Paliperidone 3 mg, 6 mg and 9 mg prolonged- release
What Paliperidone Krka is and what it is used for
Paliperidone Krka contains the active substance paliperidone which belongs to the group of antipsychotic drugs ( neuroleptics ).
Paliperidone Krka 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form of hearing, seeing, or perceiving things that do not exist, having delusions, being overly suspicious, becoming withdrawn, speaking incoherently, and having behavioral and emotional impoverishment. People with this disease may also feel depressed, anxious, guilt-ridden, or tense.
Paliperidone Krka is also used to treat the schizoaffective disorder in adults.
A 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 deal 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).
Paliperidone Krka can help relieve the symptoms of your illness and prevent your symptoms from coming back.
Paliperidone contained in Paliperidone Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paliperidone Krka
Do not use Paliperidone Krka
- 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 or pharmacist before taking Paliperidone Krka.
- 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 drug 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 in 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 a heart condition or are being treated for heart disease, your blood pressure may be low.
- 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 disorders in the regulation of body temperature or have elevated body temperature.
- If you have an abnormally high level of the hormone 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 some 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 paliperidone. Your doctor may check your white blood cell levels.
Paliperidone Krka may cause weight gain. Significant weight gain can hurt your health. Your doctor should check your body weight regularly.
Because diabetes or worsening of existing diabetes has been seen in patients taking paliperidone, 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 (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
Paliperidone Krka should not be used in children and adolescents under 15 years of age for the treatment of schizophrenia.
Paliperidone Krka should not be used in children and adolescents under 18 years of age for the treatment of a schizoaffective disorder.
This is because it is unknown whether paliperidone is safe and effective in these age groups.
Other medicines and Paliperidone Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Disorders of the heart’s electrical function can occur when this medicine is taken with certain heart medicines that control the heart’s rhythm, 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 for Parkinson’s disease and ant crawls in the legs (eg levodopa ).
The effect of this medicine may be affected if you take medicines that affect the speed of movement in 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.
Paliperidone Krka should be used with caution with drugs that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
Paliperidone Krka with food, drink, and alcohol
Alcohol should be avoided when treated with this drug.
Pregnancy, breastfeeding, and fertility
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, agitation, 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 taken into account when full alertness is required, eg when driving a car or handling machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Paliperidone Krka contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Paliperidone Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
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.
How and when to take Paliperidone Krka
This medicine should be taken orally, and the tablets should be swallowed whole with water or another 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 feces.
Patients with kidney problems
Your doctor may adjust the dose of one of these medicines depending on how your kidneys are working
If you have impaired kidney function, your doctor may want to lower your dose of this medicine.
Use for children and adolescents
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.
If you use more Paliperidone Krka than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
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 Paliperidone Krka
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 Paliperidone Krka
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 or pharmacist.
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.
- Are a man who experiences persistent and painful erections? This is called priapism. Immediate medical treatment may be needed.
- Experiences involuntary rhythmic movements in the tongue, mouth, and face. Treatment with paliperidone may need to be stopped.
- Suffers 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 (affects 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 make your movements jerky), and sometimes even a feeling of movement getting stuck (stopping) and then resuming. Other signs of parkinsonism include slow procrastination, tremors at rest, increased salivation and/or drooling, and a lack of facial expressions.
- Feeling sleepy or less alert.
Common (affects more than 1 user in 100):
- Respiratory tract infection ( bronchitis ), cold symptoms, sinusitis, urinary tract infection, flu-like sensation.
- Weight gain, increased appetite, weight loss, decreased appetite.
- Excited 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.
- Dyskinesia: this is a condition that involves involuntary muscle movements and may include repeated, convulsive or distorted movements or twitches.
- Tremor (shaking)
- Disorder in the conduction 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 getting up (consequently some Paliperidone Krka 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 menstrual periods.
- Fever, weakness, fatigue.
Uncommon (affects less than 1 user in 100):
- Pneumonia, respiratory tract infection, bladder infection, ear infection, sore throat.
- 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.
- Paliperidone 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 Paliperidone Krka 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 experience, 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 dizziness (dizziness), ringing in the ears, earache.
- Irregular heartbeat, an 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.
- Increased 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, the pain of urination.
- Erection difficulties, ejaculation disorder (ejaculation).
- Missed menstrual periods or other problems with the menstrual cycle (women), milk leakage from the breasts, sexual dysfunction, breast pain, discomfort from the breasts.
- 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.
- Pain in the chest, feeling of discomfort in the chest, feeling of illness.
Rare (affects less than 1 user in 1,000):
- Eye infection, nail fungus, skin infection, dermatitis caused by mites.
- Dangerously low levels of a certain type of white blood cell are needed to protect you from infection in the blood.
- Reduction of the type of white blood cells that help protect you from infection, increase of eosinophils (a type of white blood cell ) in the blood
- Severe allergic reactions are 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.
- Deviating levels of a hormone that regulates urine volume.
- Life-threatening complications due to uncontrolled diabetes
- Dangerous excessive water intake, low blood sugar, excessive water drinking, increased cholesterol in your blood.
- immobility and lack of reactivity in the awake state (catatonia)
- Lack of emotions.
- Malignant neuroleptic syndrome (confusion, decreased level of consciousness or unconsciousness, high fever, and severe muscle stiffness).
- Loss of consciousness, imbalance, abnormal coordination.
- Problems with blood vessels in the brain, coma due to uncontrolled diabetes, unresponsive to 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 on 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.
- Stomach blockage, 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 body temperature.
- Withdrawal symptoms.
Has been reported (occurs in the unknown number of users):
- Stop the 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 Paliperidone Krka: 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 may 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 IrisSyndrome (IFIS) ” occurs if you use or have used paliperidone. If you are going to have cataract surgery, you must inform your ophthalmologist that you are using or have used this medicine.
Additional side effects in children and adolescents
Adolescents generally experienced similar side effects to those seen in adults except 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 haste, tremors at rest, increased salivation and/or drooling, and lack of facial expression.
- Weight gain.
- Common cold symptoms.
- Tremor (shaking).
- Stomach pain.
- Milk leakage from the breasts of girls.
- Breast swelling in boys.
- Speech difficulties.
- Gastrointestinal infection.
- Nasal bleeding.
- Ear infection.
- High blood fats ( triglycerides ).
- Dizziness ( vertigo ).
How to store Paliperidone Krka
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 carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
No special temperature instructions.
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.
Contents of the pack and other information
- The active substance is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg, or 9 mg paliperidone.
- The other ingredients are macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E 172), hydroxypropylcellulose and cellulose acetate in the tablet core, and hypromellose, titanium dioxide (E 171), talc, propylene glycol (E 17 ) 6 mg tablets ) and red iron oxide (E 172) ( only for 9 mg tablets ) in the outer shell and shellac, black iron oxide (E 172) and propylene glycol in the label ink. See section 2 “Paliperidone Krka contains sodium”.
What the medicine looks like and the contents of the pack
3 mg: White to off-white, round, biconvex film-coated tablets with a possibly uneven surface and marked with P3 on one side of the tablet. Diameter: about 9 mm.
6 mg: Brown-yellow, round, biconvex, film-coated tablets with a possibly uneven surface and marked with P6 on one side of the tablet. Diameter: about 9 mm.
9 mg: Pinkish, round, biconvex, film-coated tablets with a possibly uneven surface and marked with P9 on one side of the tablet. Diameter: about 9 mm.
Paliperidone Krka is available in cartons containing:
14×1, 28×1 or 56×1 prolonged-release tablets are in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia