Paliperidone Krka

Patient Information Leaflet

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

paliperidone
Generic medicine
Please 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Paliperidone Krka is and what it is used for

Paliperidone Krka contains the active substance paliperidone, which belongs to the class of antipsychotic medicines.
Paliperidone Krka is used to treat schizophrenia in adults and adolescents from the age of 15 years.
Schizophrenia is a disorder whose symptoms include: hearing sounds or voices, seeing or sensing things that are not present, having false beliefs or being unusually suspicious, tendency towards social withdrawal, disorganized speech, and flattened behaviour and emotional expression. 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 schizophrenia symptoms (as described above) together with mood disorder symptoms (such as mania, depression, 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 prevent their recurrence.

2. What you should 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 closely 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 treated with other similar types of medicines may be at 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 a condition whose symptoms include increased body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
• If you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia). You should know that both of these conditions can be caused by this type of medicine.
• If you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• If you have diabetes or are predisposed to diabetes.
• If you have heart disease or are taking treatment for heart disease that tends to lower your blood pressure.
• If you have epilepsy.
• If you have swallowing difficulties or stomach or intestinal disorders that reduce your ability to swallow or move food normally through the intestines.
• If you have conditions associated with diarrhoea.
• If you have kidney problems.
• If you have liver problems.
• If you experience prolonged and/or painful erection.
• If you have difficulty regulating your internal body temperature or are exposed to excessive heat.
• If you have abnormally high levels 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, as antipsychotic medicines have been associated with blood clot formation.

If you have any of these conditions, consult your doctor so they can assess whether it is necessary to adjust your dosage or monitor you for a period of time.
Since 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 taking paliperidone, your doctor may check your white blood cell count.
Paliperidone Krka may cause weight gain. A significant weight gain may negatively affect your health. Your doctor should regularly monitor your body weight.
Since diabetes mellitus or 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 eye surgery for cataract (clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could lead to eye damage. If you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents
Paliperidone Krka must not be used in children and adolescents under 15 years of age for the treatment of schizophrenia.
Paliperidone Krka must 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 Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When this medicine is taken together with certain heart medications that control heart rhythm or other medicines such as antihistamines, antimalarials, or other antipsychotics, abnormalities in the heart's electrical function may occur.
Since this medicine acts mainly on the brain, interactions may occur with other medicines (or alcohol) that act on the brain, due to additive effects on brain function.
Since this medicine may lower blood pressure, be cautious when taking it with other medicines that also 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 influenced if you are taking medicines that affect the speed of intestinal movement (e.g. metoclopramide).
Consider reducing the dose of this medicine when it is administered concomitantly with valproate.
Concomitant use of oral risperidone with this medicine is not recommended, as the combination of the two medicines could lead to increased side effects.
Paliperidone Krka should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone Krka and alcohol
Alcohol should be avoided while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must 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 during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your baby shows 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 situations requiring full alertness, for example, when driving a car or operating 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Use in adults
The recommended dose for adults is 6 mg once daily, taken in the morning. Your doctor may increase or decrease the dose within the range of 3 mg to 12 mg once daily for schizophrenia, or from 6 mg to 12 mg once daily 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 older is 3 mg once daily, 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 daily.
For adolescents weighing less than 51 kg, the dose may be increased up to 6 mg once daily.
Your 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 is taken orally. The tablet must be swallowed whole with water or other liquid. It must not be chewed, divided, or crushed.
This medicine should be taken every morning either with breakfast or on an empty stomach, but always in the same way each day. Do not alternate taking the medicine one day on an empty stomach and the next day with food.
The active substance, paliperidone, dissolves after swallowing, and the tablet shell is eliminated from the body as waste.
Patients with kidney problems
Depending on kidney function, your doctor may adjust the dose of this medicine.
Elderly patients
Your doctor may reduce the dose of this medicine if you have reduced kidney function.
If you take more Paliperidone Krka than you should
Contact your doctor immediately. You may experience drowsiness, tiredness, abnormal body movements, difficulty maintaining an upright posture and walking, dizziness due to low blood pressure, and abnormal heartbeats.
If you forget to take Paliperidone Krka
Do not take a double dose to make up for the missed dose. If you miss one tablet, take the next dose the following day. If you miss two or more doses, contact your doctor.
If you stop taking Paliperidone Krka
Do not stop taking this medicine, as you will lose the benefits of the treatment. You should not stop taking the medicine unless your doctor tells you to do so, because your symptoms may return.
If you have any further questions about how to take 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.
Contact your doctor immediately if:

• You suspect you have blood clots in your veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• You have dementia and notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs (especially on one side), or if your speech becomes slurred or incomprehensible, even briefly. These may be signs of a stroke.
• You have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• You experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be required.
• You develop 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 (consistent with an "anaphylactic reaction").

Very common: may affect more than 1 in 10 people

• Difficulty falling or staying asleep
• Parkinsonism: This condition may include slow or impaired body movements, feeling of stiffness or muscle tension (resulting in jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Restlessness
• Drowsiness or reduced alertness
• Headache

Common side effects: may affect up to 1 in 10 people

• Chest infection (bronchitis), cold-like 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 contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue or jaw movements
• Dizziness
• Dyskinesia: This is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements or spasms
• Tremor
• Blurred vision
• Interruption in cardiac conduction between upper and lower parts of the heart, abnormal heart electrical conduction, QT interval prolongation, slow heart rate, rapid heart rate
• Low blood pressure upon standing (as a result, some patients taking Paliperidone Krka may feel faint, lightheaded or may faint when standing 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 blood
• Itching, skin rash
• Bone or muscle pain, back pain, joint pain
• Loss of menstrual period
• 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 blood
• Paliperidone may increase levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, these may include: (in men) breast enlargement, difficulty achieving or maintaining erection or other sexual dysfunction; (in women) breast tenderness, milk discharge from breasts, loss of menstrual period or other menstrual problems
• Diabetes or worsening of diabetes, high blood sugar levels, increased abdominal circumference, loss of appetite leading to malnutrition and low body weight, elevated triglyceride levels (a fat)
• Sleep disorders, confusion, reduced sexual drive, inability to reach orgasm, nervousness, nightmares
• Tardive dyskinesia (spasms or jerky, uncontrollable movements of the face, tongue or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to discontinue Paliperidone Krka
• Seizures (epileptic fits), fainting, urgent need to move a body part, dizziness upon standing, attention disorder, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin
• Light sensitivity of the eyes, eye infection or "slightly reddened", dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations)
• Low blood pressure
• Shortness of breath, wheezing, nosebleed
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas or air
• Increased GGT in blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in blood
• Skin rash (or hives), hair loss, eczema, acne
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released when muscle damage occurs, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence (lack of control), frequent urination, inability to urinate, pain during urination
• Erectile dysfunction, ejaculation disorders
• Loss of menstrual period or menstrual problems (females), milk discharge from breasts, sexual dysfunction, breast pain, breast tenderness
• Swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• Chills, increased body temperature
• Change in walking pattern
• Thirst
• Chest pain, chest discomfort, feeling of uneasiness
• 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 blood of a type of white blood cells that protect the body from infections, increase in eosinophils (a type of white blood cell) in blood
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, labored breathing, itching, rash and sometimes drop in blood pressure, allergic reaction
• Sugar in urine
• Inappropriate secretion of the hormone controlling urine volume
• Complications leading to life-threatening risk from uncontrolled diabetes
• Dangerously excessive water intake, decreased blood sugar, excessive water drinking, increased blood cholesterol
• Sleepwalking
• Absence of movement or response while awake (catatonia)
• Lack of emotion
• Neuroleptic Malignant Syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity)
• Loss of consciousness, balance disorders, abnormal coordination
• Problems with brain blood vessels, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, head tremor
• Glaucoma (increased pressure within the eyeball), increased tearing, eye redness, eye movement problems, rolling eye
• Atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing
• Blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately
• Decreased oxygen levels in parts of the body (due to reduced blood flow), hot flushes
• Breathing problems during sleep (sleep apnea), rapid and shallow breathing
• Pneumonia caused by inhalation of food, respiratory congestion, voice problems
• Intestinal obstruction, 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 may involve the throat and lead to breathing difficulties
• Thickening of the skin, dry skin, skin redness, skin color changes, scaly and itchy scalp or skin, dandruff
• Rupture of muscle fibers and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (prolonged penile erection that may require surgical treatment)
• Breast development in males, enlargement of mammary glands, milk discharge from breasts, vaginal discharge
• Delayed menstrual cycle, breast enlargement
• Very low body temperature, decreased body temperature
• Symptoms of medicine withdrawal

Not known: frequency cannot be estimated from available data

• Pulmonary congestion
• Increased insulin levels (a hormone that controls blood sugar levels) in blood

The following side effects have been observed with the use of another medicine called risperidone, which is very similar to paliperidone; therefore, these effects may also be expected with Paliperidone Krka: sleep-related eating disorders, other types of brain blood vessel problems, crackling lung sounds, severe or life-threatening skin rash with blisters and skin peeling that may start inside and around the mouth, nose, eyes and genitals and spread to other body areas (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis). Eye problems may also occur during cataract surgery. During cataract surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you are scheduled for cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

Other side effects in adolescents
Side effects generally experienced by adolescents are similar to those observed in adults, except for the following, which have been observed more commonly:

• Feeling drowsy or less alert
• Parkinsonism: this condition may include: slow or impaired movements, feeling of stiffness or muscle tension (resulting in jerky movements) and sometimes also a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling and loss of facial expression
• Weight gain
• Common cold symptoms
• Restlessness
• Tremor
• Stomach ache
• Milk discharge from breasts in girls
• Breast swelling in boys
• Acne
• Speech problems
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High levels of triglycerides (a fat) in blood
• Sensation of spinning (vertigo)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the pack after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via 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 Krka contains

• The active substance 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 in 6 mg tablets) and red iron oxide (E172) (only in 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: White to greyish film-coated, round, biconvex tablets with possible uneven surface,
imprinted with the code "P3" on one side. Diameter: approximately 9 mm.
6 mg: Brownish-yellow film-coated, round, biconvex tablets with possible uneven surface,
imprinted with the code "P6" on one side. Diameter: approximately 9 mm.
9 mg: Pinkish film-coated, round, biconvex tablets with possible uneven surface, imprinted
with the code "P9" on one side. Diameter: approximately 9 mm.
Paliperidone Krka is available in boxes containing:

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

Not all pack sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in 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 authorized in the European Economic Area Member States and in
the United Kingdom (Northern Ireland) under the following names: