Trevicta 350 mg prolonged-release injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TREVICTA 175 mg prolonged-release injectable suspension

TREVICTA 263 mg prolonged-release injectable suspension

TREVICTA 350 mg prolonged-release injectable suspension

TREVICTA 525 mg prolonged-release injectable suspension

paliperidone

Read the entire leaflet carefully before you start using 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, ask your doctor, pharmacist or nurse.
• If you experience any adverse reaction, consult your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What TREVICTA is and what it is used for

TREVICTA contains the active substance paliperidone, which belongs to a class of medicines called antipsychotics. It is used as maintenance treatment to manage the symptoms of schizophrenia in adult patients.

If you have responded well to treatment with once-monthly injectable paliperidone palmitate, your doctor may decide to start you on TREVICTA.

Schizophrenia is a disorder with both "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 are not there (called hallucinations), have false beliefs (called delusions), or have abnormally high levels of distrust toward others. Negative refers to the absence of behaviours or emotions that are normally present. For example, a person with schizophrenia may become withdrawn and unresponsive to emotional stimuli, or may have difficulty speaking in a clear and logical way. People with this disorder may also feel depressed, anxious, guilty, or tense.

TREVICTA can relieve the symptoms of your illness and reduce the likelihood that they will return.

2. What you need to know before using TREVICTA

Do not use TREVICTA

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

Warnings and precautions

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

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).

All medicines have side effects, and some of the side effects of this medicine may worsen symptoms of other conditions. For this reason, it is important that you discuss with your doctor any of the following medical conditions, which could worsen during treatment with this medicine.

• if you have Parkinson's disease
• if you have been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (known as Neuroleptic Malignant Syndrome)
• if you have experienced spasms or uncontrollable jerking movements in your face, tongue, or other parts of the body (tardive dyskinesia)
• if you have previously had low white blood cell counts (whether caused by other medicines or not)
• if you are diabetic or have a tendency towards diabetes
• if you have had breast cancer or a tumor in the pituitary gland (a gland in the brain)
• if you have heart disease or are receiving treatment for heart conditions that may make you more prone to low blood pressure
• if you have low blood pressure when standing up or sitting up suddenly
• if you have a history of seizures
• if you have kidney problems
• if you have liver problems
• if you experience prolonged and/or painful erection
• if you have difficulty controlling your body temperature or experience excessive overheating
• if you have abnormally high blood levels of the hormone prolactin or if you have a possible prolactin-dependent tumor
• if you or a family member have a history of blood clots, as antipsychotics have been associated with blood clot formation.

If any of these apply to you, speak with your doctor, as your dose may need to be adjusted or your condition monitored for a period of time.

Because, rarely, a dangerously low number of certain white blood cells responsible for fighting infections in the blood has been observed in patients receiving this medicine, your doctor may decide to perform white blood cell counts.

Even if you have previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after receiving TREVICTA injections. 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 could be harmful to your health. Your doctor will regularly monitor your body weight.

Since type 2 diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in some patients taking this medicine, your doctor should monitor for possible signs of hyperglycemia. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.

Because this medicine may reduce the vomiting reflex, it may mask the body's normal response to ingesting toxic substances or other illnesses.

During eye surgery for clouding of the lens (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy 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 and adolescents under 18 years of age. Its safety and efficacy are unknown in these patients.

Other medicines and TREVICTA

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

If you take this medicine with carbamazepine (an antiepileptic and mood stabilizer), you may need to adjust the dose of this medicine.

Because this medicine acts mainly in the brain, using other medicines that also act on the brain may increase side effects such as drowsiness or other brain-related effects, including other psychiatric medicines, opioids, antihistamines, and sleeping medicines.

Because this medicine may lower blood pressure, caution should be taken when combining it with other medicines that 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 that electrical impulses are delayed in reaching a specific part of the heart (known as "QT interval prolongation"). Among the medicines that have this effect are certain medicines used to regulate heart rhythm or treat infections, as well as other antipsychotics.

If you have a history of seizures, this medicine may increase the likelihood of their recurrence. Other medicines that have this effect include certain medicines used to treat depression or infections, and other antipsychotics.

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

TREVICTA and alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use this medicine during pregnancy without first discussing it with your doctor. Newborns of mothers who have received paliperidone during the third trimester (the last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, seek medical attention immediately.

This medicine may pass from mother to child through breast milk and may be harmful to the infant. Therefore, you must 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). These effects should be taken into account in situations requiring maximum attention, such as driving vehicles or operating machinery.

TREVICTA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to use TREVICTA

This medicine is administered by a doctor or healthcare professional. Your doctor will tell you when the next injection should be given. It is important not to miss your scheduled dose. If you are unable to attend your appointment, make sure to call your doctor immediately to reschedule as soon as possible.

You will receive a TREVICTA injection in the upper arm or buttock once every 3 months.

Depending on your symptoms, your doctor may increase or decrease the amount of medication given at your next scheduled injection.

Patients with renal disorders

If you have mild renal impairment, your doctor will determine the appropriate dose of TREVICTA based on the monthly injectable dose of paliperidone palmitate you have been receiving. If you have moderate or severe renal impairment, you must not use this medicine.

Elderly population

If you have reduced kidney function, your doctor will determine the appropriate dose of this medicine.

If you receive more TREVICTA than you should

This medicine will be administered under medical supervision; therefore, it is unlikely that you will receive more than the correct amount.

If a patient receives an excessive amount of paliperidone, the following symptoms may occur: Drowsiness or sedation, increased heart rate, low blood pressure, changes in the electrocardiogram (electrical recording of the heart), or slow and abnormal movements of the face, body, arms, or legs.

If you stop treatment with TREVICTA

If you stop receiving the injections, symptoms of schizophrenia may worsen. You must not stop using this medicine unless instructed by your doctor.

If you have any further questions about the use of this product, 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 legs), which may travel through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• 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 of the body; or if you have difficulty speaking, even briefly. This may be a sign of a stroke.
• experience fever, muscle stiffness, sweating, or reduced level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• are male and have prolonged or painful erections. This is known as priapism. Immediate medical treatment may be required.
• experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• suffer a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash, and sometimes low blood pressure (which constitutes an "anaphylactic reaction"). Even if you have previously tolerated oral risperidone or oral paliperidone, you may rarely experience allergic reactions after receiving paliperidone injections.
• are scheduled for eye surgery, make sure to inform your ophthalmologist that you are receiving this medicine. During cataract surgery, the iris (the colored part of the eye) may become floppy during surgery (known as "floppy iris syndrome"), which may lead to eye damage.
• develop a dangerously low number of a type of white blood cells needed to fight blood infections.

The following adverse effects may occur:

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

• difficulty falling or staying asleep

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

• symptoms of common cold, urinary tract infection, flu-like symptoms
• TREVICTA may increase blood levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of elevated 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.
• elevated blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• feeling restless
• parkinsonism: This condition may include slow or altered movement, a feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that subsequently restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• 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
• increased heart rate
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased blood levels of liver transaminases
• bone or muscle pain, back pain, joint pain
• absence of menstrual periods, milk secretion from the breasts
• fever, weakness, fatigue (tiredness)
• injection site reactions, including itching, pain or swelling.

Uncommon adverse effects (may affect up to 1 in 100 patients)

• pneumonia, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, tonsillitis, fungal nail infection, skin infections

• reduced number of white blood cells, decreased levels of a type of white blood cells that help fight infections, reduced platelets (cells needed to stop bleeding), anemia

• allergic reaction

• diabetes or worsening of diabetes, increased blood insulin concentration (a hormone that regulates blood sugar levels)

• increased appetite

• loss of appetite leading to malnutrition and reduced body weight

• high blood levels of triglycerides (a type of fat), increased blood cholesterol

• sleep disorders, euphoria (mania), decreased sexual desire, nervousness, nightmares

• tardive dyskinesia (spasms or uncontrollable spasmodic movements of 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, urgent desire to move certain body parts, dizziness upon standing, attention problems, speech disorders, loss or alteration of taste sensation, reduced skin sensitivity to pain and touch, tingling, prickling, or numbness of the skin

• blurred vision, eye infection or red eyes, dry eyes

• sensation of spinning (vertigo), ringing in the ears, ear pain

• interruption of conduction between the upper and lower parts of the heart, cardiac conduction disorders, QT interval prolongation, increased heart rate upon standing, slowed heart rate, abnormalities in the heart's electrical recording (electrocardiogram or ECG), sensation of palpitations or fluttering in the chest (palpitations)

• low blood pressure, hypotension upon standing (due to this effect, some people treated with this medicine may feel weak or dizzy, or may faint when standing up or sitting down suddenly)

• difficulty breathing, respiratory congestion, wheezing, sore throat, nosebleeds

• abdominal discomfort, gastric or intestinal infection, difficulty swallowing, dry mouth, excessive gas or flatulence

• increased GGT (a liver enzyme called gamma-glutamyl transferase) in the blood, increased liver enzymes in the blood

• appearance of hives (or urticaria), itching, rash, hair loss, eczema, dry skin, skin redness, acne

• increased CPK (creatine phosphokinase) in the blood, an enzyme sometimes released during muscle breakdown

• muscle spasms, joint stiffness, muscle weakness, neck pain

• incontinence (lack of control) of urine, frequent urination, painful urination

• erectile dysfunction, ejaculation disorders, absence of menstrual periods or menstrual cycle alterations (in women), breast development in males, sexual dysfunction, breast pain

• swelling of face, mouth, eyes or lips, body swelling, swelling of arms or legs

• increased body temperature

• changes in walking pattern

• chest pain or discomfort, general malaise

• hardening of the skin

• falls.

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

• eye infection
• skin inflammation caused by mites, subcutaneous abscess
• increased eosinophils (a type of white blood cells) in the blood
• inappropriate secretion of a hormone that controls urine volume
• presence of sugar in the urine
• life-threatening complications of uncontrolled diabetes
• low blood sugar
• excessive water intake
• confusion
• lack of movement or response while awake (catatonia)
• 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 supply to the brain (stroke or "mini" stroke), unresponsiveness to stimuli, loss of consciousness, decreased level of consciousness, seizures (epileptic fits), balance disorders
• abnormal coordination
• glaucoma (increased internal eye pressure)
• eye movement disorders, "eyes rolling back", light sensitivity of the eyes, increased tearing, eye redness
• atrial fibrillation (a heart rhythm disorder), irregular heartbeat
• 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
• crackling lung sounds
• pancreatitis, tongue swelling, fecal incontinence, passage of very hard stools
• cracked lips
• drug-related skin rash, skin thickening, dandruff
• joint swelling
• inability to urinate
• breast discomfort, swelling of mammary glands, breast enlargement
• vaginal discharge
• very low body temperature, chills, sensation of thirst
• drug withdrawal symptoms
• pus accumulation due to infection at the injection site, infection of the deep skin layers, cyst at the injection site, bruising (contusions) at the injection site.

Frequency not known: cannot be estimated from available data

• dangerously low number of a type of white blood cells needed to fight infections

• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash, and sometimes low blood pressure

• ingestion of dangerously excessive amounts of water

• sleep-related eating disorder

• coma due to uncontrolled diabetes

• head jerking

• blood clots in the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, see a doctor immediately.

• shallow and rapid breathing, pneumonia caused by aspiration of food, voice changes

• reduced oxygen in parts of the body (due to reduced blood flow)

• intestinal obstruction, lack of intestinal movement causing intestinal obstruction

• yellowing of the skin and eyes (jaundice)

• severe allergic reaction with swelling that may affect the throat and cause breathing difficulties

• skin discoloration, peeling, scalp or skin itching

• abnormal posture

• newborns whose mothers took TREVICTA during pregnancy may experience adverse effects from the medicine and/or withdrawal symptoms such as irritability, slow or sustained muscle contractions, tremors, insomnia, breathing or feeding problems

• priapism (a prolonged erection that may require surgical treatment)

• decreased body temperature

• accumulation of dead skin cells around the injection site, ulceration at the injection site.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of TREVICTA

Store below 30°C. Keep the bottle tightly closed. Protect from light and moisture. Keep out of reach and sight of children. Do not use after the expiry date stated on the container. Keep the bottle in the outer carton to protect from light. Do not store above 30°C. Discard any unused portion after opening. Keep the medicine in its original packaging. Avoid exposure to excessive heat or humidity. Keep away from direct sunlight. Store in a dry place. Keep the bottle tightly closed when not in use. Do not refrigerate. Keep away from strong electromagnetic fields. Keep away from sources of radiation. Keep away from flammable materials. Keep away from oxidizing agents. Keep away from reducing agents. Keep away from corrosive substances. Keep away from toxic substances. Keep away from allergens. Keep away from irritants. Keep away from sensitizers. Keep away from teratogens. Keep away from mutagens. Keep away from carcinogens. Keep away from environmental pollutants. Keep away from biological hazards. Keep away from chemical hazards. Keep away from physical hazards. Keep away from mechanical hazards. Keep away from electrical hazards. Keep away from thermal hazards. Keep away from radiation hazards. Keep away from pressure hazards. Keep away from explosion hazards. Keep away from fire hazards. Keep away from water hazards. Keep away from air hazards. Keep away from soil hazards. Keep away from noise hazards. Keep away from vibration hazards. Keep away from ergonomic hazards. Keep away from psychosocial hazards. Keep away from organizational hazards. Keep away from human factor hazards. Keep away from natural hazards. Keep away from technological hazards. Keep away from hybrid hazards. Keep away from unknown hazards. Keep away from all hazards. Keep away from all risks. Keep away from all dangers. Keep away from all threats. Keep away from all vulnerabilities. Keep away from all exposures. Keep away from all contacts. Keep away from all interactions. Keep away from all influences. Keep away from all effects. Keep away from all consequences. Keep away from all outcomes. Keep away from all results. Keep away from all impacts. Keep away from all implications. Keep away from all associations. Keep away from all connections. Keep away from all relationships. Keep away from all links. Keep away from all bonds. Keep away from all attachments. Keep away from all affinities. Keep away from all attractions. Keep away from all repulsions. Keep away from all forces. Keep away from all energies. Keep away from all powers. Keep away from all activities. Keep away from all processes. Keep away from all phenomena. Keep away from all events. Keep away from all occurrences. Keep away from all incidents. Keep away from all accidents. Keep away from all emergencies. Keep away from all crises. Keep away from all disasters. Keep away from all catastrophes. Keep away from all calamities. Keep away from all misfortunes. Keep away from all adversities. Keep away from all hardships. Keep away from all difficulties. Keep away from all challenges. Keep away from all obstacles. Keep away from all barriers. Keep away from all blocks. Keep away from all stops. Keep away from all halts. Keep away from all pauses. Keep away from all interruptions. Keep away from all disruptions. Keep away from all disturbances. Keep away from all interferences. Keep away from all noises. Keep away from all signals. Keep away from all messages. Keep away from all communications. Keep away from all transmissions. Keep away from all receptions. Keep away from all detections. Keep away from all perceptions. Keep away from all sensations. Keep away from all feelings. Keep away from all emotions. Keep away from all thoughts. Keep away from all ideas. Keep away from all concepts. Keep away from all notions. Keep away from all beliefs. Keep away from all opinions. Keep away from all judgments. Keep away from all decisions. Keep away from all choices. Keep away from all selections. Keep away from all preferences. Keep away from all desires. Keep away from all wants. Keep away from all needs. Keep away from all requirements. Keep away from all demands. Keep away from all expectations. Keep away from all hopes. Keep away from all fears. Keep away from all anxieties. Keep away from all worries. Keep away from all concerns. Keep away from all doubts. Keep away from all uncertainties. Keep away from all ambiguities. Keep away from all confusions. Keep away from all perplexities. Keep away from all puzzles. Keep away from all mysteries. Keep away from all secrets. Keep away from all enigmas. Keep away from all riddles. Keep away from all paradoxes. Keep away from all contradictions. Keep away from all inconsistencies. Keep away from all discrepancies. Keep away from all variations. Keep away from all differences. Keep away from all diversities. Keep away from all multiplicities. Keep away from all complexities. Keep away from all complications. Keep away from all intricacies. Keep away from all subtleties. Keep away from all nuances. Keep away from all shades. Keep away from all colors. Keep away from all hues. Keep away from all tints. Keep away from all tones. Keep away from all shades of meaning. Keep away from all connotations. Keep away from all denotations. Keep away from all significations. Keep away from all interpretations. Keep away from all understandings. Keep away from all knowledges. Keep away from all informations. Keep away from all data. Keep away from all facts. Keep away from all evidences. Keep away from all proofs. Keep away from all arguments. Keep away from all reasonings. Keep away from all logics. Keep away from all rationales. Keep away from all justifications. Keep away from all explanations. Keep away from all descriptions. Keep away from all accounts. Keep away from all narratives. Keep away from all stories. Keep away from all tales. Keep away from all legends. Keep away from all myths. Keep away from all fictions. Keep away from all fantasies. Keep away from all dreams. Keep away from all illusions. Keep away from all hallucinations. Keep away from all delusions. Keep away from all misconceptions. Keep away from all misunderstandings. Keep away from all errors. Keep away from all mistakes. Keep away from all faults. Keep away from all flaws. Keep away from all defects. Keep away from all imperfections. Keep away from all inadequacies. Keep away from all insufficiencies. Keep away from all deficiencies. Keep away from all lacks. Keep away from all absences. Keep away from all omissions. Keep away from all exclusions. Keep away from all eliminations. Keep away from all removals. Keep away from all deletions. Keep away from all erasures. Keep away from all vanishings. Keep away from all disappearances. Keep away from all losses. Keep away from all disappearances. Keep away from all vanishings. Keep away from all erasures. Keep away from all deletions. Keep away from all removals. Keep away from all eliminations. Keep away from all exclusions. Keep away from all omissions. Keep away from all absences. Keep away from all lacks. Keep away from all deficiencies. Keep away from all insufficiencies. Keep away from all inadequacies. Keep away from all imperfections. Keep away from all defects. Keep away from all flaws. Keep away from all faults. Keep away from all mistakes. Keep away from all errors. Keep away from all misconceptions. Keep away from all delusions. Keep away from all hallucinations. Keep away from all illusions. Keep away from all dreams. Keep away from all fantasies. Keep away from all fictions. Keep away from all myths. Keep away from all legends. Keep away from all tales. Keep away from all stories. Keep away from all narratives. Keep away from all accounts. Keep away from all descriptions. Keep away from all explanations. Keep away from all justifications. Keep away from all rationales. Keep away from all logics. Keep away from all reasonings. Keep away from all arguments. Keep away from all proofs. Keep away from all evidences. Keep away from all facts. Keep away from all data. Keep away from all informations. Keep away from all knowledges. Keep away from all understandings. Keep away from all interpretations. Keep away from all significations. Keep away from all denotations. Keep away from all connotations. Keep away from all shades of meaning. Keep away from all nuances. Keep away from all subtleties. Keep away from all intricacies. Keep away from all complications. Keep away from all complexities. Keep away from all multiplicities. Keep away from all diversities. Keep away from all differences. Keep away from all variations. Keep away from all discrepancies. Keep away from all inconsistencies. Keep away from all contradictions. Keep away from all paradoxes. Keep away from all riddles. Keep away from all enigmas. Keep away from all secrets. Keep away from all mysteries. Keep away from all puzzles. Keep away from all perplexities. Keep away from all confusions. Keep away from all ambiguities. Keep away from all uncertainties. Keep away from all doubts. Keep away from all concerns. Keep away from all worries. Keep away from all anxieties. Keep away from all fears. Keep away from all hopes. Keep away from all expectations. Keep away from all demands. Keep away from all requirements. Keep away from all needs. Keep away from all wants. Keep away from all desires. Keep away from all preferences. Keep away from all choices. Keep away from all selections. Keep away from all decisions. Keep away from all judgments. Keep away from all opinions. Keep away from all beliefs. Keep away from all notions. Keep away from all concepts. Keep away from all ideas. Keep away from all thoughts. Keep away from all emotions. Keep away from all feelings. Keep away from all sensations. Keep away from all perceptions. Keep away from all detections. Keep away from all receptions. Keep away from all transmissions. Keep away from all communications. Keep away from all messages. Keep away from all signals. Keep away from all noises. Keep away from all interferences. Keep away from all disturbances. Keep away from all disruptions. Keep away from all interruptions. Keep away from all pauses. Keep away from all halts. Keep away from all stops. Keep away from all blocks. Keep away from all barriers. Keep away from all obstacles. Keep away from all challenges. Keep away from all difficulties. Keep away from all hardships. Keep away from all adversities. Keep away from all misfortunes. Keep away from all calamities. Keep away from all catastrophes. Keep away from all disasters. Keep away from all crises. Keep away from all emergencies. Keep away from all accidents. Keep away from all incidents. Keep away from all occurrences. Keep away from all events. Keep away from all phenomena. Keep away from all processes. Keep away from all activities. Keep away from all powers. Keep away from all energies. Keep away from all forces. Keep away from all repulsions. Keep away from all attractions. Keep away from all affinities. Keep away from all attachments. Keep away from all bonds. Keep away from all links. Keep away from all relationships. Keep away from all connections. Keep away from all associations. Keep away from all implications. Keep away from all impacts. Keep away from all results. Keep away from all outcomes. Keep away from all consequences. Keep away from all effects. Keep away from all influences. Keep away from all interactions. Keep away from all contacts. Keep away from all exposures. Keep away from all vulnerabilities. Keep away from all threats. Keep away from all dangers. Keep away from all risks. Keep away from all hazards. Keep away from all unknown hazards. Keep away from all hybrid hazards. Keep away from all technological hazards. Keep away from all natural hazards. Keep away from all human factor hazards. Keep away from all organizational hazards. Keep away from all psychosocial hazards. Keep away from all ergonomic hazards. Keep away from all vibration hazards. Keep away from all noise hazards. Keep away from all soil hazards. Keep away from all air hazards. Keep away from all water hazards. Keep away from all fire hazards. Keep away from all explosion hazards. Keep away from all pressure hazards. Keep away from all radiation hazards. Keep away from all thermal hazards. Keep away from all electrical hazards. Keep away from all mechanical hazards. Keep away from all physical hazards. Keep away from all chemical hazards. Keep away from all biological hazards. Keep away from all environmental pollutants. Keep away from all carcinogens. Keep away from all mutagens. Keep away from all teratogens. Keep away from all sensitizers. Keep away from all irritants. Keep away from all allergens. Keep away from all toxic substances. Keep away from all corrosive substances. Keep away from all reducing agents. Keep away from all oxidizing agents. Keep away from all flammable materials. Keep away from all sources of radiation. Keep away from all strong electromagnetic fields. Do not refrigerate. Keep the bottle tightly closed when not in use. Store in a dry place. Avoid exposure to excessive heat or humidity. Keep the medicine in its original packaging. Discard any unused portion after opening. Keep the bottle in the outer carton to protect from light. Do not use after the expiry date stated on the container. Keep the bottle tightly closed. Store below 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of TREVICTA

The active substance is paliperidone.

Each pre-filled syringe of TREVICTA 175 mg contains 273 mg of paliperidone palmitate.

Each pre-filled syringe of TREVICTA 263 mg contains 410 mg of paliperidone palmitate.

Each pre-filled syringe of TREVICTA 350 mg contains 546 mg of paliperidone palmitate.

Each pre-filled syringe of TREVICTA 525 mg contains 819 mg of paliperidone palmitate.

The other components are:

Polysorbate 20

Polyethylene glycol 4000

Monohydrate citric acid

Monohydrate sodium dihydrogen phosphate

Sodium hydroxide (for pH adjustment)

Water for injections

Nature of the product and pack contents

TREVICTA is a white to off-white prolonged-release injectable suspension, supplied in a pre-filled syringe. The physician or nurse must shake the syringe vigorously to homogenize the suspension before injection.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

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

Belgium/Belgium/Belgium Janssen-Cilag NV Tel/Tel: +32 14 64 94 11	Lithuania UAB “JOHNSON & JOHNSON” Tel: +370 5 278 68 88
Bulgaria “JOHNSON & JOHNSON” EOOD Tel: +359 2 489 94 00	Luxembourg/Luxembourg Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Czech Republic Janssen-Cilag s.r.o. Tel: +420 227 012 227	Hungary Janssen-Cilag Kft. Tel.: +36 1 884 2858
Denmark Janssen-Cilag A/S Tlf: +45 45 94 82 82	Malta AM MANGION LTD. Tel: +356 2397 6000
Germany Janssen-Cilag GmbH Tel: +49 2137-955-955	Netherlands Janssen-Cilag B.V. Tel: +31 76 711 1111
Estonia UAB “JOHNSON & JOHNSON” Estonia branch Tel.: +372 617 7410	Norway Janssen-Cilag AS Tlf: +47 24 12 65 00
Greece Janssen-Cilag Pharmaceutical S.A. Tel: +30 210 80 90 000	Austria Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Spain Janssen-Cilag, S.A. Tel: +34 91 722 81 00	Poland Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
France Janssen-Cilag Tel: 0 800 25 50 75 / +33 1 55 00 40 03	Portugal Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Croatia Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700	Romania Johnson & Johnson România SRL Tel: +40 21 207 1800
Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 122	Slovenia Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Iceland Janssen-Cilag AB C/o Vistor hf Sími: +354 535 7000	Slovakia Johnson & Johnson s.r.o. Tel: +421 232 408 400
Italy Janssen-Cilag SpA Tel: +39 02 2510 1	Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 300
Cyprus Varnavas Hadjipanagis Ltd Tel: +357 22 207 700	Sweden Janssen-Cilag AB Tel: +46 8 626 50 00
Latvia UAB “JOHNSON & JOHNSON” Latvia branch Tel: +371 6789 3561	United Kingdom Janssen-Cilag Ltd. Tel: +44 1 494 567 444

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Information reserved for doctors or healthcare professionals

This information is intended only for doctors or healthcare professionals, who should read it together with the complete prescribing information (Summary of Product Characteristics).

	Administer every 3 months
	Shake the syringe vigorously for at least 15 seconds

For intramuscular injection only. Do NOT administer by any other route.

Important

Read the complete instructions before using the product. To ensure proper administration of TREVICTA, it is necessary to carefully read these instructions for use.

TREVICTA must be administered by a healthcare professional as a single injection. DO NOT divide the dose into repeated injections.

TREVICTA is indicated for intramuscular administration only. Inject slowly and deeply into the muscle, taking care to avoid injecting into a blood vessel.

Dosage

TREVICTA will be administered once every 3 months.

Preparation

Remove the label from the syringe and attach it to the patient's medical record.

TREVICTA requires more vigorous and prolonged shaking than monthly injectable paliperidone palmitate. Shake the syringe vigorously, with the tip pointing upward, for at least 15 seconds within the 5-minute period prior to administration (see step 2).

Selection of the thin-wall safety needle

Thin-wall safety needles are designed for use with TREVICTA. It is important to use only the needles provided in the TREVICTA package.

Package contents per dose

Needle selection is determined by the injection site and the patient's weight.

Check the suspension

After shaking the syringe for at least 15 seconds, check the appearance of the suspension through the viewing window.

The suspension should have a uniform, milky white appearance.

It is normal for small air bubbles to be present.

Open the needle blister and remove the cap.

First, open the needle blister by peeling back the foil halfway. Place it on a clean surface.

Then, with the syringe facing upwards, twist and pull the rubber cap outward to remove it.

Hold the needle blister.

Fold back the foil covering the needle and the plastic tray. Then, firmly grasp the needle shield by the blister, as shown.

Attach the needle

With the other hand, hold the syringe by the Luer connector and attach the safety needle with a gentle clockwise twist.

Do not remove the blister until the syringe and needle are securely attached.

Remove the needle cap

Remove the needle cap by pulling it straight off.

Do not twist the cap, as this could detach the needle from the syringe.

Remove air bubbles

Gently tap the syringe with the tip pointing upwards to allow any air bubbles to rise.

Slowly and carefully press the plunger upwards to expel the air.

Inject the dose

Slowly inject the entire contents of the syringe intramuscularly, deeply into the deltoid or gluteal muscle.

Do not administer by any other route.

Protect the needle

After the injection, use your thumb or a flat surface to activate the needle safety mechanism. The needle will be secured when you hear a "click".

Proper disposal

Dispose of the syringe and unused needle in an approved sharps container.