PALIPERIDONE 3 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Paliperidone Krka 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets
   1. What is Paliperidone Krka and what it is used for
   2. What you need to know before taking Paliperidone Krka
2. Paliperidone Krka may cause an increase in body weight. Significant weight gain
   1. How to take Paliperidone Krka
   2. Possible side effects
   3. How to store Paliperidone Krka
   4. Package Contents and Other Information

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

paliperidone

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Paliperidone Krka contains the active substance paliperidone, which belongs to the class of
antipsychotic drugs.
Paliperidone Krka 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 isolate oneself, making incoherent speech and flattening
behavioural and emotional responses. People with this disorder may also feel
depressed, anxious, guilty or tense.
Paliperidone Krka 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) as well as symptoms related to
mood disorders (excitement, sadness, agitation, distractibility, drowsiness, talkativeness,
loss of interest in daily activities, sleeping too much or too little, eating
too much or too little, and recurrent suicidal thoughts).
Paliperidone Krka can help relieve the symptoms of the illness and stop the recurrence
of the same.

2. What you need to know before taking Paliperidone Krka

Do not take Paliperidone Krka:

• 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 or pharmacist before taking Paliperidone Krka.

• 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 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 (called Neuroleptic Malignant Syndrome).
• If you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia). You should know that both of these latter conditions can be caused by this type of drug.
• If you are aware of having 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 heart disease or are taking medication for heart disease 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, 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, the doctor may check the count of white blood cells in
your blood.

Paliperidone Krka 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
elevated 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 may cause damage to the eye. If you are planning to undergo eye surgery, be sure to inform the ophthalmologist that you are taking this medicine.

Children and adolescents
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 schizoaffective disorder.
This is because it is not known if paliperidone is safe or effective in these age groups.

Other medicines and Paliperidone Krka
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
When the medicine is taken with certain medicines for the heart that control the heart rate or some other medicines such as antihistamines, antimalarials or other antipsychotics,
heart electrical function abnormalities may occur.
Because this medicine acts mainly on the brain, interference with other medicines (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 medicines that lower blood pressure.
This medicine may reduce the effect of medicines 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 medicines that
affect the speed of intestinal movements (e.g. metoclopramide).
Consider a dosage 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 may lead to greater side effects.
Paliperidone Krka should be used with caution with medicines that increase the activity of
the central nervous system (stimulants such as methylphenidate).

Paliperidone Krka with alcohol
During the intake of this medicine, alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should 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
During treatment with this medicine, dizziness and vision problems may occur
(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 using
machinery.

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

3. How to take Paliperidone Krka

Take this medicine following exactly the instructions of your doctor. 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 how the medicine works for you.

Use in adolescents
The recommended starting dose for the treatment of schizophrenia in adolescents from 15
years of age 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 Krka
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 kidney function, your doctor may adjust the dose of this medicine.

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

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

If you stop taking Paliperidone Krka
Do not stop taking this medicine as you will lose the effects of the medicine. Do
not stop taking the medicine unless your doctor tells you to
do so, as symptoms may return.
If you have any further questions about taking this medicine, ask your doctor or
pharmacist.

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 a vein, especially in the legs (symptoms include swelling, pain and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• You suffer from 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 incomprehensible, 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 rhythmic involuntary 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, resting tremor, increased saliva and/or drooling, 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
• dyskinesia: this is a condition involving involuntary muscle movements and can include repetitive, jerky or twisting movements or spasms
• tremor
• blurred vision
• an interruption of the conduction of the heart between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heart rate, rapid heart rate
• low blood pressure when getting up (consequently, some patients taking Paliperidone Krka 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 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 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, leakage of milk from the breasts, loss of menstrual cycle or other problems with the cycle
• diabetes or worsening of diabetes, high blood sugar level, increased waist 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 of the face, tongue or other parts of the body). Tell your doctor immediately if you experience rhythmic involuntary movements of the tongue, mouth and face. It may be necessary to stop taking Paliperidone Krka
• seizures (convulsions), fainting, an urgent need to move a part of the body, dizziness when getting 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 red”, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• irregular heartbeat, abnormal heart tracing (electrocardiogram or ECG), a sensation of a fast or pounding heartbeat (palpitations)
• low blood pressure
• shortness of breath, wheezing, nosebleed
• 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
• skin itching, skin rash, 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 when urinating
• erectile dysfunction, ejaculation disorders
• loss of menstrual cycle or problems with the cycle (females), leakage of milk 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) in the blood.
• 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 movement or response while awake (catatonia)
• lack of emotion
• neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle stiffness)
• loss of consciousness, balance problems, abnormal coordination
• problems with blood vessels in the brain, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, head tremor
• glaucoma (increased pressure inside the eye), increased tearing, redness of the eyes, problems with eye movement, rolling eye
• atrial fibrillation (an abnormal heart rhythm), fast heartbeat when getting up
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention
• decreased oxygen levels in parts of the body (because of decreased blood flow), hot flashes
• sleep breathing problems (sleep apnea), rapid and shallow breathing
• pneumonia caused by inhaling 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 breast glands, leakage from the breasts, vaginal discharge
• a delay in the menstrual cycle, breast enlargement
• very low body temperature, a decrease in body temperature
• withdrawal symptoms from the medicine.

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 also
with Paliperidone Krka: eating disorders related to sleep, other types of problems with the
brain blood vessels, crackling sounds in the lungs, severe or life-threatening skin rash with
blisters and peeling skin that can start inside and around the mouth, nose, eyes and genitals
and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis).
Eye problems may also occur during cataract surgery. During cataract surgery, a condition
called iris flag sign (IFIS) may occur if you take or have taken paliperidone. If you are
going to have cataract surgery, be sure to inform 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, except for those reported below which have been observed more
commonly:

• feeling sleepy or less alert
• parkinsonism: this condition may include: slow or impaired movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of parkinsonism include slow walking with shuffling feet, resting tremor, increased saliva and/or drooling and a loss of facial expression
• weight gain
• common cold symptoms
• restlessness
• tremor
• stomach pain
• leakage of milk 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 (vertigo).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 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 pack after 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 waste water 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 Krka 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 200 000, macrogol 7 000 000, macrogol 4000, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose, cellulose acetate in the tablet coating 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 Krka contains sodium”.

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

• 14x1, 28x1 or 56x1 prolonged-release tablets in divisible blister packs for unit dose.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names: