Pratiria

Leaflet accompanying the packaging: information for the user

Pratyria, 75 mg, prolonged-release suspension for injection in a pre-filled syringe

Pratyria, 100 mg, prolonged-release suspension for injection in a pre-filled syringe

Pratyria, 150 mg, prolonged-release suspension for injection in a pre-filled syringe

Treatment initiation pack

Pratyria, 150 mg, prolonged-release suspension for injection in a pre-filled syringe

Pratyria, 100 mg, prolonged-release suspension for injection in a pre-filled syringe

Paliperidone

You should carefully read the contents of this leaflet before using 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 doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Pratyria and what is it used for

Pratyria contains the active substance paliperidone, which belongs to a group of antipsychotic medicines, and is used to treat schizophrenia in already stabilized adult patients who have been treated with paliperidone or risperidone.

Schizophrenia is a disease with "positive" and "negative" symptoms. Positive symptoms mean the accumulation of symptoms that usually do not occur. A person suffering from schizophrenia may, for example, hear voices or see things that do not exist (these are hallucinations), believe in untrue things (these are delusions), or be overly suspicious of others. Negative symptoms mean the lack of normally occurring behaviors or feelings. A person suffering from schizophrenia may, for example, seem withdrawn, closed off, and not respond emotionally at all, or may have problems with understandable and logical speech. People with this disease may also experience depression, anxiety, feelings of guilt, or tension.

Pratyria helps to alleviate the symptoms of the disease and prevent their recurrence.

2. Important information before using Pratyria

When not to use Pratyria

• 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 Pratyria, you should discuss it with your doctor, pharmacist, or nurse.

This medicine has not been studied in elderly patients with dementia. However, in such patients treated with other similar medicines, there may be an increased risk of stroke or death (see section 4, Possible side effects).

All medicines can cause side effects, and some of the side effects of this medicine may worsen the symptoms of other medical conditions. Therefore, during treatment with this medicine, you should discuss with your doctor any of the following conditions:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition whose symptoms include high fever and muscle stiffness (also known as malignant neuroleptic syndrome)
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia)
• if the patient has had a low white blood cell count in the past (which may or may not have been caused by the action of other medicines)
• if the patient has diabetes or is prone to it
• if the patient has breast cancer or a pituitary tumor
• if the patient has heart disease or is being treated for heart disease that predisposes to low blood pressure
• if the patient has low blood pressure when changing position from lying down to standing or sitting
• if the patient has epilepsy
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient experiences prolonged or painful erections
• if the patient has problems with body temperature regulation or overheating
• if the patient has abnormal, elevated levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• if the patient or their family members have had cases of blood clots in blood vessels, as antipsychotic medicines are associated with their formation.

If the patient meets any of the above criteria, they should consult a doctor who may adjust the dose or periodically monitor the patient.

• The doctor may order a white blood cell count test, as very rarely, patients taking this medicine have had a dangerously low number of a certain type of white blood cell necessary for fighting infections.
• Even if the patient has previously tolerated oral paliperidone or risperidone, rare allergic reactions may occur after injections of Pratyria. Medical help should be sought immediately if the patient experiences a 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 can have a negative impact on the patient's health. The treating doctor will regularly check the patient's weight.
• The treating doctor will check if the patient has symptoms of high blood sugar, as patients taking this medicine have had new cases of diabetes or worsening of existing diabetes. In patients with existing diabetes, blood glucose levels should be regularly checked.
• Because this medicine can suppress vomiting, it may mask the body's normal response to swallowing toxic substances or other medical conditions.
• During cataract surgery, the pupil (the black circle in the center of the eye) may not dilate sufficiently. The iris (the colored part of the eye) may also be flaccid during the procedure, which can result in eye damage. If the patient is scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine.

Children and adolescents

This medicine is not used in people under 18 years of age.

Pratyria and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Taking this medicine with carbamazepine(an antiepileptic and mood stabilizer) may require a change in the dosage of Pratyria.
• Due to the fact that this medicine acts primarily in the brain, interactions with other medicines such as other psychotropic medicines, opioids, antihistamines, and sedativesthat act in the brain may cause an increase in side effects, such as drowsiness, or other effects on the brain.
• This medicine may cause a decrease in blood pressure, so caution should be exercised when using this medicine with other blood pressure-lowering medicines.
• This medicine may weaken the effect of medicines used for Parkinson's disease and restless legs syndrome (e.g., levodopa).
• This medicine may cause electrocardiogram (ECG) abnormalities, characterized by prolongation of the QT interval. Other medicines with this effect include medicines used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
• If the patient has a tendency to seizures, this medicine may increase the risk of their occurrence. Other medicines with this effect include certain medicines used to treat depression or infections, as well as other antipsychotic medicines.
• Caution should be exercised when using Pratyria with medicines that increase the activity of the central nervous system (psychostimulant medicines such as methylphenidate).

Using Pratyria with alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

This medicine should not be used during pregnancy, unless it has been discussed with a doctor.

In newborns whose mothers used paliperidone in 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 such symptoms are observed in the patient's child, they should contact a doctor.

Breastfeeding

This medicine may pass from the mother's body into her breast milk and harm the baby.

Therefore, during treatment with this medicine, breastfeeding should not be performed.

Driving and using machines

During treatment with this medicine, dizziness, extreme fatigue, and vision disturbances (see section 4) may occur. This should be taken into account in situations where full alertness is required, e.g., when driving a vehicle or operating machines.

Pratyria contains sodium

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

3. How to use Pratyria

The medicine is administered by a doctor or other medical staff. The doctor will inform the patient when the next injection should be given. It is important not to miss a scheduled dose. If it is not possible to keep the scheduled appointment, the doctor should be informed immediately to schedule another appointment as soon as possible.

Dosage and administration

The first (150 mg) and second (100 mg) injections of this medicine will be given in the upper arm with an interval of about 1 week. Then, an injection (in a dose of 25 mg to 150 mg) will be given in the upper arm or buttock once a month.

If the doctor decides to switch from using long-acting risperidone injections to this medicine, the first injection of this medicine (in a dose of 25 mg to 150 mg) will be given in the upper arm or buttock on the day of the next scheduled injection. Then, an injection (in a dose of 25 mg to 150 mg) will be given in the upper arm or buttock once a month.

Depending on the symptoms occurring in the patient, the doctor may increase or decrease the dose of the medicine by one level during the scheduled monthly injection.

Patient with kidney function disorders

The doctor will adjust the dose of the medicine, taking into account the patient's kidney function. If the patient has mild kidney function disorders, the doctor may decrease the dose. This medicine should not be used in cases of moderate or severe kidney function disorders.

Elderly patients

The doctor may decrease the dose of the medicine if the patient has impaired kidney function.

Using a higher than recommended dose of Pratyria

This medicine will be administered under medical supervision, so it is unlikely that too much of the medicine will be given.

In patients who have received too much paliperidone, the following symptoms may occur: drowsiness and sedation, rapid heart rate, low blood pressure, abnormal ECG (electrocardiogram), or slow or abnormal movements of the face, body, arms, or legs.

Stopping treatment with Pratyria

If the patient stops taking the injections, the medicine will stop working. The patient should not stop taking the medicine unless the doctor decides to do so, as the symptoms of the disease may return.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor if:

• they experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek medical help immediately.
• they experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or speech disturbances, even if only for a short time. These symptoms may indicate a stroke.
• they experience fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• a man experiences prolonged or painful erections. This condition is known as priapism. Immediate treatment may be necessary.
• they experience involuntary, rhythmic movements of the tongue, lips, or face. It may be necessary to stop treatment with paliperidone.
• they experience a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (known as anaphylactic reaction). Even if the patient has previously tolerated risperidone or paliperidone orally, rare allergic reactions may occur after injections of paliperidone.
• they are scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine. During cataract surgery, a condition known as intraoperative floppy iris syndrome may occur, which can lead to eye damage.
• they experience a dangerously low number of certain white blood cells necessary for fighting infections. The following side effects may occur:

Very common side effects:may occur in more than 1 in 10 patients

• difficulty falling asleep or waking up

Common side effects:may occur in less than 1 in 10 patients

• cold symptoms, urinary tract infections, flu-like symptoms
• Pratyria may increase the level of the hormone prolactin in the blood (which may or may not cause symptoms). If symptoms of elevated prolactin levels occur, they may include (in men): breast swelling, difficulty achieving or maintaining an erection, or other sexual disorders. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual periods, or other menstrual cycle disorders
• high blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or tension in the muscles (which makes the patient's movements uneven), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include: slow, shuffling gait, tremors, increased salivation, and (or) drooling and a face without expression
• restlessness, drowsiness, or decreased alertness
• dystonia: this condition includes slow or sustained involuntary muscle contractions. Although it can affect any part of the body (which can result in abnormal body posture), dystonia most often affects the facial muscles, including abnormal eye movements, lip movements, tongue movements, or jaw movements
• dizziness
• dyskinesia: this condition includes involuntary muscle movements and can manifest as repetitive, spasmodic, or twisting movements or jerks
• tremors
• headaches
• rapid heart rate
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver enzyme activity in the blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• reaction at the injection site, including itching, pain, or swelling

Uncommon side effects:may occur in less than 1 in 100 patients

• pneumonia, bronchitis, respiratory tract infections, sinusitis, urinary tract infections, ear infections, fungal nail infections, tonsillitis, skin infections
• decreased white blood cell count, decreased number of certain white blood cells that protect against infections, anemia
• allergic reaction
• onset of diabetes and worsening of existing diabetes, increased insulin levels in the blood (a hormone that regulates blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high levels of triglycerides (fats) in the blood, increased cholesterol levels in the blood
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• late dyskinesia (trembling or jerking uncontrolled movements of the face, tongue, or other parts of the body). The patient should immediately inform their doctor if they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to stop treatment with this medicine
• fainting, need to move limbs, dizziness when changing position to standing, balance disturbances, speech difficulties, loss of taste, decreased sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eye
• feeling of dizziness, ringing in the ears, ear pain
• abnormal heart rhythm, irregular heart rhythm
• blood clots in the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). If such symptoms occur, the patient should immediately contact their doctor
• flushing
• breathing difficulties during sleep (sleep apnea)
• blood congestion in the lungs, congestion of the respiratory tract
• crackling in the lungs, wheezing
• pancreatitis, tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• dry lips
• skin rash related to medicine use, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, breast enlargement, gynecomastia
• vaginal discharge
• priapism (prolonged erection that may require surgical intervention)
• very low body temperature, chills, feeling of thirst
• withdrawal symptoms
• abscess at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site

Rare side effects:may occur in less than 1 in 1,000 patients

• eye infection
• skin rash caused by mites, flaky, itchy skin on the head or other parts of the body
• increased number of eosinophils (a type of white blood cell) in the blood
• decreased number of platelets (blood cells that help stop bleeding)
• head tremors
• abnormal secretion of the hormone that regulates the amount of urine
• sugar in the urine
• life-threatening complications of untreated diabetes
• low blood sugar
• excessive water drinking
• lack of movement and reaction to stimuli in a patient who is not asleep (catatonia)
• confusion
• sleepwalking (walking while sleeping)
• lack of emotions
• inability to achieve orgasm
• malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness), cerebral vascular disorders including sudden cessation of blood flow to the brain (stroke or "mini" stroke), lack of reaction to stimuli, loss of consciousness, low level of consciousness, seizures, balance disturbances
• abnormal coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotational eye movements, eye sensitivity to light, increased tearing, redness of the eyes
• atrial fibrillation (abnormal heart rhythm), irregular heart rhythm
• blood clots in the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). If such symptoms occur, the patient should immediately contact their doctor
• flushing
• breathing difficulties during sleep (sleep apnea)
• blood congestion in the lungs, congestion of the respiratory tract

Side effects with unknown frequency:frequency cannot be estimated from the available data

• dangerously low number of certain white blood cells responsible for fighting infections;
• severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure
• dangerously excessive water drinking
• eating disorders related to sleep
• coma due to uncontrolled diabetes
• decreased oxygenation of various parts of the body (due to decreased blood flow)
• rapid, shallow breathing, pneumonia caused by inhalation of food, voice disturbances
• lack of intestinal movement leading to obstruction
• jaundice (yellowing of the skin and eyes)
• severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, and genitals, as well as 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 include the throat and lead to difficulty breathing
• skin discoloration
• abnormal body posture
• in newborns whose mothers used Pratyria during pregnancy, the following side effects of the medicine and (or) withdrawal symptoms may occur: irritability, slow or sustained muscle contractions, trembling, drowsiness, difficulty breathing, and difficulty feeding
• low body temperature
• necrosis at the injection site and ulcer at the injection site

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Pratyria

The medicine should be stored in a place that is not visible and inaccessible to children.

This medicine should not be used after the expiry date stated on the carton and pre-filled syringe. The expiry date (EXP) refers to the last day of the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pratyria contains

The active substance of the medicine is paliperidone.

Each pre-filled syringe of Pratyria 75 mg contains paliperidone palmitate equivalent to 75 mg of paliperidone.

Each pre-filled syringe of Pratyria 100 mg contains paliperidone palmitate equivalent to 100 mg of paliperidone.

Each pre-filled syringe of Pratyria 150 mg contains paliperidone palmitate equivalent to 150 mg of paliperidone.

The other ingredients are:

Polysorbate 20 (E 432)

Macrogol 4000

Citric acid monohydrate (E330)

Disodium phosphate anhydrous (E 339)

Sodium dihydrogen phosphate monohydrate

Sodium hydroxide (E 542) (for pH adjustment)

Water for injections

What Pratyria looks like and contents of the pack

Pratyria is a white to off-white prolonged-release suspension for injection in a pre-filled syringe.

The pre-filled syringe is made of a cycloolefin copolymer, with a bromobutyl rubber stopper (tip of the plunger), a safety device, and a tip cap.

Each single pack contains: 1 pre-filled syringe and 2 needles.

Each treatment initiation pack contains:

• 1 pack of Pratyria 150 mg, 1 pre-filled syringe, and 2 needles (taken on day 1 of treatment)
• 1 pack of Pratyria 100 mg, 1 pre-filled syringe, and 2 needles (taken on day 8 of treatment)

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG,

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

Manufacturer/Importer

STADA Arzneimittel AG,

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

STADA Arzneimittel GmbH

Muthgasse 36/2, Doebling

1190, Vienna

Austria

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

STADA Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel. +48 22 737 79 20

Date of last revision of the leaflet:

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

The suspension for injection is for single use only. Before administration, the suspension should be inspected for foreign particles. If foreign particles are visible in the pre-filled syringe, the medicinal product should not be used.

The pack contains a pre-filled syringe and 2 needles with safety devices (22G x 1½ inch [38 mm x 0.7 mm] and 23G x 1 inch [25 mm x 0.6 mm]) for intramuscular injection.

• 1. Shake the pre-filled syringe vigorously for at least 10 seconds to ensure the suspension is homogeneous.

• 2. Choose the appropriate needle.

The first, initiating dose of Pratyria (150 mg) should be administered on

• day 1 of treatment into the DELTOID MUSCLE using the DELTOID MUSCLE needle. The second initiating dose of Pratyria (100 mg) should be administered 1 week later (day 8) also into the DELTOID MUSCLE using the DELTOID MUSCLE needle.

In case of switching from risperidone long-acting injections to Pratyria, the first injection of Pratyria (in a dose of 25 mg to 150 mg) can be administered into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection.

Then, monthly maintenance doses can be administered into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle.

For injections into the DELTOID MUSCLE in patients with a body weight <90 kg, a 1-inch, 23g (25 mm x 0.6 mm) needle (needle with bluecap) should be used. If the patient's body weight is ≥ 90 kg, a 1½-inch, 22G (38 mm x 0.7 mm) needle (needle with a graycap) should be used.

For injections into the GLUTEAL MUSCLE, a 1½-inch, 22G (38 mm x 0.7 mm) needle (needle with a graycap) should be used.

• 3. Hold the syringe with the tip pointing upwards, and remove the rubber cap with a gentle twisting motion.

• 4. Tear off half of the outer part of the needle packaging. Hold the needle shield by the plastic packaging. Hold the syringe with the tip pointing upwards. Mount the needle with the safety device onto the syringe by gently screwing, taking care not to cause the needle to break or become damaged. Before administration, always check for signs of damage or leakage.

• 5. Remove the needle shield with a straight pull. Do not twist the shield, as this may cause the needle to loosen from the pre-filled syringe.

• 6. Remove the air from the pre-filled syringe by gently pressing the plunger rod while holding the syringe in an upright position.

• 7. Inject the entire contents of the pre-filled syringe intramuscularly, slowly, and deeply into the selected muscle of the patient — deltoideus or gluteus. Do not administer the product intravenously or subcutaneously.
• 8. After completing the injection, secure the needle using the thumb or finger of one hand (8a, 8b) or a flat surface (8c). The clicking sound indicates that the needle is properly secured. Dispose of the pre-filled syringe with the needle in an appropriate manner.

Any unused product or waste material should be disposed of in accordance with local regulations.