Arifrenix

Leaflet accompanying the packaging: Information for the user

Aryfrenix, 15 mg, tablets

Aryfrenix, 30 mg, tablets

Aripiprazole

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the pack:

• 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 who suffer from a disease characterized by symptoms such as seeing, hearing, and feeling things that are not real, suspiciousness, delusions, 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, reduced need for sleep, very fast 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 Aryfrenix.

2. Important information before taking Aryfrenix

When not to take Aryfrenix

• If you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Aryfrenix, you should discuss this with your doctor.

During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm.

Before taking Aryfrenix, you should inform your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, urination, increased appetite, and feeling of weakness) or a history of diabetes in your family
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely
• involuntary, irregular movements of the muscles, especially of the face
• heart or blood vessel disease, a history of heart or blood vessel disease in your family, stroke, or "mini-stroke", abnormal blood pressure
• blood clots or a history of blood clots in your family, 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 your daily activities, any difficulty swallowing, or symptoms of an allergic reaction, you should inform your doctor.

If you are an elderly patient with dementia, or if you are a caregiver or relative of such a patient, you should inform your doctor if the patient has ever had a stroke or "mini-stroke".

You should immediately inform your doctor if you experience thoughts or feelings of self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported.

You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental status changes, or very fast or irregular heartbeat.

If you or your family/caregiver notice that you are starting to feel the urge or impulse to behave in a way that is unusual for you and you cannot resist the impulse, urge, or temptation to perform an action that could harm yourself or others, you should inform your doctor. These impulses are called impulse control disorders and can be expressed as behaviors such as compulsive gambling, excessive eating or spending, excessive sexual desire, or an increased frequency and intensity of thoughts or feelings about sex.

Your doctor may consider changing your dose or stopping your treatment.

Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in your ability to move and balance, which can lead to falls. You should be careful, especially if you are an elderly or weakened patient.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 13. It is not known if the use of this medicine is safe and effective in these patients.

Aryfrenix and other medicines

You should tell your doctor or pharmacist about all the 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: Aryfrenix may increase the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.

Taking Aryfrenix with other medicines may require a change in the dose of Aryfrenix. It is especially important to inform your doctor if you are taking:

• medicines used to treat irregular heart rhythms (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 you experience any unusual symptoms while taking these medicines with Aryfrenix, you should consult your doctor.

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

• triptans, tramadol, and tryptophan, used to treat diseases including 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 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
• pain relievers (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 Aryfrenix, you should consult your doctor.

Taking Aryfrenix with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice 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 any of these symptoms in your baby, you should contact your doctor.

If you are taking Aryfrenix and are breastfeeding, your doctor will discuss with you whether you should breastfeed, considering the benefits of the treatment and the benefits of breastfeeding. You should not take this medicine and breastfeed at the same time. You should discuss with your doctor the best way to feed your baby if you are taking this medicine.

Driving and using machines

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

Aryfrenix contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Aryfrenix

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

If you feel that the effect of Aryfrenix is too strong or too weak, you should consult your doctor or pharmacist.

Aryfrenix tablets should be taken once a 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 you feel better, you should not change the dose or stop taking Aryfrenix without consulting your doctor first.

What to do if you take more Aryfrenix than you should

If you realize that you have taken more Aryfrenix tablets than your doctor has prescribed (or if someone else has taken some Aryfrenix tablets), you should immediately contact your doctor.

If you have trouble contacting your doctor, you should go to the nearest hospital, taking the packaging of the medicine with you.

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

• fast heartbeat, agitation/aggression, speech problems,
• unusual 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 feelings of great happiness, drowsiness, clumsiness, anxiety, drunkenness, 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 you experience any of these symptoms, you should seek medical attention immediately),
• 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 problems,
• 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 perform an action that could harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences,
• changed or increased sexual interest and behaviors that significantly disturb you 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 you experience any of these behaviors, you should tell your doctor, who will discuss with you 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 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, tremor, 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 not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

By reporting side effects, you can help provide more information on the safety of this 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. You should ask your 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, hydroxypropylcellulose, colloidal anhydrous silica, 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 "64" embossed on one side and "H" on the other side.

Aryfrenix, 30 mg, tablets

White, round (9 mm in diameter) uncoated tablets with "66" embossed 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