Aryfrenix

Package leaflet: Information for the user

Aryfrenix, 15 mg, tablets
Aryfrenix, 30 mg, tablets
Aripiprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Aryfrenix is and what it is used for
2. What you need to know 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 Aryfrenix is and what it is 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 have an illness characterised by symptoms such as seeing, hearing and sensing things that
are not real, suspiciousness, beliefs that are not based on reality, disorganised speech and behaviour,
and emotional detachment. Patients with these symptoms may also feel sadness, anxiety or tension,
and may have feelings of guilt.
Aryfrenix is also used to treat adults and adolescents aged 13 years and older who have an illness
characterised by symptoms such as excitement, increased energy, reduced need for sleep, rapid speech,
racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the
recurrence of these symptoms in patients who have responded to treatment with Aryfrenix.

2. Important information before using Aryfrenix

When not to use 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, discuss this with your doctor.

Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before starting treatment with Aryfrenix, inform your doctor if the patient has:

• high blood sugar levels (characterized by symptoms such as excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes
• seizures (fits), as this may mean that the doctor will want to monitor the patient closely
• involuntary, irregular muscle movements, especially of the facial muscles
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, 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 is associated with formation of blood clots
• a history of gambling addiction.

If the patient notices weight gain, unusual movements, drowsiness that interferes with daily activity, any difficulty swallowing, or allergic symptoms, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient or their caregiver/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 harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient experiences muscle stiffness or stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
If the patient or their family/caregiver notices that the patient begins to feel an urge or desire to behave in an unusual way and cannot resist the impulse, drive, or temptation to carry out activities that could harm themselves or others, they should inform their doctor.
These phenomena are called impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, or excessive spending, abnormally high sex drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may decide it is necessary to change the dose or discontinue 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
This medicine should not be used in children and adolescents under 13 years of age. It is not known whether use of the medicine is safe and effective in these patients.

Aryfrenix and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.

Medicines that lower blood pressure: Aryfrenix may enhance the effect of medicines that lower blood pressure. If the patient is taking medicines that reduce blood pressure, they should inform their doctor.

Taking Aryfrenix together with other medicines may require a dose adjustment of Aryfrenix. It is especially important to inform your doctor if the patient is taking:

• 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)
• 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 adverse effects or reduce the effectiveness of Aryfrenix. If the patient experiences any unusual symptoms while taking these medicines together with Aryfrenix, they should consult their 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 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 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 adverse 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 regardless of meals. Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Newborns whose mothers have taken aripiprazole during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems (such as difficulty sucking). If you observe any of these symptoms in your baby, contact your doctor.
If the patient is taking Aryfrenix, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. This medicine should not be taken while breastfeeding. Discuss with your doctor the best feeding methods for your baby 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.

Aryfrenix contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Aryfrenix

This medicine should always be taken as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. 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 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, which is
10 mg once daily. 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, consult your doctor or pharmacist.
Aryfrenix tablets should be taken at the same time each day. It does not matter whether the tablet is taken with or without food. The tablet should always be swallowed whole and taken with water.
Even if the patient feels better, do not change the dose or stop taking Aryfrenix without first consulting your doctor.
Taking more Aryfrenix than prescribed
If the patient realizes they have taken more tablets of Aryfrenix than prescribed (or if someone else has taken some tablets of Aryfrenix), contact a doctor immediately.
If you cannot reach your 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 problems,
• unusual body movements (especially of the face or tongue), and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures, coma, fever accompanied by rapid breathing, sweating,
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm. If any of the above symptoms occur, contact a doctor or hospital immediately.

Missing a dose of Aryfrenix
If a dose is missed, the patient should take the missed dose as soon as they remember, but should not take two doses on the same day.
Stopping Aryfrenix treatment
Do not stop treatment even if the patient feels better. It is very important to take Aryfrenix tablets exactly as prescribed by the doctor and for the duration recommended by the doctor.
If you have any further doubts about using 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 occur in 1 in 10 people):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (unpleasant sensation of inner restlessness and an irresistible urge to move constantly),
• uncontrolled tremors, jerking movements, or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• tremor and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

Uncommon side effects (may occur in 1 in 100 people):

• increased or decreased blood levels of prolactin hormone,
• too 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,
• drop in blood pressure upon standing, causing dizziness, feeling of emptiness in the head, or fainting,
• hiccups.

The following side effects have been reported after the oral arypiprazole product was marketed, but their frequency is unknown:

• decreased number of white blood cells,
• decreased number of platelets,
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, rash),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts and suicide,
• feeling 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, confusion, restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye deviation in one position,
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• myocardial infarction,
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia (lung infection),
• 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,
• abnormal liver function tests,
• skin rash,
• skin photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially 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 enzyme activity detectable 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 (urinary incontinence),
• difficulty urinating,
• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,
• prolonged and/or painful erection,
• difficulty regulating core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased levels of glycated hemoglobin,
• inability to resist the impulse, urge or temptation to engage in an activity that could 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 sex and behaviors significantly distressing to the patient or others, for example increased sexual drive,
  • uncontrolled excessive shopping,
  • uncontrolled overeating (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 any of these behaviors occur, the patient should inform their doctor, who will discuss ways to manage or reduce these symptoms.

In elderly patients with dementia treated with arypiprazole, there have been more reports of deaths. In addition, cases of stroke or "mini-strokes" have been reported.

Additional side effects in children and adolescents
In adolescents aged 13 years and older, side effects occurred at similar frequency and type as in adults, except for somnolence, uncontrolled tremors or sudden muscle 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 tremor, uncontrolled limb movements, and dizziness, particularly when standing up from a lying or sitting position, which occurred commonly (in more than 1 in 100 patients).

Reporting of side effects
If any side effects occur, 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 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
By reporting side effects, additional information on the safety of the medicine can be collected.
Side effects may also be reported to the responsible entity in Poland.

5. How to store Aryfrenix

Keep this medicine 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 specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aryfrenix contains

• The active substance is aripiprazole.

Each tablet contains 15 mg of aripiprazole.
Each tablet contains 30 mg of aripiprazole.

• The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch, 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, embossed with "64" on one side and "H" on the other.
Aryfrenix, 30 mg, tablets
White, round (9 mm in diameter) uncoated tablets, embossed with "66" on one side and "H" on the other.
Aryfrenix tablets are available in cold-forming blisters made of triple-laminated film: Polyamide/Aluminum/PVC/Aluminum, packed in a cardboard box.
Pack sizes: 10, 14, 28, 30, 42, 49, 50, 56, 91, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland
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 medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Aryfrenix
Portugal: Aryfrenix