PALIPERIDONE SANDOZ 6 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Paliperidona Sandoz 3 mg prolonged-release tablets EFG

Paliperidona Sandoz 6 mg prolonged-release tablets EFG

Paliperidona Sandoz 9 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Paliperidona Sandoz and what is it used for
2. What you need to know before you take Paliperidona Sandoz
3. How to take Paliperidona Sandoz
4. Possible side effects
5. Storage of Paliperidona Sandoz
6. Package contents and further information

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

Paliperidona Sandoz contains the active substance paliperidone, which belongs to a class of medicines called antipsychotics.

Paliperidone is used to treat schizophrenia in adults and adolescents aged 15 years and older.

Schizophrenia is a disorder that causes symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, being abnormally suspicious, being withdrawn, having disorganized speech, and a flattening of emotions and behavior. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidone is also used to treat schizoaffective disorder in adults.

Schizoaffective disorder is a mental health condition where a person experiences several symptoms of schizophrenia (listed in the previous paragraph) in addition to symptoms of mood disorder (feeling euphoric, sad, agitated, restless, insomnia, talkativeness, loss of interest in daily activities, excessive or reduced sleep or food intake, and recurring thoughts of suicide).

Paliperidone can help alleviate the symptoms of your illness and prevent them from coming back.

2. What you need to know before taking Paliperidona Sandoz

Do not takePaliperidona Sandoz

• if you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine (listed in section 6).

Warnings andprecautions

Talk to your doctor, pharmacist, or nurse before starting to take paliperidone.

• Patient with schizoaffective disorder treated with this medicine should be closely monitored due to 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 medicines may have 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 are high 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 these two disorders can be caused by this type of medicine.

• If you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• If you are diabetic or have a tendency to diabetes.
• If you have heart disease or are being treated for heart diseases that may make you more prone to a decrease in blood pressure.
• If you have epilepsy.
• If you have problems swallowing, stomach, or intestinal problems that reduce your ability to swallow food or digest it with normal intestinal movements.
• If you have diseases associated with diarrhea.
• 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 body temperature or are overheated.
• If you have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or someone in your family has a history of blood clots, as antipsychotics are associated with the formation of clots.

If you have any of these diseases, please consult your doctor, as it may be necessary to adjust your dose or keep you under observation for a while.

Because it has been very rarely observed in patients treated with paliperidone that a dangerously low number of a type of white blood cells necessary to fight infections in the blood, your doctor may check the number of white blood cells.

Paliperidone may cause you to gain weight. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

In patients treated with paliperidone, diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed, and your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not increase in size as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which can cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Children andadolescents

Paliperidone should not be given to children and adolescents under 15 years of age for the treatment of schizophrenia.

Paliperidone should not be given to 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 this age group.

Other medicines andPaliperidona Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Abnormalities in heart function may appear when taking this medicine with other medicines for controlling heart rhythm or other medicines such as antihistamines, antimalarials, or antipsychotics.

Since this medicine acts mainly on the brain, it may interfere with other medicines (or alcohol) that also act on it, due to the sum of effects on brain function.

This medicine may lower blood pressure, so be careful if you take this medicine with other medicines that also lower blood pressure.

This medicine may reduce the effect of medicines for Parkinson's disease and restless legs syndrome (e.g., levodopa).

The effects of this medicine may be affected if you take medicines that influence the speed of intestinal movement (e.g., metoclopramide).

A reduction in the dose of this medicine should be considered when administered with valproate.

The use of oral risperidone with this medicine is not recommended, as this combination may cause an increase in side effects.

Paliperidone should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).

Taking Paliperidona Sandoz withalcohol

You should avoid consuming alcohol during treatment with this medicine.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, 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 newborn babies of mothers who have been treated with paliperidone in the last trimester of pregnancy (the last three months of pregnancy): trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, you should contact your doctor.

You should not breast-feed while taking this medicine.

Driving and usingmachines

During treatment with this medicine, dizziness and vision problems may appear (see section 4, Possible side effects). This should be taken into account when requiring maximum attention, e.g., when driving or using machinery.

Paliperidona Sandoz contains sodium

This medicine contains 15.74 mg of sodium (a major component of cooking/table salt) in each prolonged-release tablet. This is equivalent to 0.79% of the maximum recommended daily intake of sodium for an adult.

3. How to take Paliperidona Sandoz

Follow exactly the administration instructions of this medicine given by your doctor, pharmacist, or nurse.

Use inadults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or decrease it within the dosage range of 3 mg to 12 mg once a day in case of schizophrenia or 6 mg to 12 mg once a day in case of schizoaffective disorder. This depends on how well the medicine works for you.

Use inadolescents

The recommended starting dose for the treatment of schizophrenia in adolescents aged 15 years and older is 3 mg once a day taken in the morning.

For adolescents who weigh 51 kg or more, the dose may be increased within the range of 6 mg to 12 mg once a day.

For adolescents who weigh less than 51 kg, the dose may be increased to 6 mg once a day.

Your doctor will decide how much you should take. The amount you take depends on how well the medicine works for you.

How and when to take Paliperidona Sandoz

This medicine should be taken by mouth, swallowed whole with water or other liquids. It should not be chewed, broken, or crushed.

This medicine should be taken in the morning with breakfast or on an empty stomach, but in the same way every day. Do not alternate between taking the medicine one day with breakfast and the next day on an empty stomach.

The active substance, paliperidone, is released once swallowed, and the tablet coating is eliminated from the body through the feces.

Patient withkidney problems

Your doctor may adjust the dose of this medicine according to your kidney function.

Elderly patients

Your doctor may reduce your dose of medicine if your kidney function is reduced.

If you take more Paliperidona Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

You may experience drowsiness, fatigue, abnormal body movements, problems standing and walking, dizziness due to decreased blood pressure, and changes in heart rhythm.

If you forget to take Paliperidona Sandoz

Do not take a double dose to make up for forgotten doses. If you forget a dose, take the next dose the next day. If you forget two or more doses, contact your doctor.

If you stop taking Paliperidona Sandoz

Do not stop taking this medicine, as you will lose the effects of the medicine. Do not stop taking this medicine unless your doctor tells you to, as your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctorif:

• You have blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These can be signs of a stroke.
• You have fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw paliperidone.
• You have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction").

Very Common Adverse Effects: may affect more than 1 in 10 patients

• Difficulty staying or falling asleep,
• Parkinsonism: This disease can include slow or altered movement, feeling of stiffness or tightness of the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors while resting, increased saliva and/or drooling, and loss of facial expressiveness,
• Restlessness,
• Feeling drowsy or less alert/awake,
• Headache.

Common Adverse Effects: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, nose infection, urinary tract infection, feeling like you have the flu,
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety,
• Dystonia: This is a condition that involves slow or continuous involuntary muscle contraction. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw,
• Dizziness,
• Discinesia: This condition involves involuntary muscle movements and can include repetitive, spasmodic, or twisting movements, or spasms,
• Tremors,
• Blurred vision,
• Disruption of conduction between the upper and lower parts of the heart, anomalies in the electrical conduction of the heart, prolongation of the QT interval in the heart, slow heartbeat, rapid heartbeat,
• Decrease in blood pressure when standing up (as a consequence, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly), increased 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, skin rash,
• Pain in bones or muscles, back pain, joint pain,
• Loss of menstrual periods,
• Fever, weakness, fatigue (tiredness).

Uncommon Adverse Effects: may affect up to 1 in 100 patients

• Pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis,
• Decrease in the number of white blood cells in the blood, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in the number of red blood cells in the blood,
• Paliperidone may increase the levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they can include: (in men) breast swelling, difficulty having or maintaining erections or other sexual dysfunctions, (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods or other cycle problems,
• Diabetes or worsening of diabetes, increased blood sugar, increased waist circumference, loss of appetite that causes malnutrition and weight loss, increased triglycerides in the blood (a type of fat),
• Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares,
• Late discinesia (involuntary spasmodic movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to withdraw paliperidone,
• Seizures (epileptic crises), fainting, restlessness that causes body movement, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, tingling sensation, pinching or numbness of the skin,

• Eye hypersensitivity to light, eye infection or "red eye", dry eyes,
• Feeling that everything is spinning (vertigo), ringing in the ears, ear pain,
• Irregular heartbeat, anomaly in heart electrical activity (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations),
• Decrease in blood pressure,
• Difficulty breathing, wheezing (whistling in the chest), nasal bleeding,
• Tongue swelling, stomach or intestine infection, difficulty swallowing, excess gas or flatulence,
• Increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood,
• Hives (or "urticaria"), hair loss, eczema, acne,
• Increased CPK (creatine phosphokinase) in blood, an enzyme that is sometimes released with muscle degradation, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain,
• Urinary incontinence (loss of control), frequent urination, inability to pass urine, pain when urinating,
• Erectile dysfunction, ejaculation disorder,
• Loss of menstrual periods or other cycle problems (in women), milk secretion from the breasts,
• Sexual dysfunction, breast pain, breast discomfort,
• Face, mouth, eyes, or lip swelling, body, arm, or leg swelling,
• Chills, increased body temperature,
• Change in gait,
• Feeling of thirst,
• Chest pain, chest discomfort, feeling of discomfort,
• Falls.

Rare Adverse Effects: may affect up to 1 in 1,000 patients

• Eye infection, fungal infection of the nails, skin infection, skin inflammation caused by mites,
• Dangerously low number of a type of white blood cells in the blood necessary to fight infections,
• Decrease in a type of white blood cells in the blood that help fight 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, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure, allergic reaction,
• Sugar in the urine,
• Inappropriate secretion of a hormone that controls urine volume,
• Life-threatening complications of uncontrolled diabetes,
• Excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood,
• Sleepwalking,
• Lack of movement or response while awake (catatonia),
• Lack of emotions,
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness),
• Loss of consciousness, balance disorder, abnormal coordination,
• Problems in the blood vessels of the brain, coma due to uncontrolled diabetes, unresponsive to stimuli, decreased level of consciousness, head tremors,
• Glaucoma (increased eye pressure), increased tearing, eye redness, problems with eye movement, eye rotation,
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat when standing up,

• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately,
• Decrease in oxygen in parts of the body (due to decreased blood flow), flushing,
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing,
• Pneumonia caused by aspiration of food, respiratory tract congestion, voice disorder,
• Intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement that causes obstruction,
• Yellow color of the skin and eyes (jaundice),
• Pancreatitis,
• Severe allergic reaction with swelling that can affect the throat, causing difficulty breathing,
• Thickening of the skin, dry skin, redness of the skin, skin discoloration, scaly and itchy skin or scalp, dandruff,
• Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal posture,
• Priapism (a prolonged erection that may require surgical treatment),
• Breast development in men, breast enlargement, milk secretion from the breasts, vaginal discharge,
• Delayed menstrual periods, breast enlargement,
• Very low body temperature, decreased body temperature,
• Drug withdrawal symptoms.

Adverse Effects of Unknown Frequency: cannot be estimated from the available data

• Lung congestion,
• Increased insulin (a hormone that controls blood sugar levels) in the blood.

The following adverse effects have appeared with the use of another medicine called risperidone, which is very similar to paliperidone, so it is also expected to appear with paliperidone: sleep-related eating disorder, other types of cerebral vascular problems, lung crackling sounds, and severe or fatal skin rash with blisters and peeling that can start around the mouth, nose, eyes, genitals, and spread to other areas of the body (Stevens-Johnson Syndrome or 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 need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

Additional Adverse Effects in Adolescents

Adolescents generally presented similar adverse effects to those found in adults, except for the following adverse effects that were detected more frequently:

• Feeling drowsy or less alert/awake,
• Parkinsonism: This disease can include slow or altered movement, feeling of stiffness or tightness of the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors while resting, increased saliva and/or drooling, and loss of facial expressiveness,
• Weight gain,
• Common cold symptoms,
• Restlessness,
• Tremors,
• Stomach pain,
• Milk secretion from the breasts in girls,
• Breast swelling in boys,
• Acne,
• Speech problems,
• Stomach or intestinal infection,
• Nasal bleeding,
• Ear infection,
• High triglycerides in the blood (a type of fat),
• Feeling of movement (vertigo).

Reporting of Adverse Effects

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Paliperidona Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the carton after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paliperidona Sandoz

• The active ingredient is paliperidone.

Paliperidona Sandoz 3 mg prolonged-release tablets.

Each tablet contains 3 mg of paliperidone.

Paliperidona Sandoz 6 mg prolonged-release tablets

Each tablet contains 6 mg of paliperidone.

Paliperidona Sandoz 9 mg prolonged-release tablets

Each tablet contains 9 mg of paliperidone.

• The other components are:

Core of the tablet

Macrogol 200000

Macrogol 7000000

Butylhydroxytoluene (E 321)

Povidone K30

Sodium chloride

Microcrystalline cellulose

Magnesium stearate

Red iron oxide (E 172)

Hydroxypropyl cellulose

Coating

(3 mg, 6 mg, 9 mg)

Cellulose acetate

Macrogol 4000

Hypromellose 6cP

Titanium dioxide (E 171)

Talc

Propylene glycol

(6 mg)

Yellow iron oxide (E 172)

(9 mg)

Red iron oxide (E 172)

Printing ink

Lacquer

Black iron oxide (E 172)

Propylene glycol

Appearance of the Product and Package Contents

Paliperidona Sandoz 3 mg are white to grayish-white, round, biconvex prolonged-release tablets with a possible irregular surface, marked with P3 on one side.

Paliperidona Sandoz 6 mg are yellowish-brown, round, biconvex prolonged-release tablets with a possible irregular surface, marked with P6 on one side.

Paliperidona Sandoz 9 mg are pink, round, biconvex prolonged-release tablets with a possible irregular surface, marked with P9 on one side.

The prolonged-release tablets are packaged in single-dose blisters of OPA/AL/PVC/Aluminum and inside a cardboard box.

Package sizes: 14x1, 28x1, 30x1, 49x1, 56x1, and 98x1 prolonged-release tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

Lek Pharmaceuticals d.d.

Verovškova 57

SLO-1526 Ljubljana

Slovenia

Date of the Last Revision of this Leaflet:March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/