Aripiprazole +pharma

Package leaflet: Information for the patient

Aripiprazole +pharma, 15 mg, tablets
Aripiprazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Aripiprazole +pharma is and what it is used for
2. Important information before taking Aripiprazole +pharma
3. How to take Aripiprazole +pharma
4. Possible side effects
5. How to store Aripiprazole +pharma
6. Contents of the pack and other information

1. What Aripiprazole +pharma is and what it is used for

Aripiprazole +pharma 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 characterized by symptoms such as seeing, hearing, or sensing things that are not real, suspiciousness, beliefs that are not based in reality, disorganized speech and behavior, and emotional blunting.
Patients with these symptoms may also feel sadness, anxiety, tension, or guilt.

Aripiprazole +pharma is also used to treat adults and adolescents aged 13 years and older whose illness is characterized by symptoms such as extreme excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent recurrence of these symptoms in patients who have responded to treatment with Aripiprazole +pharma.

2. Important information before using Aripiprazole +pharma

When not to use Aripiprazole +pharma

• if the patient is allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Aripiprazole +pharma, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before starting treatment with Aripiprazole +pharma, inform your doctor if the patient has:

• high blood sugar levels (characteristic symptoms include: excessive thirst, passing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes
• seizures (epilepsy), as this may mean your doctor will want to monitor you closely
• involuntary, irregular muscle movements, especially of the facial muscles
• cardiovascular diseases (heart and circulatory system disorders), family history of cardiovascular disease, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure
• blood clots or a family history of blood clots, as antipsychotic medicines have been associated with blood clot formation
• a history of gambling addiction

If the patient notices weight gain, development of unusual movements, drowsiness affecting daily activities, any swallowing difficulties or signs of allergy, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, caregiver or relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Immediately inform your doctor about any thoughts or feelings of self-harm. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient develops muscle stiffness or stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel an urge or craving to behave in an unusual way and cannot resist the impulse, drive or temptation to carry out activities that could harm themselves or others, they should tell the doctor.
These phenomena are known as impulse control disorders and may manifest as behaviours such as: compulsive gambling, binge eating or excessive spending, abnormally high sex drive or increased frequency and intensity of sexual thoughts or feelings. The doctor may consider adjusting or discontinuing the dose.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether the use of this medicine is safe and effective in these patients.

Aripiprazole +pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.

Medicines that lower blood pressure: Aripiprazole +pharma may enhance the effect of blood pressure-lowering medicines. If the patient is taking medicines for lowering blood pressure, they should inform their doctor.

Taking Aripiprazole +pharma with other medicines may require dose adjustments of Aripiprazole +pharma or other medicines the patient is taking. It is especially important to inform your doctor about the use of the following medicines:

• medicines used to treat heart rhythm disorders (such as: quinidine, amiodarone, flecainide)
• antidepressants or herbal medicines used to treat depression and anxiety (such as: fluoxetine, paroxetine, venlafaxine, St. John's wort)
• antifungal medicines (such as: ketoconazole, itraconazole)
• certain medicines used to treat HIV infection (such as: efavirenz, nevirapine, protease inhibitors, e.g. indinavir, ritonavir)
• antiepileptic medicines used to treat epilepsy (such as: carbamazepine, phenytoin, phenobarbital)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Aripiprazole +pharma. If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole +pharma, they should inform their doctor.

Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used to treat conditions involving depression, generalized anxiety disorder, OCD, social phobia, migraine and pain
• selective serotonin reuptake inhibitors (SSRIs) (such as: paroxetine and fluoxetine) used to treat depression, OCD, panic and anxiety
• other antidepressants (such as: venlafaxine and tryptophan) used to treat major depression
• tricyclic antidepressants (such as: clomipramine and amitriptyline) used to treat depression
• St. John's wort (Hypericum perforatum) used as a herbal remedy for mild depression
• painkillers (such as: tramadol and pethidine) used to relieve pain
• triptans (such as: sumatriptan and zolmitriptan) used to treat migraine

Taking these medicines may increase the risk of adverse effects.
If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole +pharma, they should inform their doctor.

Aripiprazole +pharma with food, drink and alcohol
Aripiprazole +pharma can be taken with or without food. Avoid drinking alcohol.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborn babies whose mothers have taken Aripiprazole +pharma during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems.
If you observe any of these symptoms in your newborn, contact your doctor.
If the patient is taking Aripiprazole +pharma, the doctor will discuss with her whether she should breastfeed, considering the benefits of treatment and the benefits of breastfeeding.
Do not take this medicine and breastfeed at the same time. Discuss with your doctor the best feeding methods for your baby if you are taking this medicine.

Driving and using machines
During treatment with this medicine, dizziness and visual disturbances may occur (see section 4).
This should be taken into account when performing tasks requiring full attention, such as driving vehicles or operating machinery.

Aripiprazole +pharma contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Aripiprazole +pharma

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of this medicine in 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 with a low dose of aripiprazole in the form of an oral solution
(liquid). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily.
However, your treating 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 +pharma is too strong or too weak, consult your doctor or pharmacist.
Aripiprazole +pharma should be taken every day at the same time. It does not matter whether the tablet is taken
with or without food. The tablet should be swallowed whole and taken with water.
Even if you feel an improvement in your condition, do not change the dose or stop taking Aripiprazole +pharma
without first discussing it with your doctor.
Taking more than the recommended dose of Aripiprazole +pharma
If you take more Aripiprazole +pharma than prescribed by your doctor (or if someone else takes some of the
medicine not intended for them), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital,
taking the medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation and (or) aggression, speech difficulties
• unusual body movements (especially of the face or tongue) and decreased level of consciousness

Other possible symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, and excessive sweating
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm

If any of the above symptoms occur in a patient, contact a doctor or hospital immediately.
Missing a dose of Aripiprazole +pharma
If a dose is missed, the patient should take the missed dose as soon as they remember. Do not take two doses
on the same day.
Stopping treatment with Aripiprazole +pharma
Do not stop treatment even if you feel better. It is important to continue taking Aripiprazole +pharma for the duration
recommended by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients):

• diabetes
• sleep disorders
• anxiety
• feeling of restlessness and inability to sit or stand still
• akathisia (unpleasant inner restlessness and an irresistible urge to keep moving)
• uncontrolled trembling, jerking movements, or writhing movements
• tremor
• headache
• fatigue
• somnolence (drowsiness)
• feeling of emptiness in the head
• blurred vision and unstable visual image
• reduced number of bowel movements or difficulty defecating
• indigestion
• nausea
• excessive salivation
• vomiting
• feeling of tiredness

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• increased or decreased prolactin blood levels
• excessively high blood sugar levels
• depression
• changes in sexuality or excessive interest in sex
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• muscle disorders causing twisting movements (dystonia)
• restless legs syndrome
• double vision
• eye sensitivity to light
• rapid heartbeat
• reduced blood pressure when standing, causing dizziness, feeling of "emptiness in the head", or fainting
• hiccups

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

• low white blood cell count
• low platelet count
• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, itching, rash)
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine), or diabetic coma
• high blood sugar levels
• low sodium levels in blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, suicide attempts, and completed suicides
• feelings of aggression
• agitation
• nervousness
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure, changes in heart rate, and fainting (neuroleptic malignant syndrome)
• seizures
• serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol intoxication-like feelings, fever, sweating, or muscle stiffness)
• speech disorders
• oculogyric crisis (fixed abnormal eye position)
• sudden unexplained death
• life-threatening irregular heartbeat
• heart attack (myocardial infarction)
• slow heartbeat
• blood clots in veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must contact a doctor immediately)
• high blood pressure
• fainting
• accidental aspiration of food with risk of developing pneumonia
• laryngospasm (spasm of muscles around the larynx)
• pancreatitis
• difficulty swallowing
• diarrhea
• abdominal discomfort
• stomach discomfort
• liver failure
• hepatitis
• yellowing of the skin and whites of the eyes (jaundice)
• abnormal liver function tests
• skin rash
• photosensitivity (skin sensitivity to light)
• alopecia (hair loss)
• excessive sweating
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a facial rash, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes (seen in blood tests), and increased levels of a specific type of white blood cells (eosinophilia)
• abnormal muscle breakdown leading to kidney dysfunction
• muscle pain
• stiffness
• involuntary urination (inability to retain urine)
• difficulty urinating
• withdrawal syndrome in newborns if exposed to the drug during pregnancy
• prolonged and/or painful erection (priapism)
• difficulty regulating core body temperature or overheating
• breast pain
• swelling of hands, ankles, or feet
• in blood tests: increased or fluctuating blood glucose levels, increased levels of glycated hemoglobin
• inability to resist an impulse, drive, or temptation to perform an activity that could harm the patient or others, including behaviors such as:
  • strong impulse to gamble excessively despite serious personal or family consequences
  • changed or increased interest in sexual activity and behaviors significantly distressing to the patient or others, for example increased sexual drive
  • uncontrolled, excessive shopping
  • compulsive overeating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger)
  • urge to wander (pica or compulsive wandering)

If such behaviors occur, the patient should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, there have been more cases of death reported. Additionally, cases of stroke or "mini-strokes" (transient ischemic attacks) have been observed.

Additional adverse reactions in children and adolescents

In adolescents aged 13 years and older, adverse reactions occurred with similar frequency and type as in adults, except for the following, which were very common (occurring in more than 1 in 10 patients): somnolence, uncontrolled tremors or sudden movements, motor restlessness, and fatigue; and common (occurring in more than 1 in 100 patients): upper abdominal pain, dryness of the oral mucosa, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled limb movements, and dizziness, particularly upon standing up from a lying or sitting position.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aripiprazole +pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry date" or "EXP". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Aripiprazole +pharma contains

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

What Aripiprazole +pharma looks like and contents of the pack
Yellow, round tablets (with possible darker specks), embossed with "ARZ" and "15" on one side, available in perforated blisters packed in cardboard boxes containing 28, 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer
Synthon Hispania S.L.
C/Castelló, 1
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon s.r.o.
Brněnská 32/čp.597
678 01 Blansko
Czech Republic
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria

This medicinal product is authorised in the following names in the European Economic Area:
Poland: Aripiprazole +pharma
Czech Republic: Aripiprazol +pharma
Austria: Aripiprazol Genericon 15 mg Tabletten

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]