Arifrenix

Leaflet attached to the packaging: Information for the user

Aryfrenix, 15 mg, tablets

Aryfrenix, 30 mg, tablets

Aripiprazole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 as yours.
• 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 Aryfrenix and what is it used for
• 2. Important information before taking Aryfrenix
• 3. How to take Aryfrenix
• 4. Possible side effects
• 5. How to store Aryfrenix
• 6. Contents of the pack and other information

1. What is Aryfrenix and what is it used for

Aryfrenix 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 are not real, suspiciousness, beliefs that are not based on reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, anxious, or tense, and may have feelings of guilt.

Aryfrenix is used to treat adults and adolescents aged 13 years and older who have a disease characterized by symptoms such as: excitement, excessive energy, less need for sleep than usual, very fast speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Aryfrenix.

2. Important information before taking Aryfrenix

When not to take Aryfrenix

• 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 Aryfrenix, 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 related to self-harm.

Before starting treatment with Aryfrenix, the patient should inform their doctor if they have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, urination, increased appetite, and feeling weak) or a family history of diabetes
• seizures (convulsions), as this may mean 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 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 the patient notices an increase in weight, 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), the patient or their caregiver 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 related to 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 disorders, or very fast or irregular heartbeat.

If the patient or their family/caregiver notices that the patient is 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 themselves or others, they should inform their doctor.

These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of sexual thoughts or feelings.

The doctor may consider it appropriate to change the dose or discontinue the medicine.

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

Children and adolescents

This medicine 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.

Aryfrenix and other medicines

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

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

Taking Aryfrenix with other medicines may require a change in the dose of Aryfrenix. It is especially important to inform the doctor about the use of:

• 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)
• 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 Aryfrenix. If the patient experiences any unusual symptoms while taking these medicines with Aryfrenix, they should consult their doctor.

Medicines 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 medicines (such as venlafaxine and tryptophan) used to treat severe depression
• tricyclic antidepressant medicines (such as clomipramine and amitriptyline) used to treat depression
• St. John's Wort (Hypericum perforatum) used as a herbal product 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 Aryfrenix, they should consult their doctor.

Taking Aryfrenix with food, drink, and alcohol

Aryfrenix can be taken with or without food. The patient should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their 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 the patient notices any of these symptoms in their baby, they should contact their doctor.

If the patient is taking Aryfrenix, their doctor will discuss with them whether they should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. The patient should not take this medicine and breastfeed. They should discuss with their doctor the best methods of feeding their baby if they are taking this medicine.

Driving and using machines

During treatment with this medicine, 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 machinery.

Aryfrenix contains lactose monohydrate

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

3. How to take Aryfrenix

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended dose of Aryfrenix for adults is 15 mg once a day.However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

Use in children and adolescents

Treatment with Aryfrenix can be started 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, which is 10 mg once a day. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

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

Aryfrenix tablets should be taken every day at the same time.It does not matter whether the tablet is taken with or without food. The tablet should always be swallowed whole and washed down with water.

Even if the patient feels better, they should not change the dose or stop taking Aryfrenix without consulting their doctor first.

Taking a higher dose of Aryfrenix than recommended

If the patient realizes they have taken more Aryfrenix tablets than their doctor prescribed (or if someone else has taken some Aryfrenix tablets), they should immediately contact their doctor.

If it is difficult to contact the doctor, the patient should go to the nearest hospital, taking the packaging of the medicine with them.

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

• fast heartbeat, agitation/aggression, speech problems,
• uncontrolled body movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• severe confusion, seizures (convulsions), coma, simultaneous occurrence of fever, rapid breathing, sweating, and changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, anxiety, feeling drunk, fever, sweating, or muscle stiffness),
• speech disorders,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• 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 the patient experiences any of these symptoms, they should immediately seek medical attention),
• high blood pressure,
• fainting,
• accidental choking on food with a risk of developing pneumonia (lung infection),
• muscle spasm around the larynx,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes,
• abnormal liver test results,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS 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 leading to kidney disorders,
• muscle pain,
• stiffness,
• involuntary urination (incontinence),
• 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 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,
• changed or increased sexual interest and behaviors that significantly disturb the patient or others, such as increased sexual drive,
• uncontrolled excessive shopping,
• 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),
• tendency to wander. If the patient experiences any of these behaviors, they should tell their doctor, who will discuss with them ways to treat or reduce these symptoms.

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 tremors or sudden muscle movements, restlessness, and fatigue, which occurred very frequently (in more than 1 in 10 patients), as well as upper 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 (in more than 1 in 100 patients).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

By reporting side effects, more information can be collected on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder in Poland.

5. How to store Aryfrenix

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.

There are no special precautions for storing the medicine.

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

6. Contents of the pack and other information

What Aryfrenix contains

• The active substance of the medicine is aripiprazole.

Each tablet contains 15 mg of aripiprazole.

Each tablet contains 30 mg of aripiprazole.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropyl cellulose, colloidal silicon dioxide, anhydrous, magnesium stearate.

What Aryfrenix looks like and contents of the pack

Tablet.

Aryfrenix, 15 mg, tablets

White, round (7 mm in diameter) uncoated tablets with the inscription "64" on one side and "H" on the other side.

Aryfrenix, 30 mg, tablets

White, round (9 mm in diameter) uncoated tablets with the inscription "66" on one side and "H" on the other side.

Aryfrenix tablets are available in cold-formed blisters made of triple-layered foil (Polyamide/Aluminum/PVC/Aluminum) in a cardboard box.

Package sizes:10, 14, 28, 30, 42, 49, 50, 56, 91, 98, and 100 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Aryfrenix

Portugal:

Aryfrenix

Date of last revision of the leaflet: 09/2022