Aripiprazole +pharma

Package Leaflet: Information for the Patient

Aripiprazole +pharma, 15 mg, Tablets

Aripiprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Aripiprazole +pharma and what is it 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 is Aripiprazole +pharma and what is it 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 with a disease characterized by symptoms such as: seeing, hearing, and feeling things that are not real, suspiciousness, delusions, disorganized thinking and behavior, and emotional flattening. Patients with these symptoms may also feel depressed, anxious, or tense, and may have feelings of guilt. Aripiprazole +pharma is used to treat adults and adolescents aged 13 years and older with a disease characterized by symptoms such as: excessive excitement, overwhelming energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Aripiprazole +pharma.

2. Important information before taking Aripiprazole +pharma

When not to take Aripiprazole +pharma

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

Warnings and precautions

Before taking Aripiprazole +pharma, discuss it with your doctor. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor about any thoughts or feelings related to self-harm. Before taking Aripiprazole +pharma, tell your doctor if you have:

• high blood sugar (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely
• involuntary, irregular movements of the muscles, especially facial muscles
• heart or blood vessel disease (heart and blood vessel disease), a family history of heart or blood vessel disease, stroke, or "mini" stroke, abnormal blood pressure
• blood clots or a family history of blood clots, as the use of antipsychotic medicines is associated with the formation of blood clots
• a history of gambling addiction

If you notice an increase in weight, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor. If an elderly patient has dementia (loss of memory and other mental abilities), the patient, caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke. You should immediately inform your doctor about any thoughts or feelings related to self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very fast or irregular heartbeat. If you or your family or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way and cannot resist the impulse, urge, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as: compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of thoughts or feelings about sex. Your doctor may consider changing the dose or discontinuing the medicine. Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

This medicine should not be used in children and adolescents under 13 years of age. It is not known if 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 you are taking, have recently taken, or might take, including those obtained without a prescription. Blood pressure-lowering medicines: Aripiprazole +pharma may enhance the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor. The use of Aripiprazole +pharma with other medicines may require a change in the dose of Aripiprazole +pharma or other medicines you are 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)
• antidepressant medicines 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 side effects or reduce the effect of Aripiprazole +pharma. If you experience any unusual symptoms while taking these medicines with Aripiprazole +pharma, you should inform your doctor. Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety
• other antidepressant medicines (such as venlafaxine and tryptophan) used to treat severe 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 side effects. If you experience any unusual symptoms while taking these medicines with Aripiprazole +pharma, you should inform your doctor.

Aripiprazole +pharma with food, drink, and alcohol

Aripiprazole +pharma can be taken with or without food. You should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In newborns whose mothers took Aripiprazole +pharma during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If you notice any of these symptoms in your baby, you should contact your doctor. If you are taking Aripiprazole +pharma, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take this medicine and breastfeed. You should discuss with your doctor the best methods of feeding your baby if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances (see section 4) may occur. You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aripiprazole +pharma contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Aripiprazole +pharma

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Aripiprazole +pharma 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 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 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 Aripiprazole +pharma is too strong or too weak, you should talk to your doctor or pharmacist. Aripiprazole +pharma should be taken once a 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 washed down with water. Even if you feel better, you should not change the dose or stop taking Aripiprazole +pharma without first discussing it with your doctor.

If you take more Aripiprazole +pharma than you should

If you have taken more Aripiprazole +pharma than your doctor prescribed (or if someone else has taken some of the medicine not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medicine pack with you. In patients who have taken too much aripiprazole, the following symptoms have occurred:

• fast heartbeat, agitation, and (or) aggression, speech problems
• unusual body movements (especially facial or tongue movements) and decreased consciousness

Other symptoms may include:

• severe confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, and changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome)
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

If you forget to take Aripiprazole +pharma

If you miss a dose, you should take the missed dose as soon as you remember. Do not take two doses on the same day.

Stopping treatment with Aripiprazole +pharma

You should not stop treatment if you feel better. It is important to take Aripiprazole +pharma for the period prescribed by your doctor. If you have any further 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 everybody gets them. Commonside effects (may affect up to 1 in 10 people)

• diabetes
• sleep disturbances
• anxiety
• restlessness and inability to sit or stand still
• akathisia (unpleasant feeling of inner restlessness and an irresistible urge to move)
• uncontrolled trembling, jerking movements, or writhing movements
• trembling
• headache
• fatigue
• drowsiness
• feeling of emptiness in the head
• blurred vision and double vision
• reduced bowel movements or difficulty passing stools
• indigestion
• nausea
• excessive salivation
• vomiting
• feeling of fatigue

Uncommonside effects (may affect up to 1 in 100 people)

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

The following side effects have been reported after the marketing of aripiprazole in the form of an oral medicine, but the frequency of their occurrence is unknown(the frequency cannot be determined based on 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 its course, ketoacidosis (presence of ketone bodies in the blood and urine) or diabetic coma
• high blood sugar
• low sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, attempted suicide, and completed suicide
• feeling of aggression
• agitation
• nervousness
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, and changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome)
• seizures
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating, or muscle stiffness)
• speech disorders
• fixation of the eyeballs in one position
• sudden unexplained death
• life-threatening irregular heartbeat
• heart attack (myocardial infarction)
• slow heartbeat
• blood clots in the veins, especially in the veins of the legs (symptoms include swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, you must immediately see a doctor)
• high blood pressure
• fainting
• accidental choking on food with a risk of pneumonia
• spasm of the muscles around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhea
• abdominal discomfort
• stomach discomfort
• liver failure
• hepatitis
• jaundice
• abnormal liver function tests
• skin rash
• increased sensitivity of the skin to light
• 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 rash on the face, and then a rash appears on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia)
• abnormal breakdown of muscle leading to kidney disorders
• muscle pain
• stiffness
• involuntary urination (inability to hold urine)
• difficulty urinating
• withdrawal syndrome in newborns in case of exposure to the medicine during pregnancy
• prolonged and (or) painful erection
• difficulty regulating body temperature or overheating
• chest pain
• swelling of the hands, ankles, or feet
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin levels
• inability to resist the impulse, urge, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive
• uncontrolled shopping
• uncontrolled eating (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

In elderly patients with dementia, more cases of death have been reported in patients taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects occurred with a similar frequency and type as in adults, except for: drowsiness, uncontrolled trembling, or sudden movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which occurred frequently (more than 1 in 100 patients).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 carboxymethylcellulose, microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, yellow iron oxide (E 172).

What Aripiprazole +pharma looks like and contents of the pack

Round, yellow tablets (with possible darker spots), with the inscription "ARZ" and "15" on one side, available in perforated blisters, packaged in cardboard boxes containing 28 or 30 tablets. Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Poland, Aripiprazole +pharma, Czech Republic, Aripiprazol +pharma, Austria, Aripiprazol Genericon 15 mg Tabletten. For more information about this medicine, please contact the representative of the marketing authorization holder: +pharma Polska sp. z o.o., ul. Podgórska 34, 31-536 Kraków, Poland, tel. +48 12 262 32 36, e-mail: [email protected]. Date of last revision of the leaflet:December 2022