Paliperidone Teva

PATIENT INFORMATION LEAFLETLeaflet attached to the packaging: information for the user

Paliperidone Teva, 75 mg, prolonged-release suspension for injection

Paliperidone Teva, 100 mg, prolonged-release suspension for injection

Paliperidone Teva, 150 mg, prolonged-release suspension for injection

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

1. What is Paliperidone Teva and what is it used for

Paliperidone Teva 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.
For patients who have previously responded to oral paliperidone or risperidone and have mild to moderate psychotic symptoms, the doctor may start treatment with Paliperidone Teva without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disease with "positive" and "negative" symptoms. Positive symptoms refer to an excess of normal symptoms. 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 refer to the lack of normal behaviors or feelings. A person with schizophrenia may, for example, appear withdrawn, isolated, and unresponsive emotionally or have difficulty understanding and speaking logically. People with this disease may also experience depression, anxiety, guilt, or tension.
Paliperidone Teva helps to alleviate the symptoms of the disease and prevent their recurrence.

2. Important information before using Paliperidone Teva

When not to use Paliperidone Teva:

• if the patient is allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6). 2
• if the patient is allergic to another antipsychotic medicine, including the active substance risperidone.

Warnings and precautions

Before starting treatment with Paliperidone Teva, the patient should discuss it with their doctor, pharmacist, or nurse.
The use of 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. Some side effects of this medicine may worsen the symptoms of other medical conditions. Therefore, it is essential to discuss with the doctor any of the following conditions that may potentially worsen:

• if the patient has Parkinson's disease
• if the patient has been diagnosed with a condition characterized by high fever and muscle stiffness (also known as malignant neuroleptic syndrome)
• if the patient has 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 use of other medicines)
• if the patient has diabetes or is at risk of developing 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 may lead to low blood pressure
• if the patient has low blood pressure when changing position from lying down or sitting to standing
• 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 regulating body temperature or overheating
• if the patient has elevated prolactin levels in the blood or suspected prolactin-dependent tumors
• if the patient or their family members have had blood clots in blood vessels, as antipsychotic medicines are associated with their formation.

If the patient has any of the above conditions, they should consult their doctor, who may adjust the dose or monitor the patient periodically.
The 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 the patient has previously tolerated oral paliperidone or risperidone, rare allergic reactions may occur after injections of paliperidone. The patient should seek immediate medical attention if they 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 the patient's health. The doctor will regularly check the patient's weight.
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The doctor will check if the patient has symptoms of high blood sugar levels, as new cases of diabetes or worsening of existing diabetes have been reported in patients taking this medicine. In patients with existing diabetes, blood glucose levels should be regularly checked.
Since this medicine can suppress vomiting, it may mask the body's normal response to ingesting toxic substances or other medical conditions.
During cataract surgery, the pupil (the black dot in the center of the eye) may not dilate sufficiently. The iris (the colored part of the eye) may also be floppy 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.

Paliperidone Teva 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 dose adjustment 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 enhance side effects, such as drowsiness, or other effects on the brain.
This medicine may cause low blood pressure, so caution should be exercised when taking it 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 abnormal heart rhythms (ECG changes) characterized by prolongation of the QT interval. Other medicines with similar effects include those used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
If the patient has a history of seizures, this medicine may increase the risk of their occurrence. Other medicines with similar effects include certain antidepressants or antiepileptics, as well as other antipsychotic medicines.
Care should be taken when using Paliperidone Teva with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).

Using Paliperidone Teva 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. This medicine should not be used during pregnancy unless discussed with the doctor. In newborns whose mothers used paliperidone during 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 their doctor.
This medicine may pass from the mother's body into her breast milk and harm the baby. Therefore, breastfeeding should be avoided while using this medicine.

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 that require full alertness, such as driving a vehicle or operating machinery.

Important information about some ingredients of Paliperidone Teva

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

3. How to use Paliperidone Teva

The medicine is administered by a doctor or other healthcare professional. The doctor will inform the patient when the next injection is due. It is essential not to miss a scheduled dose. If the patient cannot keep the scheduled appointment, they should immediately inform their doctor to arrange an alternative appointment as soon as possible.
The first (150 mg) and second (100 mg) injections of this medicine will be administered into the upper arm with an interval of approximately 1 week. Subsequent injections (in a dose range of 25 mg to 150 mg) will be administered into the upper arm or buttock once a month.
If the doctor decides to switch from using risperidone long-acting injections to this medicine, the first injection of this medicine (in a dose range of 25 mg to 150 mg) will be administered into the upper arm or buttock on the day of the next scheduled risperidone injection. Subsequent injections (in a dose range of 25 mg to 150 mg) will be administered into the upper arm or buttock once a month.
Depending on the symptoms experienced by the patient, the doctor may increase or decrease the administered dose of the medicine by one level during the scheduled monthly injection.
Patients with kidney function disorders
The doctor will adjust the dose of the medicine based on the patient's kidney function. If the patient has mild kidney function disorders, the doctor may reduce the dose. This medicine should not be used in patients with moderate or severe kidney function disorders.
Elderly patients
The doctor may reduce the dose of the medicine if the patient has impaired kidney function.

Using a higher than recommended dose of Paliperidone Teva

This medicine will be administered under medical supervision, so it is unlikely that an overdose will occur.
In patients who have received an overdose 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.
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Stopping treatment with Paliperidone Teva

If the patient stops receiving injections, the medicine will stop working. The patient should not stop using the medicine unless their doctor decides to do so, as the symptoms of the disease may return.
In case of any further doubts about using this medicine, the patient 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 travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek immediate medical attention;
• they have dementia and 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. These symptoms may indicate a stroke;
• they experience fever, muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary;
• they experience prolonged or painful erections. This condition is called priapism. Immediate treatment may be necessary;
• they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with paliperidone;
• they experience a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, or 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;
• they are scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) 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 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
• paliperidone 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 problems. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual periods, or other menstrual disorders;
• high blood sugar levels, 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 the patient's movements to be uneven, jerky), 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

Other symptoms of parkinsonism include: slow, shuffling gait, tremors at rest, increased saliva production and (or) drooling, and a mask-like face

• 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 abnormal 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 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 menstrual periods
• 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, 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, high cholesterol levels in the blood;
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• late dyskinesia (involuntary, repetitive, or jerky movements of the face, tongue, or other body parts). The patient should immediately inform their doctor if they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with this medicine
• fainting, need to move limbs, dizziness when changing position to standing, disturbances of attention, difficulty speaking, loss of taste, decreased sensation of pain or 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 rhythms (arrhythmias), irregular heart rhythm;
• blood clots in the lungs, causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek immediate medical attention

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• 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 seek immediate medical attention
• flushing
• sleep apnea (breathing disturbances during sleep)
• pulmonary congestion, respiratory tract congestion
• crackling in the lungs, wheezing
• pancreatitis, tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• dry lips
• skin rash related to drug use, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• urinary retention
• 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 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 available data)

• dangerously low number of certain white blood cells in the blood, necessary for fighting infections
• severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, or a drop in blood pressure
• life-threatening condition of excessive water intake - water poisoning
• sleep-related eating disorders
• coma due to uncontrolled diabetes
• decreased oxygen supply to various parts of the body (due to decreased blood flow);
• rapid, shallow breathing, aspiration pneumonia, voice disturbances
• absence of intestinal movements leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening skin rash with blisters and peeling, which can start in the mouth, nose, eyes, or genitals and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• skin discoloration
• abnormal posture
• in newborns whose mothers used paliperidone during pregnancy, side effects of the medicine and (or) withdrawal symptoms may occur, such as 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Paliperidone Teva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton after "EXP" or Expiry Date (EXP). The expiry date refers to the last day of the month stated.
This medicine does not require special storage conditions.
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 Paliperidone Teva contains

The active substance of the medicine is paliperidone.
Each ampoule of Paliperidone Teva 75 mg contains 117 mg of paliperidone palmitate in 0.75 ml of suspension.
Each ampoule of Paliperidone Teva 100 mg contains 156 mg of paliperidone palmitate in 1 ml of suspension.
Each ampoule of Paliperidone Teva 150 mg contains 234 mg of paliperidone palmitate in 1.5 ml of suspension.
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 Paliperidone Teva looks like and contents of the pack

Paliperidone Teva is a white or off-white suspension for injection with prolonged release, in an ampoule (prolonged-release injection).
The ampoule, containing 0.75, 1, or 1.5 ml of suspension, (cycloolefin copolymer) with a plunger made of PP and a plunger tip (made of bromobutyl rubber) and a needle 22G x 1.5 inches (38.1 mm x 0.72 mm) and 23G x 1 inch (25.4 mm x 0.64 mm) made of stainless steel with a safety device.
Each pack contains: 1 ampoule and 2 needles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: +48 22 345 93 00

Manufacturer

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:
Paliperidon-ratiopharm 25 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 50 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 75 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 100 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 150 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 150 mg und 100 mg Depot-Injektionssuspension
Austria:
Paliperidon ratiopharm 25 mg Depot-Injektionssuspension
Paliperidon ratiopharm 50 mg Depot-Injektionssuspension
Paliperidon ratiopharm 75 mg Depot-Injektionssuspension
Paliperidon ratiopharm 100 mg Depot-Injektionssuspension
Paliperidon ratiopharm 150 mg Depot-Injektionssuspension
Paliperidon ratiopharm Starterpackung 100 mg und Paliperidon ratiopharm
150 mg Depot-Injektionssuspension
Belgium:
Paliperidone Teva 25 mg suspensie voor injectie met verlengde afgifte/
suspension injectable à libération prolongée/ Depot-Injektionssuspension
Paliperidone Teva 50 mg suspensie voor injectie met verlengde afgifte/
suspension injectable à libération prolongée/ Depot-Injektionssuspension
Paliperidone Teva 75 mg suspensie voor injectie met verlengde afgifte/
suspension injectable à libération prolongée/ Depot-Injektionssuspension
Paliperidone Teva 100 mg suspensie voor injectie met verlengde afgifte/
suspension injectable à libération prolongée/ Depot-Injektionssuspension
Paliperidone Teva 150 mg suspensie voor injectie met verlengde afgifte/
suspension injectable à libération prolongée/ Depot-Injektionssuspension
Paliperidone Teva 150 mg & 100 mg suspensie voor injectie met verlengde
afgifte/suspension injectable à libération prolongée/Depot-
Injektionssuspension
Bulgaria:
Палиперидон Тева 75 mg инжекционна суспензия с удължено
освобождаване
Палиперидон Тева 100 mg инжекционна суспензия с удължено
освобождаване
Палиперидон Тева 150 mg инжекционна суспензия с удължено
освобождаване
Croatia:
Paliperidon Teva 50 mg suspenzija za injekciju s produljenim oslobađanjem
Paliperidon Teva 75 mg suspenzija za injekciju s produljenim oslobađanjem
Paliperidon Teva 100 mg suspenzija za injekciju s produljenim
oslobađanjem
Paliperidon Teva 150 mg suspenzija za injekciju s produljenim
oslobađanjem
Cyprus:
Paliperidone/Teva Pharma 75 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Paliperidone/Teva Pharma 100 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Paliperidone/Teva Pharma 150 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Denmark:
Estonia:
Paliperidon Teva
Paliperidone Teva
Finland:
Paliperidone ratiopharm 25 mg injektioneste, depotsuspensio
Paliperidone ratiopharm 50 mg injektioneste, depotsuspensio
Paliperidone ratiopharm 75 mg injektioneste, depotsuspensio
Paliperidone ratiopharm 100 mg injektioneste, depotsuspensio
Paliperidone ratiopharm 150 mg injektioneste, depotsuspensio
Paliperidone ratiopharm 100 mg + 150 mg injektioneste, depotsuspensio
France:
PALIPERIDONE TEVA 25mg suspension injectable à libération prolongée
PALIPERIDONE TEVA 50mg suspension injectable à libération prolongée
PALIPERIDONE TEVA 75mg suspension injectable à libération prolongée
PALIPERIDONE TEVA 100mg suspension injectable à libération
prolongée
PALIPERIDONE TEVA 150mg suspension injectable à libération
prolongée
Greece:
Paliperidone/Teva Pharma 75 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Paliperidone/Teva Pharma 100 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Paliperidone/Teva Pharma 150 mg ενέσιμο εναιώρημα παρατεταμένης
αποδέσμευσης
Hungary:
Paliperidon Teva 25 mg retard szuszpenziós injekció
Paliperidon Teva 50 mg retard szuszpenziós injekció
Paliperidon Teva 75 mg retard szuszpenziós injekció
Paliperidon Teva 100 mg retard szuszpenziós injekció
Paliperidon Teva 150 mg retard szuszpenziós
Injekció Paliperidon Teva 150 mg és 100 mg retard szuszpenziós injekció
Iceland:
Paliperidon Teva
Ireland:
Paliperidone Teva 25mg Prolonged-release Suspension for Injection
Paliperidone Teva 50mg Prolonged-release Suspension for Injection
Paliperidone Teva 75mg Prolonged-release Suspension for Injection
Paliperidone Teva 100mg Prolonged-release Suspension for Injection
Paliperidone Teva 150mg Prolonged-release Suspension for Injection
Paliperidone Teva 150mg and 100mg Prolonged-release Suspension for
Injection
Italy:
Paliperidone Teva Italia
Latvia:
Paliperidone Teva 75 mg ilgstošās darbības suspensija injekcijām
Paliperidone Teva 100 mg ilgstošās darbības suspensija injekcijām
Palieridone Teva 150 mg ilgstošās darbības suspensija injekcijām
Lithuania:
Paliperidone Teva 50 mg pailginto atpalaidavimo injekcinė suspensija
Paliperidone Teva 75 mg pailginto atpalaidavimo injekcinė suspensija
Paliperidone Teva 100 mg pailginto atpalaidavimo injekcinė suspensija
Palieridone Teva 150 mg pailginto atpalaidavimo injekcinė suspensija
Luxembourg:
Paliperidon-ratiopharm 25 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 50 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 75 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 100 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 150 mg Depot-Injektionssuspension
Paliperidon-ratiopharm 150 mg und 100 mg Depot-Injektionssuspension
Netherlands:
Paliperidon Teva 25 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Teva 50 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Teva 75 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Teva 100 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Teva 150 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Teva 150 mg, en 100 mg, suspensie voor injectie met verlengde
afgifte
Norway:
Paliperidon Teva
Poland:
Paliperidone Teva
Portugal:
Paliperidona Teva
Romania:
Paliperidonă Teva 50 mg suspensie injectabilă cu eliberare prelungită
Paliperidonă Teva 75 mg suspensie injectabilă cu eliberare prelungită
Paliperidonă Teva 100 mg suspensie injectabilă cu eliberare prelungită
Paliperidonă Teva 150 mg suspensie injectabilă cu eliberare prelungită
Slovakia:
Paliperidón Teva 25 mg injekčná suspenzia s predĺženým uvoľňovaním
Paliperidón Teva 50 mg injekčná suspenzia s predĺženým uvoľňovaním
Paliperidón Teva 75 mg injekčná suspenzia s predĺženým uvoľňovaním
Paliperidón Teva 100 mg injekčná suspenzia s predĺženým uvoľňovaním
Paliperidón Teva 150 mg injekčná suspenzia s predĺženým uvoľňovaním
Paliperidón Teva 150 mg injekčná suspenzia s predĺženým uvoľňovaním a
Paliperidón Teva 100 mg injekčná suspenzia s predĺženým uvoľňovaním
Slovenia:
Paliperidon Teva 50 mg suspenzija s podaljšanim sproščanjem za injiciranje
Paliperidon Teva 75 mg suspenzija s podaljšanim sproščanjem za injiciranje
Paliperidon Teva 100 mg suspenzija s podaljšanim sproščanjem za
injiciranje
Paliperidon Teva 150 mg suspenzija s podaljšanim sproščanjem za
injiciranje
Paliperidon Teva 150 mg in 100 mg suspenzija s podaljšanim sproščanjem
za injiciranje
Spain:
Paliperidona Teva 50 mg suspension inyectable de liberación prolongada
EFG
Paliperidona Teva 75 mg suspension inyectable de liberación prolongada
EFG
Paliperidona Teva 100 mg suspension inyectable de liberación prolongada
EFG
Paliperidona Teva 150 mg suspension inyectable de liberación prolongada
EFG
Paliperidona Teva 150 mg y Paliperidona Teva 100 mg suspensión
inyectable de liberación prolongada EFG
Sweden:
Paliperidon Teva
United Kingdom
(Northern Ireland):
Paliperidone Teva 25 mg Prolonged-release Suspension for Injection
Paliperidone Teva 50 mg Prolonged-release Suspension for Injection
Paliperidone Teva 75 mg Prolonged-release Suspension for Injection
Paliperidone Teva 100 mg Prolonged-release Suspension for Injection
Paliperidone Teva 150 mg Prolonged-release Suspension for Injection
Paliperidone Teva 150 mg and 100 mg Prolonged-release Suspension for
Injection Treatment Initiation Pack
Date of last revision of the leaflet:February 2024
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The following information is intended for healthcare professionals only and should be read in conjunction with the full product information (Summary of Product Characteristics)

Medicinal Product.

The suspension for injection is intended for single use only. Before administration, check if there are any foreign particles in the suspension. If foreign particles are visible in the pre-filled syringe, do not use the medicinal product.
The packaging contains a pre-filled syringe and 2 needles with a safety device [22G 1.5 inches (38.1 mm x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular administration. The medicinal product Paliperidone Teva is also available in a starter pack containing two pre-filled syringes (150 mg + 100 mg) and 2 additional needles with a safety device.

• 1. Shake the pre-filled syringe vigorously for at least 10 seconds to ensure the uniformity of the suspension. Hold the syringe with the plunger in a vertical position. Gently tap the syringe so that all air bubbles rise to the top of the syringe.

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• 2. Choose the appropriate needle.

The first initiating dose of the medicinal product Paliperidone Teva (150 mg) should be administered on the 1st day of treatment into the DELTOID MUSCLE using the needle for the DELTOID MUSCLE. The second initiating dose of the medicinal product Paliperidone Teva (100 mg) should be administered one week later (8th day) also into the DELTOID MUSCLE using the needle for the DELTOID MUSCLE.
In case of switching from risperidone long-acting injections to the medicinal product Paliperidone Teva, the first injection of the medicinal product Paliperidone Teva (at a dose of 25 mg to 150 mg) can be administered into the DELTOID MUSCLE or the GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection.
Subsequently, monthly maintenance doses can be injected into the DELTOID MUSCLE or the GLUTEAL MUSCLE using the appropriate needle.
For injections into the DELTOID MUSCLE in patients with a body weight of less than 90 kg, use the 1-inch, 23G (25.4 mm x 0.64 mm) needle (needle with a bluehub). If the patient's body weight is 90 kg or more, use the 1.5-inch, 22G (38.1 mm x 0.72 mm) needle (needle with a grayhub).
For injections into the GLUTEAL MUSCLE, use the 1.5-inch, 22G (38.1 mm x 0.72 mm) needle (needle with a grayhub).

• 3. Holding the pre-filled syringe vertically upwards, remove the rubber cap from the tip with a gentle twisting motion.

• 4. Tear off the outer part of the blister packaging of the safety needle to about half way. Grasp the needle shield by the plastic packaging. Hold the syringe upright. Connect the Luer lock of the needle shield to the pre-filled syringe with a gentle twisting motion to avoid breaking or damaging the needle tip. Always check for signs of damage or leakage before administration.

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

• 6. Position the pre-filled syringe with the attached needle in a vertical position to remove air.

Remove air from the pre-filled syringe by gently pressing the plunger rod until 3 drops of suspension are released from the syringe.

• 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 that the needle is properly secured. Dispose of the pre-filled syringe with the needle in an appropriate manner.

8a

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8b

8c

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