Paliperidone teva

Package leaflet: Information for the user

Paliperidone Teva, 75 mg, prolonged-release injection suspension
Paliperidone Teva, 100 mg, prolonged-release injection suspension
Paliperidone Teva, 150 mg, prolonged-release injection suspension
Paliperidone
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of the leaflet

1. What Paliperidone Teva is and what it is used for
2. What you need to know 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 Paliperidone Teva is and what it is used for

Paliperidone Teva contains the active substance paliperidone, which belongs to a group of medicines called antipsychotics. It is used for the maintenance treatment of symptoms of schizophrenia in stable adult patients previously treated with paliperidone or risperidone.
For patients who have previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, the doctor may initiate treatment with Paliperidone Teva without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a disorder with both "positive" and "negative" symptoms. Positive symptoms refer to the presence of symptoms that normally do not occur. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence of usual behaviours or emotions. A person with schizophrenia may, for example, appear withdrawn, emotionally unresponsive, or have difficulty speaking in a clear and logical way. People affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.
Paliperidone Teva helps to relieve the symptoms of the illness 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).
• if the patient is allergic to another antipsychotic medicine, including the substance risperidone.

Warnings and precautions
Before starting treatment with Paliperidone Teva, discuss this with your doctor, pharmacist, or
nurse.
The use of this medicine in elderly patients with dementia has not been studied. However, in such
patients treated with other medicines of similar type, an increased risk of stroke or death has been
observed (see section 4. Possible side effects).
All medicines have side effects. Some side effects of this medicine may worsen symptoms of other medical conditions. Therefore, it is important to discuss with your doctor any of the following conditions that may potentially worsen during treatment with this medicine:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterised by symptoms such as high fever and muscle stiffness (also known as neuroleptic malignant syndrome)
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia)
• if the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines)
• if the patient has diabetes or is predisposed to developing diabetes
• if the patient has breast cancer or a pituitary gland tumour
• if the patient has heart disease or is being treated for heart conditions that predispose to hypotension
• if the patient has low blood pressure upon sudden change to a standing or sitting position
• if the patient has epilepsy
• if the patient has been diagnosed with kidney function disorders
• if the patient has been diagnosed with liver function disorders
• if the patient experiences prolonged and (or) painful erection
• if the patient has problems with body temperature regulation or overheating
• if the patient has abnormally elevated levels of prolactin hormone in the blood or suspicion of a prolactin-dependent tumour
• if the patient or family members have a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient has any of the conditions listed above, consult a doctor, who may adjust the dose or perform periodic monitoring.
The treating doctor may order a white blood cell count test, as very rarely, this medicine has been associated with dangerously low levels of a certain type of white blood cells necessary to fight infections.
Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after paliperidone injections. Immediate medical help should be sought if the patient develops rash, throat swelling, itching, or difficulty breathing, as these may be symptoms of a severe allergic reaction.
This medicine may cause weight gain. Significant weight gain may adversely affect the patient's health. The treating doctor will regularly monitor the patient's body weight.
The treating doctor will monitor for symptoms of elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Since this medicine may suppress vomiting, it could mask the body's normal response to ingestion of toxic substances or other medical conditions.
During cataract surgery (removal of cataract from the eye), the pupil (black spot in the centre of the eye) may not dilate sufficiently. Also, the iris of the eye (the part responsible for eye colour) may be floppy during surgery, which could lead to eye damage. If the patient has planned eye surgery, inform the ophthalmologist about taking this medicine.
Children and adolescents
This medicine is not used in individuals under 18 years of age.
Paliperidone Teva and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilising medicine) may require adjustment of the dose of this medicine.
Since this medicine acts primarily in the brain, combining it with other medicines acting on the brain—such as other psychotropic medicines, opioids, antihistamines, and sedatives—may increase the risk of side effects such as drowsiness or other central nervous system effects.
This medicine may cause low blood pressure; therefore, caution is advised when using it together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g. levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG), manifested by prolongation of the time it takes for an electrical impulse to pass through a certain part of the heart (known as "QT interval prolongation"). Other medicines with such effects include certain medicines used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with such effects include certain antidepressants or medicines used to treat infections, as well as other antipsychotics.
Caution is advised when using Paliperidone Teva together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
Alcohol and Paliperidone Teva
Alcohol consumption should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy unless discussed with a doctor. Newborns whose mothers took paliperidone during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact your doctor.
This medicine may pass from the mother's body into breast milk and harm the baby. Therefore, breastfeeding should not be undertaken while taking this medicine.
Driving and operating machinery
During treatment with this medicine, dizziness, extreme tiredness, and vision disturbances may occur (see section 4). These effects should be taken into account in situations requiring full alertness, such as driving or operating machinery.
Important information about certain ingredients of Paliperidone Teva
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Paliperidone Teva

The medicine will be administered by a doctor or other healthcare professional. Your doctor will inform you when the next injection is due. It is important not to miss a scheduled dose. If you are unable to keep the scheduled appointment, you should contact your doctor immediately to arrange a new appointment as soon as possible.

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

If your doctor decides to switch you from long-acting risperidone injections to this medicine, the first injection of Paliperidone Teva (at a dose ranging from 25 mg to 150 mg) will be given into the upper arm or buttock on the day your next risperidone injection is due. After that, monthly injections (at a dose ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock.

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

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

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

Use of a higher than recommended dose of Paliperidone Teva
This medicine is administered under medical supervision, so overdose is unlikely.

In patients who have received an excessive dose of paliperidone, the following symptoms may occur: drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram) findings, or slowed or abnormal movements of the face, body, arms, or legs.

Stopping treatment with Paliperidone Teva
If you stop receiving the injections, the medicine will no longer work. Do not discontinue treatment unless instructed by your doctor, as symptoms of your illness may return.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You should immediately inform your doctor if:

• the patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help;
• the patient with dementia experiences a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke;
• the patient develops fever, muscle stiffness, sweating or decreased level of consciousness (a condition known as neuroleptic malignant syndrome). Immediate treatment may be required;
• a man experiences prolonged or painful erection. This condition is known as priapism. Immediate treatment may be required;
• the patient develops involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone treatment may be necessary;
• the patient develops a severe allergic reaction characterised by: fever, swelling of the lips, face, tongue or mouth, shortness of breath, itching, skin rash, and sometimes a drop in blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or orally administered paliperidone, allergic reactions may rarely occur after paliperidone injections;
• the patient is scheduled for eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract removal surgery, floppy iris syndrome (affecting the part responsible for eye colour) may occur, which could lead to eye damage;
• the patient has dangerously low levels of certain white blood cells essential for fighting infections.

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

• difficulty falling asleep or waking up.

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

• cold-like symptoms, urinary tract infection, flu-like symptoms

• paliperidone may increase the level of the hormone prolactin in the blood (this may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection or other sexual problems. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual periods or other menstrual cycle disturbances;

• high blood sugar levels, weight gain, weight loss, decreased appetite

• irritability, depression, anxiety

• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face

• psychomotor restlessness, drowsiness or reduced alertness

• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal body posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements

• dizziness

• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks

• tremor

• headache

• rapid heartbeat

• high blood pressure

• cough, stuffy nose

• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache

• increased liver enzyme activity in blood

• bone or muscle pain, back pain, joint pain

• absence of menstruation

• fever, weakness, fatigue

• injection site reaction, including itching, pain or swelling

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

• pneumonia, bronchitis, respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of certain white blood cells protecting against infections, anaemia
• allergic reaction
• onset of diabetes and worsening of pre-existing diabetes, increased blood insulin levels (hormone regulating blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high blood triglyceride (fats) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• tardive dyskinesia (twitching or jerking uncontrolled movements of the face, tongue or other body parts). Inform your doctor immediately if you notice involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon standing, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, prickling or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• sensation of dizziness, ringing in the ears, ear pain
• heart conduction block between chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, rapid heartbeat upon standing, slow heart rate, abnormal ECG reading, sensation of heart pounding (palpitations)
• low blood pressure, low blood pressure upon standing (as a result, some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly or rising)
• shallow breathing, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• skin rash, itching, rash, hair loss, skin rash, dry skin, skin redness, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) enzyme activity in blood, an enzyme sometimes released from damaged muscles
• muscle cramps, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disorders, breast pain, galactorrhoea
• swelling of the face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in gait
• chest pain, chest discomfort, feeling unwell
• skin hardening
• fall

Rare side effects (may affect up to 1 in 1000 people)

• eye infection

• skin inflammation caused by mites, scaly, itchy scalp or other body parts

• increased number of eosinophils (a type of white blood cell) in blood

• decreased number of platelets (blood cells responsible for stopping bleeding)

• head tremors

• abnormal secretion of the hormone regulating urine production

• sugar in urine

• life-threatening complications of untreated diabetes

• low blood sugar levels

• excessive water drinking

• lack of movement and response to stimuli in a patient who is not asleep (catatonia)

• confusion

• sleepwalking

• lack of emotions

• inability to achieve orgasm

• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, reduced level of consciousness, seizures, balance disturbances;

• abnormal motor coordination

• glaucoma (increased pressure inside the eyeball)

• eye movement disorders, rotary eye movements, light sensitivity of the eyes, increased tearing, eye redness

• atrial fibrillation (irregular heartbeat), irregular heartbeat;

• blood clot in the lungs causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help

• blood clots in the veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, seek immediate medical help

• episodes of flushing

• breathing disturbances during sleep (sleep apnoea)

• blood congestion in the lungs, respiratory tract congestion

• crackling sounds in the lungs, wheezing

• pancreatitis, tongue swelling, faecal incontinence, very hard stool

• intestinal obstruction

• 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 (prolonged erection, which may require surgical intervention);

• very low body temperature, chills, sensation of thirst

• withdrawal symptoms

• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site

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

• dangerously low number of certain white blood cells in blood, responsible for fighting blood infection
• severe allergic reaction characterised by fever, swelling of lips, face, mouth or tongue, shallow breathing, itching, skin rash, and sometimes drop in blood pressure
• dangerously excessive water drinking - water intoxication
• sleep-related eating disorders
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow);
• rapid, shallow breathing, pneumonia caused by food aspiration, voice disturbances
• lack of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may start around the mouth, nose, eyes and genital organs and spread to other body areas (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling which may involve the throat and lead to breathing difficulties
• skin depigmentation
• abnormal body posture
• in newborns whose mothers used paliperidone during pregnancy, drug side effects and (or) withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• decreased body temperature
• necrosis at injection site and ulcer at injection site

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Paliperidone Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the prefilled syringe and
packaging after "EXP" or Expiry date (EXP). The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Paliperidone Teva contains
The active substance is paliperidone.
Each pre-filled syringe of Paliperidone Teva 75 mg contains 117 mg of paliperidone palmitate
in 0.75 ml of suspension.
Each pre-filled syringe of Paliperidone Teva 100 mg contains 156 mg of paliperidone palmitate
in 1 ml of suspension.
Each pre-filled syringe 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 prolonged-release injectable suspension in a pre-filled syringe.
The pre-filled syringe contains 0.75, 1 or 1.5 ml of suspension (cyclic olefin copolymer), with a plunger made of PP and a plunger tip (made of bromobutyl rubber), and is supplied with two needles: 22G x 1.5 inches (38.1 mm x 0.72 mm) and 23G x 1 inch (25.4 mm x 0.64 mm), both stainless steel, each with a safety device.
Each pack contains: 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. +48 22 345 93 00

Manufacturer
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

This medicinal product is authorised in 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: Paliperidon Teva

Estonia: 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
Paliperidone 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
Paliperidone 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

The following information is intended exclusively for medical or healthcare professionals and should be read in conjunction with the full product information (Summary of Product Characteristics).

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

The package contains one prefilled syringe and two safety needles [22G 1.5 inch (38.1 mm x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular administration. The medicinal product Paliperidone Teva is also available in a starter pack containing two prefilled syringes (150 mg + 100 mg) and two additional safety needles.

1. Shake the prefilled syringe vigorously for at least 10 seconds to ensure homogeneity of the suspension. Place the syringe in an upright vertical position with the plunger down. Gently tap the syringe to allow all air bubbles to rise to the top of the syringe.

2. Select the appropriate needle.

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

If switching from long-acting risperidone injections to the medicinal product Paliperidone Teva, the first injection of Paliperidone Teva (at a dose ranging from 25 mg to 150 mg) may be administered on the day of the next scheduled injection into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle.

Subsequently, monthly maintenance doses may be administered into either the DELTOID MUSCLE or the GLUTEAL MUSCLE using the appropriate needle.

For injections into the DELTOID MUSCLE in patients with body weight <90 kg, use the 1-inch, 23G needle (25.4 mm x 0.64 mm) (needle with blue hub). If the patient's body weight is ≥90 kg, use the 1.5-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

For injections into the GLUTEAL MUSCLE, use a 1½-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

3. Holding the prefilled syringe upright, remove the rubber cap from the tip with a gentle twisting motion.

4. Partially peel open the outer blister packaging of the safety needle. Hold the needle sheath through the plastic packaging. Keep the syringe upright. Attach the Luer tip of the safety needle to the prefilled syringe with a gentle twisting motion to avoid breakage or damage to the needle tip. Before administration, always check for signs of damage or leakage.

5. Remove the needle sheath with a straight pull. Do not twist the sheath, as this may loosen the needle from the prefilled syringe.

6. Position the prefilled syringe with attached needle in an upright vertical position to remove air. Expel air from the prefilled syringe by gently pressing the plunger until 3 drops of the suspension are expelled from the syringe.

7. Administer the entire contents of the prefilled syringe intramuscularly, slowly and deeply, into the selected muscle (deltoid or gluteal) of the patient. Do not administer the medicinal product intravenously or subcutaneously.

8. After completing the injection, activate the needle safety mechanism by using the thumb or finger of one hand (8a, 8b) or a flat surface (8c). A clicking sound indicates successful activation of the needle safety mechanism. Dispose of the prefilled syringe with the needle properly.

8a

8b

8c

Any unused portions of the product or waste materials should be disposed of in accordance with local regulations.