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What Paliperidone is and what it is used for
Paliperidone contains the active substance paliperidone, which belongs to the group of antipsychotic drugs.
Paliperidone is used to treat schizophrenia in adults and adolescents aged 15 and over.
Schizophrenia is a disorder with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, social isolation, disjointed speech, behavioral and emotional flattening. People with this disorder may also feel depressed, anxious, guilty, or tense.
Paliperidone is also used to treat schizoaffective disorder in adults. Schizoaffective disorder is a mental condition in which a person has a combination of symptoms of schizophrenia (such as those listed above) along with symptoms of an affective disorder (extremely good mood, feeling sad, feeling agitated, distracted, insomnia, talkativeness, loss of interest in daily activities, too much or too little sleep, too much or too little food intake, and recurrent suicidal thoughts).
Paliperidone can help relieve the symptoms of your disease and prevent them from coming back.
2. What you need to know before you take Paliperidone
Do not take Paliperidone
If you are allergic to paliperidone, risperidone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paliperidone.
Patients with schizoaffective disorder treated with this drug should be monitored closely for a potential switch from manic to depressive symptoms.
This medicine has not been studied in elderly patients with dementia. In elderly patients with dementia, however, who are treated with other similar drugs, there may be an increased risk of stroke or death, (see section 4, Possible side effects)
if you have Parkinson's disease or dementia.
if you have ever been diagnosed with an illness whose symptoms include fever and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
if you have ever experienced unusual movements of the tongue or face (tardive dyskinesia).
You should know that both diseases can be caused by this type of medicine.
if you know that you have had a low white blood cell count in the past (which may or may not be due to taking other medicines) if you have diabetes or a tendency to diabetes.
if you have heart disease or are being treated for heart disease that can cause low blood pressure if you have epilepsy.
if you have difficulty swallowing, stomach or intestinal disorders that reduce the ability to swallow or pass food through normal bowel movements,
if you have diseases accompanied by diarrhoea.
if you have kidney problems.
if you have liver problems.
if you have a prolonged and/or painful erection.
if you have difficulty controlling your body temperature or overheat,
if you have abnormally high levels of the hormone prolactin in your blood or if you have a prolactin-dependent tumour.
if you or a member of your family have a history of blood clots, as antipsychotics are associated with blood clots.
If you have any of these conditions, tell your doctor as he/she may consider adjusting your dose or monitoring you for a while.
Because in very rare cases patients on paliperidone have dangerously low numbers of a certain type of white blood cell, your doctor may check your white blood cell count.
Paliperidone Teva may cause weight gain. Significant weight gain can adversely affect your health, your doctor should monitor your body weight regularly.
Since cases of diabetes or worsening of existing diabetes mellitus have been observed in patients taking paliperidone, your doctor should monitor you for signs of high blood sugar. In patients with existing diabetes mellitus, blood sugar should be measured regularly.
During eye surgery for clouding of the lens (cataract), the pupil (the black circle in the middle of the eye) may not enlarge to the required size. Also, during surgery, the iris (the colored part of the eye) can lose tone and this can cause damage to the eye. If you are planning to have eye surgery, you should tell the eye doctor that you are taking this medicine.
Children and adolescents
Paliperidone Teva is not intended for use in children and adolescents under 15 years of age in the treatment of schizophrenia.
Paliperidone Teva is not intended for use in children and adolescents under 18 years of age in the treatment of schizoaffective disorder.
This is because it is not known whether paliperidone is safe or effective in these age groups.
Other medicines and Paliperidone Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Abnormalities in the electrical function of the heart are possible when this drug is taken with certain heart drugs that control heart rhythm or other types of drugs such as antihistamines, antimalarials, or other antipsychotics.
Because this drug works primarily in the brain, it may interact with other drugs (or alcohol) that work in the brain because of the additive effect on brain function.
Because this medicine can lower blood pressure, care should be taken when it is taken with other medicines that lower blood pressure.
This medicine may reduce the effect of medicines for Parkinson's disease and for restless legs syndrome (eg levodopa).
The effects of this medicine may be affected if you are taking medicines that affect the speed of passage through the gastrointestinal tract (eg metoclopramide).
A dose reduction of this drug should be considered when this drug is taken concurrently with valproate.
The simultaneous use of oral risperidone and this drug is not recommended, because combining the two drugs can lead to an increase in side effects.
Paliperidone Teva should be used with caution with drugs that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Paliperidone Teva with alcohol
Alcohol should be avoided while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor before taking this medicine.
You should not take this medicine during pregnancy unless you have discussed this with your doctor. The following symptoms may occur in newborns whose mothers have taken paliperidone during the last trimester (the last three months of pregnancy):
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty eating. If your baby develops any of these symptoms, you may need to seek medical attention.
You should not breast-feed while taking this medicine.
Driving and using machines
Dizziness and visual problems may occur during treatment with this medicine (see section 4, Possible side effects). This should be taken into account in cases where full attention is required, for example when driving and operating machinery.
Paliperidone Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.
3. How to take Paliperidone Teva
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.
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 in the dose range of 3 mg to 12 mg once daily in schizophrenia or 6 mg to 12 mg once daily in schizoaffective disorder. Depending on how well the medicine works for you.
Use in adolescents
The recommended starting dose for the treatment of schizophrenia in adolescents 15 years of age and older is 3 mg once daily taken in the morning.
For adolescents weighing 51 kg or more, the dose may be increased in the dose range of 6 mg to 12 mg once daily.
For adolescents weighing less than 51 kg, the dose may be increased to 6 mg once daily.
Your doctor will decide what dose to prescribe. The amount you take depends on how the medicine works for you.
How and when to take Paliperidone Teva
This medicine should be taken by mouth, the tablets should be swallowed whole with water or other liquids. They should not be chewed, broken or crushed.
This medicine should be taken every morning with or without breakfast, but in the same way every day. Do not alternate taking this medicine with breakfast one day and without breakfast the next.
The active ingredient paliperidone dissolves after ingestion and the tablet coating is excreted from the body as waste material.
Patients with kidney problems
Your doctor may adjust the dose of this medicine based on your kidney function.
Your doctor may reduce the dose of the medicine if your kidney function is reduced.
If you have taken more Paliperidone Teva than you should
Contact your doctor immediately - you may feel sleepy, tired, unusual body movements, difficulty standing up and walking, dizziness from low blood pressure and abnormal heart rhythm.
If you forget to take Paliperidone Teva
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next one the day after the missed dose. If you miss two or more doses, contact your doctor.
If you have stopped taking Paliperidone Teva
Do not stop taking this medicine as you will lose the effect of the medicine. You should not stop this medicine unless your doctor tells you to, as your symptoms may come back.
If you have any further questions on the use of this medicine, 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 have blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which can travel through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
you have dementia and experience a sudden change in your mental status or sudden weakness or numbness of the face, arms or legs, especially on one side, or slurred speech even for a short period of time. These could be signs of a stroke,
you have a fever, muscle stiffness, - sweating or a reduced level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). You may need immediate treatment.
if you are a man and experience a prolonged or painful erection. This is called priapism. Immediate treatment may be required.
you have involuntary rhythmic movements of the tongue, mouth and face. Paliperidone may need to be discontinued.
have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (reaching an 'anaphylactic reaction').
Very common: may affect more than 1 in 10 people
difficulty falling asleep or waking up frequently
parkinsonism: this disease can include slowed or impaired movements, a feeling of stiffness or tension in the muscles (making your movements jerky), and sometimes even a feeling of "stopping" and then moving again. Other signs of parkinsonism include a slow, shuffling gait , tremor at rest, increased salivation and/or drooling and loss of facial expression
drowsiness or lack of attention
Common side effects: may affect up to 1 in 10 people
chest infection (bronchitis), cold symptoms, sinus infection
urinary tract infection, flu-like symptoms
weight gain, increased appetite, weight loss, poor appetite
overexcited mood (mania), irritability, depression, anxiety
dystonia: this is a condition in which there are delayed or prolonged involuntary muscle contractions. Because dystonia can affect any part of the body (and result in abnormal posture), dystonia often involves the facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw.
dyskinesia: this is a condition in which there are involuntary muscle movements and may include repetitive, spastic or twisting movements or twitching,
interruption of conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolonged QT interval of the heart, slow heart rate, fast heart rate
low blood pressure when standing up (so some people taking Paliperidone Teva may feel weak, dizzy or pass out when standing up or sitting down suddenly), high blood pressure
sore throat, cough, stuffy nose
abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, stomach upset, dry mouth,
convulsions (seizures), fainting, an overwhelming urge to move parts of the body, dizziness when standing up, impaired attention, difficulty speaking, loss or unusual sense of taste, decreased sensitivity of the skin to pain and touch, tingling, pricking or tingling sensations in the skin
hypersensitivity of the eyes to light, eye infection or "red eye", dry eyes
feeling dizzy (vertigo), ringing in the ears, ear pain
irregular heartbeat, abnormal recording of electrical signals from the heart (electrocardiogram or EKG), feeling of fast or strong beating in the chest (palpitations)
low blood pressure
shortness of breath, wheezing, nosebleeds
swelling of the tongue, stomach or intestinal infection, difficulty swallowing, increased gas production
increased levels of GTT (a liver enzyme called gamma-glutamyl transferase) in the blood, increased liver enzymes in the blood
rash (or "hives"), hair loss, eczema, acne
increased levels of creatine phosphokinase (creatine phosphokinase) in the blood - an enzyme that is sometimes released in muscle trauma, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
urinary incontinence (lack of control), frequent urination, inability to urinate, pain when urinating
erectile dysfunction, impaired ejaculation
missed periods or other menstrual cycle problems (women), leakage of breast milk, sexual dysfunction, breast pain, breast discomfort
swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
chills, increased body temperature
change in gait feeling thirsty
chest pain, chest discomfort, feeling unwell
Rare side effects: may affect up to 1 in 1,000 people
eye infection, fungal nail infection, skin infection, skin inflammation caused by ticks
a dangerously low number of a certain type of white blood cell needed to fight infections in the blood
decreased number of a type of white blood cell that helps protect against infection, increased number of eosinophils (a type of white blood cell) in the blood severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes lowering of blood pressure, allergic reaction
sugar in the urine
inadequate secretion of the hormone that controls urine volume
life-threatening complications of uncontrolled diabetes
dangerously excessive water intake, low blood sugar, drinking too much water, elevated blood cholesterol level
lack of movement or response when awake (catatonia)
lack of emotions
neuroleptic malignant syndrome (confusion, decreased level or loss of consciousness, high fever and severe muscle stiffness)
loss of consciousness, impaired balance, impaired coordination
problems with blood vessels in the brain, coma due to uncontrolled diabetes, unresponsive to stimuli, decreased level of consciousness, head tremors glaucoma (increased pressure in the eyeballs), increased tearing, eye redness, eye movement problems, eye rotation the eyes
atrial fibrillation (abnormal heart rhythm), fast heart rate when standing up
blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice these symptoms, seek medical attention immediately. more
reduced oxygen level in some parts of the body (due to reduced blood flow), facial flushing
difficulty breathing during sleep (sleep apnea), rapid, shallow breathing
pneumonia as a result of inhalation of food, obstruction of the respiratory tract, voice disorder
bowel obstruction, faecal incontinence, very hard stools, lack of bowel muscle movement causing blockage
yellowing of the skin and eyes (jaundice)
inflammation of the pancreas
a serious allergic reaction with swelling that may affect the throat and cause difficulty breathing
thickening of the skin, dry skin, reddening of the skin, discoloration of the skin, scaly and itchy scalp or skin, dandruff
muscle fiber damage and muscle pain (rhabdomyolysis), abnormal posture
priapism (prolonged erection that may require surgical treatment)
male breast development, mammary gland enlargement, breast discharge, vaginal discharge
delay in menstrual cycles, breast growth
very low body temperature, low body temperature
Not known: no estimate can be made from the available data
an increased level of insulin (a hormone that controls blood sugar levels) in the blood
The following side effects have been seen with another medicine called risperidone, which is very similar to paliperidone, so they can also be expected with Paliperidone Teva: disorder
5. How to store Paliperidone Teva
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date corresponds to the last day of the month indicated.
Store in original packaging to protect from moisture. This medicinal product does not require special storage conditions
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Paliperidone Teva contains
The active substance is paliperidone. Each prolonged-release tablet contains 3 mg or 6 mg of paliperidone.
The other ingredients are macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, iron oxide red (E 172), hydroxypropyl cellulose and cellulose acetate in the tablet core and hypromellose, titanium dioxide (E 171), talc, propylene glycol, iron oxide yellow (E 172) (for 6 mg tablets only) in the coating and shellac, iron oxide black (E 172) and propylene glycol in the printing ink. See section 2 "Paliperidone Teva contains sodium".
What Paliperidone Teva looks like and contents of the pack
Paliperidone Teva 3 mg: White to off-white round, biconvex and film-coated tablets with a possibly uneven surface and imprinted PG on one side of the tablet. Diameter: approximately 9 mm.
Paliperidone Teva 6 mg: Brownish-yellow, round, biconvex, film-coated tablets with a possibly uneven surface and imprinted with P6 on one side of the tablet. Diameter: approximately 9 mm.
Paliperidone Teva is available in packs containing:
14, 28, 30, 56, 98, 112 or 196 extended-release tablets in perforated unit-dose blisters.
Not all types of packaging can be marketed.
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