Aripsan

Package Leaflet: Information for the User

ARIPSAN, 5 mg, tablets

ARIPSAN, 10 mg, tablets

ARIPSAN, 15 mg, tablets

Aripiprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

• 1. What is ARIPSAN and what is it used for
• 2. Important information before taking ARIPSAN
• 3. How to take ARIPSAN
• 4. Possible side effects
• 5. How to store ARIPSAN
• 6. Contents of the pack and other information

1. What is ARIPSAN and what is it used for

ARIPSAN 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 do not exist in reality, suspiciousness, beliefs that are not based on reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.

ARIPSAN is used to treat adults and adolescents aged 13 years and older whose disease is characterized by symptoms such as: severe excitement, excessive energy, reduced need for sleep, very rapid 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 ARIPSAN.

2. Important information before taking ARIPSAN

When not to take ARIPSAN

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

Warnings and precautions

Before starting treatment with ARIPSAN, discuss with your doctor or pharmacist if you have:

• High blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• Seizures;
• Involuntary, irregular muscle movements, especially facial muscles;
• Cardiovascular disease, 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 you notice an increase in weight, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.

Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. Be careful, especially in elderly or weakened patients.

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".

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

Immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disturbances, or very rapid or irregular heartbeat.

Children and adolescents

Do not take ARIPSAN if you are under 13 years old. Consult your doctor or pharmacist before taking ARIPSAN.

ARIPSAN and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Blood pressure-lowering medicines: ARIPSAN may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, inform your doctor.

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

• Medicines used to treat heart rhythm disorders;
• Antidepressant medicines or herbal medicines used to treat depression and anxiety;
• Antifungal medicines;
• Certain medicines used to treat HIV infection;
• Antiepileptic medicines used to treat epilepsy.

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, SSRI medicines (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort, and venlafaxine. These medicines increase the risk of side effects; if you experience any unusual symptoms while taking any of these medicines with ARIPSAN, contact your doctor.

Taking ARIPSAN with food, drink, and alcohol

ARIPSAN can be taken with or without food.

Do not drink alcohol during treatment with ARIPSAN.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In newborns whose mothers took ARIPSAN 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 child, contact your doctor.

If you are breastfeeding, inform your doctor immediately.

If you are taking ARIPSAN, do not breastfeed.

Driving and using machines

Do not drive or operate any tools or machines until you know how ARIPSAN affects you.

ARIPSAN contains lactose

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

3. How to take ARIPSAN

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose 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 once a day.

Taking ARIPSAN in children and adolescents

Treatment with ARIPSAN may be started with a low dose 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 once a day.

If you feel that the effect of ARIPSAN is too strong or too weak, talk to your doctor or pharmacist.

ARIPSAN tablets should be taken once a day at the same time every day.It does not matter whether you take the tablet with or without food. Swallow the tablet whole with a glass of water.

Even if you feel better,do not change the dose or stop taking ARIPSAN without first talking to your doctor.

Taking more ARIPSAN than prescribed

If you have taken more ARIPSAN than your doctor prescribed (or if someone else has taken some of your ARIPSAN), contact your doctor immediately. If you have trouble contacting your doctor, go to the nearest hospital, taking the medicine pack with you.

Missing a dose of ARIPSAN

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ARIPSAN can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people): uncontrolled movements or sudden movements, headaches, feeling tired, nausea, vomiting, stomach upset, constipation, increased saliva production, feeling of emptiness in the head, difficulty sleeping, restlessness, especially movement-related, feeling anxious, drowsiness, trembling, blurred vision.

Uncommon side effects (may affect up to 1 in 100 people): some people may experience dizziness, especially when standing up from a lying or sitting position, double vision, some people may experience a sudden increase in heart rate.

Some people may experience sensitivity to light. Some people may experience depression. Some people may experience changed or increased interest in sex. Hiccups.

The following side effects have been reported since the introduction of aripiprazole to the market, but the frequency of their occurrence is not known (the frequency cannot be determined based on available data):

Changes in the number of certain blood cells, abnormal heart rhythm, sudden unexplained death, heart attack (myocardial infarction); allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, skin rash); high blood sugar levels, onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine) or coma, low sodium levels in the blood; weight gain, weight loss, loss of appetite; nervousness, agitation, anxiety, gambling addiction; suicidal thoughts, attempted suicide, and suicide; speech disorders, seizures, serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially movement-related, feeling drunk, fever, sweating, or muscle stiffness), simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, and sudden changes in blood pressure and heart rate; fainting; high blood pressure, 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, seek medical help immediately); muscle spasm around the vocal cords, accidental choking on food with a risk of pneumonia, difficulty swallowing; pancreatitis; liver failure, hepatitis, yellowing of the skin and whites of the eyes, abnormal liver test results, discomfort in the abdominal and stomach area, diarrhea; fixation of the eyeballs in one position; skin rash and sensitivity to light; hair loss or thinning, excessive sweating; muscle stiffness or spasms, muscle pain, weakness; involuntary urination, difficulty urinating; prolonged and/or painful erection; difficulty regulating body temperature or overheating; chest pain and swelling of the hands, ankles, or feet.

In elderly patients with dementia, taking aripiprazole has been associated with a higher number of deaths. Additionally, cases of stroke or "mini-stroke" have been reported.

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 movements or sudden movements, restlessness, especially movement-related, and fatigue, which occurred very frequently (more than 1 in 10 patients) and abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, tremors, involuntary movements of the limbs, 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 those not listed in this leaflet, tell your 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 181 C, 02-222 Warsaw, Tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store ARIPSAN

Keep this medicine out of the sight and reach of children.

There are no special storage instructions for this medicinal product.

Store in the original package to protect from moisture.

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

Medicines should 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 ARIPSAN contains

• ARIPSAN, 5 mg tablets: The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole. The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate, indigo carmine (E 132).
• ARIPSAN, 10 mg tablets: The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole. The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate, red iron oxide (E 172).
• ARIPSAN, 15 mg tablets: The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.

The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (E 172).

What ARIPSAN looks like and contents of the pack

ARIPSAN, 5 mg tablets are blue, uncoated, scored tablets of modified rectangular shape, with the marking "250" on one side and smooth on the other side.

ARIPSAN, 10 mg tablets are pink, uncoated, scored tablets of modified rectangular shape, with the marking "252" on one side and smooth on the other side.

ARIPSAN, 15 mg tablets are yellow, uncoated, scored, round tablets with beveled edges, with the marking "253" on one side and smooth on the other side.

Diameter: 7.3 mm.

The tablets are packaged in blisters, in cardboard boxes, containing 7, 10, 14, 28, 30, 56, 60, or 100 tablets.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s.

Telčská 377/1, Michle

140 00 Praha 4

Czech Republic

Date of last revision of the leaflet:June 2020