EXPLEMED 30 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Explemed, 10 mg, tablets
3. Explemed, 15 mg, tablets
4. Explemed, 30 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Contents of the leaflet
5. What is Explemed and what is it used for
6. Important information before taking Explemed
   1. When not to take Explemed
   2. Warnings and precautions
   3. Children and adolescents
   4. Explemed and other medicines
   5. Taking Explemed with food, drinks, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
7. How to take Explemed
   1. Use in children and adolescents over 13 years
   2. Taking a higher dose of Explemed than recommended
   3. Missing a dose of Explemed
   4. Stopping treatment with Explemed
8. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
9. How to store Explemed
10. Contents of the packaging and other information
    1. What Explemed contains
    2. What Explemed looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the leaflet: 24.08.2022

Leaflet accompanying the packaging: information for the user

Explemed, 10 mg, tablets

Explemed, 15 mg, tablets

Explemed, 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 further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What is Explemed and what is it used for

Explemed 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 do not exist in reality,
paranoia, delusions, chaotic speech and behavior, and emotional numbness. Patients with these
symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.
Explemed is used to treat adults and adolescents aged 13 years and older whose disease is
characterized by symptoms such as: excessive excitement, overwhelming energy, reduced need for
sleep, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine
also prevents the recurrence of these symptoms in patients who have responded to Explemed treatment.

2. Important information before taking Explemed

When not to take Explemed

Warnings and precautions

Before starting to take Explemed, you should discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. You should
immediately inform your doctor if you experience thoughts or feelings related to self-harm.
Before starting treatment with Explemed, you should inform your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feelings of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may indicate that your doctor will want to monitor you 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 you notice an increase in weight, unusual movements, drowsiness that interferes with daily activities, any swallowing difficulties, or signs of an allergic reaction, you should inform your doctor.
If an elderly patient has dementia (loss of memory and other mental abilities), the patient, their caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
You should immediately inform your doctor if you experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very rapid or irregular heartbeat.
If you or your family member or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, urge, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as:

• strong impulse to gamble excessively despite serious personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending money,
• 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);
• urge to wander.

Your doctor may consider changing the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls.
You should be careful, 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 the use of this medicine is safe and effective in these patients.

Explemed and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Blood pressure-lowering medicines: Explemed may enhance the effects of blood pressure-lowering medicines.
If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Explemed with certain medicines may require a change in the dose of Explemed or other medicines you are taking. It is especially important to inform your doctor about the use of the following medicines:

• 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);
• 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);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or reduce the effect of Explemed. If you experience any unusual symptoms while taking these medicines with Explemed, you should tell 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 medicines (such as clomipramine and amitriptyline) used to treat depression;
• St. John's Wort (Hypericum perforatum) used as a herbal preparation 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 any of these medicines with Explemed, you should tell your doctor.

Taking Explemed with food, drinks, and alcohol

The medicine 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 consult your doctor before taking this medicine.
In newborns whose mothers took Explemed during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.
If you are taking Explemed, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best methods for feeding your child if you are taking this medicine.

Driving and using machines

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

3. How to take Explemed

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose of Explemed 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.

Use in children and adolescents over 13 years

Aripiprazole treatment may be started with a low dose, which may be gradually increased to a recommended dose for adolescents of 10 mg once a day. Your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
Since it is not possible to obtain a dose lower than 10 mg with Explemed, your doctor may prescribe another aripiprazole-containing medicine for this purpose (in the treatment of children and adolescents, elderly patients, patients with severe liver function disorders, and in cases where dose adjustment is required due to drug interactions, doses lower than 10 mg may be required).
If you feel that the effect of Explemed is too strong or too weak, you should consult your doctor or pharmacist.
You should try to take Explemed at the same time every day.It does not matter whether it is taken with or without food. The tablet should be swallowed whole and washed down with water.
Even if you feel better, you should not change the dose or stop taking Explemed without first discussing it with your doctor.

Taking a higher dose of Explemed than recommended

If you take more Explemed tablets than your doctor prescribed (or if someone else takes some of the medicine not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation/aggression, speech problems;
• unusual body movements (especially of the face or tongue) and decreased consciousness. Other symptoms may include:
• severe confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, excessive sweating;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missing a dose of Explemed

If you miss a dose, you should take the missed dose as soon as you remember.
You should not take two doses on the same day.

Stopping treatment with Explemed

You should not stop treatment if you feel better. It is very important to take Explemed tablets for the period prescribed by your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Explemed can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes
• difficulty sleeping
• feeling anxious
• restlessness or inability to stay still, difficulty sitting still
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled muscle contractions, jerky or twitching movements,
• trembling
• headache
• feeling tired
• drowsiness
• feeling empty-headed
• blurred vision
• decreased number of bowel movements or difficulty with bowel movements
• indigestion
• nausea
• increased salivation
• vomiting
• feeling tired

Uncommon side effects (may affect up to 1 in 100 people):

• increased or decreased prolactin levels in the blood
• high blood sugar levels
• depression
• changed or increased interest in sex
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• muscle disorder causing twisting of different body parts (dystonia)
• restless legs syndrome
• double vision
• increased sensitivity of the eyes to light
• rapid heartbeat
• decreased blood pressure when standing up, causing dizziness, decreased consciousness, or fainting
• hiccups

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

• low white blood cell count
• low platelet count
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, rash)
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine), or diabetic coma
• low sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, attempted suicide, and suicide
• aggression
• agitation
• nervousness
• a combination of fever, muscle stiffness, rapid breathing, excessive sweating, decreased consciousness, and sudden changes in blood pressure and heart rate (malignant neuroleptic syndrome)
• seizures
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feelings of intoxication, fever, sweating)
• speech disorders
• fixation of the eyeballs in one position
• sudden, unexplained death
• life-threatening, irregular heartbeat
• heart attack
• slow heart rate
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, you must seek medical attention immediately)
• high blood pressure
• fainting
• accidental choking on food with a risk of pneumonia
• muscle spasm around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhea
• discomfort in the abdominal area
• stomach problems
• liver failure
• hepatitis
• yellowing of the skin and whites of the eyes
• abnormal liver test results
• skin rash
• 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, and then a rash appears on other parts of the body, high fever, swollen 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 tissue, which can lead to kidney problems
• muscle pain
• stiffness
• involuntary urination (incontinence)
• difficulty urinating
• withdrawal syndrome in newborns whose mothers took 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: fluctuations in blood sugar levels, increased glycated hemoglobin levels
• inability to resist the impulse, urge, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending money,
• 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);
• urge to wander.

If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.
In elderly patients with dementia taking aripiprazole, more cases of death have been reported. Additionally, cases of stroke or "mini" stroke have been noted.

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 twitching or sudden movements, restlessness, and fatigue, which occurred very frequently (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 (more than 1 in 100 patients).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Explemed

There are no special instructions for storing the medicine at a certain temperature.
Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month.
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 packaging and other information

What Explemed contains

• The active substance of Explemed is aripiprazole. Each tablet contains 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate.

What Explemed looks like and contents of the pack

Explemed, 10 mg: white or almost white, round, convex tablets, odorless or almost odorless, with the letter E and code 562 engraved on one side, without engraving on the other side. The diameter of the tablet is approximately 7 mm.
Explemed, 15 mg: white or almost white, round, flat tablets with beveled edges, odorless or almost odorless, with the letter E and code 563 engraved on one side, without engraving on the other side. The diameter of the tablet is approximately 9 mm.
Explemed, 30 mg: white or almost white, round, convex tablets, odorless or almost odorless, with the letter E and code 564 engraved on one side, without engraving on the other side. The diameter of the tablet is approximately 11 mm.
Packaging: 2x14, 4x14, or 6x14 tablets in blisters made of OPA/Aluminum/PVC/Aluminum in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

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

Hungary
Explemed 10 mg, 15 mg, 30 mg tablet
Bulgaria
Експлемед 10 mg, 15 mg, 30 mg tablets
Czech Republic
Explemed
Poland
Explemed
Romania
Explemed 10 mg, 15 mg, 30 mg tablets

Date of last revision of the leaflet: 24.08.2022