Palifren long

Patient Information Leaflet

Palifren Long, 25 mg, prolonged-release injectable suspension
in pre-filled syringe
Palifren Long, 50 mg, prolonged-release injectable suspension
in pre-filled syringe
Palifren Long, 75 mg, prolonged-release injectable suspension
in pre-filled syringe
Palifren Long, 100 mg, prolonged-release injectable suspension
in pre-filled syringe
Palifren Long, 150 mg, prolonged-release injectable suspension
in pre-filled syringe
Palifren Long, 100 mg / 150 mg, prolonged-release injectable suspension
in pre-filled syringe: initiation pack
Paliperidone
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Table of Contents

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

Palifren Long 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 stable adult patients previously treated with paliperidone or risperidone.

For patients who have previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, your doctor may initiate treatment with Palifren Long without prior stabilization with paliperidone or risperidone.

Schizophrenia is a disorder characterized by "positive" and "negative" symptoms. Positive symptoms refer to the presence of abnormal experiences that are usually not present. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence or reduction of normal behaviors or emotions. A person with schizophrenia may appear withdrawn, emotionally flat or unresponsive, or may have difficulty speaking clearly and logically. People affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.

Palifren Long helps to reduce the symptoms of the illness and helps prevent their recurrence.

2. Important information before using Palifren Long

When not to use Palifren Long

• If the patient is allergic to paliperidone or to 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 Palifren Long, 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, there may be an increased risk of stroke or death (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:

• 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 diabetes
• if the patient has breast cancer or a 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 standing or sitting position
• if the patient has epilepsy
• if the patient has been diagnosed with kidney function disorders
• if the patient has been diagnosed with liver function disorders
• 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 suspected prolactin-dependent tumor
• if the patient or family members have a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient meets any of the above criteria, 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, dangerously low levels of certain types of white blood cells essential for fighting infections have been observed in patients taking this medicine.
Even if the patient previously tolerated oral paliperidone or risperidone well, allergic reactions may rarely occur after Palifren Long 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 adversely 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 ingested toxic substances or other medical conditions.
During cataract removal surgery, the pupil may not dilate sufficiently.
Also, the iris of the eye may be flaccid during the procedure, which may result in eye damage.
If the patient has planned eye surgery, inform the ophthalmologist about taking this medicine.

Children and adolescents
This medicine is not intended for use in individuals under 18 years of age.

Palifren Long 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 together with carbamazepine (an antiepileptic and mood-stabilizing agent) may require adjustment of the dosage of this medicine.
Since this medicine acts primarily in the brain, interactions with other medicines such as other psychotropic medicines, opioids, antihistamines, and sedatives that act on the brain 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 for Parkinson's disease and restless legs syndrome (e.g., levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG), manifesting as prolongation of the time it takes for an electrical impulse to pass through a specific part of the heart (known as "QT interval prolongation"). Other medicines with this effect include certain drugs 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 antimicrobials, as well as other antipsychotic medicines.
Caution is advised when using Palifren Long together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Palifren Long and 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 baby, 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 used 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 such symptoms are observed in the newborn, contact a doctor immediately.
This medicine may pass from the mother's body into breast milk and harm the baby. Therefore, breastfeeding must not be used during treatment with this medicine.

Driving and operating machinery
Dizziness, extreme fatigue, and vision disturbances (see section 4) may occur during treatment with this medicine. This should be considered in situations requiring full alertness, such as driving or operating machinery.

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

3. How to use Palifren Long

The medicine is administered by a doctor or other medical personnel. 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 the scheduled appointment, you should immediately inform your doctor so that a new appointment can be arranged as soon as possible.

The first (150 mg) and second (100 mg) injections of this medicine will be given into the upper arm, approximately one week apart. Afterwards, an injection (in a dose ranging from 25 mg to 150 mg) will be administered once monthly into the upper arm or buttock.

If your doctor decides to switch you from 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 into the upper arm or buttock on the day of your next scheduled injection. Afterwards, an injection (in a dose ranging from 25 mg to 150 mg) will be administered once monthly into the upper arm or buttock.

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

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

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

Use of a higher than recommended dose of Palifren Long
This medicine will be administered under medical supervision, so 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 movements of the face, body, arms, or legs.

Stopping Palifren Long treatment
If you stop receiving the injections, the medicine will stop working. 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, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side 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 of 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.
• in a patient with dementia, there is 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 decreased level of consciousness occurs (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary.
• a man experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be required.
• involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs, characterised by: fever, swelling of the lips, face, mouth or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or paliperidone taken orally, 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 removal, floppy iris syndrome may occur, which can lead to eye damage.
• the patient has a dangerously low number of certain white blood cells essential for fighting infections. The following adverse reactions 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-like symptoms, urinary tract infection, flu-like symptoms
• Palifren Long may increase the level of prolactin hormone 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 leakage 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 feeling of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face
• psychomotor restlessness, feeling of drowsiness or reduced alertness
• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (which may result 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, stuffy nose
• 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
• galactorrhoea
• fever, weakness, fatigue
• injection site reaction, including itching, pain or swelling

Uncommon side effects (may occur in less than 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, decreased platelet count (blood cells responsible for stopping bleeding), anaemia
• allergic reaction
• onset of diabetes and 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 (fats) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• tardive dyskinesia (jerking or twitching uncontrolled movements of the face, tongue or other body parts). Inform your doctor immediately if involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon standing, 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 eyes
• feeling of dizziness, ringing in the ears, ear pain
• conduction block of impulses between heart chambers, abnormal electrical conduction 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 or rising)
• shallow breathing, congestion of the airways, wheezing, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• muscle cramps, joint stiffness, muscle weakness, neck pain
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstrual bleeding and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain
• 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, general malaise
• skin hardening
• fall

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

• eye infection
• skin inflammation caused by mites, subcutaneous abscess
• increased number of eosinophils (a type of white blood cell) in blood
• abnormal secretion of the hormone regulating urine volume
• 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)
• disorientation
• sleepwalking
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, decreased or loss of consciousness, high fever and severe muscle rigidity), cerebral vascular disorders involving sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures, balance disturbances
• abnormal motor coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity of the eyes, increased tearing, redness of the eyes
• atrial fibrillation (irregular heartbeat), irregular heartbeat
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, seek immediate medical help
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• blood congestion in the lungs
• crackling sounds in the lungs
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• breakdown of muscle fibres and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• very low body temperature, chills, feeling of thirst
• withdrawal symptoms
• abscess caused by infection at injection site, deep skin infection, cyst at injection site, bruising at injection site

Adverse reactions of 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, mouth or tongue, 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
• head tremors
• pulmonary embolism causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, pneumonia caused by food aspiration, voice disturbances
• intestinal obstruction, 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 genitals 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 discoloration, peeling and itching of the scalp or body skin
• abnormal body posture
• in newborns whose mothers used Palifren Long during pregnancy, adverse drug reactions and (or) withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• priapism (prolonged erection which may require surgical intervention)
• decreased body temperature
• necrosis at injection site and ulcer at injection site

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

5. How to store Palifren Long

Keep this medicine out of 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 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Palifren Long contains
The active substance is paliperidone.
Each Palifren Long 25 mg pre-filled syringe contains 39 mg of paliperidone palmitate, equivalent to
25 mg of paliperidone.
Each Palifren Long 50 mg pre-filled syringe contains 78 mg of paliperidone palmitate, equivalent to
50 mg of paliperidone.
Each Palifren Long 75 mg pre-filled syringe contains 117 mg of paliperidone palmitate, equivalent to
75 mg of paliperidone.
Each Palifren Long 100 mg pre-filled syringe contains 156 mg of paliperidone palmitate, equivalent to
100 mg of paliperidone.
Each Palifren Long 150 mg pre-filled syringe contains 234 mg of paliperidone palmitate, equivalent 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 colour) injectable suspension for prolonged release,
contained in a pre-filled syringe.
Each pack contains: 1 pre-filled syringe and 2 needles.
Starting dose 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 Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +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 medicinal product is authorised for sale in the European Economic Area under the following names:
Austria: Palibon
Croatia: Arion
Cyprus: Psokardon
Denmark: Psokardon
Greece: Psokardon
Luxembourg: Psokardon
Portugal: Psokardon

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

The injectable suspension is intended for single use only. Prior to administration, inspect the suspension visually for the presence of foreign particles. If foreign particles are observed in the prefilled syringe, do not use the medicinal product.

The package contains one prefilled syringe and two safety needles [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. The medicinal product Palifren Long is also available in a starter pack containing two prefilled syringes (150 mg + 100 mg) and two additional safety needles.

(A) 22G x 1.5 inch (gray hub)
(B) 23G x 1 inch (blue hub)
(C) Prefilled syringe
(D) Hub
(E) Tip cap

1. Shake the prefilled 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 Palifren Long (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE using the needle intended for the DELTOID MUSCLE. The second initiating dose of the medicinal product Palifren Long (100 mg) should be administered one week later (day 8), also into the DELTOID MUSCLE using the needle intended for the DELTOID MUSCLE.

When switching from long-acting risperidone injections to the medicinal product Palifren Long, the first injection of Palifren Long (at a dose ranging from 25 mg to 150 mg) may be administered either into the DELTOID MUSCLE or the GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection. Subsequently, monthly maintenance doses may be administered into either the DELTOID MUSCLE or the 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 (25.4 mm x 0.64 mm) needle (blue hub). If the patient's body weight is ≥90 kg, use a 1.5-inch, 22G (38.1 mm x 0.72 mm) needle (gray hub).

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

3. Holding the prefilled syringe vertically with the tip pointing upward, remove the rubber tip cap by twisting it off.

4. Partially peel open the outer blister packaging of the safety needle. Hold the needle shield through the plastic packaging. Attach the Luer-lock tip of the safety needle to the prefilled syringe by gently turning clockwise until securely fastened.

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

6. Expel air from the prefilled syringe by gently pressing the plunger while holding the syringe vertically.

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

8. After completing the injection, activate the needle safety mechanism by pressing the thumb or finger of one hand against the shield (8a, 8b) or against a flat surface (8c). A clicking sound indicates successful needle shielding. Dispose of the prefilled syringe with the attached needle appropriately.

8a

8b

8c