ABERIPRA 5 mg Tabletka

Treść ulotki

1. Aberipra 5 mg tablets, 10 mg tablets, 15 mg tablets
   1. What is Aberipra and what is it used for
   2. What you need to know before taking Aberipra
   3. How to take Aberipra
   4. Possible side effects
   5. How to store Aberipra
   6. Contents of the pack and other information

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

Aripiprazole
Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Aberipra and what is it used for

Aberipra contains the active substance aripiprazole and belongs to a group of medicines called
antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who are affected by
an illness characterized by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, incoherent speech and behavior, and emotional blunting. People who present this
condition may also feel depressed, guilty, anxious or tense.
Aberipra is used for the treatment of adults and adolescents starting from 13 years of age who are affected by a
condition characterized by symptoms such as feeling “revved up”, having excessive energy, not needing to
sleep compared to usual, talking very quickly 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 need to know before taking Aberipra

Do not take Aberipra

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

Warnings and precautions
Talk to your doctor before taking Aberipra.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Tell your
doctor immediately if you are having any thoughts or feelings of self-harm.
Talk to your doctor before taking Aberipra if you suffer from:

• high blood sugar levels(characterised by symptoms such as excessive thirst, producing 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 circulation diseases) , a family history of cardiovascular disorders,stroke or transient ischaemic attack, abnormal blood pressure;
• blood clots (blood clots in the veins) or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which
interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, tell
your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your
carer must inform the doctor if you have had a stroke or transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself. Thoughts and behaviours of self-harm have been reported during treatment with
aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family or your carer 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 may harm yourself or others. These phenomena are
called impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, an unusually high sexual drive or preoccupation
with sexual thoughts or feelings.
Your doctor may need to adjust your dose or stop your treatment.
Aripiprazole can cause drowsiness, low blood pressure when getting up, dizziness and changes in your ability to move and maintain balance, which can lead to falls. Be
careful, especially if you are elderly or in any way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 13 years.
It has not been shown to be safe and effective in these patients.

Other medicines and Aberipra
Tell 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 can increase the effect of medicines used to
lower blood pressure. Tell your doctor if you are taking a medicine to control your blood
pressure.
Taking Aberipra with other medicines may require a change in the dosage of Aberipra or the other
medicines.
It is important to tell your doctor in particular if you are taking the following medicines:

• Medicines that correct the 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 can increase the risk of side 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 in 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 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 for the treatment of migraine.

These medicines can increase the risk of side 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 independently of food.
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used aripiprazole in the last
trimester (last three months of pregnancy): tremor, rigidity and/or muscle weakness, drowsiness, agitation,
breathing problems, and difficulty feeding. If the baby presents 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 therapy and the benefit for the baby from breastfeeding. One 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 vision disturbances may occur during treatment with this medicine (see
section 4). This should be taken into account in situations where full alertness is required, for example when
driving a vehicle or using machinery. Do not drive or use tools or machines until you
know how Aberipra affects you.

Aberipra contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe a
lower or higher dose up to a maximum of 30 mg once a day.

Use in children and adolescents
Treatment with aripiprazole may be started with a lower dose using other commercially available aripiprazole
products in the oral solution (liquid) formulation. The dose may be gradually increased to the recommended
dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose up
to a maximum of 30 mg once a day.
If you feel that the effect of Aberipra is too strong or too weak, talk to your doctor or pharmacist.

Try to take the Aberipra tablet every day at the same time. It does not matter if you take it with or
without food. Always take the tablet with water, swallowing it whole.

Even if you feel well, do not change or stop the daily dose of Aberipra without first consulting your
doctor.

If you take more Aberipra than you should
If you should realize that you have taken more Aberipra tablets than recommended by your
doctor (or if someone else has taken some of your Aberipra tablets), contact your doctor
immediately. If you cannot reach your doctor, go to the nearest hospital and take the
package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms: rapid
heartbeat, agitation/aggression, speech problems; unusual movements (especially of the face or tongue) and
decreased level of consciousness. Other symptoms may include: acute confused state, seizures
(epilepsy), coma, a combination of fever, rapid breathing, sweating; muscle rigidity and
drowsiness or sleepiness, slowed breathing, feeling of suffocation, high or low blood pressure,
changes in heart rhythm.
Contact your doctor or hospital immediately if you have 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 to take your
Aberipra tablets for the entire time prescribed by your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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 move continuously),
• uncontrollable muscle contractions, jerking or twisting movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling lightheaded,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty evacuating,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

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,
• alteration or increase in sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heartbeat,
• lowering of blood pressure when getting up, which causes dizziness, lightheadedness or fainting,
• hiccups.

Side effects that follow have been reported since the marketing of oral aripiprazole
began, but the frequency with which they occurred is not known (frequency cannot be defined on the
basis of 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 the blood and urine) or coma,
• high blood sugar levels,
• low sodium level in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, attempted suicide and suicide,
• excessive gambling,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• speech disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through blood vessels to the lungs causing chest pain and difficulty breathing (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 the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values,
• 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 manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• rigidity, muscle pain,
• withdrawal symptoms in newborns in case of exposure 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 of blood sugar levels, increased glycosylated hemoglobin,
• inability to resist the urge, drive or temptation to perform 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 behavior that causes significant concern to you or others, for example increased sexual drive, excessive shopping or spending, and uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating,
• tendency to withdraw. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the intake of aripiprazole.
In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in frequency and type to those
of adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness
and fatigue which were very common (more than 1 in 10) and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased
appetite, muscle contraction, uncontrolled limb movements and feeling dizzy, especially
when getting up from a lying or sitting position, which were common (more than 1 in 100).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the package after “Exp”. The
expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aberipra contains

5 mg tablets

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

10 mg tablets

• The active ingredient is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, red iron oxide (E 172). 15 mg tablets
• The active ingredient is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, yellow iron oxide (E 172).

Description of the appearance of Aberipra and contents of the pack
Aberipra 5 mg tablets are white and round, with “ARZ” imprinted on one side and “5” on the other side.
They are available in divisible blister packs for single doses packaged in cartons containing 28 tablets.
Aberipra 10 mg tablets are pink and oblong (with possible black spots), with “ARZ” and “10”
imprinted on one side. They are available in divisible blister packs for single doses packaged in cartons containing 28
tablets.
Aberipra 15 mg tablets are yellow and round (with possible black spots), with “ARZ” and “15”
imprinted on one side. They are available in divisible blister packs for single doses packaged in cartons containing 28
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l, Via Mazzini 20, 20123 Milan, 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