Egoropal

Package leaflet: Information for the user

Egoropal, 25 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 50 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 75 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 100 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 150 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

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

Contents of the leaflet

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

1. What Egoropal is and what it is used for

Egoropal contains the active substance paliperidone, which belongs to a group of medicines called antipsychotics. It is used for the maintenance treatment of symptoms of schizophrenia in adult patients stabilized on paliperidone or risperidone.
If you have previously responded to paliperidone or risperidone and have mild or moderate symptoms, your doctor may initiate treatment with Egoropal without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disease with "positive" and "negative" symptoms. Positive symptoms refer to the presence of symptoms that normally do not occur. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe in things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence of normal behaviors or emotions. For example, a person with schizophrenia may appear withdrawn, isolated, emotionally unresponsive, or may have difficulty speaking clearly and logically. People affected by this illness may also experience depression, anxiety, feelings of guilt, or tension.
Egoropal may help to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Egoropal

When not to use Egoropal

• if the patient is allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to another antipsychotic medicine, including the substance risperidone.

Warnings and precautions
Before starting treatment with Egoropal, discuss this with your doctor, pharmacist, or nurse.
The use of this medicine in elderly patients with dementia has not been studied. However, in such
patients treated with other similar medicines, an increased risk of stroke or death may occur (see section 4, Possible side effects).
All medicines have side effects. Some of the side effects of this medicine may worsen symptoms of other medical conditions. Therefore, during treatment with this medicine, discuss with your doctor any of the following conditions, which may potentially worsen during treatment with this medicine:

• if the patient has Parkinson's disease;
• if the patient has ever been diagnosed with a condition characterized by symptoms such as high fever and muscle stiffness (also known as neuroleptic malignant syndrome);
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia);
• if the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines);
• if the patient has diabetes or is predisposed to developing it;
• if the patient has a breast tumor or pituitary gland tumor;
• if the patient has heart disease or is being treated for heart conditions that predispose to hypotension;
• if the patient has low blood pressure upon sudden change to a standing or sitting position;
• if the patient has epilepsy;
• if the patient has impaired kidney function;
• if the patient has impaired liver function;
• if the patient experiences prolonged and (or) painful erection;
• if the patient has problems with body temperature regulation or overheating;
• if the patient has abnormally increased levels of prolactin hormone in the blood or suspicion of a prolactin-dependent tumor;
• if the patient or their family members have a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient has any of the above conditions, consult a doctor, who may adjust the dose or monitor the patient periodically.
The treating doctor may order a white blood cell count test, as very rarely, this medicine has been associated with dangerously low levels of certain types of white blood cells essential for fighting infections.
Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after paliperidone injections. Seek immediate medical help if the patient develops rash, throat swelling, itching, or difficulty breathing, as these may be symptoms of a severe allergic reaction.
This medicine may cause weight gain. Significant weight gain may negatively affect the patient's health. The treating doctor will regularly monitor the patient's body weight.
The treating doctor will check for symptoms of elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Since this medicine may suppress vomiting, it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
During cataract surgery (clouding of the lens), the pupil (black part of the eye) may not dilate sufficiently. Also, the iris (colored part of the eye) may be floppy during surgery, which could lead to eye damage. If the patient has planned eye surgery, inform the ophthalmologist about taking this medicine.

Children and adolescents
This medicine is not used in individuals under 18 years of age.

Egoropal with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilizing medicine) may require a dosage adjustment of this medicine.
Because this medicine acts primarily in the brain, combining it with other medicines that act in the brain—such as other psychotropic medicines, opioids, antihistamines, and sedatives—may increase side effects such as drowsiness or other effects on the brain.
This medicine may lower blood pressure; therefore, caution is advised when using it together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g., levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG), manifested by prolongation of the electrical impulse through a specific part of the heart (known as "QT interval prolongation"). Other medicines with this effect include those used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with this effect include certain antidepressants or medicines used to treat infections, as well as other antipsychotics.
Caution is advised when using Egoropal together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Use of Egoropal with alcohol
Alcohol consumption should be avoided.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless discussed with a doctor.
Newborns whose mothers took paliperidone 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. If any of these symptoms are observed in the child, contact a doctor immediately.
This medicine may pass from the mother's body into breast milk and harm the child. Therefore, breastfeeding should not be performed while taking this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness, extreme fatigue, and visual disturbances may occur (see section 4). These effects should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Egoropal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free."

3. How to use Egoropal

This medicine will be administered by a doctor or other healthcare professional. Your doctor will inform you when the next injection is due. It is important not to miss a scheduled dose. If you are unable to keep your appointment, you should contact your doctor immediately by phone to reschedule as soon as possible.

You will receive the first (150 mg) and second (100 mg) injections of this medicine into the upper arm, approximately one week apart. After that, you will receive an injection (in a dose ranging from 25 mg to 150 mg) into the upper arm or buttock once a month.

If your doctor decides to switch from long-acting risperidone injections or other long-acting paliperidone injections to this medicine, the first injection of this medicine (in a dose ranging from 25 mg to 150 mg) will be given into the upper arm or buttock on the day of your next scheduled injection. After that, injections (in a dose ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock once a month.

Depending on your symptoms, your doctor may increase or decrease the dose by one strength level during your scheduled monthly injection.

Patients with kidney function disorders

Your doctor will adjust the dose of the medicine based on kidney function. If you have mild kidney function impairment, your doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney function impairment.

Elderly patients

Your doctor may reduce the dose if you have impaired kidney function.

Use of a higher than recommended dose of Egoropal

This medicine will be administered under medical supervision, so an overdose is unlikely.

In patients who have received too high a dose of paliperidone, the following symptoms may occur: drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram) findings, or slowed or abnormal muscle movements of the face, body, arms, or legs.

Stopping treatment with Egoropal

If you stop receiving the injections, the medicine will no longer work. Do not discontinue treatment unless instructed by your doctor, as symptoms of the illness may return.

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.
You should immediately inform your doctor if:

• the patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help.
• the patient with dementia experiences a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke.
• fever, muscle stiffness, sweating or reduced level of consciousness occur (a condition known as neuroleptic malignant syndrome). Immediate treatment may be necessary.
• the male patient experiences prolonged or painful erection. This condition is known as priapism. Immediate treatment may be required.
• involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs characterised by: fever, swelling of the lips, face, tongue or throat, shortness of breath, itching, skin rash, and sometimes low blood pressure (referred to as "anaphylactic reaction"). Even if the patient previously tolerated oral risperidone or paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient has planned eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract surgery (clouding of the lens), the iris (the coloured part of the eye) may become floppy (so-called "intraoperative floppy iris syndrome"), which may lead to eye damage.
• the patient has a dangerously low number of certain white blood cells essential for fighting infections.

The following adverse effects may occur:
Very common adverse effects: may affect more than 1 in 10 patients

• difficulty falling asleep or maintaining sleep.

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

• cold-like symptoms, urinary tract infection, flu-like symptoms
• the medicine Egoropal may increase the level of the hormone prolactin in the blood (this may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection or other sexual disturbances. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding or other menstrual cycle disturbances
• high blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation/drooling, and expressionless face
• psychomotor restlessness, drowsiness or reduced alertness
• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• dizziness
• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks
• tremor
• headache
• rapid heartbeat
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
• increased liver enzyme activity in blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• injection site reaction, including itching, pain or swelling.

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

• pneumonia, bronchitis, respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of certain white blood cells protecting against infections, anaemia
• allergic reaction
• development of diabetes or worsening of pre-existing diabetes, increased blood insulin levels (hormone regulating blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high blood triglyceride (fat) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• tardive dyskinesia (twitching or jerking uncontrollable movements of the face, tongue or other body parts). Inform your doctor immediately if involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon changing to upright position, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eye
• sensation of dizziness, ringing in the ears, ear pain
• conduction block of impulses between heart chambers, abnormal conduction of electrical impulses in the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heart rate, abnormal electrocardiogram (ECG), palpitations
• low blood pressure, low blood pressure upon standing (as a result, some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly)
• shallow breathing, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased activity of GGTP enzyme (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• skin rash, itching, urticaria, hair loss, skin rash, dry skin, skin redness, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) enzyme activity in blood, an enzyme sometimes released from damaged muscles
• muscle cramps, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhea
• swelling of the face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• skin hardening
• falls.

Rare adverse effects: may affect up to 1 in 1,000 patients

• eye infection
• skin inflammation caused by mites, peeling and itching of the scalp or body skin
• increased number of eosinophils (a type of white blood cell) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• head tremors
• abnormal secretion of the hormone regulating urine production
• glucose in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement and response to stimuli in a patient who is not asleep (catatonia)
• confusion
• sleepwalking
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, decreased level of consciousness, seizures, balance disturbances
• impaired motor coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity, increased tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heartbeat - blood clot in the lungs causing chest pain and breathing difficulties. In case of such symptoms, seek immediate medical help.
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). In case of such symptoms, seek immediate medical help
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• blood congestion in the lungs, congestion of the airways
• respiratory sounds, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• muscle fibre breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to pass urine
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, thirst sensation
• withdrawal symptoms
• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.

Adverse effects with unknown frequency: frequency cannot be estimated from available data

• dangerously low number of certain white blood cells responsible for fighting infections
• severe allergic reaction characterised by fever, swelling of lips, face, tongue or throat, shallow breathing, itching, skin rash, and sometimes low blood pressure
• dangerously excessive water drinking - water intoxication
• sleep-related eating disorders
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, pneumonia caused by food aspiration, voice disturbances
• lack of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes and genital areas and around these areas and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling which may involve the larynx and lead to breathing difficulties
• skin depigmentation
• abnormal posture
• in newborns whose mothers used Egoropal during pregnancy, adverse effects of the medicine and/or withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• low body temperature
• necrosis at injection site and ulceration at injection site.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Egoropal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the pre-filled syringe.
The expiry date refers to the last day of the stated month.
Do not store above 30 ° C.
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 package and other information

What Egoropal contains

• The active substance is paliperidone. Each pre-filled syringe of Egoropal 25 mg contains 39 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 50 mg contains 78 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 75 mg contains 117 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 100 mg contains 156 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 150 mg contains 234 mg of paliperidone palmitate.
• Other ingredients are: Polysorbate 20, Macrogol 4000, Citric acid monohydrate, Disodium phosphate, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide (for pH adjustment), Water for injections.

What Egoropal looks like and contents of the pack
Egoropal is a white or almost white prolonged-release injectable suspension in a pre-filled syringe.
Each cardboard box contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer
PHARMATHEN INTERNATIONAL S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
69300 Rodopi
Greece
Pharmathen S.A
Dervenakion 6
15351 Pallini Attiki
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Egoropal
Poland Egoropal
Hungary Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, retardszuszpenziós injekció előretöltött fecskendőben
Czech Republic Egoropal
Bulgaria Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, инжекционна суспензия с удължено освобождаване в предварително напълнена спринцовка
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection
Lithuania Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, pailginto atpalaidavimo injekcinė suspensija užpildytame švirkšte
Latvia Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, ilgstošas darbības suspensija injekcijām pilnšļircē
Slovakia Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, injekčná suspenzia s predĺženým uvoľňovaním v naplnenej injekčnej striekačke

For further information, please contact the Marketing Authorisation Holder.
EGIS Polska sp. z o.o.:
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Telephone number: +48 22 417 92 00

Information intended exclusively for medical personnel or healthcare professionals and should be read together with the full product information (Summary of Product Characteristics).

The injectable suspension is for single use only. Before administration, inspect the suspension for foreign particles. If foreign particles are visible in the pre-filled syringe, do not use the medicinal product.

The package contains a pre-filled syringe and two needles with safety device [22G 1.5 inch (38.1 mm x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular administration.

1. Shake the pre-filled syringe vigorously for at least 10 seconds to ensure homogeneity of the suspension.

2. Select the appropriate needle.

The first initiating dose of the medicinal product Egoropal (150 mg) should be administered on Day 1 into the DELTOID MUSCLE using a needle for deltoid injections. The second initiating dose of the medicinal product Egoropal (100 mg) should be administered one week later (Day 8) into the DELTOID MUSCLE using a needle for deltoid injections.

When switching from long-acting risperidone injections to the medicinal product Egoropal, the first injection of Egoropal (at a dose between 25 mg and 150 mg) may be administered into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection.

Monthly maintenance doses may be administered into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle.

For intramuscular injections into the DELTOID MUSCLE in patients with body weight < 90 kg, use a 1-inch, 23G needle (25.4 mm x 0.64 mm) (needle with blue hub). If the patient's body weight is ≥ 90 kg, use a 1.5-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

For intramuscular injections into the GLUTEAL MUSCLE, use a 1.5-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

3. Holding the pre-filled syringe with the tip pointing upward, remove the rubber cap from the tip with a gentle twisting motion.

4. Partially peel off the outer layer of the blister packaging of the safety needle. Grasp the needle shield through the plastic packaging. Hold the pre-filled syringe upright. Attach the safety needle to the syringe by gently screwing it on to avoid breakage or damage to the needle tip. Before administration, always check for signs of damage or leakage.

5. Remove the needle shield by pulling it straight off. Do not twist the shield, as this may loosen the needle from the pre-filled syringe.

6. Position the pre-filled syringe with attached needle vertically to remove air. Expel air from the syringe by gently pushing the plunger forward.

7. Administer the entire content of the pre-filled syringe intramuscularly, slowly and deeply, into the selected muscle of the patient — either deltoid or gluteal. Do not administer the medicinal product intravenously or subcutaneously.

8. After completing the injection, use the thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle safety device. A clicking sound indicates successful needle protection. Dispose of the pre-filled syringe with the needle properly.

8a

8b

8c