazole Teva 5mg Tablets
Italy: Aripiprazolo Teva
Spain: Aripiprazol Teva-ratiopharm 5 mg comprimidos EFG
Sweden: Aripiprazole Teva

DE/H/5039/002
Belgium: Aripiprazole Teva 10 mg tabletten/comprimés/Tabletten
Croatia: Aripiprazol Pliva 10 mg tablete
Czech Republic: Aripiprazole Teva 10 mg
Denmark: Aripiprazole Teva
Germany: Aripiprazol AbZ 10 mg Tabletten
Ireland: Aripiprazole Teva 10mg Tablets
Italy: Aripiprazolo Teva
Netherlands: Aripiprazol Teva 10 mg, tabletten
Portugal: Aripiprazol Teva
Romania: ARIPIPRAZOL TEVA 10 mg comprimate
Slovenia: Aripiprazol Teva 10 mg tablete
Spain: Aripiprazol Teva-ratiopharm 10 mg comprimidos EFG
Sweden: Aripiprazole Teva

DE/H/5039/003
Belgium: Aripiprazole Teva 15 mg tabletten/comprimés/Tabletten
Bulgaria: Aripiprazole TEVA 15mg tablet
Croatia: Aripiprazol Pliva 15 mg tablete
Czech Republic: Aripiprazole Teva 15 mg
Denmark: Aripiprazole Teva
Estonia: Aripiprazole Teva
Germany: Aripiprazol AbZ 15 mg Tabletten
Hungary: Aripiprazol-Teva 15 mg tabletta
Ireland: Aripiprazole Teva 15mg Tablets
Italy: Aripiprazolo Teva
Latvia: Aripiprazole Teva 15 mg tabletes
Lithuania: Aripiprazole Teva 15 mg tabletės
Netherlands: Aripiprazol Teva 15 mg, tabletten
Portugal: Aripiprazol Teva
Romania: ARIPIPRAZOL TEVA 15 mg comprimate
Slovenia: Aripiprazol Teva 15 mg tablete
Spain: Aripiprazol Teva-ratiopharm 15 mg comprimidos EFG
Sweden: Aripiprazole Teva