3 mg, 6 mg, 9 mg, 12 mg prolonged-release tablet is paliperidone
1. What INVEGA is and what it is used for
INVEGA contains the active substance paliperidone, which belongs to the group of antipsychotic drugs ( neuroleptics ).
INVEGA is used to treat schizophrenia in adults and adolescents 15 years of age and older.
Schizophrenia is a disease with symptoms in the form of hearing, seeing, or perceiving things that do not exist, have delusions, are overly suspicious, become withdrawn, speak incoherently and have behavioral and emotional impoverishment. People with this disease may also feel depressed, anxious, guilt-ridden, or tense.
INVEGA is also used to treat the schizoaffective disorder in adults.
The schizoaffective syndrome is a psychiatric condition in which the sufferer experiences a combination of different schizophrenia symptoms (such as those listed above) and in addition symptoms of mood disorders (feels a great rush of happiness, feels sad, upset, confused, suffers from insomnia, unusual talk, loses interest for everyday activities, sleeps too much or too little, eats too much or too little and has recurring thoughts of suicide).
INVEGA can help relieve the symptoms of your illness and prevent your symptoms from coming back.
2. What you need to know before using INVEGA
Do not use INVEGA
- if you are allergic to paliperidone, risperidone , or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using INVEGA.
- Patients with schizoaffective disorder treated with this medicine should be closely monitored to see if there is a possible shift from manic to depressive symptoms.
- This medicine has not been studied in elderly patients with dementia. Elderly patients with dementia, who are being treated with other similar types of medicines, may be at increased risk of having a stroke or dying (see section 4, Possible side effects ).
- if you have Parkinson’s disease or dementia.
- if you have ever been diagnosed with a condition in which the symptoms include fever and muscle stiffness (also called malignant neuroleptic syndrome).
- if you have ever had abnormal movements of the tongue or face ( tardive dyskinesia ). You should be aware that both of these conditions can be caused by this type of medicine.
- if you know you have had low white blood cell counts (caused by other medicines or not)
- if you are diabetic or have a predisposition to get diabetes .
- if you have heart disease or are taking treatment for heart disease which may cause your blood pressure to drop .
- if you have epilepsy .
- if you have a disease that affects swallowing, stomach or intestinal function, where the ability to swallow or the normal bowel movements are impaired.
- if you have diseases associated with diarrhea.
- if you have kidney problems.
- if you have liver problems.
- if you have a prolonged and / or painful erection .
- if you have disturbances in the regulation of body temperature or have elevated body temperature.
- if you have an abnormally high level of the hormone et prolactin in your blood or if you have a tumor that may be prolactin dependent.
- if you or anyone else in your family has had blood clots, because antipsychotic drugs have been linked to the formation of blood clots.
If you have any of these conditions, talk to your doctor as he/she may want to adjust your dosage or follow up with you for a period of time.
A dangerously low level of a certain type of white blood cell needed to fight infection in the blood has been rarely seen in patients taking INVEGA. Your doctor may check your white blood cell levels
INVEGA may cause weight gain. Significant weight gain can have a negative impact on your health. Your doctor should check your body weight regularly.
Because diabetes or worsening of existing diabetes has been seen in patients using INVEGA, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes, blood sugar should be monitored regularly.
In cataract surgery ( cataract ) it may happen that the pupil one (the black circle in the middle of the eye) does not increase in size as much as needed. In addition, you can get reduced muscle tension in the iris (colored part of the eye) during the operation and it can lead to eye injuries. If you have an eye operation planned, you must inform your ophthalmologist that you are using this medicine.
Children and young people
INVEGA should not be used in children and adolescents under 15 years of age for the treatment of schizophrenia.
INVEGA should not be used in children and adolescents under 18 years of age for the treatment of the schizoaffective disorder.
This is because it is unknown whether INVEGA is safe and effective in these age groups.
Other medicines and INVEGA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Disorders in the electrical function of the heart can occur when this medicine is taken with certain heart medicines that control the rhythm of the heart, or certain types of medicines such as antihistamines, antimalarials, or other antipsychotics.
Because this drug primarily has an effect on the brain, disorders of other drugs (or alcohol) that also act in the brain can occur, depending on the overall effect on brain function.
As this medicine may lower your blood pressure, caution should be exercised when using this medicine with other medicines that lower your blood pressure.
This medicine may reduce the effects of medicines used to treat Parkinson’s disease and ant infestations (eg levodopa ).
The effect of this medicine may be affected if you are taking medicines that affect the speed of movement of the intestine (eg metoclopramide).
A reduction in the dose of one of these drugs should be considered when this drug is co-administered with valproate.
The use of risperidone orally (orally) with this medicine is not recommended as the combination of these two medicines may cause more side effects.
INVEGA should be used with caution with drugs that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
INVEGA with alcohol
Alcohol should be avoided when treated with this drug.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine during pregnancy unless you have discussed this with your doctor. In newborns whose mothers have taken paliperidone during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, upset, difficulty breathing, and difficulty eating. If your child gets any of these symptoms, you may need to contact your doctor.
You should not breastfeed while taking this medicine.
Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see section 4, Possible side effects ). This should be considered when full vigilance is required, e.g. when driving a car or handling machines.
INVEGA contains lactose
The 3 mg tablet of this medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
INVEGA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use INVEGA
Use this medicine exactly as your doctor, pharmacist, or nurse has told you.
Use in adults
The recommended dose for adults is 6 mg once daily taken in the morning. The dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once daily for schizophrenia or 6 mg to 12 mg once daily for schizoaffective disorder. This depends on how well the drug works for you.
Use for young people
The recommended starting dose for the treatment of schizophrenia in adolescents 15 years and older is 3 mg once daily in the morning.
For adolescents weighing 51 kg or more, the dose can be increased to between 6 mg and 12 mg once a day.
For adolescents weighing less than 51 kg, the dose may be increased to 6 mg once daily.
The doctor decides how much you should get. How much you get depends on how well the drug works for you.
How and when to take INVEGA
This medicine should be taken by mouth, and the tablets should be swallowed whole with water or other beverage. The tablets must not be chewed, broken, or crushed.
This medicine should be taken every morning, with breakfast or without breakfast, but in the same way every day. Do not switch between taking this medicine with breakfast one day and without breakfast the next.
The active substance, paliperidone, is released when the tablet is swallowed, and the tablet shell passes out of the body with the faeces.
Patients with kidney problems
Your doctor may adjust the dose of one of these medicines depending on how your kidneys are working.
Older
If you have impaired kidney function, your doctor may want to lower your dose of this medicine.
If you use more INVEGA than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and abnormal heartbeat.
If you forget to use INVEGA
Do not take a double dose to make up for a forgotten dose. If you have missed a dose, take the next dose the day after you missed it. If you have missed two or more doses, contact your doctor.
If you stop using INVEGA
Do not stop taking this medicine as you will lose the effects of the medicine. You should not stop taking this medicine unless you have been asked to do so by your doctor, as your symptoms may return.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
- get blood clots, especially in the legs (symptoms are swelling, pain and redness on the legs), which can be transported through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
- have dementia and experience a sudden mental change or sudden weakness or numbness in the face, arms or legs, especially on one side, or slurred speech, even for a short period. This may be a sign of a stroke .
- experiencing fever, muscle stiffness, sweating or decreased consciousness (a condition called “malignant neuroleptic syndrome”). Immediate medical treatment may be needed.
- is a man and experiences persistent and painful erections . This is called priapism. Immediate medical treatment may be needed.
- experiencing involuntary rhythmic movements in the tongue, mouth and face. Paliperidone treatment may need to be stopped.
- suffer from a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching , rash, and sometimes a drop in blood pressure (a so-called anaphylactic reaction ).
Very common (may affect more than 1 user in 10):
- difficulty falling asleep or sleeping without interruption
- Parkinsonism: this condition can include slow or impaired mobility, feeling of tense or stiff muscles (which makes your movements jerky) and sometimes even a feeling of movement getting stuck (stopping) and then resuming. Other signs of parkinsonism include a slow procrastination, tremors at rest, increased salivation and / or drooling, and a lack of facial expressions.
- restlessness
- feeling sleepy or less alert
- headache.
Common (may affect up to 1 in 100 people):
- infection of the airways ( bronchitis ), cold symptoms, sinusitis, urinary tract infection, flu-like feeling
- weight gain, increased appetite, weight loss, decreased appetite
- elated mood, mania, irritation, depression, anxiety
- dystonia: this is a condition that involves slow or persistent involuntary muscle contractions. Dystonia can affect any part of the body (and lead to an abnormal posture) but often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
- dizziness
- dyskinesia: this is a condition that involves involuntary muscle movements and may include repeated, convulsive or distorted movements or twitches
- tremor (tremors)
- dimsyn
- conduction disturbance between the upper and lower parts of the heart, abnormal electrical conduction in the heart, prolonged QT interval from the heart, slow heart rhythm, fast heart rhythm
- low blood pressure when you get up (consequently some INVEGA users may feel weak, dizzy or faint when standing or sitting up suddenly), high blood pressure
- sore throat, cough, nasal congestion
- abdominal discomfort or pain, vomiting, nausea, constipation, diarrhea, stomach upset, dry mouth, toothache
- increased levels of liver transaminases in the blood
- itching , rash
- leg or muscle pain, back pain, joint pain
- missed periods of menstruation
- fever, weakness, fatigue.
Uncommon (may affect up to 1 in 100 people):
- pneumonia , respiratory tract infection, infection of the urinary bladder, ear infection, tonsillitis
- reduction in the number of white blood cells , reduction in the number of platelets (which causes you to stop bleeding), anemia ( reduction in anemia ), reduction in red blood cells
- INVEGA may increase your levels of a hormone called “prolactin” which is seen with a blood test (this may or may not cause symptoms). Symptoms of high prolactin levels in men may include swollen breasts, difficulty getting or maintaining an erection or other sexual dysfunction . In women, the symptoms can be breast discomfort, milk leakage, missed periods or other problems with the menstrual cycle.
- diabetes or worsening diabetes , high blood sugar, increased waist size, loss of appetite with malnutrition and low body weight as a result, high levels of triglycerides (a type of blood fat)
- sleep disturbance, confusion, decreased sex drive, inability to orgasm, nervousness, nightmares
- tardive dyskinesia (involuntary twitching movements of the face, tongue or other parts of the body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Treatment with INVEGA may need to be stopped.
- seizures, fainting, a restless need to move parts of the body, dizziness when standing up, attention difficulties, speech difficulties, loss of taste or abnormal taste sensation, decreased sensation in the skin for touch and pain, tingling or stinging sensation, or numbness in the skin
- hypersensitivity to light, eye infection , dry eyes
- feeling of spinning (dizziness), ringing in the ears, ear pain
- irregular heartbeat, abnormal electrical signal in the heart ( electrocardiogram or ECG ), a fluttering or throbbing sensation in the chest (palpitations)
- low blood pressure
- shortness of breath, wheezing and wheezing, nosebleeds
- swollen tongue, gastrointestinal infection, difficulty swallowing, excessive gas formation
- increased gamma-GT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased levels of liver enzymes in the blood
- rash ( hives ), hair loss, eczema , acne
- increase in CK (creatine phosphokinase) in the blood, an enzyme that is sometimes released during muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
- urinary incontinence (lack of control), frequent urination, inability to urinate, pain of urination
- erection difficulties, ejaculation disorder (ejaculation)
- missed periods or other problems with the menstrual cycle (women), milk leakage from the breasts, sexual dysfunction , breast pain, breast discomfort
- swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
- chills, increase in body temperature
- change in the way of walking
- feeling thirsty
- chest pain, chest discomfort, malaise
- case.
Rare (may affect up to 1 in 1,000 people):
- eye infection , nail fungus, skin infection, dermatitis caused by mites
- dangerously low levels of a certain type of white blood cell needed to protect you from infection in the blood
- decrease in the type of white blood cells that help protect you from infection , increase in eosinophils (a type of white blood cell ) in the blood
- severe allergic reactions characterized by fever, swollen mouth, face, lips or tongue, shortness of breath, itching , rash and sometimes drop in blood pressure, allergic reaction
- sugar in the urine
- abnormal levels of a hormone that regulates urine volume
- life-threatening complications due to uncontrolled diabetes
- dangerously excessive intake of water, low blood sugar, excessive water drinking, increased cholesterol in your blood
- sleepwalking
- immobility and lack of reactivity in the awake state (catatonia)
- lack of emotion
- neuroleptic malignant syndrome (confusion, decreased consciousness or unconsciousness, high fever and severe muscle stiffness)
- loss of consciousness, balance disorder, abnormal coordination
- problems with blood vessels in the brain, coma due to uncontrolled diabetes , unresponsive stimulation, low level of consciousness, headaches
- glaucoma (increased pressure inside the eye), increased tear flow, red eyes, problems with eye movements, eye rolling
- atrial fibrillation (an abnormal heart rhythm), rapid heartbeat when standing up
- Blood clots, especially in the legs (symptoms are swelling, pain and redness of the legs), can be transported through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
- decreased amount of oxygen in parts of the body (due to decreased blood flow), flushing (feeling of heat and redness of the skin)
- difficulty breathing during sleep ( sleep apnea ), rapid shallow breathing
- pneumonia due to inhalation of food, blockage (obstruction) in the airways, voice disturbance
- bowel obstruction, stool incontinence, very hard stools, lack of bowel muscle movements (causes blockage)
- yellowing of the skin and eyes (jaundice)
- inflammation of the pancreas
- severe allergic reaction with swelling that may include the throat and lead to difficulty breathing
- thickening of the skin, dry skin, reddening of the skin, discoloration of the skin, flaky itchy scalp or skin, dandruff
- degradation of muscle fiber and pain in muscles ( rhabdomyolysis ), abnormal posture
- priapism (prolonged penile erection which may require surgery)
- breast development in men, enlargement of the mammary glands, secretion from the breasts, discharge from the abdomen
- delay of menstrual periods, breast enlargement
- very low body temperature, lowering of body temperature
- withdrawal symptoms.
No known frequency (cannot be calculated from the available data):
- blockage of blood flow in the lungs
- increased insulin levels in your blood (a hormone that regulates blood sugar levels)
The following side effects have been seen with the use of another drug called risperidone, which is very similar to paliperidone, these can also be expected during treatment with INVEGA: sleep-related eating disorder, other types of blood vessel problems in the brain, crackling breathing sounds and severe or life-threatening rash with blisters and flaky skin that can start in and around the mouth, nose, eyes or genitals and spread to other parts of the body ( Stevens-Johnson syndrome or toxic epidermal necrolysis ). Eye problems during cataract surgery ( cataracts ) can also occur. During cataract surgery, a condition called “Intraoperative Floppy Iris ” may occurSyndrome (IFIS) ”occur if you use or have used INVEGA. If you are going to have cataract surgery, you must inform your ophthalmologist that you are using or have used this medicine.
An additional side effect is in young people
Adolescents generally experienced similar side effects to those seen in adults with the exception of the following car effects which were more common:
- feeling tired or less alert
- Parkinsonism: This condition can include slow or reduced mobility, a feeling of stiffness or tightness in the muscles (makes the movements jerky) and sometimes even a feeling of “movement freezing” to then start again. Other signs of parkinsonism include slow gait, tremors at rest, increased salivation and / or drooling, and lack of facial expression.
- weight gain
- common cold symptoms
- restlessness
- tremor (tremors)
- abdominal pain
- milk leakage from the breasts of girls
- breast swelling in boys
- acne
- speech difficulties
- gastrointestinal infection
- nosebleeds
- ear infection
- high blood fats ( triglycerides )
- dizziness ( vertigo ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store INVEGA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister/can and carton after EXP. The expiration date is the last day of the specified month.
Jars: Do not store above 30 ° C. Close the package tightly. Moisture sensitive.
Blister: Do not store above 30 ° C. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is paliperidone
Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Each INVEGA 9 mg prolonged-release tablet contains 9 mg paliperidone.
Each INVEGA 12 mg prolonged-release tablet contains 12 mg paliperidone.
Other ingredients are:
Coated tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butylhydroxytoluene (E321)
Iron oxide (yellow) (E172) (3 and 12 mg tablets only)
Polyethylene oxide 7000K
Iron oxide (red) (E172)
Hydroxyethylcellulose
Polyethylene glycol 3350
Cellulose acetate
Iron oxide (black) (E172) (9 mg tablet only)
Colored outer casing:
Hypromellos
Titanium dioxide (E171)
Polyethylene glycol 400 (6, 9, and 12 mg tablets only)
Iron oxide (yellow) (E172) (6 and 12 mg tablets only)
Iron oxide (red) (E172) (6 and 9 mg tablets only)
Lactose monohydrate (3 mg tablet only)
Triacetin (3 mg tablet only)
Carnauba wax
Marking ink:
Iron oxide (black) (E172)
Propylene glycol
Hypromellos
What the medicine looks like and contents of the pack
INVEGA prolonged-release tablets are capsule-shaped. The 3 mg tablet is white and labeled “PAL 3”, the 6 mg tablet is beige and labeled “PAL 6”, the 9 mg tablet is pink and labeled “PAL 9”, the 12 mg tablet is dark yellow and labeled “PAL 12 ”. All tablets are available in the following pack sizes:
- Jars: The tablets are supplied in a plastic jar with a child-resistant plastic lid. Each jar contains either 30 or 350 tablets. Each jar contains two bags of silica gel that are there to absorb moisture and keep the tablets dry.
- Blister: the tablets are supplied in blisters packaged in cartons of 14, 28, 30, 49, 56 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen-Cilag SpA
Via C. Janssen
04100 Borgo San Michele
Latina
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine: