Paliperidone Teva 75 mg prolonged-release injectable suspension EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Paliperidona Teva 50 mg prolonged-release injectable suspension EFG

Paliperidona Teva 75 mg prolonged-release injectable suspension EFG

Paliperidona Teva 100 mg prolonged-release injectable suspension EFG

Paliperidona Teva 150 mg prolonged-release injectable suspension EFG

Initial treatment pack:

Paliperidona Teva 150 mg and Paliperidona Teva 100 mg prolonged-release injectable suspension EFG

Read the entire leaflet carefully before starting to use this medicine, because

it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Paliperidona Teva contains the active substance paliperidona, which belongs to the class of antipsychotic medicines. It is used as maintenance treatment for the symptoms of schizophrenia in adult patients who have been stabilized with paliperidona or risperidone.

If you have previously responded to paliperidona or risperidone and have mild or moderate symptoms, your doctor may initiate treatment with Paliperidona Teva without prior stabilization with paliperidona or risperidone.

Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive means an excess of symptoms that are not normally present. For example, a person with schizophrenia may hear voices or see things that do not exist (called hallucinations), have false beliefs (called delusions), or have abnormally high levels of distrust toward others. Negative refers to the absence of behaviours or feelings that are normally present. For instance, a person with schizophrenia may withdraw into themselves and fail to respond to emotional stimuli, or may have difficulty speaking in a clear and logical manner. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidona Teva can help relieve the symptoms of your illness and prevent them from returning.

2. What you need to know before using Paliperidona Teva

Do not use paliperidona

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Paliperidona Teva.

This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are 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 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 have previously had low levels of white blood cells in the blood (which may or may not have been caused by other medicines);
• if you have diabetes or are prone to diabetes;
• if you have had breast cancer or a tumor in the pituitary gland of the brain;
• if you have heart disease or are receiving treatment for heart conditions that may make you more susceptible to a drop in blood pressure;
• if you have low blood pressure when standing up or getting up suddenly;
• 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 regulating body temperature or feel overheated;
• if you have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent;
• if you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, please consult your doctor, as you may require a dose adjustment or monitoring during treatment.

Rarely, patients treated with this medicine have experienced a dangerously low number of a type of white blood cells needed to fight infections in the blood. Your doctor may check your white blood cell count.

Even if you have previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after receiving injections of Paliperidona Teva. Seek immediate medical help if you experience a skin 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. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

Diabetes mellitus has been observed or pre-existing diabetes mellitus has worsened in patients treated with this medicine. Your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Since this medicine may reduce the urge to vomit, it may mask the body's normal response to ingesting toxic substances or other medical conditions.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

Do not use this medicine in children or adolescents under 18 years of age.

Other medicines and Paliperidona Teva

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Taking this medicine together with carbamazepine (an antiepileptic and mood stabilizer) may require a change in your dose of this medicine.

Since this medicine acts mainly on the brain, interactions with other medicines that also act on the brain may increase side effects such as drowsiness or other central nervous system effects, including psychiatric medicines, opioids, antihistamines, and sleeping medicines.

Since this medicine may lower blood pressure, you should be cautious if using it with other medicines that also lower blood pressure.

This medicine may reduce the effect of medicines used for Parkinson's disease and restless legs syndrome (e.g., levodopa).

This medicine may cause an abnormality in the electrocardiogram (ECG) indicating a prolonged time for an electrical impulse to travel through a certain 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, as well as other antipsychotics.

If you are prone to seizures, this medicine may increase your risk of experiencing them. Other medicines that have this effect include certain antidepressants and antibiotics, as well as other antipsychotics.

Paliperidona Teva should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Use of Paliperidona Teva with alcohol

Alcohol should be avoided.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use this medicine during pregnancy unless discussed with your doctor. The following symptoms may occur in newborn babies whose mothers were treated with paliperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.

This medicine may pass from mother to baby through breast milk and may harm the baby. Therefore, you should not breastfeed while using this medicine.

Driving and using machines

Dizziness, extreme tiredness, and vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account when maximum attention is required, e.g., when driving or operating machinery.

Paliperidona Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free."

3. How to use Paliperidona Teva

Your doctor or another healthcare professional will administer this medicine to you. Your doctor will tell you when the next injection should be given. It is important not to miss any of the scheduled doses. If you are unable to attend your appointment, make sure to contact your doctor immediately to schedule another appointment as soon as possible.

You will receive the first injection (150 mg) and the second injection (100 mg) of this medicine in the upper arm, approximately one week apart. After that, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

If your doctor is switching you from long-acting injectable risperidone to this medicine, you will receive your first injection of this medicine (between 25 mg and 150 mg) in the upper arm or buttocks at your next scheduled injection. After that, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive to a different dose level at the time of your scheduled monthly injection.

Patients with kidney problems

Your doctor may adjust the dose of this medicine according to your kidney function. If you have mild kidney problems, your doctor may give you a lower dose. You must not use this medicine if you have moderate or severe kidney problems.

Elderly patients

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

If you use more Paliperidona Teva than you should

You will receive this medicine under medical supervision; therefore, it is unlikely that you will receive an overdose.

Patients who have received an overdose of paliperidone may experience the following symptoms: drowsiness or sedation, rapid heartbeat, low blood pressure, abnormalities in the electrocardiogram (electrical tracing of the heart), or slow or abnormal movements of the face, body, arms, or legs.

If you stop using Paliperidona Teva

If you stop receiving your injections, the effects of the medicine will be lost. You must not stop using this medicine unless instructed by your doctor, as your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if:

• you develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• you have dementia and experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short time. These may be signs of a stroke.
• you develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). You may require immediate medical treatment.
• you are male and experience a prolonged or painful erection. This is known as priapism. You may require immediate medical treatment.
• you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary.
• you have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction"). Even if you have previously tolerated oral risperidone or oral paliperidone, allergic reactions have rarely occurred after receiving paliperidone injections.
• you are scheduled for eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery, the iris (the colored part of the eye) may become floppy during the procedure (known as "floppy iris syndrome"), which may cause eye damage.
• you experience a dangerously low number of a type of white blood cell necessary to fight blood infections.

The following adverse effects may occur:

Very common adverse effects: may affect more than 1 in 10 patients

• difficulty falling or staying asleep.

Common adverse effects: may affect up to 1 in 10 patients

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• paliperidone may increase levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin occur, they may include (in men) breast swelling, difficulty achieving or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems
• increased blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: This condition may include slow or altered movement, a feeling of stiffness or tightness in muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness
• restlessness, feeling drowsy or less alert
• dystonia: A disorder involving involuntary slow or sustained muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements
• dizziness
• dyskinesia: This disorder involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• tremor (shakiness)
• headache
• rapid heartbeat
• increased blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain, or swelling.

Uncommon adverse effects: may affect up to 1 in 100 patients

• pneumonia, chest infection (bronchitis), respiratory tract infection, nasal infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of a type of white blood cells that help fight infections, anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in blood
• increased appetite
• loss of appetite leading to malnutrition and decreased body weight
• increased blood triglycerides (fat), increased blood cholesterol
• sleep disorder, euphoria (mania), decreased sexual desire, nervousness, nightmares
• tardive dyskinesia (spasms or spasmodic movements that cannot be controlled in the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of this medicine may be necessary.
• fainting, a restlessness causing movement of body parts, dizziness upon standing, attention disturbance, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin
• blurred vision, eye infection or "red eye", dry eyes
• sensation of spinning (dizziness), ringing in the ears, ear pain
• interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heartbeat, abnormalities in the heart's electrical tracing (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• decreased blood pressure, low blood pressure upon standing (thus, some people taking this medicine may feel weak, dizzy, or may faint when standing or sitting up suddenly)
• shortness of breath, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excess gas or flatulence
• increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• hives (or "urticaria"), itching, rash, hair loss, eczema, dry skin, skin redness, acne, abscesses under the skin
• increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
• muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (loss of control), frequent urination, pain when urinating
• erectile dysfunction, ejaculation disorder, absence of menstrual periods or other cycle problems (women), breast development in men, sexual dysfunction, breast pain, milk secretion from the breasts
• swelling of the face, mouth, eyes, or lips, body swelling, arms or legs swelling
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling of uneasiness
• skin hardening
• falls.

Rare adverse effects: may affect up to 1 in 1,000 patients

• eye infection
• skin inflammation caused by mites, scaly abscess of the scalp with itching under the skin
• increased eosinophils (a type of white blood cell) in blood
• decreased platelets (blood cells that help stop bleeding)
• head agitation
• inappropriate secretion of the hormone controlling urine volume
• sugar in urine
• potentially life-threatening complications of uncontrolled diabetes
• decreased blood sugar
• excessive water intake
• lack of movement or response while awake (catatonia)
• confusion
• sleepwalking
• absence of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle rigidity), problems in brain blood vessels including sudden loss of blood flow to the brain (stroke or "mini" stroke), unresponsiveness to stimuli, loss of consciousness, decreased level of consciousness, seizures (epileptic fits), balance disorder
• abnormal coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, eye rolling, light sensitivity of the eyes, increased tearing, eye redness
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clot in the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg). If you experience any of these symptoms, seek medical help immediately.
• flushing
• difficulty breathing during sleep (sleep apnea)
• pulmonary congestion, respiratory tract congestion
• crackling lung sounds, wheezing
• pancreatitis (inflammation of the pancreas), tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• cracked lips
• drug-related skin rash, skin thickening, dandruff
• muscle fiber rupture and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of breast glands, breast growth
• vaginal discharge
• priapism (a prolonged penile erection that may require surgical treatment), very low body temperature, chills, feeling of thirst,
• medication withdrawal symptoms
• pus accumulation due to infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site.

Frequency not known: cannot be estimated from available data

• dangerously low number of a type of white blood cells necessary to fight infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes drop in blood pressure
• dangerously excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• decreased oxygen in parts of the body (due to decreased blood flow)
• rapid, shallow breathing, pneumonia caused by aspiration of food, voice disorder
• absence of intestinal movement causing obstruction
• yellowing of the skin and eyes (jaundice)
• severe or potentially life-threatening skin rash with blisters and skin peeling that may start around the mouth, nose, eyes, and genitals and spread to other body areas (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that may affect the throat, causing breathing difficulty
• skin discoloration
• postural abnormality
• newborn babies of mothers treated with paliperidone during pregnancy may experience adverse effects from the medicine and/or withdrawal symptoms such as irritability, weak or sustained muscle contractions, agitation, drowsiness, breathing problems, or feeding difficulties
• decreased body temperature
• dead skin cells at the injection site and ulcer at the injection site

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paliperidone Teva

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 outer carton following “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paliperidona Teva

The active substance is paliperidone.

Each Paliperidona Teva 50 mg pre-filled syringe contains 78 mg of paliperidone palmitate in 0.5 ml.

Each Paliperidona Teva 75 mg pre-filled syringe contains 117 mg of paliperidone palmitate in 0.75 ml.

Each Paliperidona Teva 100 mg pre-filled syringe contains 156 mg of paliperidone palmitate in 1 ml.

Each Paliperidona Teva 150 mg pre-filled syringe contains 234 mg of paliperidone palmitate in 1.5 ml.

Initiation treatment pack:

Each Paliperidona Teva 100 mg pre-filled syringe contains 156 mg of paliperidone palmitate in 1 ml.

Each Paliperidona Teva 150 mg pre-filled syringe contains 234 mg of paliperidone palmitate in 1.5 ml.

The other components are:

Polysorbate 20

Macrogol 4000

Monohydrate citric acid

Disodium phosphate

Monohydrate sodium dihydrogen phosphate

Sodium hydroxide (for pH adjustment)

Water for injections

Appearance of the medicinal product and contents of the pack

Paliperidona Teva is a white to off-white prolonged-release injectable suspension supplied in a pre-filled syringe (prolonged-release injection).

Each pack contains 1 pre-filled syringe and 2 needles.

Initiation treatment pack:

Each pack contains 1 pack of Paliperidona Teva 150 mg and 1 pack of Paliperidona Teva 100 mg.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer:

Actavis Group PTC ehf.

Dalshraun 1,

Hafnarfjörður 220

Iceland

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

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

Germany:	Paliperidone-ratiopharm 25 mg Depot Injection Suspension Paliperidone-ratiopharm 50 mg Depot Injection Suspension Paliperidone-ratiopharm 75 mg Depot Injection Suspension Paliperidone-ratiopharm 100 mg Depot Injection Suspension Paliperidone-ratiopharm 150 mg Depot Injection Suspension Paliperidone-ratiopharm 150 mg and 100 mg Depot Injection Suspension
Austria:	Paliperidone ratiopharm 25 mg Depot Injection Suspension Paliperidone ratiopharm 50 mg Depot Injection Suspension Paliperidone ratiopharm 75 mg Depot Injection Suspension Paliperidone ratiopharm 100 mg Depot Injection Suspension Paliperidone ratiopharm 150 mg Depot Injection Suspension Paliperidone ratiopharm Starter Pack 100 mg and Paliperidone ratiopharm 150 mg Depot Injection Suspension
Belgium:	Paliperidone Teva 25 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension Paliperidone Teva 50 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension Paliperidone Teva 75 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension Paliperidone Teva 100 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension Paliperidone Teva 150 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension Paliperidone Teva 150 mg & 100 mg suspension for injection with prolonged release / suspension injectable à libération prolongée / Depot-Injektionssuspension
Bulgaria:	Paliperidone Teva 75 mg prolonged-release injectable suspension Paliperidone Teva 100 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension
Croatia:	Paliperidone Teva 50 mg suspension for injection with prolonged release Paliperidone Teva 75 mg suspension for injection with prolonged release Paliperidone Teva 100 mg suspension for injection with prolonged release Paliperidone Teva 150 mg suspension for injection with prolonged release
Cyprus:	Paliperidone/Teva Pharma 75 mg prolonged-release injectable suspension Paliperidone/Teva Pharma 100 mg prolonged-release injectable suspension Paliperidone/Teva Pharma 150 mg prolonged-release injectable suspension
Denmark:	Paliperidone Teva
Estonia:	Paliperidone Teva
Finland:	Paliperidone ratiopharm 25 mg injection suspension, depot suspension Paliperidone ratiopharm 50 mg injection suspension, depot suspension Paliperidone ratiopharm 75 mg injection suspension, depot suspension Paliperidone ratiopharm 100 mg injection suspension, depot suspension Paliperidone ratiopharm 150 mg injection suspension, depot suspension Paliperidone ratiopharm 100 mg + 150 mg injection suspension, depot suspension
France:	PALIPERIDONE TEVA 25 mg prolonged-release injectable suspension PALIPERIDONE TEVA 50 mg prolonged-release injectable suspension PALIPERIDONE TEVA 75 mg prolonged-release injectable suspension PALIPERIDONE TEVA 100 mg prolonged-release injectable suspension PALIPERIDONE TEVA 150 mg prolonged-release injectable suspension
Greece:	Paliperidone/Teva Pharma 75 mg prolonged-release injectable suspension Paliperidone/Teva Pharma 100 mg prolonged-release injectable suspension Paliperidone/Teva Pharma 150 mg prolonged-release injectable suspension
Hungary:	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
Iceland:	Paliperidone Teva
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
Italy:	Paliperidone Teva Italia
Latvia:	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
Lithuania:	Paliperidone Teva 50 mg prolonged-release injectable suspension Paliperidone Teva 75 mg prolonged-release injectable suspension Paliperidone Teva 100 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension
Luxembourg:	Paliperidone-ratiopharm 25 mg Depot Injection Suspension Paliperidone-ratiopharm 50 mg Depot Injection Suspension Paliperidone-ratiopharm 75 mg Depot Injection Suspension Paliperidone-ratiopharm 100 mg Depot Injection Suspension Paliperidone-ratiopharm 150 mg Depot Injection Suspension Paliperidone-ratiopharm 150 mg and 100 mg Depot Injection Suspension
Netherlands:	Paliperidone Teva 25 mg, suspension for injection with prolonged release Paliperidone Teva 50 mg, suspension for injection with prolonged release Paliperidone Teva 75 mg, suspension for injection with prolonged release Paliperidone Teva 100 mg, suspension for injection with prolonged release Paliperidone Teva 150 mg, suspension for injection with prolonged release Paliperidone Teva 150 mg and 100 mg, suspension for injection with prolonged release
Norway:	Paliperidone Teva
Poland:	Paliperidone Teva
Portugal:	Paliperidone Teva
Romania:	Paliperidone Teva 50 mg prolonged-release injectable suspension Paliperidone Teva 75 mg prolonged-release injectable suspension Paliperidone Teva 100 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension
Slovakia:	Paliperidone Teva 25 mg prolonged-release injectable suspension Paliperidone Teva 50 mg prolonged-release injectable suspension Paliperidone Teva 75 mg prolonged-release injectable suspension Paliperidone Teva 100 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension and Paliperidone Teva 100 mg prolonged-release injectable suspension
Slovenia:	Paliperidone Teva 50 mg prolonged-release injectable suspension Paliperidone Teva 75 mg prolonged-release injectable suspension Paliperidone Teva 100 mg prolonged-release injectable suspension Paliperidone Teva 150 mg prolonged-release injectable suspension Paliperidone Teva 150 mg and 100 mg prolonged-release injectable suspension
Spain:	Paliperidone Teva 50 mg prolonged-release injectable suspension EFG Paliperidone Teva 75 mg prolonged-release injectable suspension EFG Paliperidone Teva 100 mg prolonged-release injectable suspension EFG Paliperidone Teva 150 mg prolonged-release injectable suspension EFG Paliperidone Teva 150 mg and Paliperidone Teva 100 mg prolonged-release injectable suspension EFG
Sweden:	Paliperidone Teva
United Kingdom (Northern Ireland):	Paliperidone Teva 25 mg Prolonged-release Suspension for Injection Paliperidone Teva 50 mg Prolonged-release Suspension for Injection Paliperidone Teva 75 mg Prolonged-release Suspension for Injection Paliperidone Teva 100 mg Prolonged-release Suspension for Injection Paliperidone Teva 150 mg Prolonged-release Suspension for Injection Paliperidone Teva 150 mg and 100 mg Prolonged-release Suspension for Injection Treatment Initiation Pack

Date of the most recent review of this leaflet: February 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only and should be read together with the complete prescribing information (Summary of Product Characteristics).

The injectable suspension is for single use only. It should be inspected visually for any foreign particles prior to administration. Do not use the product if the syringe is not visually free of foreign particles.

The package contains a pre-filled syringe and two safety needles (one 22-gauge 1½ inch [38.1 mm x 0.72 mm] needle and one 23-gauge 1 inch [25.4 mm x 0.64 mm] needle) for intramuscular injection. Paliperidona Teva is also available as a treatment initiation pack containing two pre-filled syringes (150 mg + 100 mg) and two additional safety needles.

1. Shake the syringe vigorously in an upright vertical position for at least 10 seconds to ensure a homogeneous suspension. Place the syringe with the nozzle in an upright vertical position. Tap the syringe gently to ensure all air bubbles rise to the top of the syringe.

1. Select the appropriate needle.

The first initiation dose of Paliperidona Teva (150 mg) is administered on Day 1 into the DELTOID muscle using the needle intended for injection into the DELTOID. The second initiation dose of Paliperidona Teva (100 mg) is also administered into the DELTOID muscle one week later (Day 8) using the needle intended for injection into the DELTOID.

If a patient is being switched from long-acting injectable risperidone to Paliperidona Teva, the first injection of Paliperidona Teva (dose range 25 mg to 150 mg) may be administered into either the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site, at the time of the next scheduled injection.

Subsequently, monthly maintenance injections may be administered into either the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site.

For injection into the DELTOID: if the patient weighs < 90 kg, use the 23-gauge 1 inch (25.4 mm x 0.64 mm) needle (needle with blue hub); if the patient weighs ≥ 90 kg, use the 22-gauge 1½ inch (38.1 mm x 0.72 mm) needle (needle with grey hub).

For injection into the GLUTEAL muscle, use the 22-gauge 1½ inch (38.1 mm x 0.72 mm) needle (needle with grey hub).

1. While holding the syringe in an upright vertical position, remove the rubber cap from the tip with a gentle twisting motion.

1. Open the safety needle blister pack halfway. Hold the needle cover by the plastic film. Hold the syringe pointing upwards. Attach the safety needle to the luer connector of the syringe with a gentle twisting motion to avoid cracks or damage to the needle hub. Always check for any signs of damage or leakage before administration.

2. Pull the cover straight off the needle in a straight line. Do not twist the cover, as the needle may detach from the syringe.

1. Position the syringe with the attached needle in an upright vertical position to proceed with air removal. Remove air from the syringe by carefully pushing the plunger forward until three drops of suspension foam are expelled from the syringe.

1. Inject the entire contents slowly and deeply by intramuscular route into the selected deltoid or gluteal muscle. Must not be administered by intravenous or subcutaneous route.

2. After completing the injection, use the thumb or another finger of the hand (8a, 8b) or a flat surface (8c) to activate the needle safety system. The system is fully activated when a click is heard. Dispose of the syringe with the needle appropriately.

8.a

8b

8c

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.