PALIPERIDONE CINFA 9 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking paliperidona cinfa

Do not take paliperidona cinfa

• If you are allergic to paliperidona, risperidona, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take paliperidona cinfa.

• Patients with schizoaffective disorder treated with this medication should be closely monitored for a possible change from manic symptoms to depressive symptoms.
• This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with similar medications 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 fever 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 medication.

• If you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• 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 a swallowing disorder, stomach disorder, or intestinal disorder that reduces 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 period of time.

Because a dangerously low number of a type of white blood cell necessary to fight infections in the blood has been observed in patients treated with paliperidona, your doctor may check your white blood cell count.

Paliperidona 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 paliperidona, 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 center 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 planning to have eye surgery, make sure to inform your ophthalmologist that you are using this medication.

Children and adolescents

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

Paliperidona 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 paliperidona is safe or effective in this age group.

Other medications and paliperidona cinfa

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

Abnormalities in heart function may occur when taking this medication with other medications for heart rhythm control or other medications such as antihistamines, antimalarials, or antipsychotics.

Since this medication acts primarily on the brain, it may interfere with other medications (or alcohol) that also act on the brain, due to the cumulative effect on brain function.

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

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

The effects of this medication may be affected if you take medications that influence intestinal motility (e.g., metoclopramide).

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

The use of oral risperidone with this medication is not recommended, as this combination may increase the risk of side effects.

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

Taking paliperidona cinfa with alcohol

You should avoid consuming alcohol during treatment with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take this medication 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 paliperidona in the last trimester of pregnancy (last three months of pregnancy): tremors, 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 take this medication during breastfeeding.

Driving and using machines

Paliperidona may cause symptoms such as drowsiness, dizziness, or vision changes, and may reduce your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Paliperidona cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take paliperidona cinfa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Use in adults

The recommended dose in adults is 6 mg once daily in the morning. Your doctor may increase or decrease the dose within the dosage range of 3 mg to 12 mg once daily for schizophrenia or 6 mg to 12 mg once daily for schizoaffective disorder, depending on how well the medication 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 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 daily.

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

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

How and when to take paliperidona cinfa

This medication should be taken orally, swallowed whole with water or other liquids. It should not be chewed, broken, or crushed.

This medication 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 medication one day with breakfast and the next day on an empty stomach.

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

Patients with kidney problems

Your doctor may adjust the dose of this medication based on your kidney function.

Elderly patients

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

If you take more paliperidona cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to decreased blood pressure, and changes in heart rhythm.

If you forget to take paliperidona cinfa

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

If you stop taking paliperidona cinfa

Do not stop taking this medication, as you will lose its effects. You should not stop taking this medication unless your doctor tells you to, as your symptoms may recur.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Report immediately to your doctorif:

• Presents 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
• Has dementia and presents a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or has difficulty speaking even for a short period. These can be signs of a stroke
• Presents fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). May need immediate medical treatment
• Is a man and presents a prolonged or painful erection. It is known as priapism. May need immediate medical treatment
• Presents rhythmic involuntary movements of the tongue, mouth, and face. May require withdrawal of paliperidone
• Presents 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 frequent: 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 muscle tension (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, trembling while at rest, increased saliva and/or drooling, and loss of facial expressiveness

rigidity or muscle tension (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, trembling while at rest, increased saliva and/or drooling, and loss of facial expressiveness

• Restlessness
• Feeling drowsy or less attentive
• Headache

Frequent: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, nose infection, urinary tract infection, feeling like having the flu
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: It is a disease that involves slow or continuous involuntary contraction of the muscles. 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
• Dyskinesia: This disease involves involuntary muscle movements and can include repetitive, spasmodic, or twisting movements, or spasms
• Tremors (agitation)
• 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 getting 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
• Bone or muscle pain, back pain, joint pain
• Loss of menstrual periods
• Fever, weakness, fatigue (tiredness)

Uncommon: may affect up to 1 in 100 patients

• Pneumonia, respiratory tract infection, bladder infection, ear infection, angina
• 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

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

• 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 may include: (in men) breast swelling, difficulty having or maintaining an erection or other sexual dysfunctions, (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods or other problems with the cycle
• 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

inability to achieve orgasm, nervousness, nightmares

• Tardive dyskinesia (involuntary spasmodic or rhythmic movements of 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. Withdrawal of paliperidone may be necessary
• Seizures (epileptic crises), fainting, restlessness that causes movement of parts of the body, dizziness when standing up, attention alteration, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of tingling, pinching, or numbness of the skin
• Eye hypersensitivity to light, eye infection or "red eye", dry eyes
• Sensation that everything spins (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, anomaly in the electrical activity of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decrease in blood pressure
• Shortness of breath, wheezing, nasal bleeding
• Tongue swelling, stomach or intestine infection, difficulty swallowing, excess gas or flatulence

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

muscle weakness, neck pain

• Urinary incontinence (loss of control), frequent urination, inability to urinate, painful urination
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods or other problems with the cycle (women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort

breast discomfort

• Facial swelling, mouth, eye, or lip swelling, body swelling, arm or leg swelling
• Chills, increased body temperature
• Change in gait
• Feeling of thirst
• Chest pain, chest discomfort, feeling of discomfort
• Falls

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

• Eye infection, fungal infection of the nails, skin infection, skin inflammation caused by mites

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, 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, 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
• Complications of uncontrolled diabetes with life-threatening risk
• Excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood
• Sleepwalking
• Lack of movement or response while being awake (catatonia)
• Absence 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 agitation
• 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 suffer from 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, congestion of the airways, voice disorder

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, which 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
• Rupture of muscle fibers and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (a prolonged erection that may require surgical treatment)
• Development of breasts in men, breast enlargement, milk secretion from the breasts, vaginal secretion
• Delayed menstrual periods, breast enlargement
• Very low body temperature, decreased body temperature
• Withdrawal symptoms from the medication

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 medication called risperidone that is very similar to paliperidone, so it is also expected to appear with paliperidone: sleep-related eating disorder, other types of cerebrovascular problems, crackling sounds in the lungs, and severe or fatal skin rash with blisters and peeling that can start inside and around the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis). Eye problems may also occur during cataract surgery. During cataract surgery, a condition called 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 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 attentive
• Parkinsonism: This disease can include slow or altered movement, feeling of stiffness or muscle tension (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, trembling while at rest, increased saliva and/or drooling, and loss of facial expressiveness
• Weight gain
• Common cold symptoms
• Restlessness
• Tremors (agitation)
• 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)
• Sensation of movement (vertigo)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. 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 medication.

5. Conservation of paliperidone cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications that 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 medications that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of paliperidone cinfa

• The active ingredient is paliperidone. Each prolonged-release tablet of paliperidone cinfa 3 mg contains 3 mg of paliperidone.
• The other components are: macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose, and cellulose acetate in the core of the tablet, and hypromellose, titanium dioxide (E171), talc, and propylene glycol in the coating, and shellac lacquer, black iron oxide (E172), and propylene glycol in the printing ink. See section 2 "paliperidone cinfa contains sodium".

Appearance of the product and package contents

White to grayish-white, round, biconvex film-coated tablets with a possible irregular surface and marked with P3 on one side. Approximate diameter 9 mm.

• Paliperidone cinfa is available in packages containing 7, 14, 28, or 98 prolonged-release tablets in blister packs marked with the days of the week (calendar package).
• 7x1, 14x1, 28x1, or 98x1 prolonged-release tablets in single-dose blister packs marked with the days of the week (calendar package).

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus: April 2024

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

You can access detailed and updated information on this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85826/P_85826.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85826/P_85826.html