PALIPERIDONE 3 mg Extended-Release Tablet

Зміст інструкції

1. Paliperidone Teva 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets
   1. What is Paliperidone Teva and what it is used for
   2. What you need to know before you take Paliperidone Teva
2. Paliperidone Teva may cause an increase in body weight. Significant weight gain can negatively affect your health. Your doctor should regularly check your body weight. Since diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking paliperidone, the doctor should check for high blood sugar levels. Blood glucose levels should be regularly monitored in patients with pre-existing diabetes mellitus. During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery, and this can cause damage to the eye. If you are planning to have an eye operation, be sure to inform the ophthalmologist that you are taking this medication.
   1. How to take Paliperidone Teva
   2. Possible side effects
   3. How to store Paliperidone Teva
   4. Package contents and other information

Paliperidone Teva 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets

Paliperidone

Generic medicine

Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Paliperidone Teva is and what it is used for
• 2. What you need to know before you take Paliperidone Teva
• 3. How to take Paliperidone Teva
• 4. Possible side effects
• 5. How to store Paliperidone Teva
• 6. Contents of the pack and other information

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

Paliperidone Teva contains the active substance paliperidone, which belongs to the class of drugs
known as antipsychotics.
Paliperidone Teva is used for the treatment of schizophrenia in adults and adolescents aged
15 years and over.
Schizophrenia is a disorder whose symptoms include hearing, seeing or perceiving things that are not
present, having false beliefs or being unusually suspicious, having a tendency
to isolate oneself, making incoherent speech and manifesting behavioral and emotional apathy. People
with this disorder may also feel depressed, anxious, guilty or tense.
Paliperidone Teva is also used to treat schizoaffective disorder in adults.
Schizoaffective disorder is a mental condition in which a person experiences a combination of
symptoms of schizophrenia (as indicated above) in addition to symptoms related to mood disorders
(excitement, sadness, agitation, distraction, insomnia, talkativeness, loss of interest in daily
activities, sleeping too much or too little, eating too much or too little, and recurrent suicidal
thoughts).
Paliperidone Teva can help relieve the symptoms of the disease and stop the recurrence of
them.

2. What you need to know before you take Paliperidone Teva

Do not take Paliperidone Teva

• 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 Teva.

• Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential shift from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are being treated with other medicines of a similar type, may be exposed to 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 increased temperature and muscle rigidity (also known as Neuroleptic Malignant 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 that you have had low levels of white blood cells in the past (whether or not caused by other medicines).
• If you are diabetic or predisposed to diabetes.
• If you have heart disease or are being treated for heart disease that tends to lower your blood pressure.
• If you suffer from epilepsy.
• If you have swallowing problems, or stomach or intestinal disorders that reduce your ability to swallow or expel food through normal intestinal movements.
• If you suffer from conditions associated with 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 internal body temperature or conditions of excessive heat.
• If you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour.
• If you or someone in your family has a history of blood clots (thrombi), as antipsychotic medicines have been associated with the formation of blood clots.

If any of these conditions apply to you, talk to your doctor, so they can assess
whether it is necessary to adjust the dosage or monitor you for a certain period.
Because a dangerously low number of a certain type of white blood cells needed to fight infections in the
blood has been observed very rarely in patients who have taken paliperidone, your doctor may check the count of white blood cells in your blood.

Paliperidone Teva may cause an increase in body weight. Significant weight gain can negatively affect your health. Your doctor should regularly check your body weight.
Since diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking paliperidone, the doctor should check for high blood sugar levels. Blood glucose levels should be regularly monitored in patients with pre-existing diabetes mellitus.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery, and this can cause damage to the eye. If you are planning to have an eye operation, be sure to inform the ophthalmologist that you are taking this medication.

Children and adolescents
Paliperidone Teva should not be used in children and adolescents under the age of 15 years for the treatment of schizophrenia.
Paliperidone Teva should not be used in children and adolescents under the age of 18 years for the treatment of schizoaffective disorder.
This is because it is not known whether paliperidone is safe or effective in these age groups.

Other medications and Paliperidone Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
When this medication is taken with certain medications for the heart that control heart rhythm, or with some other medications such as antihistamines, antimalarials, or other antipsychotics, abnormalities in the electrical activity of the heart may occur.
Because this medication acts primarily on the brain, interference with other medications (or alcohol) that act on the brain may occur, due to the additive effect on brain function.
Because this medication can lower blood pressure, be careful when taking this medication with other medications that lower blood pressure.
This medication may reduce the effect of medications used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa).
The effects of this medication may be affected if you are taking medications that affect the speed of intestinal movements (e.g., metoclopramide).
A reduction in dosage should be considered when this medication is administered concurrently with valproate.
The concomitant use of oral risperidone with this medication is not recommended, as the combination of the two medications may lead to greater side effects.
Paliperidone Teva should be used with caution together with medications that increase the activity of the central nervous system (stimulants such as methylphenidate).

Paliperidone Teva with alcohol
Avoid consuming alcohol while taking this medication.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medication.
Do not take this medication during pregnancy unless this has been agreed upon with your doctor. The following symptoms may occur in newborns of mothers who have used paliperidone in the last trimester (last three months of pregnancy): tremor, stiffness and/or weakness of muscles, drowsiness, agitation, breathing problems, and difficulty feeding. If your child presents any of these symptoms, you may need to contact your doctor.
Avoid breastfeeding while taking this medication.

Driving and operating machinery
Dizziness and vision problems may occur during treatment with this medication (see section 4, Possible side effects). This should be taken into account in cases where complete alertness is required, e.g., when driving a car or operating machinery.

Paliperidone Teva contains sodium
This medication contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Paliperidone Teva

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor or pharmacist.

Use in adults
The recommended dose in adults is 6 mg once a day, to be taken in the morning. The dose
may be increased or decreased by your doctor within the range of 3 mg to 12 mg once a
day for schizophrenia or from 6 mg to 12 mg once a day for schizoaffective disorder. This
depends on your response to the medicine.

Use in adolescents
The recommended starting dose for the treatment of schizophrenia in adolescents aged 15 years and
over is 3 mg once a day, to be taken in the morning.
For adolescents weighing 51 kg or more, the dose may be increased within the range of 6 mg
to 12 mg once a day.
For adolescents weighing less than 51 kg, the dose may be increased to 6 mg once a
day.
The doctor will decide the appropriate dose in your case. The dose you take depends on your
response to the medicine.

How and when to take Paliperidone Teva
This medicine must be taken orally, the tablet must be swallowed whole with
water or other liquids. It must not be chewed, divided, or crushed.
This medicine must be taken every morning with breakfast or on an empty stomach, but in
the same way every day. Do not alternate taking the medicine one day on an empty stomach and
the next with food.
The active ingredient, paliperidone, dissolves once swallowed and the tablet coating is
eliminated from the body as waste.

Patients with kidney problems
Based on your kidney function, your doctor may adjust the dose of this medicine.

Elderly
The doctor may reduce the dose of the medicine in case of reduced kidney function.

If you take more Paliperidone Teva than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body
movements, problems maintaining an upright position and walking, dizziness caused
by low blood pressure, and abnormal heartbeats.

If you forget to take Paliperidone Teva
Do not take a double dose to make up for a missed dose. If you miss a tablet, take the next
dose the following day. If you miss two or more doses, contact your doctor.

If you stop taking Paliperidone Teva
Do not stop taking this medicine as you will lose its effects. You should not stop
taking the medicine unless your doctor tells you to, as your symptoms
may return.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Tell your doctor immediately if:

• You think you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, see your doctor immediately.
• You suffer from dementia and notice a sudden change in your mental state or a sudden weakness or numbness in your face, arms or legs, especially on one side, or if your speech is unintelligible, even for a short period. These may be signs of a stroke.
• You have a fever, muscle rigidity, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• You are a man and have a prolonged or painful erection. This condition is called

priapism. Immediate medical treatment may be necessary.

• You have involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop paliperidone.
• You experience 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 (corresponding to an “anaphylactic reaction”).

Very common: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep
• parkinsonism. This condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (which makes movements jerky), and sometimes a feeling of movement that stops and then restarts. Other signs of parkinsonism include, walking slowly dragging your feet, resting tremor, increased saliva and/or loss of saliva, and a loss of facial expression
• restlessness
• feeling sleepy or reduced alertness
• headache

Common: may affect up to 1 in 10 people

• chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, feeling like you have the flu
• weight gain, increased appetite, weight loss, decreased appetite
• elevated mood (mania), irritability, depression, anxiety
• dystonia: this is a condition involving slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• dizziness
• dyskinesia: this is a condition concerning involuntary muscle movements and can consist of repetitive, spastic or contorted movements or spasms.
• tremors (shaking)
• blurred vision
• an interruption of the conduction of the heart between the upper and lower parts of the heart, abnormal heart electrical conduction, prolongation of the QT interval of the heart, slow heart rate, fast heart rate
• low blood pressure when standing up (consequently, some patients taking Paliperidone Teva may feel faint, dizzy or may faint when getting up or sitting down suddenly), high blood pressure
• sore throat, cough, nasal congestion
• abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• increased liver transaminases in the blood
• itching, rash
• bone or muscle pain, back pain, joint pain
• loss of menstrual cycle
• fever, weakness, fatigue (tiredness)

Uncommon: may affect up to 1 in 100 people

• pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
• decreased white blood cell count, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells in the blood
• paliperidone may increase the levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). When symptoms due to a high level of prolactin occur, these may include: (in men) breast enlargement, difficulty having or maintaining an erection or other sexual dysfunction, (in women) breast discomfort, milk production from the breasts, loss of menstrual cycle or other problems with the cycle
• diabetes or worsening of diabetes, high blood sugar level, increased abdominal circumference, loss of appetite resulting in malnutrition and low body weight, high levels of triglycerides (a fat)
• sleep disorders, confusion, reduced sexual drive, inability to reach orgasm, nervousness, nightmares
• tardive dyskinesia (spasms or jerking movements that you cannot control, affecting the face, tongue or other parts of the body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop taking Paliperidone Teva.
• seizures (convulsions), fainting, an urgent need to move a part of the body, dizziness when standing up, attention disorder, speech problems, loss or alteration of the sense of pain and touch, a sensation of tingling, prickling or numbness of the skin
• hypersensitivity of the eyes to light, eye infection or “mild redness”, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• irregular heartbeat, abnormal heart tracing (electrocardiogram or ECG), a feeling of a fast or pounding heartbeat (palpitations)
• low blood pressure.
• shortness of breath, wheezing, nosebleeds
• swelling of the tongue, infection of the stomach or intestines, difficulty swallowing, excessive passing of gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
• rash (or hives), hair loss, eczema, acne
• an increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• incontinence (loss of control) of urine, frequent urination, inability to urinate, pain during urination
• erectile dysfunction, ejaculation disorders
• loss of menstrual cycle or problems with the cycle (females), milk production 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, increased body temperature
• change in the way you walk
• feeling thirsty
• chest pain, chest discomfort, feeling unwell
• falls

Rare: may affect up to 1 in 1,000 people

• eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• dangerously low number of a certain type of white blood cells in the blood needed to fight infections
• decrease in the blood of a type of white blood cells that helps protect the body from infections, increase in eosinophils (a type of white blood cell)
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, lack of breath, itching, rash and sometimes a drop in blood pressure, allergic reaction
• sugar in the urine
• inappropriate secretion of the hormone that controls urine volume
• complications leading to life-threatening uncontrolled diabetes
• dangerously excessive intake of water, decreased blood sugar, drinking water excessively, increased cholesterol in the blood
• sleepwalking
• not moving or reacting while awake (catatonia)
• lack of emotions
• neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle rigidity)
• loss of consciousness, balance disorders, abnormal coordination
• problems with blood vessels in the brain, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, head tremor
• glaucoma (increased pressure inside the eyeball), increased tearing, redness of the eyes, problems with eye movement, eye rotation
• atrial fibrillation (an abnormal heart rhythm), fast heartbeat when standing up.
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to the lungs with resulting chest pain and difficulty breathing. If you notice any of these symptoms, see your doctor immediately.
• decreased oxygen level in parts of the body (due to decreased blood flow), hot flashes
• sleep breathing problems (sleep apnea), fast and shallow breathing
• pneumonia caused by inhalation of food, congestion of the airways, problems with voice
• intestinal blockage, fecal incontinence, hard stools, lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• inflammation of the pancreas
• severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• thickening of the skin, dry skin, redness of the skin, altered skin color, scaly and itchy scalp or skin, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
• priapism (a prolonged erection of the penis that may require surgical treatment)
• development of breast tissue in men, enlargement of the mammary glands, breast discharge, vaginal discharge
• a delay in the menstrual cycle, breast enlargement
• very low body temperature, a decrease in body temperature
• withdrawal symptoms from the medicine

Frequency not known: frequency cannot be estimated based on available data

• pulmonary congestion
• increased levels of insulin (a hormone that controls blood sugar levels)

The following side effects have been observed with the use of another medicine called
risperidone which is very similar to paliperidone, so that these effects may be expected also
with Paliperidone Teva: eating disorders related to sleep, other types of problems with the brain
vessels and crackling sounds in the lungs. Problems with the eyes may also occur
during cataract surgery. During cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS) may occur if you take or have taken
paliperidone. If you are going to have cataract surgery, be sure to tell
your ophthalmologist if you take or have taken this medicine.

Other side effects in adolescents
The side effects generally experienced by adolescents are similar to those observed
in
adults, with the exception of those reported below which have been observed more commonly:

• feeling sleepy or reduced alertness
• parkinsonism. This condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (which makes movements jerky), and sometimes a feeling of movement that stops and then restarts. Other signs of parkinsonism include, walking slowly dragging your feet, resting tremor, increased saliva and/or loss of saliva, and a loss of facial expression
• weight gain
• common cold symptoms
• restlessness
• tremors (shaking)
• stomach pain
• milk production from the breasts in girls
• breast enlargement in boys
• acne
• speech problems
• stomach or intestinal infection
• nosebleeds
• ear infection
• high levels of triglycerides (a fat) in the blood
• feeling dizzy

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the national
reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Paliperidone Teva

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 and the package after
the wording Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paliperidone Teva contains

• The active ingredient is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg or 9 mg of paliperidone.
• The other ingredients are macrogol, butylated hydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose and cellulose acetate in the tablet core and hypromellose, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) ( only for 6 mg tablets) and red iron oxide (E172) ( only for 9 mg tablets) in the coating and shellac, black iron oxide (E172) and propylene glycol in the printing ink. See section 2 “Paliperidone Teva contains sodium”

Description of Paliperidone Teva and package contents
3 mg: Film-coated tablets, biconvex, round, from white to greyish in colour with a possible irregular surface and with the marking P3 imprinted on one side of the tablet.
Diameter: approximately 9 mm.
6 mg: Film-coated tablets, biconvex, round, brownish-yellow in colour with a possible irregular surface and with the marking P6 imprinted on one side of the tablet. Diameter: approximately
9 mm.
9 mg: Film-coated tablets, biconvex, round, pinkish in colour with a possible irregular surface and with the marking P9 imprinted on one side of the tablet. Diameter: approximately 9 mm.
Paliperidone Teva is available in packs containing:

• 14x1, 28x1, 30x1, 56x1, 98x1, 112x1 or 196x1 prolonged-release tablets in perforated single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - Netherlands

Manufacturer
KRKA d.d., Novo mesto
Šmarješka cesta 6, Novo mesto, 8501, Slovenia
Laboratoria Qualiphar NV (Qualiphar NV)
Rijksweg 9, 2880 Bornem, Belgium
Teva Pharma, S.L.U.
S.L.U. C/ C, nº 4. Polígono Industrial Malpica, 50016 Zaragoza, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: