Aberipra: detailed information

Patient Information Leaflet

Aberipra 5 mg tablets, 10 mg tablets, 15 mg tablets

Aripiprazole
Generic medicine
Please read all of this leaflet carefully before you start 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, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Aberipra is and what it is used for

Aberipra 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 condition characterised by symptoms such as hearing, seeing or perceiving things that are not present, suspiciousness, false beliefs, disorganised speech and behaviour, and blunting of emotions. People with this condition may also feel depressed, guilty, anxious or tense.
Aberipra is used to treat adults and adolescents from the age of 13 who are affected by a condition characterised by symptoms such as feeling "high", having excessive energy, needing less sleep than usual, talking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents this condition in adults who have responded to treatment with Aberipra.

2. What you should know before taking Aberipra

Do not take Aberipra

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

Warnings and precautions
Talk to your doctor before taking Aberipra.
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 before taking Aberipra if you suffer from:

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;
irregular, involuntary muscle movements, especially of the face;
cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disorders, stroke or transient ischaemic attack (TIA), abnormal blood pressure;
blood clots (blood clots in veins) or family history of blood clots, as antipsychotics have been associated with blood clot formation;
previous experience 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 your doctor if you have previously had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself. Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental status, or 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 called impulse control disorders and may include behaviours such as gambling addiction, excessive eating, excessive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and 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 Aberipra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: Aberipra 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 Aberipra with other medicines may require adjusting the dose of Aberipra or the other medicines.
It is important to inform your doctor especially if you are taking the following medicines:

Medicines that regulate 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 for the treatment of HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor such as indinavir, ritonavir);
Anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
Some antibiotics used to treat tuberculosis (e.g. rifabutin, rifampicin).

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

triptans, tramadol, and tryptophan used for 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 for major depression;
tricyclics (e.g. clomipramine and amitriptiline) 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 Aberipra.

Aberipra with food, drinks, and alcohol
Aberipra can be taken regardless of food intake.
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns whose mothers have used aripiprazole during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aberipra, 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
During treatment with this medicine, dizziness and visual disturbances may occur (see section 4). This should be taken into account in situations requiring full alertness, for example when driving a vehicle or operating machinery.

Aberipra contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Aberipra contains sodium
Aberipra contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Aberipra

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 with aripiprazole may be initiated at a lower dose using other commercially available
aripiprazole products in the oral solution (liquid) formulation. The dose may then 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 Aberipra is too strong or too weak, consult your doctor or pharmacist.
Try to take your Aberipra tablet at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water, swallowing it whole.
Even if you feel better, do not change or stop your daily dose of Aberipra without first consulting your doctor.
If you take more Aberipra than you should
If you realize you have taken more Aberipra tablets than prescribed (or if someone else has taken some of your 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 an overdose of 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 sedation, slowed 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 Aberipra
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aberipra
Do not stop treatment just because you feel better. It is important that you continue taking your Aberipra tablets for as long as your doctor has prescribed.
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 everybody gets them.

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

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to stay still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
uncontrollable muscle contractions, jerky movements or twisting movements,
tremors,
headache,
tiredness,
drowsiness,
feeling of light-headedness,
agitation and blurred vision,
reduced number of bowel movements or difficulty passing stools,
indigestion,
nausea,
increased saliva production,
vomiting,
feeling of fatigue.

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,
change or increase in sexual interest,
uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restlessness in the legs,
double vision,
sensitivity of the eyes to light,
rapid heartbeat,
drop in blood pressure when standing up, causing dizziness, light-headedness or fainting,
hiccups.

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

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 attempt and suicide,
excessive gambling,
feeling of aggressiveness,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, 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,
eyes fixed in one position,
unexplained sudden death,
potentially fatal 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 advice),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
muscle spasms 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 test results,
skin rash,
skin sensitivity to light,
unusual hair loss (baldness),
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 which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and an increase in a type of white blood cell (eosinophilia),
abnormal breakdown of muscle tissue which may cause kidney problems,
muscle pain,
stiffness,
involuntary loss of urine (incontinence),
difficulty urinating,
stiffness, muscle pain,
withdrawal symptoms in newborns if exposed 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: fluctuation in blood sugar levels, increased glycated haemoglobin,
inability to resist the impulse, urge or temptation to carry out 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 behaviour causing significant concern to you or others, for example increased sex drive, compulsive shopping or spending, 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 off. 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, more deaths have been reported during treatment with aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents

Adolescents from the age of 13 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, uncontrollable 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 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 Aberipra

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 outer packaging after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 Aberipra Contains
5 mg Tablets

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other ingredients are sodium starch glycolate, microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, magnesium stearate.

10 mg Tablets

The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
The other ingredients are sodium starch glycolate, microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, magnesium stearate, red iron oxide (E 172).

15 mg Tablets

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are sodium starch glycolate, microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, magnesium stearate, yellow iron oxide (E 172).

Description of the Appearance of Aberipra and Pack Contents
Aberipra 5 mg tablets are white and round, with "ARZ" engraved on one side and "5" on the other. They are available in unit-dose divisible blisters, packaged in boxes containing 28 tablets.
Aberipra 10 mg tablets are pink and oblong (with possible black specks), with "ARZ" and "10" engraved on one side. They are available in unit-dose divisible blisters, packaged in boxes containing 28 tablets.
Aberipra 15 mg tablets are yellow and round (with possible black specks), with "ARZ" and "15" engraved on one side. They are available in unit-dose divisible blisters, packaged in boxes containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Ecupharma S.r.l., Via Mazzini 20, 20123 Milano, Italy

Manufacturers
Synthon Hispania S.L., C/Castelló, 1, Polígono Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain
Synthon s.r.o., Brnĕnská 32 /čp. 597, 678 01 Blansko, Czech Republic