Asduter

Package Leaflet: Information for the User

Asduter 10 mg tablets

Asduter 15 mg tablets

Asduter 30 mg tablets

Aripiprazole

Read all of 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1.

What Asduter is and what it is used for

2.

Important information before you take Asduter
3.
How to take Asduter

4.

Possible side effects

5.

How to store Asduter

6.

Contents of the pack and other information

1. What Asduter is and what it is used for

Asduter 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 suffer from a disease characterized by symptoms such as: seeing, hearing, and feeling things that are not real, suspiciousness, delusions, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, anxious, or tense, and may have a sense of guilt.
Asduter is used to treat adults and adolescents aged 13 years and older who have a disease characterized by symptoms such as: strong excitement, overflowing energy, less need for sleep than usual, very fast speech, racing thoughts, and sometimes very severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to aripiprazole treatment.

2. Important information before you take Asduter

When not to take Asduter

Warnings and precautions

Before starting treatment with Asduter, you should discuss this with your doctor.
During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm.
Before starting treatment with Asduter, you should inform your doctor if you have:

• high blood sugar levels (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 of the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a 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, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergy, you should inform your doctor.
If an elderly patient with dementia is taking Asduter, they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
You should immediately inform your doctor if you experience thoughts or feelings of 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 that you 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:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending;
• 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. If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.

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 movement and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

Asduter 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.

Asduter and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, as well as any medicines you plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Asduter may enhance the effect of blood pressure-lowering medicines.
If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Asduter with other medicines may require changing the dose of Asduter 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 Asduter. If you experience any unusual symptoms while taking these medicines with Asduter, you should tell 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 medicines (such as clomipramine and amitriptyline) used to treat depression;
• St. John's Wort ( Hypericum perforatum) used as a herbal preparation 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 any of these medicines with Asduter, you should contact your doctor.

Taking Asduter with food, drink, and alcohol

Asduter can be taken with or without food.
You should not drink alcohol during treatment with Asduter.

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 Asduter during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice any of these symptoms in your baby, you should contact your doctor.
If you are taking Asduter, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best way to feed your baby if you are taking this medicine.

Driving and using machines

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

Asduter contains lactose

Patients with intolerance to some sugars should contact their doctor before taking the medicine.

3. How to take Asduter

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 Asduter 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 Asduter may be started with a low dose. 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.
Since it is not possible to obtain a dose lower than 5 mg using Asduter, your doctor may prescribe an oral solution containing aripiprazole for this purpose.
If you feel that the effect of Asduter is too strong or too weak, you should talk to your doctor or pharmacist.
Asduter tablets 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 Asduter without first discussing it with your doctor.

If you take more Asduter than you should

If you have taken more Asduter tablets than your doctor prescribed (or if someone else has taken some of your Asduter tablets), you should contact your doctor immediately. If you have trouble 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/aggression, speech problems;
• unusual body movements (especially of the face or tongue) and decreased consciousness.

Other symptoms may include:

• severe confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, changes in blood pressure, and changes in heart rate, fainting (malignant neuroleptic 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 contact your doctor or hospital immediately.

If you forget to take Asduter

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.

If you stop taking Asduter

You should not stop treatment if you feel better. It is very important to take Asduter as prescribed by your doctor and for the duration prescribed by your doctor.
If you have any further questions on the use of this product, ask 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,
• sleep disturbances,
• feeling anxious,
• feeling restless and unable to sit or stand still,
• akathisia (feeling of inner restlessness and a compelling need to be in constant motion),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• image tremor and blurred vision,
• decreased number of bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling tired.

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

• decreased or increased prolactin levels in the blood,
• high blood sugar levels,
• 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 oral form, but the frequency of their occurrence is not known ( frequency cannot be estimated from the available data):

• decreased number of white blood cells,
• decreased number of platelets,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching of the skin, hives),
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the 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, attempted suicide, and completed suicide,
• feeling aggressive,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in consciousness, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating),
• 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 legs (symptoms include swelling, pain, and redness of the legs), which can travel through the blood vessels to the lungs, causing chest pain and breathing difficulties (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 (yellowing of the skin and whites of the eyes),
• abnormal liver test results,
• 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 problems,
• muscle pain,
• stiffness,
• involuntary urination,
• 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 glycosylated 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,
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending,
• 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. If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.

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

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 movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients) and 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Asduter

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. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Use within 56 days after first opening the HDPE container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Asduter contains

• The active substance is aripiprazole. Each Asduter 10 mg tablet contains 10 mg of aripiprazole. Each Asduter 15 mg tablet contains 15 mg of aripiprazole. Each Asduter 30 mg tablet contains 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172) (for 10 and 30 mg doses) and yellow iron oxide (for 15 mg dose), anhydrous colloidal silica.

What Asduter looks like and contents of the pack

Asduter 10 mg tablets are light red, round, flat tablets with beveled edges, 5.8 - 6.2 mm in size.
Asduter 15 mg tablets are light yellow, round, flat tablets with beveled edges, 6.8 - 7.2 mm in size.
Asduter 30 mg tablets are light red, round, flat tablets with beveled edges, 8.8 - 9.2 mm in size.
The tablets are available in OPA/Aluminum/PVC/Aluminum blisters, packaged in cardboard boxes containing:
Asduter 10 mg: 28, 56, 98 tablets
Asduter 15 mg: 28, 56, 98 tablets
Asduter 30 mg: 28, 56, 98 tablets.
HDPE container with LDPE cap and tamper-evident closure, containing a desiccant - silica gel.
Asduter 10 mg: 28, 56 tablets
Asduter 15 mg: 28, 56 tablets
Asduter 30 mg: 28, 56 tablets.
Polyethylene HDPE containers with polypropylene caps and integrated desiccant.
Asduter 10 mg: 28, 56 tablets
Asduter 15 mg: 28, 56 tablets
Asduter 30 mg: 28, 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Date of last revision of the leaflet:

• 07.03.2024