Asduter

Package leaflet: Information for the user

Asduter 10 mg tablets
Asduter 15 mg tablets
Asduter 30 mg tablets
Aripiprazole
Please read this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Asduter is and what it is used for
2. 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 have an illness characterised by symptoms such as seeing, hearing or experiencing things that are not real, suspiciousness, beliefs that are contrary to reality, disorganised speech and behaviour, and emotional blunting.
Patients with these symptoms may also experience sadness, anxiety or tension, as well as feelings of guilt.
Asduter is also used to treat adults and adolescents aged 13 years and older whose illness is characterised 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 the recurrence of these symptoms in patients who have responded to treatment with aripiprazole.

2. Important information before using Asduter

When not to use Asduter

• 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 Asduter, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should
inform your doctor immediately if you experience any thoughts or feelings related to harming
yourself.
Before starting treatment with Asduter, 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 that the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and circulation problems), a 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, because antipsychotic medicines have been associated with blood clot formation;
• a history of gambling addiction.

If the patient notices weight gain, the appearance of unusual movements, drowsiness that interferes
with daily activities, any difficulty swallowing, or symptoms of an allergic reaction, they should
inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient,
their caregiver, or a family member should inform the doctor if the patient has ever had a stroke or
"mini" stroke.
Inform the doctor immediately if the patient experiences thoughts or feelings related to self-harm.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform the doctor immediately if the patient experiences muscle stiffness or stiffness accompanied
by high fever, sweating, altered mental state, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel an urge or desire to
behave in an unusual way and cannot resist an 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 compulsive gambling, binge eating, excessive spending,
increased sex drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it appropriate to adjust the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in
motor function and balance, which may lead to falls. Exercise caution, particularly in elderly or frail
patients.
Children and adolescents
Asduter must not be used in children and adolescents under 13 years of age. It is not known whether
the use of the medicine is safe and effective in these patients.
Asduter with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, including medicines obtained without a prescription, as well as any medicines the patient
plans to take.
Medicines that lower blood pressure: Asduter may enhance the effects of medicines that lower blood
pressure. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Asduter together with other medicines may require adjustment of the dose of Asduter or of
other medicines the patient is taking. It is especially important to inform the 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 side effects or reduce the effectiveness of Asduter. If the patient experiences any unusual symptoms while taking these medicines with Asduter, 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 in conditions involving depression, generalized anxiety disorder, obsessive-compulsive 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 side effects; if any unusual symptoms occur while
taking any of the above medicines together with Asduter, contact your doctor.
Taking Asduter with food, drink and alcohol
Asduter can be taken with or without food.
During treatment with Asduter, alcohol must not be consumed.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, thinks 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 Asduter 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 (such as difficulty sucking). If
you observe any of these symptoms in your baby, contact your doctor.
If the patient is taking Asduter, the doctor will discuss with her whether she should breastfeed,
taking into account the benefits of treatment and the benefits of breastfeeding. Do not take this
medicine and breastfeed at the same time. Talk to your doctor about the best ways to feed your baby
if you are taking this medicine.
Driving and operating machinery
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 or
operating machinery.
Asduter contains lactose
Patients with intolerance to certain sugars should consult their doctor before taking this medicine.

3. How to use Asduter

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your 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 per day.
Use in children and adolescents
Treatment with Asduter may be initiated at a low dose. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
Since it is not possible to obtain a dose smaller than 5 mg using Asduter tablets, your doctor may prescribe an oral solution containing aripiprazole for this purpose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Asduter tablets should be taken at the same time every day. 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 Asduter without first discussing it with your treating doctor.
Taking more Asduter than prescribed
If you take more Asduter tablets than prescribed by your doctor (or if someone else takes any amount of Asduter tablets 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/aggression, speech difficulties;
• unusual body movements (especially of the face or tongue) and decreased level of consciousness.

Other 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 Asduter
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 Asduter
Do not stop treatment even if you feel better. It is very important to take Asduter exactly as prescribed by your doctor and 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 affect 1 in 10 patients):

• Diabetes,
• Sleep disturbances,
• Feelings of anxiety,
• Feelings of restlessness and inability to sit or stand still,
• Akathisia (a sensation of inner restlessness and a compulsion to keep moving),
• Uncontrollable tremors, jerking movements, or writhing movements,
• Tremor,
• Headache,
• Fatigue,
• Drowsiness,
• Feeling of emptiness in the head,
• Blurred vision or unstable visual images,
• Reduced number of bowel movements or difficulty defecating,
• Indigestion,
• Nausea,
• Excessive salivation,
• Vomiting,
• Feeling of tiredness.

Uncommon adverse reactions (may affect 1 in 100 patients):

• Decreased or increased blood levels of prolactin,
• High blood sugar levels,
• Depression,
• Changes in sexual interest or excessive sexual interest,
• Uncontrollable movements of the mouth, tongue, or limbs (tardive dyskinesia),
• Muscle disorders causing twisting movements (dystonia),
• Restless legs syndrome,
• Double vision,
• Light sensitivity of the eyes,
• Rapid heartbeat,
• Decreased blood pressure upon standing, causing dizziness, feeling of emptiness in the head, or fainting,
• Hiccups.

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

• Decreased white blood cell count,
• Decreased platelet count,
• Allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, skin itching, urticaria),
• Development or worsening of diabetes, ketoacidosis (presence of ketones in blood and urine), or coma,
• High blood sugar levels,
• Low blood sodium levels,
• Loss of appetite (anorexia),
• Decreased body weight,
• Increased body weight,
• Suicidal thoughts, suicide attempts, and completed suicides,
• Feelings of aggression,
• Psychomotor agitation,
• Nervousness,
• Concurrent occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• Seizures,
• Serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• Speech disorders,
• Ocular fixation in one position,
• Sudden unexplained death,
• Life-threatening irregular heart rhythm,
• 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 breathing difficulties (if a patient experiences any of these symptoms, they must contact a doctor immediately),
• High blood pressure,
• Fainting,
• Accidental aspiration of food with risk of developing pneumonia,
• 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,
• Skin photosensitivity,
• 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 body parts, high fever, swollen lymph nodes, elevated liver enzymes (visible 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,
• Difficulty urinating,
• Withdrawal syndrome in newborns following exposure 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 engage in an activity that may harm the patient or others, including behaviors such as:
  • Strong impulse to gamble excessively despite serious personal or family consequences,
  • Altered or increased interest in sexual activity and behaviors significantly distressing to the patient or others, e.g. increased sexual drive,
  • Uncontrolled excessive shopping or spending,
  • Compulsive overeating (consuming large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger),
  • Impulse to wander (pica or aimless wandering).

If such behaviors occur in a patient, they should be reported to the doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of fatal cases have been 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 at similar frequencies and types as in adults, except for drowsiness, uncontrollable tremors or movements, motor restlessness, and fatigue, which were very common (affecting more than 1 in 10 patients), and abdominal pain in the upper part of the abdomen, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable limb movements, and dizziness—especially when standing up from a lying or sitting position—which were common (affecting more than 1 in 100 patients).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
e-mail: https://smz.ezdrowie.gov.pl

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

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

5. How to store Asduter

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Use within 56 days after first opening the HDPE container.
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 package 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: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, red iron oxide (E172) (for 10 mg and 30 mg doses), yellow iron oxide (for 15 mg dose), and anhydrous colloidal silicon dioxide.

What Asduter looks like and contents of the pack
Asduter 10 mg tablets are light red, round, flat tablets with bevelled edges, measuring 5.8 – 6.2 mm.
Asduter 15 mg tablets are light yellow, round, flat tablets with bevelled edges, measuring 6.8 – 7.2 mm.
Asduter 30 mg tablets are light red, round, flat tablets with bevelled edges, measuring 8.8 – 9.2 mm.

The tablets are available in OPA/Aluminium/PVC/Aluminium blisters, packed 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 seal, containing a desiccant – silica gel.
Asduter 10 mg: 28, 56 tablets
Asduter 15 mg: 28, 56 tablets
Asduter 30 mg: 28, 56 tablets.

HDPE polyethylene containers with polypropylene screw cap with security ring 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 Authorisation Holder and Manufacturer
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland
07.03.2024