Apra-svift

Package Leaflet: Information for the Patient

Apra-swift, 10 mg, Orally Disintegrating Tablets

Apra-swift, 15 mg, Orally Disintegrating Tablets

Apra-swift, 30 mg, Orally Disintegrating Tablets

Aripiprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package Contents 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 medications called antipsychotics. It is used to treat adults and adolescents aged 15 years and older with a condition characterized by symptoms such as seeing, hearing, and feeling things that are not real, suspiciousness, delusional beliefs, 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 with a condition characterized by symptoms such as excitement, excessive energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medication also prevents the recurrence of these symptoms in patients who have responded to Apra-swift treatment.

2. Important Information Before Taking Apra-swift

When Not to Take Apra-swift

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

Warnings and Precautions

Before starting treatment with Apra-swift, the patient should discuss it with their doctor. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. The patient should immediately inform their doctor if they experience thoughts or feelings of self-harm.

Before starting treatment with Apra-swift, the patient should inform their doctor if they 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 indicate that the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular diseases, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a history of blood clots, as the use of antipsychotic medications is associated with the formation of blood clots;
• a history of gambling addiction.

If the patient experiences weight gain, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, they should inform their 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.

The patient should immediately inform their doctor if they experience thoughts or feelings of self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.

The patient should immediately inform their doctor if they experience muscle stiffness or stiffness with high fever, sweating, mental status changes, or very rapid or irregular heartbeat.

If the patient or their family or caregiver notices that the patient starts 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 themselves or others, they should tell their doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as:

• strong impulse to gamble excessively despite significant personal or family consequences;
• altered or increased sexual interest and behaviors that significantly disturb the patient 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.

The doctor may consider changing the dose or discontinuing the medication.

Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which may lead to falls. The patient should be cautious, especially if they are elderly or weakened.

Children and Adolescents

Apra-swift should not be used in children and adolescents under 13 years of age. It is not known if the medication is safe and effective in these patients.

Apra-swift and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those that are available without a prescription.

Blood pressure-lowering medications: Apra-swift may enhance the effects of blood pressure-lowering medications. If the patient is taking blood pressure-lowering medications, they should inform their doctor.

Taking Apra-swift with certain medications may require a dose adjustment of Apra-swift. It is especially important to inform the doctor about the use of the following medications:

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

Taking these medications may increase the risk of side effects or decrease the effectiveness of Apra-swift. If the patient experiences any unusual symptoms while taking these medications with Apra-swift, they should inform their doctor.

Medications that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and migraine and pain:

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

Taking these medications may increase the risk of side effects. If the patient experiences any unusual symptoms while taking these medications with Apra-swift, they should inform their doctor.

Taking Apra-swift with Food, Drink, and Alcohol

Apra-swift can be taken with or without food.

The patient should not drink alcohol during treatment with Apra-swift.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before taking this medication.

In newborns whose mothers took aripiprazole during the last trimester (last 3 months of pregnancy), the following symptoms may occur: tremors, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient notices such symptoms in their child, they should contact their doctor.

If the patient is taking Apra-swift, their doctor will discuss with them whether they should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. The patient should not take the medication and breastfeed. They should discuss with their doctor the best methods for feeding their child if they are taking this medication.

Driving and Operating Machines

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

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 elimination.

Lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking this medication.

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 this medication, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (such as metabolic acidosis).

Patients with liver or kidney disease should contact their doctor before taking this medication, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (such as metabolic acidosis).

Sodium

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

3. How to Take Apra-swift

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

The recommended dose for adults is 15 mg once daily.However, the doctor may prescribe a lower or higher dose, which should not exceed 30 mg once daily.

Administration in Children and Adolescents

Treatment with Apra-swift can be initiated 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 daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.

If the patient feels that the medication is too strong or too weak, they should consult their doctor or pharmacist.

Apra-swift Orally Disintegrating Tablets Should be Taken

Once Daily at the Same Time.It does not matter if the tablet is taken with or without food.

The patient should not open the blister until they are ready to take the medication. They should peel off the foil to remove a single tablet. They should not push the tablet through the foil, as this may damage it. After opening the blister, the patient should remove the tablet with dry hands and place it whole on their tongue. The tablet will dissolve quickly in saliva. The orally disintegrating tablet can be taken with or without liquid.

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

Even if the patient feels better,they should not change the dose or stop taking Apra-swift without first discussing it with their doctor.

Overdose of Apra-swift

In case of taking a higher dose of Apra-swift than prescribed by the doctor (or if someone else has taken some of the patient's Apra-swift), the patient should immediately contact their doctor. If it is difficult to contact the doctor, the patient should go to the nearest hospital, taking the medication packaging with them.

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:
• acute confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, and changes in blood pressure and heart rate, loss of consciousness;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm. If the patient experiences any of these symptoms, they should immediately contact their doctor or hospital.

Missing a Dose of Apra-swift

If the patient misses a dose, they should take the missed dose as soon as they remember. They should not take two doses on the same day.

Stopping Treatment with Apra-swift

The patient should not stop treatment if they feel better.

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

If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Apra-swift can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• anxiety,
• 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,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• decreased 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 marketing of aripiprazole, but their frequency is not known (the frequency cannot be estimated 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,
• aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in mental status, and sudden changes in blood pressure and heart rate, loss of consciousness (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, agitation, 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 legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties (if the patient experiences any of these symptoms, they should immediately contact their doctor),
• high blood pressure,
• loss of consciousness,
• 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, 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 medication 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 glycated hemoglobin levels,
• inability to resist the impulse, urge, or temptation to engage in activities that may harm the patient or others, including behaviors such as:
• strong impulse to gamble excessively despite significant personal or family consequences;
• altered or increased sexual interest and behaviors that significantly disturb the patient 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 the patient experiences any of these behaviors, they should tell their doctor, who will discuss 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), as well as upper abdominal pain, dry mouth, rapid heartbeat, 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 the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, it is possible to gather more information on the safety of the medication.

5. How to Store Apra-swift

This medication should be stored out of sight and reach of children.

Do not use this medication after the expiration date stated on the blister and carton.

There are no special precautions for storing the medication.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents 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 medication 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).

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

What Apra-swift Looks Like and Contents of the Package

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 Package Leaflet: