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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 adults who have already been stabilized 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 A person suffering from schizophrenia may, for example, seem withdrawn, closed off, and not react emotionally at all, or may have problems with understandable and logical speech. People with this disease may also experience depression, anxiety, 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, 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, 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, which may predispose 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 elevated prolactin levels 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 lead to 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

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Taking this medicine with carbamazepine(an antiepileptic and mood stabilizer) may require a change in the dose of Pratyria.
• Due to the fact that this medicine acts mainly 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 interactions 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 some 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 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 feeding difficulties. 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 done.

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 is needed. It is essential 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 approximately 1 week. Then, an injection (in a dose ranging from 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 ranging from 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 ranging from 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 administered 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 administering too high a dose is unlikely.

In patients who received too high a dose of paliperidone, the following symptoms may occur: drowsiness and sedation, rapid heart rate, low blood pressure, abnormal ECG (electrocardiogram), or slowed 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. Treatment with this medicine should not be stopped unless the doctor decides to do so, as the symptoms of the disease may return.

In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Inform your doctor immediately if:

• the patient experiences 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, seek medical help immediately.
• the patient with dementia experiences 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.
• a fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome) occurs. Immediate treatment may be necessary.
• a man experiences prolonged or painful erections. This condition is called priapism. Immediate treatment may be necessary.
• involuntary rhythmic movements of the tongue, lips, or face occur. It may be necessary to discontinue treatment with paliperidone.
• a severe allergic reaction occurs, characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (anaphylactic reaction). Even if the patient has previously tolerated risperidone or paliperidone orally, rare allergic reactions may occur after injections of paliperidone.
• the patient is scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine. During cataract surgery, a condition called intraoperative floppy iris syndrome may occur, which can lead to eye damage.
• the patient has 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 bleeding, 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 unlocking. Other symptoms of parkinsonism include: slow, shuffling gait, tremors, increased saliva production, and (or) drooling and a face without expression
• psychomotor agitation, feeling of 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 an abnormal body posture), dystonia most commonly affects the facial muscles, including abnormal movements of the eyes, lips, tongue, or jaw
• dizziness
• dyskinesia: this condition includes involuntary muscle movements and can take the form of 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 (twitching or jerking uncontrolled movements of the face, tongue, or other parts of the body). If involuntary rhythmic movements of the tongue, lips, or face occur, the doctor should be informed immediately. It may be necessary to discontinue treatment with this medicine
• fainting, need to move limbs, dizziness when changing position to standing, balance disturbances, speech difficulties, loss of taste, decreased sensitivity to pain and touch on the skin, feeling of tingling, prickling, 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, seek medical help immediately
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). If such symptoms occur, seek medical help immediately
• 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, which may require surgical intervention)
• very low body temperature, chills, feeling of thirst
• withdrawal symptoms
• abscess formation at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site

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 due to inhalation of food, voice disturbances
• lack of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• 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 feeding difficulties
• 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 doctor, pharmacist, or nurse should be informed.

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

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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pratyria

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and pre-filled syringe. The expiry date (EXP) refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask a 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 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), with a lock 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, please 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 and should be read in conjunction with the full product information (Summary of Product Characteristics).

The suspension for injection is for single use only. Before administration, check for any visible particles in the suspension. If visible particles are observed in the pre-filled syringe, do not use the medicinal product.

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 needle. The second initiating dose of Pratyria (100 mg) should be administered 1 week later (day 8) into the deltoid muscle using the deltoid needle.

In case of switching from risperidone long-acting injections to Pratyria, the first injection of Pratyria (in a dose ranging from 25 mg to 150 mg) can be administered into the deltoid or gluteal muscle using the appropriate needle on the day of the next scheduled injection. Subsequent monthly maintenance doses can be administered into the deltoid or gluteal muscle using the appropriate needle.

For deltoid muscle injections in patients with a body weight <90 kg, use the 1-inch, 23g (25 mm x 0.6 mm) needle (needle with a bluecap). If the patient's body weight is ≥ 90 kg, use the 1½-inch, 22G (38 mm x 0.7 mm) needle (needle with a graycap). For gluteal muscle injections, use the 1½-inch, 22G (38 mm x 0.7 mm) needle (needle with a graycap).

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

• 4. Tear off the outer part of the needle packaging halfway. 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, avoiding breaking or damaging the needle tip. 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 on the pre-filled syringe.

• 6. Remove the air from the pre-filled syringe by gently pressing the plunger rod of the pre-filled syringe while holding it in a vertical position.

• 7. Inject the entire contents of the pre-filled syringe intramuscularly, slowly, and deeply into the selected muscle of the patient — deltoid or gluteal. Do not administer the medicinal 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 proper securing of the needle. 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.