Paliperidone Sandoz GmbH

Package leaflet: Information for the user

Paliperidone Sandoz GmbH 50 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Sandoz GmbH 75 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Sandoz GmbH 100 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Sandoz GmbH 150 mg prolonged-release injectable suspension in pre-filled syringe
Equivalent medicinal product
Please read all of this leaflet carefully before you start using this medicine because 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 Sandoz GmbH is and what it is used for
2. What you need to know before using Paliperidone Sandoz GmbH
3. How to use Paliperidone Sandoz GmbH
4. Possible side effects
5. How to store Paliperidone Sandoz GmbH
6. Contents of the pack and other information

1. What Paliperidone Sandoz GmbH is and what it is used for

Paliperidone Sandoz GmbH contains the active substance paliperidone, which belongs to the class of medicines called antipsychotics. It is used as maintenance treatment for the symptoms of schizophrenia in adult patients stabilized on paliperidone or risperidone.
If you have previously responded to paliperidone or risperidone and have mild to moderate symptoms, your doctor may initiate treatment with Paliperidone Sandoz GmbH without prior stabilization with paliperidone or risperidone.
Schizophrenia is a condition characterized 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 do not actually exist (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 and 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 Sandoz GmbH can help relieve the symptoms of your illness and help prevent them from returning.

2. What you need to know before using Paliperidone Sandoz GmbH

Do not use Paliperidone Sandoz GmbH:

• 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 Sandoz GmbH.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who have been treated with similar 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. For this reason, it is important that you discuss with your doctor if you have 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 a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you know you have previously had low levels of white blood cells in your 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 being treated for a heart condition that tends to lower your blood pressure
• if you have low blood pressure when standing up or when changing suddenly from a lying to a sitting position
• if you have 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 (thrombosis), as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, talk to 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 injections of Paliperidone Sandoz GmbH. Contact your doctor immediately if you develop a rash, swelling of the throat, 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 has been observed or pre-existing diabetes mellitus has worsened in patients taking this medicine, your doctor should check for high blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Since this medicine may reduce the vomiting reflex, it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
During cataract surgery (an operation to remove 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 floppy 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 must not be used in children and adolescents under 18 years of age.

Other medicines and Paliperidone Sandoz GmbH
Tell 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 dose of this medicine.
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 an exaggeration of side effects such as drowsiness or other brain-related effects.
Since this medicine may lower blood pressure, caution is advised when using it together 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 duration of electrical impulse conduction through a specific part of the heart (known as "QT interval prolongation"). Other medicines that have 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 having them. Other medicines that have this effect include certain antidepressants or medicines used to treat infections, and other antipsychotics.
Paliperidone Sandoz GmbH should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone Sandoz GmbH and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use this medicine during pregnancy unless you have discussed it 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.
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
While being treated with this medicine, dizziness, extreme tiredness, and vision problems may occur (see section 4). This should be taken into account in situations requiring full alertness, such as driving a car or operating machinery.

Paliperidone Sandoz GmbH contains sodium and polysorbate
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.
This medicine contains 12.0 mg of polysorbate 20 in each mL of injectable paliperidone. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Paliperidone Sandoz GmbH

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

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 injectable risperidone to this medicine, you will receive the 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 kidney problems
Your doctor may adjust the dose of this medicine based on your kidney function. If you have mild kidney problems, your doctor may prescribe 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 are given more Paliperidone Sandoz GmbH than you should
This medicine will be administered under medical supervision; therefore, it is unlikely that you will receive too much.

In patients who have received an overdose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, low blood pressure, abnormal electrocardiogram (record of the heart's electrical activity), or slow or abnormal movements of the face, body, arms, or legs.

If you stop treatment with Paliperidone Sandoz GmbH
If you stop receiving your injections, you will lose the benefits of the medicine. You must not stop using this medicine unless instructed by your doctor, 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.
Contact your doctor immediately if:

• you think you may have blood clots in your 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 if only 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. Discontinuation of paliperidone may be necessary.
• 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 (consistent with an 'anaphylactic reaction'). Although you may previously have tolerated oral risperidone or oral paliperidone, allergic reactions rarely occur after receiving paliperidone injections.
• you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery (clouding of the lens), the iris (the coloured part of the eye) may become floppy during the procedure (known as "intraoperative floppy iris syndrome"), which may lead to eye damage.
• you know you have a dangerously low number of a certain type of white blood cells in your blood needed to fight infections.

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

• difficulty falling asleep or staying asleep.

Common: may affect up to 1 in 10 people

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• Paliperidone Sandoz GmbH may increase levels of a hormone called "prolactin" detected in a blood test (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, these may include (in men) breast enlargement, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk discharge from the breast, 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 abnormal movements, feeling of stiffness or muscle tension (resulting in 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. While it may affect any part of the body (resulting in abnormal posture), dystonia 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
• headache
• rapid heartbeat
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
• increased liver transaminases in the blood
• bone or muscle pain, back pain, joint pain
• loss of menstrual periods
• fever, weakness, fatigue (tiredness)
• reaction at the injection site, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• lung infection, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decrease in white blood cell count, decrease in a certain type of white blood cells in the blood that help protect the body from infections, anaemia
• allergic reaction
• diabetes or worsening of diabetes, increased 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 disorders, elevated mood (mania), reduced sexual desire, nervousness, nightmares
• tardive dyskinesia (spasms or jerky movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of this medicine may be necessary.
• fainting, an urgent need to move a part of the body, dizziness when standing up, attention disturbances, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, a tingling, prickling or numbness sensation in the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of conduction between upper and lower parts of the heart, abnormal heart electrical conduction, QT interval prolongation of the heart, rapid heartbeat when standing up, slow heartbeat, abnormal heart electrical trace (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations)
• low blood pressure, decrease in blood pressure when standing up (as a result, some people taking this medicine may feel faint, lightheaded 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 rash, hair loss, eczema, dry skin, red skin, acne, subcutaneous abscess
• increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage
• 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 breast
• swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• increased body temperature
• change in the way of walking
• chest pain, chest discomfort, feeling of uneasiness
• hardening of the skin
• fall

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

• eye infection
• skin inflammation caused by mites, scalp or skin flaking and itching
• increase in eosinophils (a type of white blood cells) in your blood
• decrease in platelets (blood cells that help stop bleeding)
• head tremor
• inappropriate secretion of a hormone controlling urine volume
• sugar in the urine
• complications leading to life-threatening conditions due to uncontrolled diabetes
• low blood sugar
• excessive water intake
• absence of movements or responses when awake (catatonia)
• confusion
• sleepwalking
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity), vascular problems in the brain including sudden loss of blood supply to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, reduced level of consciousness, seizures (fits), balance disorders
• abnormal coordination
• glaucoma (increased pressure inside 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 difficulty breathing. If you notice any of these symptoms, contact 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.
• hot flushes
• breathing problems during sleep (sleep apnoea)
• lung congestion, respiratory congestion
• lung crackles, wheezing
• pancreatitis (inflammation of the pancreas), tongue swelling, faecal incontinence, very hard stools
• intestinal blockage
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• muscle fibre breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (a prolonged penile erection which may require surgical treatment)
• very low body temperature, chills, feeling of thirst
• drug withdrawal symptoms
• 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 that helps protect the body from infections
• 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
• dangerous and excessive water consumption
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• decrease in 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 causing a 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 Sandoz GmbH during pregnancy may experience drug-related adverse events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• a reduction in 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paliperidone Sandoz GmbH

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

6. Package contents and other information

What Paliperidone Sandoz GmbH contains
The active substance is paliperidone.
50 mg: each pre-filled syringe contains 78 mg of paliperidone palmitate in 0.5 mL equivalent to 50 mg of
paliperidone.
75 mg: each pre-filled syringe contains 117 mg of paliperidone palmitate in 0.75 mL equivalent to 75 mg of
paliperidone.
100 mg: each pre-filled syringe contains 156 mg of paliperidone palmitate in 1 mL equivalent to 100 mg of
paliperidone.
150 mg: each pre-filled syringe contains 234 mg of paliperidone palmitate in 1.5 mL equivalent to 150 mg of
paliperidone.
The other components are:
Polysorbate 20, macrogol, monohydrate citric acid, dibasic sodium phosphate, monobasic sodium phosphate monohydrate, sodium hydroxide (for pH adjustment), water for injectable preparations.

Description of the appearance of Paliperidone Sandoz GmbH and contents of the pack
Paliperidone Sandoz GmbH is a white to off-white prolonged-release injectable suspension in a pre-filled glass syringe.
The pre-filled syringe is made of clear glass, with a rubber plunger stopper, safety clip, and closure cap, and includes two safety needles: one 22G 1½ inch (35.5–39.5 mm) safety needle and one 23G 1 inch (22.5–26.5 mm) safety needle.
Each pack contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milano
Italy

Manufacturer
Pharmascience International Limited
1st Floor Jacovides Tower 81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names
Denmark Paliperidone Sandoz
Estonia Paliperidone Sandoz
Finland Paliperidone Sandoz 25 mg injektioneste, depotsuspensio
Paliperidone Sandoz 50 mg injektioneste, depotsuspensio
Paliperidone Sandoz 75 mg injektioneste, depotsuspensio
Paliperidone Sandoz 100 mg injektioneste, depotsuspensio
Paliperidone Sandoz 150 mg injektioneste, depotsuspensio
France PALIPERIDONE SANDOZ 25 mg, suspension
injectable à libération prolongée en seringue préremplie
PALIPERIDONE SANDOZ 50 mg, suspension
injectable à libération prolongée en seringue préremplie
PALIPERIDONE SANDOZ 75 mg, suspension
injectable à libération prolongée en seringue préremplie
PALIPERIDONE SANDOZ 100 mg, suspension
injectable à libération prolongée en seringue préremplie
PALIPERIDONE SANDOZ 150 mg, suspension
injectable à libération prolongée en seringue préremplie
Germany Paliperidon – 1 A Pharma 25 mg Depot-Injektionssuspension in einer
Fertigspritze
Paliperidon – 1 A Pharma 50 mg Depot-Injektionssuspension in einer
Fertigspritze
Paliperidon – 1 A Pharma 75 mg Depot-Injektionssuspension in einer
Fertigspritze
Paliperidon – 1 A Pharma 100 mg Depot-Injektionssuspension in einer
Fertigspritze
Paliperidon – 1 A Pharma 150 mg Depot-Injektionssuspension in einer
Fertigspritze
Paliperidon – 1 A Pharma 150 mg und 100 mg Depot-Injektionssuspension in
einer Fertigspritze
Greece PALIPERIDONE/SANDOZ
Iceland Paliperidone Sandoz
Italy Paliperidone Sandoz GmbH
Latvia Paliperidone Sandoz 50 mg ilgstošas darbibas suspensija injekcijam
Paliperidone Sandoz 75 mg ilgstošas darbibas suspensija injekcijam
Paliperidone Sandoz 100 mg ilgstošas darbibas suspensija injekcijam
Paliperidone Sandoz 150 mg ilgstošas darbibas suspensija injekcijam
Lithuania Paliperidone Sandoz 50 mg pailginto atpalaidavimo injekcine suspensija užpildytame švirkšte
Paliperidone Sandoz 75 mg pailginto atpalaidavimo injekcine suspensija užpildytame švirkšte
Paliperidone Sandoz 100 mg pailginto atpalaidavimo injekcine suspensija užpildytame švirkšte
Paliperidone Sandoz 150 mg pailginto atpalaidavimo injekcine suspensija užpildytame švirkšte
Norway Paliperidone Sandoz
Netherlands Paliperidon Sandoz 25 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Sandoz 50 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Sandoz 75 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Sandoz 100 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Sandoz 150 mg, suspensie voor injectie met verlengde afgifte
Paliperidon Sandoz 100 mg en 150 mg, suspensie voor injectie met verlengde afgifte
Portugal Paliperidona Sandoz
Sweden Paliperidone Sandoz
Hungary Paliperidon Sandoz 25 mg retard szuszpenziós injekció
Paliperidon Sandoz 50 mg retard szuszpenziós injekció
Paliperidon Sandoz 75 mg retard szuszpenziós injekció
Paliperidon Sandoz 100 mg retard szuszpenziós injekció
Paliperidon Sandoz 150 mg retard szuszpenziós injekció
Paliperidon Sandoz 150 mg és Paliperidon Sandoz 100 mg retard szuszpenziós injekció

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 of particulate matter.
The pack contains one pre-filled syringe and two safety needles (one 1½ inch, 22 G [35.5–39.5 mm] needle and one 1 inch, 23 G [22.5–26.5 mm] needle) for intramuscular injection.

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

2. Select the appropriate needle.

The first initial dose of Paliperidone Sandoz GmbH (150 mg) must be administered on Day 1 into the DELTOID muscle using the needle for DELTOID injection. The second initial dose of Paliperidone Sandoz GmbH (100 mg) must also be administered into the DELTOID muscle one week later (Day 8) using the needle for DELTOID injection.
If the patient is switching from long-acting injectable risperidone to Paliperidone Sandoz GmbH, the first injection of Paliperidone Sandoz GmbH (which may range from 25 mg to 150 mg) may be administered either into the DELTOID or the GLUTEAL muscle at the time of the next scheduled injection, using the appropriate needle 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 needle (the needle with the blue hub); if the patient weighs ≥ 90 kg, use the 1½ inch, 22 G needle (the needle with the grey hub).
For GLUTEAL injection: use the 1½ inch, 22 G needle (the needle with the grey hub).

3. Holding the syringe in an upright position with the closure cap facing upwards, remove the rubber closure cap with a slight twisting motion.

4. Open the safety needle blister. Grasp the base of the needle, not the safety shield. Attach the safety needle to the Luer fitting of the syringe by pushing and turning with a slight clockwise rotational movement.

5. Pull the safety shield away from the needle and slide it towards the syringe barrel until the indicated angle is formed.

6. Remove the protective needle cap with a straight pulling motion. Do not twist the cap, as the needle may loosen from the syringe.

7. Hold the syringe with the attached needle in an upright position to expel air. Carefully expel air from the syringe by gently pushing the plunger forward.

8. Inject the entire contents slowly and deeply into the selected deltoid or gluteal muscle by intramuscular route. Do not administer by intravenous or subcutaneous route.
9. After completing the injection, use the thumb or another finger (9a, 9b), or a flat surface (9c) to activate the needle safety system. The safety system is fully activated when a clicking sound ("click") is heard. Dispose of the syringe with the needle appropriately.

9a

9b

9c

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