Apra-swift

Package leaflet: Information for the patient

Apra-swift, 10 mg, orodispersible tablets
Apra-swift, 15 mg, orodispersible tablets
Apra-swift, 30 mg, orodispersible tablets
Aripiprazole
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Apra-swift is and what it is 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 pack and other information

1. What Apra-swift is and what it is 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 who have a disorder characterized by symptoms such as seeing, hearing, or sensing things that are not real, suspiciousness, beliefs that are not in accordance with reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety or tension, and feelings of guilt.
Apra-swift is also used to treat adults and adolescents aged 13 years and older whose illness is characterized by symptoms such as excitement, increased energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent recurrence of the above symptoms in patients who responded to treatment with Apra-swift.

2. Important information before using Apra-swift

When not to use Apra-swift

• 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 Apra-swift, 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 Apra-swift, 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 your doctor will want to monitor you closely;
• involuntary, irregular movements of muscles, especially facial muscles;
• cardiovascular diseases (heart and circulatory disorders), a family history of circulatory disorders, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure;
• blood clots or a family history of blood clots, as use of antipsychotic medicines has been associated with blood clot formation;
• a history of gambling addiction.

If the patient notices weight gain, unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or signs 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, caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
Inform your doctor immediately if you experience thoughts or feelings related to harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if the patient develops muscle stiffness or stiffness with high fever, sweating, changes in 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 engage in activities that could harm themselves or others, this should be reported to the doctor. These phenomena are known as impulse control disorders and may manifest as compulsive gambling, binge eating, excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider adjusting the dose or discontinuing 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, especially in elderly or weakened patients.

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

Apra-swift with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Medicines that lower blood pressure: Apra-swift may enhance the effect of blood pressure-lowering medicines. If the patient is taking such medicines, they should inform their doctor.
Taking Apra-swift with certain medicines may require a dose adjustment of Apra-swift. It is especially important to inform your doctor if the patient is taking any 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);
• specific antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or reduce the effectiveness of Apra-swift. If the patient experiences any unusual symptoms while taking these medicines with Apra-swift, inform the 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 treating conditions involving depression, generalized anxiety 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, 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 the patient experiences any unusual symptoms while taking these medicines with ABILIFY, inform the doctor.

Taking Apra-swift with food, drink, and alcohol
Apra-swift may be taken regardless of meals.
Alcohol should not be consumed during treatment with Apra-swift.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Newborns whose mothers have taken aripiprazole during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact a doctor.
If the patient is taking Apra-swift, the doctor will discuss whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. The medicine should not be taken while breastfeeding. Discuss the best feeding methods for the baby with your doctor if you are taking this medicine.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account when performing tasks requiring 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 improper excretion.

Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this 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 consult their doctor before using this medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using this medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, meaning the medicine is considered "sodium-free".

3. How to use Apra-swift

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The recommended dose of the medicine in adults is 15 mg once daily. However, the doctor may prescribe a lower or
higher dose, which must not exceed 30 mg per day.
Use in children and adolescents
Treatment with Apra-swift may be initiated 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 daily. However, the treating physician may prescribe a lower or higher
dose, up to a maximum of 30 mg per day.
If the effect of the medicine seems too strong or too weak, consult the doctor or pharmacist.
Orally disintegrating tablets of Apra-swift should be taken at the same time each day. It does not matter whether the tablet is taken with or without food.
Do not open the blister pack until ready to take the medicine. Peel back the foil to release the individual tablet. Do not push the tablet through the foil, as this may damage it. After opening the blister, remove the tablet with dry hands and place it whole on the tongue. The tablet disintegrates rapidly in saliva. Orally disintegrating tablets may be taken with or without liquid.
The tablet may also be dissolved in water and the resulting suspension drunk.
Even if you feel an improvement in your condition, do not change the dose or stop taking Apra-swift without first discussing it with your treating physician.
Taking more than the recommended dose of Apra-swift
If a higher dose of Apra-swift orally disintegrating tablets is taken than prescribed by the doctor (or if someone else takes some of the medicine not intended for them), contact the treating physician immediately. If unable to contact the 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 stiffness 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.

Missed dose of Apra-swift
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 Apra-swift
Do not stop treatment even if the patient feels better.
It is very important to take Apra-swift exactly as directed by the doctor and for the duration prescribed by the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may affect 1 in 10 patients):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (a sensation of inner restlessness and a compulsion to keep moving),
• uncontrolled tremors, jerking movements, or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision or unstable visual image,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

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

The following adverse effects have been reported after arypiprazole was introduced into the market, but their frequency is unknown (frequency cannot be estimated from 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, rash),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketones in blood and urine), or diabetic coma,
• very high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts, and completed suicides,
• feelings of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixed eye position (oculogyria),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• muscle spasms 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 sensitivity 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes (seen 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 medicine 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: fluctuations in blood sugar levels, increased levels of glycated hemoglobin,
• inability to resist an impulse, urge, 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, for example 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),
  • urge to wander (pica or aimless wandering).

If such behaviors occur, the patient should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with arypiprazole, there have been reports of a higher number of deaths. In addition, cases of stroke or "mini" strokes have been observed.

Additional adverse effects in children and adolescents

In adolescents aged 13 years and older, adverse effects occurred at similar frequency and type as in adults, except for somnolence, uncontrolled tremors or movements, motor restlessness, and fatigue, which occurred very commonly (in 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, uncontrolled limb movements, and dizziness—especially upon standing up from a lying or sitting position—which occurred commonly (in more than 1 in 100 patients).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.

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

5. How to store Apra-swift

This medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton.
No special storage instructions apply for this medicine.
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 packaging and other information

What Apra-swift contains
The active substance is aripiprazole. Each orodispersible tablet contains
10 mg, 15 mg or 30 mg of aripiprazole.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
anhydrous colloidal silicon dioxide, aspartame (E 951), magnesium stearate, vanilla flavour,
maltodextrin, arabic gum E 414, propylene glycol E 1520, benzyl alcohol E 1519.

• Iron oxide red (E 172) – for 10 mg and 30 mg orodispersible tablets
• Iron oxide yellow (E 172) – for 15 mg orodispersible tablets

What Apra-swift looks like and contents of the pack
Apra-swift 10 mg orodispersible tablets are round, flat, pink, with a diameter of
8.00 mm, marked with the number “10” on one side.
Apra-swift 15 mg orodispersible tablets are round, flat, yellow, with a diameter of
9.00 mm, marked with the number “15” on one side.
Apra-swift 30 mg orodispersible tablets are round, flat, pink,
with a diameter of 10.00 mm, marked with the number “30” on one side.
Apra-swift 10 mg and Apra-swift 15 mg tablets are available in aluminium blisters
packed in cardboard boxes containing 7, 14, 28, 56 and 84 orodispersible tablets.
Apra-swift 30 mg tablets are available in aluminium blisters packed in
cardboard boxes containing 7, 14 and 28 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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