Paliperidone Sandoz

Package leaflet: Information for the patient

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

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, pharmacist or nurse.
• 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 effect, including those not listed in this leaflet, talk to 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 taking 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 Paliperidone Sandoz is and what it is used for

Paliperidone Sandoz contains the active substance paliperidone, which belongs to a class of medicines called antipsychotics.
Paliperidone Sandoz 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 emotional and behavioural 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 schizophrenia symptoms (as described above) together with mood disorder symptoms (such as excitement, sadness, agitation, distractibility, 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 may help relieve the symptoms of the illness and prevent their recurrence.

2. What you need to know before taking 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 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 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 rigidity (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 through the intestines normally.
• If you have conditions associated with diarrhea.
• 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 may have a prolactin-dependent tumour.
• If you or someone else in your family has a history of blood clots (thrombi), as antipsychotic medicines have been associated with blood clot formation.

If you have any of these conditions, talk to your doctor so they can assess whether
dose adjustment or monitoring over a certain period is necessary.
Since a dangerously low count of a certain type of white blood cells needed to fight infections has been observed very rarely in patients taking paliperidone,
your doctor may check your white blood cell count.
Paliperidone may cause weight gain. 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 Sandoz must not be used in children and adolescents under 15 years of age for the treatment of schizophrenia.
Paliperidone Sandoz 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 Sandoz
Tell 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 regulate heart rhythm or other medicines such as antihistamines, antimalarials, or other antipsychotics, abnormalities in the electrical function of the heart may occur.
Since this medicine acts mainly on the brain, interactions may occur with other medicines (or alcohol) that also act on the brain, due to additive effects on brain function.
Since this medicine may lower blood pressure, be cautious when taking it together 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 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 combining the two medicines may lead to increased side effects.
Paliperidone Sandoz should be used with caution together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone Sandoz and alcohol
Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, plan to become pregnant, or 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 whose mothers have used paliperidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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
While being treated 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, such as driving a car or operating 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 exactly as directed by your doctor, pharmacist, or nurse.
Use in adults
The recommended dose for adults is 6 mg once daily, taken in the morning. Your doctor may increase or decrease your 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 adjustment will depend 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 to between 6 mg and 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 determine 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 should be swallowed whole with water or other liquid. It must not be chewed, split, 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
Based on your kidney function, your doctor may adjust the dose of this medicine.
Elderly patients
Your doctor may reduce the dose if you have reduced kidney function.
If you take more Paliperidone Sandoz than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, 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 Sandoz
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 Sandoz
Do not stop taking this medicine, as you will lose its beneficial effects. You should not discontinue treatment unless instructed by your doctor, because symptoms may return.
If you have any further questions about how to take this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately inform your doctor if:
You think you have blood clots in your veins, particularly in your legs (symptoms include swelling, pain, and redness in the legs), which may travel through 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, sudden weakness or numbness of the face, arms, or legs—especially on one side—or if your speech becomes 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 asleep or staying asleep
Parkinsonism: This condition may include slow or impaired body movements, a sensation of muscle stiffness or tightness (resulting in jerky movements), and sometimes a feeling that movement starts and stops. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and reduced 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 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
A disruption in the heart's electrical conduction between the upper and lower chambers, 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 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 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 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, they may include: (in men) breast enlargement, difficulty achieving or maintaining erection, or other sexual dysfunctions; (in women) breast discomfort, milk leakage from breasts, loss of menstrual cycle, 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 type of fat)
Sleep disturbances, confusion, reduced sexual drive, inability to achieve orgasm, nervousness, nightmares
Tardive dyskinesia (involuntary spasms or jerky movements of the face, tongue, or other body parts that cannot be controlled). Immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary.
Seizures (epileptic fits), fainting, an urgent need to move a body part, dizziness upon standing, attention disturbances, speech problems, loss or altered sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling, or numbness of the skin
Eye sensitivity to light, eye infection or "slightly red," 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, 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
Increased CPK (creatine phosphokinase) in the blood—a muscle 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 cycle or menstrual problems (females), milk discharge from breasts, sexual dysfunction, breast pain, breast discomfort
Swelling of the face, mouth, eyes, or lips, body swelling, swelling of arms or legs
Chills, increased body temperature
Change in walking pattern
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 count of a certain type of white blood cells in the blood needed to fight infections
Decreased levels in the blood of a type of white blood cell that protects 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 drop in blood pressure, allergic reaction
Sugar in the urine
Inappropriate secretion of the hormone controlling urine volume
Complications leading to life-threatening conditions due to uncontrolled diabetes
Dangerously excessive water intake, low blood sugar, excessive water drinking, increased cholesterol in the blood
Sleepwalking
Lack of movement or response while awake (catatonia)
Lack of emotion
Neuroleptic Malignant Syndrome (confusion, reduced or lost consciousness, high fever, severe muscle rigidity)
Loss of consciousness, balance problems, abnormal coordination
Problems with cerebral blood vessels, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, low level of consciousness, head tremor
Glaucoma (increased pressure inside the eyeball), increased tearing, red eyes, eye movement problems, eyes rolling backward
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.
Reduced 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 blockage, fecal incontinence, hard stools, lack of intestinal muscle movement leading to obstruction
Yellowing of the skin and eyes (jaundice)
Pancreatitis (inflammation of the pancreas)
Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
Thickened skin, dry skin, skin redness, skin color changes, scaly and itchy scalp or skin, dandruff
Muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
Priapism (a prolonged penile erection that may require surgical treatment)
Breast development in males, enlarged breast glands, milk discharge from breasts, vaginal discharge
Delayed menstrual cycle, breast enlargement
Very low body temperature, decreased body temperature
Medication withdrawal symptoms

Not known: frequency cannot be determined from available data
Pulmonary congestion
Increased insulin levels (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; therefore, these effects may also be expected with Paliperidone Sandoz: sleep-related eating disorder, other types of cerebral blood vessel problems, and lung crackling sounds. 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.

Additional 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, sensation of muscle stiffness or tightness (making movements jerky), and sometimes a feeling that movement stops and restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression
Weight gain
Common cold symptoms
Restlessness
Tremor
Stomach ache
Milk leakage 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 the blood
Sensation of spinning (dizziness)

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 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 carton after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 Sandoz contains
The active substance 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 components 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 appearing as film-coated tablets, white to off-white, round, biconvex, with possible irregular surface, printed with "P3" on one side.
Paliperidone Sandoz 6 mg prolonged-release tablets
Prolonged-release tablets appearing as film-coated tablets, yellowish-brown, round, biconvex, with possible irregular surface, printed with "P6" on one side.
Paliperidone Sandoz 9 mg prolonged-release tablets
Prolonged-release tablets appearing as film-coated tablets, pinkish, round, biconvex, with possible irregular surface, printed with "P9" on one side.
Unit dose divisible blisters in OPA/AL/PVC/Aluminum.
Pack sizes: 14 x 1, 28 x 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 Authorization 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 authorized in the European Economic Area countries under the
following names:
Belgium Paliperidone Sandoz 3 mg tabletten met verlengde afgifte
Paliperidone Sandoz 6 mg tabletten met verlengde afgifte
Paliperidone Sandoz 9 mg tabletten met verlengde afgifte
Italy Paliperidone Sandoz
Netherlands Paliperidon Sandoz retard 3 mg, tabletten met verlengde afgifte
Paliperidon Sandoz retard 6 mg, tabletten met verlengde afgifte
Paliperidon Sandoz retard 9 mg, tabletten met verlengde afgifte
Portugal Paliperidona Sandoz
Spain Paliperidona Sandoz 3 mg comprimidos de liberación prolongada EFG
Paliperidona Sandoz 6 mg comprimidos de liberación prolongada EFG
Paliperidona Sandoz 9 mg comprimidos de liberación prolongada EFG
Hungary Paliperidon Sandoz 3 mg retard tabletta
Paliperidon Sandoz 6 mg retard tabletta
Paliperidon Sandoz 9 mg retard tabletta