Apra-svift

Leaflet accompanying the packaging: patient information

Apra-swift, 10 mg, orally disintegrating tablets

Apra-swift, 15 mg, orally disintegrating tablets

Apra-swift, 30 mg, orally disintegrating tablets

Aripiprazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Apra-swift and what is it used for
• 2. Important information before taking Apra-swift
• 3. How to take Apra-swift
• 4. Possible side effects
• 5. How to store Apra-swift
• 6. Contents of the packaging and other information

1. What is Apra-swift and what is it used for

Apra-swift 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 do not exist in reality, suspiciousness, beliefs that are not based on reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.

Apra-swift is used to treat adults and adolescents aged 13 years and older whose disease is characterized by symptoms such as excitement, excessive energy, reduced need for sleep, very rapid 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 Apra-swift.

2. Important information before taking Apra-swift

When not to take Apra-swift

Warnings and precautions

Before starting treatment with Apra-swift, discuss it with your doctor. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. Immediately inform your doctor if you experience thoughts or feelings related to self-harm.

Before starting treatment with Apra-swift, 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 muscle movements, 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 experience weight gain, 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), they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.

Immediately inform your doctor if you experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.

Immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very rapid or irregular heartbeat. If you or your family member 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:

• 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 excessive shopping or spending;
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• urge to wander.

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. Be careful, especially in elderly or weakened patients.

Children and adolescents

Do not use Apra-swift in children and adolescents under 13 years of age. It is not known if the use of the medicine is safe and effective in these patients.

Apra-swift and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those that are available without a prescription.

Blood pressure-lowering medicines: Apra-swift may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, inform your doctor.

Taking Apra-swift with certain medicines may require a change in the dose of Apra-swift. 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 Apra-swift. If you experience any unusual symptoms while taking these medicines with Apra-swift, 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 medicines (such as clomipramine, 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 these medicines with Apra-swift, inform your doctor.

Taking Apra-swift with food, drinks, and alcohol

Apra-swift can be taken with or without food.

During treatment with Apra-swift, do not drink alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

In newborns whose mothers took aripiprazole 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 such symptoms in your child, contact your doctor.

If you are taking Apra-swift, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. Do not take the medicine and breastfeed. Discuss with your doctor the best methods for feeding your child if you are taking this medicine.

Driving and using machines

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

Apra-swift contains aspartame, lactose, sodium, and benzyl alcohol

Aspartame

Apra-swift 10 mg contains 1 mg of aspartame in each orally disintegrating tablet.

Apra-swift 15 mg contains 1.5 mg of aspartame in each orally disintegrating tablet.

Apra-swift 30 mg contains 3 mg of aspartame in each orally disintegrating tablet.

Aspartame is a source of phenylalanine.

It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Benzyl alcohol

Apra-swift 10 mg contains 0.0036 mg of benzyl alcohol in each orally disintegrating tablet.

Apra-swift 15 mg contains 0.0054 mg of benzyl alcohol in each orally disintegrating tablet.

Apra-swift 30 mg contains 0.0108 mg of benzyl alcohol in each orally disintegrating tablet.

Benzyl alcohol may cause allergic reactions.

Pregnant or breastfeeding women should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Patients with liver or kidney disease should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium in each orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Apra-swift

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose of Apra-swift for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day.

Use in children and adolescents

Treatment with Apra-swift can be started with a low dose of aripiprazole in the form of an oral solution (liquid). The dose can be gradually increased to the recommended dose for adolescents, which is 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 the medicine is too strong or too weak, consult your doctor or pharmacist.

Apra-swift orally disintegrating tablets should be taken

once a day at the same time.It does not matter whether the tablet is taken with or without food.

Do not open the blister until you are ready to take the medicine. To take the tablet, peel off the foil from the blister to reveal a single tablet. Do not push the tablet through the foil, as this may damage it. After opening the blister with dry hands, remove the tablet and place it on your tongue. The tablet will dissolve quickly in your saliva. The orally disintegrating tablet can be taken with or without liquid.

You can also dissolve the tablet in water and drink the resulting suspension.

Even if you feel better, do not change the dose or stop taking Apra-swift without first discussing it with your doctor.

Taking a higher dose of Apra-swift than recommended

If you have taken more Apra-swift orally disintegrating tablets than your doctor recommended (or if someone else has taken some of your Apra-swift orally disintegrating tablets), immediately contact your doctor. If you have trouble contacting your doctor, go to the nearest hospital, taking the medicine packaging with you.

In patients who have taken too much aripiprazole, the following symptoms have occurred:

• rapid 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 heart rate, loss of consciousness;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heart rhythm. If you experience any of these symptoms, immediately contact your doctor or hospital.

Missing a dose of Apra-swift

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

Stopping treatment with Apra-swift

Do not stop treatment if you feel better.

It is very important to take Apra-swift as directed by your doctor and for the duration recommended by your doctor.

If you have any further doubts about taking this medicine, consult 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,
• anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and urge to move constantly),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• reduced number of bowel movements or difficulty with bowel movements,
• nausea,
• vomiting,
• excessive salivation,
• feeling of fatigue.

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

• 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,
• rapid 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 medicine was placed on the market, but their frequency is not known (the frequency cannot be determined from the available data):

• decreased white blood cell count,
• decreased 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 levels,
• 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, changes in blood pressure, and changes in heart rate, loss of consciousness (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 heart rhythm,
• 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 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,
• muscle spasm 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, enlarged 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 tissue leading to kidney dysfunction,
• 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,
• breast pain,
• swelling of the hands, ankles, or feet,
• in blood tests: fluctuations in 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;
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• urge to wander.

If you experience such behaviors, 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 recorded.

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, including any side effects not listed in this leaflet, tell 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, phone: +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 Apra-swift

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Apra-swift contains

The active substance is aripiprazole. Each orally disintegrating tablet contains 10 mg, 15 mg, or 30 mg of aripiprazole.

The medicine also contains lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, silicon dioxide, aspartame (E 951), magnesium stearate, vanilla flavor, maltodextrin, arabic gum E 414, propylene glycol E 1520, benzyl alcohol E 1519).

• red iron oxide (E 172) - for 10 mg and 30 mg orally disintegrating tablets
• yellow iron oxide (E 172) - for 15 mg orally disintegrating tablets

What Apra-swift looks like and contents of the pack

Apra-swift 10 mg orally disintegrating tablets are round, flat, and pink, with a diameter of 8.00 mm and marked with the number "10" on one side.

Apra-swift 15 mg orally disintegrating tablets are round, flat, and yellow, with a diameter of 9.00 mm and marked with the number "15" on one side.

Apra-swift 30 mg orally disintegrating tablets are round, flat, and pink, with a diameter of 10.00 mm and marked with the number "30" on one side.

Apra-swift 10 mg and 15 mg tablets are available in aluminum blisters, packaged in cardboard boxes containing 7, 14, 28, 56, and 84 orally disintegrating tablets.

Apra-swift 30 mg tablets are available in aluminum blisters, packaged in cardboard boxes containing 7, 14, and 28 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturer

Rontis Hellas S.A., Medical and Pharmaceutical Products

P.O. Box 3012 Larisa Industrial Area, Larisa

41004 Greece

GENEPHARM S.A.

18th km Marathonos Avenue, Pallini Attiki

15351 Greece

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Date of last revision of the leaflet