Paliperidone EG

Patient Information Leaflet: Information for the User

Paliperidone EG 25 mg prolonged-release injectable suspension in pre-filled syringe, 50 mg prolonged-release injectable suspension in pre-filled syringe, 75 mg prolonged-release injectable suspension in pre-filled syringe

Paliperidone EG 100 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone EG 150 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone EG 100 mg + Paliperidone EG 150 mg prolonged-release injectable suspension in
pre-filled syringe
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of this leaflet:

1. What Paliperidone EG is and what it is used for
2. What you need to know before using Paliperidone EG
3. How to use Paliperidone EG
4. Possible side effects
5. How to store Paliperidone EG
6. Contents of the pack and other information

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

Paliperidone EG contains the active substance paliperidone, which belongs to a class of medicines called
antipsychotics. It is used as maintenance treatment for the symptoms of schizophrenia in adult patients who
have already been stabilised with paliperidone or risperidone.
If you have previously responded to paliperidone or risperidone and have mild to moderate symptoms, your
doctor may start treatment with Paliperidone EG without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a condition characterised by “positive” and “negative” symptoms. Positive symptoms refer
to an excess of symptoms that are normally not present. For example, a person with schizophrenia may hear
voices or see things that are not actually there (called hallucinations), believe things that are not true (called
delusions), or be unusually suspicious of others. Negative symptoms refer to a lack of behaviours or feelings
that are normally present. For example, a person with schizophrenia may tend to isolate themselves, may
not respond emotionally, or may have difficulty speaking clearly and logically. People with this condition may
also feel depressed, anxious, guilty, or tense.
Paliperidone EG can help relieve the symptoms of your illness and help prevent them from returning.

2. What you need to know before using Paliperidone EG

Do NOT use Paliperidone EG

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Paliperidone EG.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia treated with similar types of medicines may have an increased risk of stroke or death (see section 4, Possible side effects).
All medicines have side effects, and some of the side effects of this medicine may worsen symptoms of other medical conditions. Therefore, it is important that you discuss with your doctor any of the following conditions, which could potentially worsen during treatment with this medicine:

• if you have Parkinson’s disease;
• if you have ever been diagnosed with an illness whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome);
• if you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia);
• if you know you have previously had low levels of white blood cells in the blood (whether or not caused by other medicines);
• if you have diabetes or are predisposed to diabetes;
• if you have been diagnosed with breast cancer or a tumour of the pituitary gland in the brain;
• if you have heart disease or are taking treatment for heart disease that tends to lower your blood pressure;
• if you have low blood pressure when standing up or changing suddenly from lying down to sitting;
• if you suffer from epilepsy;
• if you have kidney problems;
• if you have liver problems;
• if you have a prolonged and/or painful erection;
• if you have difficulty controlling your internal body temperature or conditions involving excessive heat;
• if you have abnormally high levels of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour;
• if you or someone else in your family has a history of blood clots (thrombi), as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, consult your doctor so they can assess whether it is necessary to adjust your dose or monitor you closely for a period of time.

• Since a dangerously low number of a certain type of white blood cells necessary to fight infections in the blood has been observed very rarely in patients taking this medicine, your doctor may check your white blood cell count.

• Even if you previously tolerated oral paliperidone or oral risperidone, allergic reactions may rarely occur after receiving Paliperidone EG injections. Contact your doctor immediately if you develop a skin rash, throat swelling, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.

• This medicine may cause weight gain. A significant weight gain may negatively affect your health. Your doctor should weigh you regularly.

• Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking this medicine, your doctor must check for high blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels must be monitored regularly.

• As this medicine may reduce the vomiting reflex, it may mask the body’s normal response to ingesting toxic substances or other medical conditions.

• During eye surgery for cataract (clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become flaccid during surgery, which could lead to eye damage. If you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine is not intended for patients under 18 years of age.
Other medicines and Paliperidone EG
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Taking this medicine with carbamazepine (an antiepileptic and mood stabilizer) may require adjustment of the Paliperidone EG dose.
• Since this medicine acts mainly on the brain, interactions with other medicines acting on the brain, such as other psychiatric medicines, opioids, antihistamines, and sleep disorder medicines, may lead to worsening of side effects such as drowsiness or other brain effects.
• Since this medicine may lower blood pressure, be cautious when using it with other medicines that lower blood pressure.
• This medicine may reduce the effect of medicines used to treat Parkinson’s disease and restless legs syndrome (e.g. levodopa).
• This medicine may cause an abnormality in the electrocardiogram (ECG), characterized by a longer time for an electrical impulse to travel through a specific part of the heart (known as “QT interval prolongation”). Other medicines with this effect include certain medicines used to treat heart rhythm disorders or infections, and other antipsychotics.
• If you are predisposed to seizures, this medicine may increase the likelihood of experiencing them. Other medicines with this effect include certain medicines used to treat depression or infections, and other antipsychotics.
• Paliperidone EG should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone EG and alcohol
Alcohol consumption should be avoided.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not use this medicine during pregnancy unless this has been agreed with your doctor. The following symptoms may occur in newborns of mothers who used paliperidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Breastfeeding
This medicine may pass from mother to child through breast milk and may harm the baby. Therefore, do not breastfeed while using this medicine.
Driving and using machines
During treatment with this medicine, dizziness, extreme tiredness, and vision problems may occur (see section 4). This should be taken into account when full alertness is required, e.g., when driving a car or operating machinery.
Paliperidone EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to use Paliperidone EG

This medicine is administered by a doctor or another healthcare professional. Your doctor will determine when you will need your next injection. It is important not to miss your scheduled dose. If you think you will be unable to attend your appointment with the doctor, contact them immediately to arrange a new appointment as soon as possible.

Dosage and method of administration
You will receive a first injection (150 mg) and a second injection (100 mg) of this medicine in the upper arm, approximately one week apart. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.

If your doctor is switching you from long-acting risperidone to this medicine, you will receive your first injection of this medicine (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock on the date already scheduled for your next injection. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.

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

Patients with renal problems
Your doctor may adjust the dose of this medicine based on kidney function. If you have mild kidney problems, your doctor may administer a lower dose. If you have moderate to severe kidney problems, this medicine must not be used.

Elderly patients
Your doctor may reduce the dose of this medicine if kidney function is reduced.

If you use more Paliperidone EG than you should
This medicine will be administered under medical supervision, so it is unlikely that you will receive an overdose.
In patients who have received an excessive dose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, low blood pressure, abnormal electrocardiogram (ECG; recording of the heart's electrical activity), or slow or abnormal movements of the face, body, arms, or legs.

If you stop treatment with Paliperidone EG
If you stop receiving your injections, you will lose the beneficial effects of the medicine. You must not stop using this medicine unless your doctor tells you to do so, as your symptoms may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:

• you think you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately;
• you have dementia and notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes slurred, even briefly. These may be signs of a stroke;
• you have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required;
• you are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be required;
• you experience involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to discontinue paliperidone;
• you develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (anaphylactic reaction). Even if you previously tolerated oral paliperidone or oral risperidone, allergic reactions may rarely occur after receiving paliperidone injections;
• if you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery (removal of the clouded lens), the iris (the colored part of the eye) may become floppy during the procedure (known as "intraoperative floppy iris syndrome"), which may lead to eye damage;
• certain tests have shown a dangerously low number of a certain type of white blood cells in the blood needed to fight infections.

The following side effects may occur:
Very common side effects: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep.

Common side effects: may affect up to 1 in 10 people

• symptoms of the common cold, urinary tract infection, feeling as if you have the flu;
• Paliperidone EG may increase levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, they may include (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk discharge from the breasts, loss of menstrual periods or other menstrual problems;
• high blood sugar levels, weight gain, weight loss, decreased appetite;
• irritability, depression, anxiety;
• parkinsonism: this condition may include slow or impaired body movements, feeling of muscle stiffness or tightness (causing jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression;
• restlessness, drowsiness or reduced alertness;
• dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. Although it may affect any part of the body (resulting in abnormal posture), it often

involves facial muscles, including abnormal eye, mouth, tongue or jaw movements;

• dizziness;
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements or spasms;
• tremor (shaking);
• headache;
• fast heartbeat;
• high blood pressure;
• cough, stuffy nose;
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache;
• increased liver transaminases in the blood;
• bone or muscle pain, back pain, joint pain;
• loss of menstrual period;
• fever, weakness, fatigue (tiredness);
• a reaction at the injection site, including itching, pain or swelling.

Uncommon side effects: may affect up to 1 in 100 people

• pneumonia, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection;
• decreased white blood cell count, decreased levels of a certain type of white blood cells in the blood that help protect the body from infections, anemia;
• allergic reaction;
• diabetes or worsening of diabetes, increased levels of insulin in the blood (a hormone that controls blood sugar levels);
• increased appetite;
• loss of appetite leading to malnutrition and low body weight;
• increased triglycerides (a fat) in the blood, increased cholesterol in the blood;
• sleep disturbances, elevated mood (mania), reduced sexual drive, nervousness, nightmares;
• tardive dyskinesia (spasms or jerky movements that cannot be controlled, affecting the face, tongue or other body parts). Contact your doctor immediately if you develop involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of this medicine may be necessary;
• fainting, an urgent need to move a body part, dizziness when standing up, attention disturbances, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin;
• blurred vision, eye infection or "slightly red eye", dry eyes;
• sensation of spinning (vertigo), ringing in the ears, ear pain;
• interruption of conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation of the heart, rapid heartbeat when standing up, slow heartbeat, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations);
• low blood pressure, drop in blood pressure when standing up (as a result, some people taking this medicine may feel faint, dizzy or may faint when standing up or sitting down suddenly);
• shortness of breath, sore throat, nosebleed;
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth;
• excessive passing of gas or air;
• increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood;
• skin rash (or hives), itching, skin eruption, hair loss, eczema, dry skin, red skin, acne, skin abscess;
• increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when muscle damage occurs;
• muscle spasms, joint stiffness, muscle weakness;
• urinary incontinence (lack of control), frequent urination, pain during urination;
• erectile dysfunction, ejaculation disorders, absence of menstruation or other menstrual problems (females), breast development in males, sexual dysfunction, breast pain, milk discharge from the breasts;
• swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs;
• increased body temperature;
• change in walking pattern;
• chest pain, chest discomfort, feeling unwell;
• hardened skin;
• falls.

Rare side effects: may affect up to 1 in 1,000 people

• eye infection;
• skin inflammation caused by mites, scalp or skin flaking and itching;
• increased eosinophils (a type of white blood cells) in the blood;
• decreased platelets (blood cells that help stop bleeding);
• head tremor;
• inappropriate secretion of a hormone that controls urine volume;
• sugar in the urine;
• potentially life-threatening complications of uncontrolled diabetes;
• low blood sugar levels;
• excessive water intake;
• absence of movements or responses when awake (catatonia);
• confusion;
• sleepwalking;
• lack of emotion;
• inability to reach orgasm;
• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity), brain vascular problems including sudden loss of blood supply to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (epileptic fits), balance disturbances;
• abnormal coordination;
• glaucoma (increased pressure within the eyeball);
• problems with eye movements, eye rolling, light sensitivity of the eyes, increased tearing, eye redness;
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat;
• blood clots in the lungs which may cause chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately;
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs). If you notice any of these symptoms, consult your doctor immediately;
• flushing;
• breathing problems during sleep (sleep apnea);
• lung congestion, respiratory congestion;
• lung crackles, wheezing;
• pancreatitis, tongue swelling, fecal incontinence, very hard stools;
• chapped lips;
• drug-related skin rash, skin thickening, dandruff;
• muscle fiber breakdown and muscle pain (rhabdomyolysis);
• joint swelling;
• inability to urinate;
• breast discomfort, enlargement of breast glands, breast enlargement;
• vaginal discharge;
• priapism (a prolonged erection of the penis that may require surgical treatment);
• very low body temperature, chills, feeling thirsty;
• withdrawal symptoms from the medicine;
• pus accumulation due to infection at the injection site, deep skin infection, a cyst at the injection site, bruising at the injection site.

Not known: frequency cannot be estimated from the available data

• dangerous decrease in a certain type of white blood cells in the blood needed to fight infections;
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure;
• dangerous and excessive water intake;
• sleep-related eating disorder;
• coma due to uncontrolled diabetes;
• reduced oxygen supply to parts of your body (due to reduced blood flow);
• rapid and shallow breathing, pneumonia caused by inhalation of food, voice disorder;
• lack of intestinal muscle movement leading to blockage;
• yellowing of the skin and eyes (jaundice);
• severe or life-threatening skin rash with blisters and skin peeling that may start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis);
• severe allergic reaction with swelling that may affect the throat causing breathing difficulties;
• skin discoloration;
• abnormal posture;
• babies born to mothers who took Paliperidone EG during pregnancy may experience drug-related adverse events and/or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems;
• reduced body temperature;
• death of skin cells at the injection site and ulceration at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Paliperidone EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pre-filled syringe.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paliperidone EG contains
The active substance is paliperidone.
Each pre-filled syringe of Paliperidone EG 25 mg contains paliperidone palmitate equivalent to 25 mg of
paliperidone.
Each pre-filled syringe of Paliperidone EG 50 mg contains paliperidone palmitate equivalent to 50 mg of
paliperidone.
Each pre-filled syringe of Paliperidone EG 75 mg contains paliperidone palmitate equivalent to 75 mg of
paliperidone.
Each pre-filled syringe of Paliperidone EG 100 mg contains paliperidone palmitate equivalent to 100 mg of
paliperidone.
Each pre-filled syringe of Paliperidone EG 150 mg contains paliperidone palmitate equivalent to 150 mg of
paliperidone.

The other components are:
Polysorbate 20 (E 432)
Macrogol
Monohydrate citric acid (E 330)
Disodium phosphate (E 339)
Monohydrate sodium dihydrogen phosphate
Sodium hydroxide (E 542) (for pH adjustment)
Water for injections

Description of the appearance of Paliperidone EG and contents of the pack
Paliperidone EG is available as a prolonged-release injectable suspension, varying in colour from white to off-white, in a pre-filled syringe.
The pre-filled syringe is made of a cyclic olefin copolymer with a plunger rod and flange extender/anti-retraction device with a plunger stopper (bromobutyl rubber).
Each pack contains 1 pre-filled syringe and 2 needles.
Each multiple treatment initiation pack contains:

• 1 pack of Paliperidone EG 150 mg, 1 pre-filled syringe and 2 needles (to be used on day 1 of treatment);
• 1 pack of Paliperidone EG 100 mg, 1 pre-filled syringe and 2 needles (to be used on day 8 of treatment).

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna - Austria
Centrafarm Services B.V., Van de Reijtstraat 31-E, 4814 NE Breda - The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
SE Paliperidone STADA
AT Paliperidon STADA 50 mg; 75 mg; 100 mg; 150 mg Depot-Injektionssuspension
Paliperidon STADA Starterpackung 100 mg + 150 mg Depot-Injektionssuspension
BE Paliperidon EG 25 mg; 50 mg; 75 mg; 100 mg; 150 mg suspensie voor injectie met verlengde afgifte in een voorgevulde spuit
Paliperidon EG 150 mg + 100 mg suspensie voor injectie met verlengde afgifte in een voorgevulde spuit
CY Paliperidone Palmitate /STADA
DE Paliperidon AL 25 mg; 50 mg; 75 mg; 100 mg; 150 mg Depot-Injektionssuspension
Paliperidon AL 150 mg und 100 mg Depot-Injektionssuspension
DK Paliperidone STADA 25 mg; 50 mg; 75 mg; 100 mg; 150 mg
EL Paliperidone Palmitate /STADA
ES Paliperidona STADA 50 mg; 75 mg; 100 mg; 150 mg suspensión inyectable de liberación prolongada en jeringa precargada EFG
FI Paliperidone STADA 25 mg; 50 mg; 75 mg; 100 mg; 150 mg injektioneste, depotsuspensio
FR PALIPERIDONE EG 25 mg; 50 mg; 75 mg; 100 mg; 150 mg, suspension injectable à libération prolongée
PALIPERIDONE EG 150 mg et PALIPERIDONE EG 100 mg, suspension injectable à libération prolongée
HU Paliperidone Stada 25 mg; 50 mg; 75 mg; 100 mg; 150 mg retard szuszpenziós injekció
Paliperidone Stada 150 mg és Paliperidone Stada 100 mg retard szuszpenziós injekció
IE Paliperidone Clonmel 50 mg prolonged-release suspension for injection in pre-filled syringe
Paliperidone Clonmel 75 mg prolonged-release suspension for injection in pre-filled syringe
Paliperidone Clonmel 100 mg prolonged-release suspension for injection in pre-filled syringe
Paliperidone Clonmel 50 mg; 75 mg; 100 mg; 150 mg prolonged-release suspension for injection in pre-filled syringe
IS Paliperidone STADA 25 mg; 50 mg; 75 mg; 100 mg; 150 mg stungulyf, forðadreifa
IT Paliperidone EG
LU Paliperidon EG 25 mg; 50 mg; 75 mg; 100 mg; 150 mg suspension injectable à libération prolongée en seringue préremplie
Paliperidon EG 150 mg + 100 mg suspension injectable à libération prolongée en seringue préremplie
MT Paliperidone Clonmel 50 mg; 75 mg; 100 mg; 150 mg prolonged-release suspension for injection
NL Paliperidon CF 25 mg; 50 mg; 75 mg; 100 mg; 150 mg, suspensie voor injectie met verlengde afgifte in een voorgevulde spuit
Paliperidon CF 100 mg + 150 mg, suspensie voor injectie met verlengde afgifte in een voorgevulde spuit
NO Paliperidone STADA
PT Paliperidona STADA
RO Paliperidonă Stada 25 mg; 50 mg; 75 mg; 100 mg; 150 mg suspensie injectabilă cu eliberare prelungită în seringă preumplută
SK Paliperidón STADA 25 mg; 50 mg; 75 mg; 100 mg; 150 mg injekčná suspenzia s predĺženým uvoľňovaním v naplnenej injekčnej striekačke
Paliperidón STADA 150 mg+100 mg injekčná suspenzia s predĺženým uvoľňovaním v naplnenej injekčnej striekačke

Packs supplied with Magellan Safety Needle
The following information is intended exclusively for physicians or healthcare professionals and must be read by physicians or healthcare professionals together with the complete prescribing information (Summary of Product Characteristics)
The injectable suspension is for single use only. A visual inspection must be performed to exclude the presence of particulate matter prior to administration. Do not use if the syringe is not visually free from particulate matter.
The pack contains one pre-filled syringe and 2 safety needles (one 1½ inch, 22 G [38 mm x 0.7 mm] and one 1 inch, 23 G [25 mm x 0.6 mm]) for intramuscular injection.

1. Shake the syringe vigorously for at least 10 seconds to ensure a homogeneous suspension.

2. Select the appropriate needle. The initial dose of Paliperidone EG (150 mg) must be administered on Day 1 into the DELTOID muscle using the needle intended for DELTOID injection. The second initial dose of Paliperidone EG (100 mg) must also be administered into the DELTOID muscle one week later (Day 8) using the needle intended for DELTOID injection.

If the patient is switching from long-acting risperidone injection to Paliperidone EG, the first injection of Paliperidone EG (which may range from 25 mg to 150 mg) can be administered either into the DELTOID or the GLUTEAL muscle at the time of the next scheduled injection, using the needle appropriate for the injection site.
Subsequently, monthly maintenance injections may be administered either into the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
For DELTOID injection: if the patient weighs < 90 kg, use the 1 inch, 23 G (25 mm x 0.6 mm) needle (the needle with the blue-coloured hub); if the patient weighs ≥ 90 kg, use the 1½ inch, 22 G (38 mm x 0.7 mm) needle (the needle with the grey-coloured hub).
For GLUTEAL injection: use the 1½ inch, 22 G (38 mm x 0.7 mm) needle (the needle with the grey-coloured hub).

3. While holding the syringe in an upright position, remove the rubber closure cap with a twisting motion.

4. Open the safety needle blister halfway. Grasp the needle cap using the open plastic wrapper. Attach the safety needle to the syringe's Luer connection with a simple clockwise twisting motion.

5. Remove the protective needle cap with a straight pull. Do not rotate the cap, as the needle may loosen from the syringe.

6. Hold the syringe with attached needle in an upright position to remove air. Remove air from the syringe by gently pushing the plunger forward.

7. Inject the entire content slowly and deeply into the selected deltoid or gluteal muscle. Do not administer intravenously or subcutaneously.
8. After completing the injection, use the thumb or another finger (8a, 8b), or a flat surface (8c) to activate the needle safety system. The system is fully activated when a clicking sound (“click”) is heard. Dispose of the syringe with the needle appropriately.

Unused medicine and waste material from this medicine must be disposed of in accordance with local regulations.

Packs supplied with Terumo Safety Needle
The following information is intended exclusively for physicians or healthcare professionals and must be read by physicians or healthcare professionals together with the complete prescribing information (Summary of Product Characteristics).
The injectable suspension is for single use only. A visual inspection must be performed to exclude the presence of particulate matter prior to administration. Do not use if the syringe is not visually free from particulate matter.
The pack contains one pre-filled syringe and 2 safety needles (one 1½ inch, 22 G [38 mm x 0.7 mm] and one 1 inch, 23 G [25 mm x 0.6 mm]) for intramuscular injection.

1. Shake the syringe vigorously for at least 10 seconds to ensure a homogeneous suspension.

2. Select the appropriate needle.

For DELTOID injection:

• If the patient weighs < 90 kg, use the 1 inch, 23 G needle (the needle with the blue-coloured hub).
• If the patient weighs ≥ 90 kg, use the 1½ inch, 22 G needle (the needle with the grey-coloured hub).

For GLUTEAL injection:
Use the 1½ inch, 22 G needle (the needle with the grey-coloured hub) regardless of patient weight.

3. While holding the syringe in an upright position, remove the rubber closure cap with a twisting motion.

4. Open the safety needle blister halfway. Grasp the needle cap using the open plastic wrapper. Attach the safety needle to the syringe's Luer connection with a simple clockwise twisting motion.

5. 1. Move the needle safety shield towards the syringe. 2) Remove the protective needle cap with a straight pull. Do not rotate the cap, as the needle may loosen from the syringe.

6. Hold the syringe with attached needle in an upright position to remove air. Remove air from the syringe by gently pushing the plunger forward.

7. Inject the entire content slowly and deeply into the selected deltoid or gluteal muscle. Do not administer intravenously or subcutaneously.
8. After completing the injection, use the thumb or another finger (8a, 8b), or a flat surface (8c) to activate the needle safety system. The system is fully activated when a clicking sound (“click”) is heard. Dispose of the syringe with the needle appropriately.

Keep out of the reach of children.
Unused medicine and waste material from this medicine must be disposed of in accordance with local regulations.