PALIPERIDONE 3 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Paliperidone Sandoz 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets
   1. What is Paliperidone Sandoz and what it is used for
   2. What you need to know before you take Paliperidone Sandoz
   3. How to take Paliperidone Sandoz
   4. Possible side effects
   5. How to store Paliperidone Sandoz
   6. Contents of the pack and other information
2. Paliperidone Sandoz 6 mg extended-release tablets, 9 mg extended-release tablets

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

Generic medicine

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

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

Paliperidone Sandoz contains the active substance paliperidone which belongs to the class of drugs
antipsychotics.
Paliperidone Sandoz is used for the treatment of schizophrenia in adults and adolescents aged
15 years and over.
Schizophrenia is a disorder whose symptoms include: hearing sounds or voices, seeing or perceiving things
that are not present, having false beliefs or being unusually suspicious, having a
tendency to isolation, making incoherent speech and flattening of behavioral and emotional responses. People with this disorder may also feel depressed, anxious, guilty or tense.
Paliperidone Sandoz 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 Sandoz can help relieve the symptoms of the disease and stop the recurrence of
them.

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

Do not take Paliperidone Sandoz

• 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 Sandoz.

• Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential transition 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 similar types of medicines, may be at increased risk of stroke or death (see section 4, Possible side effects).
• If you suffer from 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 know that both of these conditions can be caused by this type of drug.
• If you are aware that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• If you are diabetic or predisposed to diabetes.
• If you have a heart condition or are taking treatment for a heart condition that tends to lower your blood pressure.
• If you suffer from epilepsy.
• If you have difficulty swallowing, 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 tumor.
• If you or someone in your family has a history of blood clot formation (thrombosis), as antipsychotic drugs have been associated with the formation of blood clots.

If you have any of these conditions, 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 can cause an increase in body weight. Significant weight gain can
negatively affect your health. Your doctor should check your body weight regularly.
Because diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking paliperidone, your 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 floppy during surgery and this can cause damage
to the eye. If you are planning to have an eye operation, be sure to inform
your ophthalmologist that you are taking this medicine.

Children and adolescents
Paliperidone Sandoz should not be used in children and adolescents under 15 years of age, for
the treatment of schizophrenia.
Paliperidone Sandoz should not be used in children and adolescents under 18 years of age,
for 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 Sandoz
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
When the medicine is taken with some medicines for the heart that control the heart rate or
some other medicines such as antihistamines, antimalarials or other antipsychotics, abnormalities in the electrical function of the heart may occur.
Because this medicine acts mainly on the brain, interference with
other drugs (or alcohol) that act on the brain may occur, due to the additive effect on brain function.
Because this medicine can lower blood pressure, be careful when taking
this medicine with other drugs that lower blood pressure.
This medicine may reduce the effect of drugs used to treat Parkinson's disease and
restless legs syndrome (e.g. levodopa).
The effects of this medicine may be affected if you are taking drugs that affect
the speed of intestinal movements (e.g. metoclopramide).
Consider a dose reduction for this medicine when this medicine is
administered in conjunction with valproate.
The concomitant use of oral risperidone with this medicine is not recommended as
the combination of the two medicines could lead to greater side effects.
Paliperidone Sandoz should be used with caution with medicines that increase the activity of the central
nervous system (stimulants such as methylphenidate).

Paliperidone Sandoz with alcohol
Avoid drinking alcohol while taking this medicine

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. Do not
take this medicine during pregnancy unless you have discussed it 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 muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.
Avoid breastfeeding 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 in cases where full
vigilance is required, for example, when driving a car or using machinery.

Paliperidone Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Paliperidone Sandoz

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse.

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 how the medicine works for you.

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 for you. The dose you take depends on how the medicine
works for you.

How and when to take Paliperidone Sandoz
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 should 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 decreased kidney function.

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

If you forget to take Paliperidone Sandoz
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 Sandoz
Do not stop taking this medicine as you will lose the effects of the drug. You should not
stop taking the medicine unless your doctor tells you to, as the
symptoms may return.
If you have any further questions about taking 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 think you have a blood clot in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately
You have dementia and notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech is unintelligible, even for a short period. These may be signs of a stroke
You have a fever, muscle stiffness, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary
You are a male 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 (making movements jerky), and sometimes a feeling of movement that stops and then restarts. Other signs of parkinsonism include slow walking with shuffling feet, tremor at rest, increased saliva and/or loss of saliva, and a loss of facial expression
restlessness
feeling sleepy or reduced alertness
headache

Common side effects: may affect up to 1 in 10 people
chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, feeling as if 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
discinesia: this is a condition involving involuntary muscle movements and can include repetitive, jerky or contorted movements or spasms
tremor
blurred vision
a disruption 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, rapid heart rate
low blood pressure when standing up (consequently, some patients taking paliperidone may feel faint, dizzy or may faint when getting up or sitting down suddenly), high blood pressure
sore throat, cough, stuffy nose
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

Uncommon side effects: 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 can 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 prolactin level 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, decreased sexual drive, inability to reach orgasm, nervousness, nightmares
tardive dyskinesia (spasms or jerky movements that you cannot control, of 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
seizures (convulsions), fainting, an urgent need to move a part of the body, dizziness when standing up, attention disorder, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a sensation of tingling, prickling or numbness of the skin
hypersensitivity of the eyes to light, eye infection or “slightly reddened”, dry eye
sensation of spinning (vertigo), ringing in the ears, ear pain
irregular heartbeat, abnormal heart electrical tracing (electrocardiogram or ECG), a sensation of a fast or pounding heartbeat (palpitations)
low blood pressure
shortness of breath, wheezing, nosebleeds
swelling of the tongue, stomach or intestinal infection, 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 side effects: 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, increased eosinophils (a type of white blood cell)
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, allergic reaction
sugar in the urine
inappropriate secretion of the hormone that controls urine volume
complications leading to life-threatening diabetes, dangerously excessive intake of water, decreased blood sugar, drinking water excessively, increased cholesterol in the blood
sleepwalking
absence of movements or responses when awake (catatonia)
lack of emotion
neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle stiffness)
loss of consciousness, balance disorders, abnormal coordination
problems with blood vessels in the brain, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, tremor of the head
glaucoma (increased pressure inside the eyeball), increased tearing, redness of the eyes, problems with eye movement, rotating the eyes towards the back of the head
atrial fibrillation (an abnormal heart rhythm), fast heartbeat when standing up
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
decreased oxygen levels in parts of the body (because of decreased blood flow), hot flushes
sleep breathing problems (sleep apnea), fast and shallow breathing
pneumonia caused by inhaling food, congestion of the airways, problems with the 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
breakdown of muscle fibers 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 breast glands, discharge from the breasts, vaginal discharge
a delay in the menstrual cycle, breast enlargement
very low body temperature, a decrease in body temperature
withdrawal symptoms

Not known: frequency cannot be estimated from available data
pulmonary congestion
increased levels of insulin (a hormone that controls blood sugar levels) in the blood
The following side effects have been observed with the use of another medicine called risperidone which is very similar to paliperidone, so these effects may be expected with Paliperidone Sandoz: sleep-related eating disorder, other types of problems with blood vessels in the brain and crackling sounds in the lungs. Problems with the eyes may also occur during cataract surgery. During cataract surgery, a condition called iris flag syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you are going to have cataract surgery, be sure to tell your ophthalmologist if you are taking or have taken this medicine.

Other side effects in adolescents
The side effects generally experienced by adolescents are similar to those observed in adults, except for those reported below which have been observed more commonly:
feeling sleepy or less alert
parkinsonism: This condition may include slow or impaired body movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes a feeling of movement that stops and then restarts. Other signs of parkinsonism include slow walking with shuffling feet, tremor at rest, increased saliva and/or loss of saliva and a loss of facial expression
weight gain
common cold symptoms
restlessness
tremor
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
sensation of spinning (dizziness)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Sandoz

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
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
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. Contents of the pack and other information

What Paliperidone Sandoz contains
The active ingredient is paliperidone.
Paliperidone Sandoz 3 mg prolonged-release tablets
Each prolonged-release tablet contains 3 mg of paliperidone.
Paliperidone Sandoz 6 mg prolonged-release tablets
Each prolonged-release tablet contains 6 mg of paliperidone.
Paliperidone Sandoz 9 mg prolonged-release tablets
Each prolonged-release tablet contains 9 mg of paliperidone

• Other ingredients are:

Tablet core
Macrogol 200000
Macrogol 7000000
Butylhydroxytoluene (E321)
Povidone K30
Sodium chloride
Microcrystalline cellulose
Magnesium stearate
Red iron oxide (E172)
Hydroxypropylcellulose

Coating
Cellulose acetate
Macrogol 4000
Yellow iron oxide (E172)
Red iron oxide (E172)
Hypromellose 6cP
Titanium dioxide (E171)
Talc
Propylene glycol

Printing ink
Shellac
Black iron oxide (E172)
Propylene glycol

Description of the appearance of Paliperidone Sandoz and contents of the pack
Paliperidone Sandoz 3 mg prolonged-release tablets
Prolonged-release tablets that appear as film-coated tablets, white in colour
white-greyish, round, biconvex, with possible irregular surface and with imprinted the inscription P3
on one side of the tablet.
Paliperidone Sandoz 6 mg prolonged-release tablets
Prolonged-release tablets that appear as film-coated tablets of yellowish-
brownish colour, round, biconvex, with possible irregular surface and with imprinted the inscription P6 on one
side of the tablet.
Paliperidone Sandoz 9 mg prolonged-release tablets
Prolonged-release tablets that appear as film-coated tablets of pink colour,
round, biconvex, with possible irregular surface and with imprinted the inscription P9 on one side of the
tablet.
Divisible blister for unit dose in OPA/AL/PVC/Aluminum.
Packs: 14 x1, 28x 1, 30 x 1, 49 x 1, 56 x 1 and 98 x 1 prolonged-release tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
KRKA d.d., Novo mesto
Šmarješka cesta 6,
Novo mesto, 8501, Slovenia
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium Paliperidone Sandoz 3 mg prolonged-release tablets

Paliperidone Sandoz 6 mg extended-release tablets, 9 mg extended-release tablets

Italy Paliperidone Sandoz
Netherlands Paliperidon Sandoz retard 3 mg, extended-release tablets
Paliperidon Sandoz retard 6 mg, extended-release tablets
Paliperidon Sandoz retard 9 mg, extended-release tablets
Portugal Paliperidona Sandoz
Spain Paliperidona Sandoz 3 mg prolonged-release tablets EFG
Paliperidona Sandoz 6 mg prolonged-release tablets EFG
Paliperidona Sandoz 9 mg prolonged-release tablets EFG
Hungary Paliperidon Sandoz 3 mg retard tablet
Paliperidon Sandoz 6 mg retard tablet
Paliperidon Sandoz 9 mg retard tablet