Explemed

Package leaflet: Information for the user

Explemed, 10 mg, tablets
Explemed, 15 mg, tablets
Explemed, 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 so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Explemed is and what it is 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 have a disorder characterised by symptoms such as: seeing, hearing or feeling things that are not real, suspiciousness, beliefs that are not based on reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety or tension, as well as feelings of guilt.
Explemed is also used to treat adults and adolescents aged 13 years and older whose illness is characterised by symptoms such as: extreme excitement, a sense of overflowing energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of the above symptoms in patients who responded to treatment with Explemed.

2. Important information before using Explemed

When not to use Explemed

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Explemed, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should
inform your doctor immediately if you experience any thoughts or feelings related to harming yourself.
Before starting treatment with Explemed, inform your doctor if the patient has:

• high blood sugar levels (characteristic symptoms include: excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (epilepsy), 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 disorders), family history of circulatory disorders, stroke or "mini" stroke, or abnormal blood pressure;
• blood clots or a family history of blood clots, as the use of antipsychotic medicines has been associated with blood clot formation;
• a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily
activities, any swallowing difficulties, or symptoms of allergy, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, their
caregiver, or a relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Inform your doctor immediately if you experience thoughts or feelings related to harming yourself. Suicidal
thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if the patient develops muscle stiffness or stiffness with high fever, sweating,
mental disturbances, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel an urge or desire to behave
in an unusual way and cannot resist an impulse, urge, or temptation to perform activities that could harm
themselves or others, they should tell the doctor. These phenomena are called impulse control disorders and
may manifest as behaviours such as compulsive gambling, binge eating, excessive spending, abnormally
increased sex drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may decide to adjust the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in movement
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
its use is safe and effective in these patients.

Explemed and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Blood pressure-lowering medicines: Explemed may enhance the effect of blood pressure-lowering medicines.
If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
Taking Explemed with certain medicines may require a dose adjustment of Explemed or of other medicines
the patient is taking. It is especially important to inform the doctor about the use of the following medicines:

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

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Explemed.
If the patient experiences any unusual symptoms while taking these medicines together with Explemed,
they should inform 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 treating conditions involving depression, generalized anxiety disorder, obsessive-compulsive 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 remedy 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 any of the above medicines together with
Explemed, they should inform their doctor.

Taking Explemed with food, drink, and alcohol
This medicine can be taken regardless of meals.
Avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby,
she should consult her doctor before using this medicine.
Newborns whose mothers have taken Explemed during the third trimester (last 3 months of pregnancy)
may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness,
irritability, breathing difficulties, and feeding problems. If you observe such symptoms in your newborn,
contact your doctor.
If the patient is taking Explemed, the doctor will discuss with her whether she should breastfeed, taking
into account the benefits of treatment and the benefits of breastfeeding. Do not take this medicine and
breastfeed at the same time. Discuss the best feeding methods for your baby with your doctor 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.

3. How to use Explemed

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The recommended dose of the medicine in adults is 15 mg once daily. However, the doctor may prescribe a lower or
higher dose, up to a maximum of 30 mg per day.
Use in children and adolescents above 13 years of age
Aripiprazole may be initiated at a low dose, which can be gradually increased to the
recommended dose for adolescents of 10 mg once daily. The treating doctor may
prescribe a lower or higher dose, up to a maximum of 30 mg per day.
Since it is not possible to achieve doses lower than 10 mg using Explemed tablets,
the treating doctor may prescribe another aripiprazole-containing medicine for this purpose (lower doses than 10 mg may be required when treating children and
adolescents, elderly patients, patients with severe hepatic impairment, or when adjusting the dose due to drug interactions).
If you feel the effect of Explemed is too strong or too weak, consult your doctor or pharmacist.
Explemed should be taken at approximately the same time each day. It does not matter whether
it is taken with or without food. The tablet should be swallowed whole and taken with water.
Even if you feel an improvement in your condition, do not change the dose or stop taking
Explemed without first consulting your treating doctor.
Taking more Explemed than recommended
If you take more Explemed tablets than prescribed by your doctor (or if someone else takes
Explemed tablets not intended for them), contact your 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 difficulties;
• unusual body movements (particularly of the face or tongue) and decreased level of consciousness. Other symptoms may include:
• acute confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, excessive 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 in a patient, contact a doctor or hospital immediately.
Missing a dose of Explemed
If a dose is missed, the patient should take the missed dose as soon as they remember.
Do not take two doses on the same day.
Stopping Explemed treatment
Do not stop treatment even if the patient feels better. It is very important to continue taking Explemed tablets for the duration recommended by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may affect up to 1 in 10 patients):

• diabetes
• difficulty sleeping
• feeling of anxiety
• motor restlessness or inability to remain still, difficulty sitting quietly
• akathisia (a sense of inner restlessness and a compulsion to keep moving)
• uncontrolled muscle contractions, jerky or twitching movements
• tremor
• headache
• feeling of fatigue
• drowsiness
• feeling of emptiness in the head
• blurred vision and unstable visual image
• reduced number of bowel movements or difficulty defecating
• indigestion
• nausea
• increased salivation in the mouth
• vomiting
• feeling of tiredness

Uncommon adverse effects (may affect up to 1 in 100 patients):

• increased or decreased level of prolactin hormone in the blood
• abnormally high blood sugar levels
• depression
• altered or increased interest in sexual activity
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• muscle disorder causing twisting of various body parts (dystonia)
• restless legs syndrome
• double vision
• light sensitivity of the eyes
• increased heart rate
• drop in blood pressure upon standing, causing dizziness, reduced consciousness, or fainting
• hiccups

The following adverse effects have been reported after the oral form of aripiprazole was introduced into clinical use, but their frequency is unknown (frequency cannot be estimated from available data):

• low white blood cell count
• low platelet count
• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, skin itching, rash)
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketones in blood and urine), or coma
• abnormally low sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, suicide attempts, and suicides
• aggression
• agitation
• nervousness
• combination of fever, muscle stiffness, rapid breathing, excessive sweating, reduced consciousness, and sudden changes in blood pressure and heart rate (neuroleptic malignant syndrome)
• seizures
• serotonin syndrome (a reaction that may cause feelings of intense well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness)
• speech disorders
• oculogyric crisis (fixed eye deviation in one position)
• sudden, unexplained death
• life-threatening irregular heartbeat
• myocardial infarction (heart attack)
• slow heart rate
• blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must seek immediate medical help)
• high blood pressure
• fainting
• accidental aspiration of food, with risk of developing pneumonia
• muscle spasm around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhoea
• discomfort in the abdominal area
• gastrointestinal discomfort
• liver failure
• hepatitis
• yellowing of the skin and whites of the eyes (jaundice)
• abnormal liver function test results
• skin rash
• photosensitivity
• 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and increased levels of a specific type of white blood cells (eosinophilia)
• abnormal muscle breakdown, which may lead to kidney problems
• muscle pain
• stiffness
• involuntary urination (urinary incontinence)
• difficulty urinating
• withdrawal syndrome in newborns whose mothers took the medicine during pregnancy
• prolonged and/or painful erection (priapism)
• difficulty regulating core body temperature or overheating
• chest pain
• swelling of hands, ankles, or feet
• in blood tests: fluctuations in blood glucose levels, increased levels of glycated hemoglobin
• inability to resist an impulse, drive, or temptation to engage in an activity that may 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 sexual activity and behaviors significantly distressing to the patient or others, for example increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive overeating (consuming 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 (pica or aimless wandering).

If such behaviors occur in a patient, they should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of deaths have been reported. Additionally, cases of stroke or "mini" strokes (transient ischemic attacks) have been observed.

Additional adverse effects in children and adolescents

In adolescents aged 13 years and older, adverse effects occurred at similar frequency and type as in adults, except for drowsiness, uncontrolled twitching or sudden 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—especially when rising from a lying or sitting position—which occurred commonly (in more than 1 in 100 patients).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting adverse effects helps gather more information on the safety of the medicine.

5. How to store Explemed

No special temperature requirements for storage of the medicinal product.
Store in the original packaging to protect from moisture.
Keep the medicine 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Explemed contains

• The active substance is aripiprazole. Each tablet contains 10 mg, 15 mg, or 30 mg of aripiprazole, respectively.
• The other ingredients are: microcrystalline cellulose, pregelatinized starch (maize), colloidal anhydrous silica, magnesium stearate.

What Explemed looks like and contents of the pack
Explemed 10 mg: white or almost white, round, convex tablets, odourless or almost odourless, with the letter E and code 562 engraved on one side and no engraving on the other side. The tablet diameter is approximately 7 mm.
Explemed 15 mg: white or almost white, round, flat tablets with bevelled edges, odourless or almost odourless, with the letter E and code 563 engraved on one side and no engraving on the other side. The tablet diameter is approximately 9 mm.
Explemed 30 mg: white or almost white, round, convex tablets, odourless or almost odourless, with the letter E and code 564 engraved on one side and no engraving on the other side. The tablet diameter is approximately 11 mm.
Pack: 2x14, 4x14 or 6x14 tablets in blisters made of OPA/Aluminum/PVC/Aluminum, packed in a cardboard carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder
PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

Manufacturer
EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Hungary: Explemed 10 mg, 15 mg, 30 mg tabletta
Bulgaria: Експлемед 10 mg, 15 mg, 30 mg таблетки
Czech Republic: Explemed
Poland: Explemed
Romania: Explemed 10 mg, 15 mg, 30 mg comprimate