Palifren Long

Package Leaflet: Information for the User

Palifren Long, 25 mg, prolonged-release suspension for injection

In a pre-filled syringe

Palifren Long, 50 mg, prolonged-release suspension for injection in a pre-filled syringe

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

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

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

Palifren Long, 100 mg / 150 mg, prolonged-release suspension for injection in a pre-filled syringe: starter pack

Paliperidone

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What is Palifren Long and what is it used for

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

Schizophrenia is a disease with "positive" and "negative" symptoms. Positive symptoms mean the presence of symptoms that usually do not occur. A person with schizophrenia may, for example, hear voices or see things that do not exist (these are hallucinations), believe in things that are not true (these are delusions), or be overly suspicious of others. Negative symptoms mean the absence of behaviors or feelings that usually occur. A person with schizophrenia may, for example, appear withdrawn, closed off, and unresponsive emotionally or may have difficulty speaking clearly and logically. People with this disease may also experience depression, anxiety, guilt, or tension.

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

2. Important information before using Palifren Long

When not to use Palifren Long

• If you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to another antipsychotic medicine, including the active substance risperidone.

Warnings and precautions

Before starting treatment with Palifren Long, 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, although not everyone gets them. Some 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 you have Parkinson's disease
• if you have ever been diagnosed with a condition characterized by high fever and muscle stiffness (also known as malignant neuroleptic syndrome)
• if you have ever had abnormal movements of the tongue or facial muscles (tardive dyskinesia)
• if you have 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 you have diabetes or are at risk of developing it
• if you have breast cancer or a pituitary tumor
• if you have heart disease or are being treated for heart disease that may lead to low blood pressure
• if you have low blood pressure when changing position from lying down or sitting to standing
• if you have epilepsy
• if you have kidney or liver function disorders
• if you experience prolonged or painful erections
• if you have problems with body temperature regulation or overheating
• if you have high levels of the hormone prolactin in your blood or suspected prolactin-dependent tumors
• if you or your family members have had blood clots in the blood vessels, as antipsychotic medicines are associated with their formation.

If you meet any of the above criteria, you should consult your doctor, who may adjust the dose or periodically monitor you.

Your doctor may order a white blood cell count test, as very rare cases of a dangerously low number of a certain type of white blood cell necessary for fighting infections have been reported in patients taking this medicine.

Even if you have previously tolerated oral paliperidone or risperidone, rare allergic reactions may occur after injections of Palifren Long. You should seek medical help immediately if you experience 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 your health. Your doctor will regularly check your weight.

Your doctor will check if you have symptoms of high blood sugar, as new cases of diabetes or worsening of existing diabetes have been reported in patients taking this medicine. If you already have diabetes, you should have your blood glucose levels checked regularly.

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 may not dilate sufficiently.

The iris may also be flaccid during the procedure, which can lead to eye damage.

If you are scheduled for eye surgery, you should tell your ophthalmologist about taking this medicine.

Children and adolescents

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

Palifren Long and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Taking this medicine with carbamazepine (a medicine with antiepileptic and mood-stabilizing effects) may require a change in the dose of this medicine.

Due to the fact that this medicine acts primarily in the brain, interactions with other medicines, such as other psychotropic medicines, opioids, antihistamines, and sedatives that act in the brain, may intensify 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 medicines that lower blood pressure.

This medicine may weaken the effect of medicines used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa).

This medicine may cause abnormalities in the electrocardiogram (ECG) characterized by prolongation of the QT interval. Other medicines with such effects include those used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.

If you have a tendency to seizures, this medicine may increase the risk of their occurrence. Other medicines with such effects include certain medicines used to treat depression or infections, as well as other antipsychotic medicines.

Caution should be exercised when using Palifren Long with medicines that increase the activity of the central nervous system (psychostimulant medicines such as methylphenidate).

Palifren Long and alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy unless discussed with your 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 you notice such symptoms in your child, you should contact your doctor.

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

Therefore, during treatment with this medicine, you should not breastfeed.

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 machinery.

Palifren Long contains sodium

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

3. How to use Palifren Long

The medicine is administered by a doctor or other medical staff. Your doctor will inform you when the next injection is needed. It is important not to miss a scheduled dose. If you cannot keep the scheduled appointment, you should immediately inform your doctor to schedule another appointment as soon as possible.

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

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

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

Patients with kidney function disorders

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

Elderly patients

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

Using more than the recommended dose of Palifren Long

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 slowed or abnormal muscle movements of the face, body, arms, or legs.

Stopping treatment with Palifren Long

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You should immediately inform your doctor if:

• you 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 you experience such symptoms, you should seek medical help immediately.
• you have dementia and experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially one-sided, or speech disturbances. These symptoms may indicate a stroke.
• you experience fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• you experience prolonged or painful erections. This condition is known as priapism. Immediate treatment may be necessary.
• you experience involuntary rhythmic movements of the tongue, lips, or face. Immediate treatment may be necessary, and it may be necessary to stop treatment with paliperidone.
• you experience a severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (known as anaphylactic reaction). Even if you have previously tolerated risperidone or paliperidone orally, rare allergic reactions may occur after injections of paliperidone.
• you are scheduled for eye surgery, you should tell your ophthalmologist about taking this medicine. During cataract surgery, a condition known as intraoperative floppy iris syndrome may occur, which can lead to eye damage.
• you 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 affect more than 1 in 10 people)

• difficulty sleeping or waking up

Common side effects (may affect up to 1 in 10 people)

• cold symptoms, urinary tract infections, flu-like symptoms
• Palifren Long may increase the level of the hormone prolactin in the blood (which may or may not cause symptoms). If symptoms of high 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 secretion, absence of menstrual periods, or other menstrual disorders
• high blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, feeling of stiffness or tension in the muscles (which can cause uneven, jerky movements), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include: slow, shuffling gait, tremors at rest, increased saliva production, and/or drooling, and a mask-like face
• 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 posture), dystonia most commonly affects the muscles of the face, 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 activity of liver enzymes in the blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• galactorrhea
• fever, weakness, fatigue
• reaction at the injection site, including itching, pain, or swelling

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

• 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, decreased platelet count (blood cells responsible for stopping bleeding), anemia
• allergic reaction
• development 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). You should immediately inform your doctor if you 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, concentration disorders, 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 veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). If you experience such symptoms, you should seek medical help immediately
• flushing
• breathing difficulties during sleep (sleep apnea)
• blood congestion in the lungs
• crackling in the lungs
• pancreatitis, tongue swelling, fecal incontinence, very hard stool
• chapped lips
• skin rash related to drug use, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• urinary incontinence
• breast discomfort, breast enlargement, gynecomastia
• vaginal discharge
• 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

in the injection site

Side effects with unknown frequency (frequency cannot be estimated from available data)

• dangerously low number of certain white blood cells necessary for fighting infections;
• severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure
• dangerously excessive water intake - water poisoning
• eating disorders related to sleep
• coma due to uncontrolled diabetes
• head tremors
• blood clot in the lungs causing chest pain and difficulty breathing. If you experience such symptoms, you should seek medical help immediately
• decreased oxygenation of various parts of the body (due to decreased blood flow)
• rapid, shallow breathing, pneumonia due to aspiration of food, voice disorders
• intestinal obstruction, absence of intestinal peristalsis 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 involve the throat and lead to difficulty breathing
• skin discoloration, peeling, and itching of the scalp or body
• abnormal posture
• in newborns whose mothers used Palifren Long 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
• priapism (prolonged erection, which may require surgical intervention)
• low body temperature
• gangrene at the injection site and ulcer at the injection site

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Palifren Long

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Palifren Long contains

The active substance of the medicine is paliperidone.

Each pre-filled syringe of Palifren Long 25 mg contains 39 mg of paliperidone palmitate, which corresponds to 25 mg of paliperidone.

Each pre-filled syringe of Palifren Long 50 mg contains 78 mg of paliperidone palmitate, which corresponds to 50 mg of paliperidone.

Each pre-filled syringe of Palifren Long 75 mg contains 117 mg of paliperidone palmitate, which corresponds to 75 mg of paliperidone.

Each pre-filled syringe of Palifren Long 100 mg contains 156 mg of paliperidone palmitate, which corresponds to 100 mg of paliperidone.

Each pre-filled syringe of Palifren Long 150 mg contains 234 mg of paliperidone palmitate, which corresponds to 150 mg of paliperidone.

The 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 Palifren Long looks like and contents of the pack

Palifren Long is a white or off-white (broken white) suspension for injection in a pre-filled syringe.

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

Starter pack:

Each pack contains: 1 pre-filled syringe containing 150 mg of paliperidone and 2 needles, and 1 pre-filled syringe containing 100 mg of paliperidone and 2 needles.

Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Palibon

Croatia: Arion

Cyprus: Psokardon

Denmark: Psokardon

Greece: Psokardon

Luxembourg: Psokardon

Portugal: Psokardon

Date of last revision of the package leaflet: 07.2024

Information intended for healthcare professionals only or healthcare workers 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 the suspension for foreign particles. If foreign particles are visible in the pre-filled syringe, do not use the medicinal product.

The pack contains a pre-filled syringe and 2 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 injection. Palifren Long is also available in a starter pack containing two pre-filled syringes (150 mg + 100 mg) and 2 additional needles with safety device.

• (A) 22 G x 1.5 inch (gray nozzle)
• (B) 23 G x 1 inch (blue nozzle)
• (C) Pre-filled syringe
• (D) Nozzle
• (E) End cap
• 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 starting dose of Palifren Long (150 mg) should be administered on

• Day 1 of treatment into the deltoid muscle using the deltoid needle. The second starting dose of Palifren Long (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 Palifren Long, the first injection of Palifren Long (in a dose range of 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 maintenance doses can be administered into the deltoid or gluteal muscle using the appropriate needle once a month.

For deltoid muscle injections in patients with a body weight <90 kg, use the 1-inch (25.4 mm x 0.64 mm) 23g needle (blue nozzle). if patient's body weight is ≥90 1.5-inch (38.1 0.72 22g (gray for gluteal muscle injections, nozzle).< p>

• 3. Holding the pre-filled syringe upright, remove the rubber end cap by a twisting motion.

• 4. Tear the outer part of the needle packaging in half. Grasp the needle shield by the plastic packaging. Connect the Luer lock of the needle shield to the pre-filled syringe by a gentle twisting motion in a clockwise direction.

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

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

• 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, shield the needle using your thumb or finger of one hand (8a, 8b) or a flat surface (8c). The click sound confirms the needle is properly shielded. Dispose of the pre-filled syringe with the needle in an appropriate manner.

8a

8b

8c