Patient Information Leaflet

Paliperidone Sandoz 3 mg prolonged-release tablets EFG

Paliperidone Sandoz 6 mg prolonged-release tablets EFG

Paliperidone Sandoz 9 mg prolonged-release tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isPaliperidone Sandozand what it is used for

2. What you need to know before you start takingPaliperidone Sandoz

3. How to takePaliperidone Sandoz

4. Possible side effects

5. Storage ofPaliperidone Sandoz

6. Contents of the pack and additional information

Paliperidone Sandoz contains the active ingredient paliperidone, which belongs to the class ofmedicamentosantipsicóticos.

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

Schizophrenia is a disorder that causes symptoms that include hearing, seeing or feeling things thatdonotexist, holding false beliefs, having an abnormal distrust, withdrawing into oneself,speaking incoherently and flattening of behavior and emotion. People with this disorder may also feeldepressed,anxious,guiltyoranxious.

Paliperidone is also used to treat schizoaffective disorder in adults.

Schizoaffective disorder is a mental condition in which the person experiences several of the symptoms ofschizophrenia(enumeratedinthepreviousparagraphhingtoschizophreniasymptomsofmaniacdepressiondisorder(euphoria,depression,agitation,distraction,insomnia,excesiveorinsueñoexcessive,orlessinkingoestatingoorlylosofinterestsonlypensatingsofsuiciding).

Paliperidone may help alleviate the symptoms of your illness and prevent it from recurring.

Do not takePaliperidone Sandoz

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

Warnings and precautions

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

• Patients with schizoaffective disorder treated with this medicine should be closely monitored due to a potential change from manic symptoms to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other 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 conditions may 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 be diabetic.
• If you have any heart disease or are receiving treatment for heart diseases that may make you more prone to a reduction in blood pressure.
• If you have epilepsy.
• If you have any problems swallowing, stomach, or intestine that reduce your ability to swallow food or digest it with normal bowel movements.
• If you have diseases associated with diarrhea.
• If you have urinary problems.
• If you have liver problems.
• If you have an erection that lasts for a long time and/or is painful.
• If you have difficulty controlling your body temperature or are overheated.
• If you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or a family member has a history of blood clots, as antipsychotics are related to the formation of blood clots.

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

Because in very rare cases, a dangerously low number of a type of white blood cells necessary to fight infections in the blood has been observed in patients treated with paliperidone, 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. 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 dilate as needed. Additionally, 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 have eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

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

Paliperidone should not be administered to children and adolescents under 18 years of age for the treatment of schizoaffective disorder.

This is because it is unknown whether paliperidone is safe or effective in this age group.

Other medicines and Paliperidone Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

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

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

This medicine may reduce the effect of medicines for Parkinson's disease and restless leg 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).

Reduction of this medicine dose should be considered when administered with valproate.

It is not recommended to use oral risperidone with this medicine as this combination may cause an increase in adverse effects.

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

Paliperidone Sandoz with alcohol

You should avoid consuming alcohol during treatment with this medicine.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist 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, from mothers who have been treated with paliperidone in the last three months of pregnancy: tremor, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

You should not breastfeed your child while taking this medicine.

Driving and use of machines

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

Paliperidone Sandoz contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist or nurse.

Use in adults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or decrease it within the dosing interval 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 medication works for you.

Use in adolescents and children

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

For adolescents weighing 51 kg or more, the dose can be increased within the interval of 6 mg to 12 mg once a day.

For adolescents weighing less than 51 kg, the dose can be increased to 6 mg once a day.

Your doctor will decide how much to administer to you. The amount you take depends on how well the medication works for you.

How and when to take Paliperidone Sandoz

This medication should be taken by mouth, swallowed whole with water or other liquids. Do not chew, break or crush it.

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

The active ingredient, paliperidone, dissolves once swallowed, and the coating of the tablet is eliminated from the body by the kidneys.

Patients with kidney problems

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

Patients of advanced age

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

If you take more Paliperidone Sandoz than you should

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

You may experience drowsiness, dizziness, abnormal movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and alterations in heartbeats.

If you forgot to take Paliperidone Sandoz

Do not take a double dose to compensate for the missed 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 interrupt the treatment with Paliperidone Sandoz

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone gets them.notallpeoplesgetthem.

Inform your doctor immediately if you experience any of the following:s:

•Present with blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.

•Have dementia and experience a sudden change in your mental state or sudden weakness or numbness in the face, arms, or legs, especially on one side, or difficulty speaking even for a short period of time. These may be signs of a heart attack.

•Present with fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.

•Are a man and experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.

•Experience involuntary rhythmic movements of the tongue, mouth, and face. You may need to discontinue paliperidone.

•Present with a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, skin rash, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction).

Very common side effects: may affect more than 1 in 10 patients:pacients

• difficulty staying or falling asleep,
• parkinsonism: This disease can include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, trembling while resting, increased saliva and/or drooling, and loss of facial expression,
• inquietude,
• feeling drowsy or less alert,
• abdominal pain.

Common side effects: may affect up to 1 in 10 patients:pacients

• chest infection (bronchitis), common cold symptoms, nasal 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 condition involves involuntary slow or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia typically affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible,
• dizziness,
• discinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms,
• shaking,
• blurred vision,
• intermittent conduction between the upper and lower parts of the heart, cardiac conduction anomalies, prolonged QT interval in the heart, heart palpitations, rapid heart rate,
• decreased blood pressure when standing (as a result, 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, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, jaw pain,
• increased liver enzymes in the blood (i.e., transaminases),
• itching, skin rash,
• bone or muscle pain, back pain, joint pain,
• loss of menstrual periods,
• fever, weakness, fatigue (i.e., cancio).

Rare side effects: may affect up to 1 in 1,000 patients:pacients

• eye infection, fungal infection of the nails, skin infection, skin inflammation caused by bacteria,
• dangerously low number of a type of white blood cell necessary for infections,
• decrease in a type of white blood cell that helps fight infections, increase in 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, hives, skin rash, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction),
• high blood sugar,
• inappropriate secretion of a hormone that controls urine volume,
• complications of uncontrolled diabetes with a risk to life,
• excessive water intake, low blood sugar, excessive water intake, increased cholesterol in the blood,
• sleepwalking,
• lack of movement or response while awake (catatonia),
• absence of emotions,
• neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness),
• loss of consciousness, balance, and coordination disorders,
• problems in the blood vessels of the brain, coma due to uncontrolled diabetes, decreased response to stimuli, decreased level of consciousness, tremors of the face,
• glaucoma (increased pressure in the eyeball), increased tear production, eye redness, eye movement problems, eye rotation,
• atrial fibrillation (abnormal heart rhythm), rapid heart rate when standing up,

• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.
• decreased oxygen in parts of the body (due to decreased blood flow), flushing,
• respiratory problems during sleep (sleep apnea), rapid breathing,
• lung congestion caused by aspiration of food, respiratory tract congestion, voice disorder,
• intestinal obstruction, fecal incontinence, hard stools, absence of intestinal movement causing obstruction,
• yellow skin and eyes (i.e., ictericia),
• pancreatitis inflammation,
• severe allergic reaction with swelling, which can affect the throat causing difficulty breathing,
• skin thickening, skin dryness, skin redness, skin discoloration, scaly and itchy skin, caspa,
• muscle fiber rupture and muscle pain (rhabdomyolysis), muscle anomaly,
• prolonged erection (priapism) that may require surgical treatment,
• breast development in men, increased breast gland size, milk secretion by the breasts, vaginal secretion,
• delayed menstrual periods, increased breast size,
• very low body temperature, decreased body temperature,
• symptoms of withdrawal from the medication.

Side effects of unknown frequency: cannot be estimated from available data:

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

The following side effects have appeared with the use of another medication called risperidone, which is very similar to paliperidone, so it is also expected to appear with paliperidone: eating disorder related to sleep, other types of blood vessel problems in the brain, lung crackling sounds, and severe or fatal skin rash with blisters and peeling of the skin that can start around the mouth, nose, eyes, genitals, and spread to other parts 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 medication.

Additional side effects in adolescents:

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

• feeling drowsy or less alert/despierto,
• parkinsonism: This disease can include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, trembling while resting, increased saliva and/or drooling, and loss of facial expression,
• weight gain,
• common cold symptoms,
• restlessness,
• shaking,
• abdominal pain,
• milk secretion by the breasts in girls,
• breast swelling in boys,
• acne,
• speech problems,
• gastrointestinal infection,
• nasal bleeding,
• ear infection,
• high triglycerides in the blood (a type of fat),
• feeling of movement (dizziness).

Reporting side effects:

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

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

Do not use this medication after the expiration date that appears on the blister pack and on the box 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 disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Paliperidone Sandoz

• The active ingredient is paliperidone.

Paliperidone Sandoz 3 mg prolonged-release tablets.

Each tablet contains 3 mg of paliperidone.

Paliperidone Sandoz 6 mg prolonged-release tablets

Each tablet contains 6 mg of paliperidone.

Paliperidone Sandoz 9 mg prolonged-release tablets

Each tablet contains 9 mg of paliperidone.

• The other components are:

Tablet core

Macrogol 200000

Macrogol 7000000

Butilhydroxytoluene (E 321)

Povidone K30

Sodium chloride

Microcrystalline cellulose

Magnesium stearate

Iron oxide red (E 172)

Hydroxypropyl cellulose

Covering

(3 mg, 6 mg, 9 mg)

Cellulose acetate

Macrogol 4000

Hydroxypropyl methylcellulose 6cP

Titanium dioxide (E 171)

Talc

Propylene glycol

(6 mg)

Iron oxide yellow (E 172)

( 9 mg)

Iron oxide red (E 172)

Printing ink

Lacquer

Iron oxide black (E 172)

Propylene glycol

Appearance of the product and contents of the package

Paliperidone Sandoz 3 mg are white to off-white, round, biconvex tablets with a possible irregular surface, marked with P3 on one side.

Paliperidone Sandoz 6 mg are yellowish, round, biconvex tablets with a possible irregular surface, marked with P6 on one side.

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

Lek Pharmaceuticals d.d.

Verovškova 57

SLO-1526 Ljubljana

Slovenia

Last revision date of thisleaflet:March 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/