Package Leaflet: Information for the user

paliperidone cinfa 3 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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as 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.

Paliperidone 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 of schizophrenia (listed in the previous paragraph) in addition to symptoms of mood disorder (feeling of euphoria, sadness, agitation, being distracted, insomnia, loquaciousness,lossof interest in daily activities, excessive or inadequate sleep, excessive or inadequate food intake,recurrentthoughts ofsuicidedallons).

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

Do not take paliperidone cinfa

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

Warnings and precautions

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

• Patients with schizoaffective disorder treated with this medication should be closely monitored for any change in 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 characterized by high 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 these two conditions may 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 develop diabetes.
• If you have any heart disease or are receiving treatment for heart conditions that may make you more prone to a decrease in blood pressure.
• If you have epilepsy.
• If you have any swallowing, stomach, or intestinal disorders that reduce your ability to swallow food or digest it normally.
• If you have diseases associated with diarrhea.
• If you have kidney problems.
• If you have liver problems.
• If you have a prolonged and painful erection.
• 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 associated with 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 period of time.

Since very rarely, 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 paliperidone, your doctor may check your white blood cell count.

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 eye damage. If you are planning to have eye surgery, be sure to inform your ophthalmologist that you are taking this medication.

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 medications and paliperidone cinfa

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

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

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

This medication may reduce blood pressure, so 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 leg syndrome (e.g., levodopa).

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

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

The use of oral risperidone with this medication is not recommended as this combination may cause an increase in adverse effects.

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

Paliperidone cinfa and alcohol

You should avoid consuming alcohol during treatment with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 paliperidone in the last three months of pregnancy (last trimester): tremor, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

You should not take this medication during breastfeeding.

Driving and operating machinery

Paliperidone may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Paliperidone cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by yourmedico. In case of doubt, consult your doctor orpharmacisticianagain.

Use inadults

The recommended dose in adults is 6 mg once a day in the morning. Your doctormaybe able to 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 dependsonhow well the medication works foryou.

Use inadolescentscents

The recommended starting dose for the treatment of schizophrenia in adolescents from 15 years of age is 3 mg once a day taken in themorning.

For adolescents weighing 51 kg or more, the dose can be increased within the interval of 6 mg to12mg 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 wellthemedicationworksforyou.

How and when to take paliperidone cinfa

This medication should be taken by mouth, swallowed whole with water or other liquids. Do notmasticate,break,ormachacarite.

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 one day with breakfast and the next dayenauny.

The active ingredient, paliperidone, dissolves once swallowed, and the coating of the tablet iseliminatedfrom the body by theintestinestines.

Patients with kidney problems

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

Patients of advanced age

Your doctor may reduce your medication dose if your kidney function isreduced.

If you take more paliperidone cinfa than youshould

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately orcallthe Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested. You may experience drowsiness,sleepiness,abnomalmovements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and alterations in heartbeatrrhythms.

If you forgot to take paliperidone cinfa

Do not take a double dose to compensate for the missed doses. If you forget a dose, take thenextdday's dose the next day. If you forget two or more doses, contact yourdoctor.

If you interrupt the treatment with paliperidone cinfa

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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, althoughnotall people experience them.

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

- 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 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 in the face, arms, or legs, especially on one side, or you have trouble speaking even for a short period of time. These may be signs of a stroke.

- You experience fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical attention.

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

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

- You experience 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: may affect more than 1 in 10 patients:

- Difficulty staying or remaining asleep.

- Parkinsonism: This disease may 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 descending stairs, increased saliva and/or drooling, and loss of facial expression.

- Incontinence (loss of bladder control), frequent urination, inability to urinate, painful urination.

- Euphoria (mania), irritability, depression, anxiety.

- Dystonia: A disease that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.

- Dizziness.

- Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.

- Tremor (agitation).

- Blurred vision.

- Interruption of conduction between the upper and lower parts of the heart, anomalies in heart electrical conduction, prolongation of the QT interval in the heart, irregular heartbeat, rapid heartbeat.

- Decreased blood pressure upon standing (as a result, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting suddenly), increased blood pressure.

- Sore throat, cough, congestion.

- Abdominal pain, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, toothache.

- Increased liver transaminases in the blood.

- Itching, skin rash.

- Back pain, muscle pain, joint pain.

- Loss of menstrual periods.

- Fever, weakness, fatigue (cansaço).

Common: may affect up to 1 in 10 patients:

- Chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, feeling like you have a cold.

- Weight gain, increased appetite, weight loss, decreased appetite.

- Euphoria (mania), irritability, depression, anxiety.

- Dystonia: A disease that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.

- Dizziness.

- Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.

- Tremor (agitation).

- Blurred vision.

- Interruption of conduction between the upper and lower parts of the heart, anomalies in heart electrical conduction, prolongation of the QT interval in the heart, irregular heartbeat, rapid heartbeat.

- Decreased blood pressure upon standing (as a result, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting suddenly), increased blood pressure.

- Sore throat, cough, congestion.

- Abdominal pain, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, toothache.

- Increased liver transaminases in the blood.

- Itching, skin rash.

- Back pain, muscle pain, joint pain.

- Loss of menstrual periods.

- Fever, weakness, fatigue (cansaço).

Uncommon: may affect up to 1 in 100 patients:

- Pneumonia, respiratory tract infection, urinary tract infection, ear infection, vaginitis.

- Decreased white blood cell count, decreased platelet count (a type of blood cell that helps stop bleeding), anemia, decreased red blood cell count.

- Paliperidone may increase 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 getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems.

- Diabetes or worsening of diabetes, increased blood sugar, increased blood glucose, decreased appetite causing malnutrition and weight loss, increased triglycerides in the blood (a type of fat).

- Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, pesadillas.

- Tardive dyskinesia (spasms or involuntary movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. You may need to discontinue paliperidone.

- Convulsions (epileptic seizures), fainting, restlessness that causes movement of parts of the body, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of pins and needles, numbness, or tingling of the skin.

- Increased sensitivity of the eyes to light, eye infection, or "red eye," dry eyes.

- Sensation of spinning (vertigo), ringing in the ears, ear pain.

- Irregular heartbeat, anomaly in heart electrical activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).

- Decreased blood pressure.

- Labored breathing, gasping, nasal bleeding.

- Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive gas or flatulence.

- Increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.

- Hives, hair loss, eczema, acne.

- Increased CPK (creatine phosphokinase) in the blood, an enzyme that sometimes is released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, muscle pain.

- Urinary incontinence, frequent urination, inability to urinate, painful urination.

- Erectile dysfunction, sexual dysfunction.

- Loss of menstrual periods or other menstrual cycle problems (women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort.

- Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs.

- Chills, increased body temperature.

- Change in the way you walk.

- Sensation of sedation.

- Chest pain, chest discomfort, sensation of malaise.

- Falls.

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

- Eye infection, fungal infection of the nails, skin infection, inflammation of the skin caused by bacteria.

- Dangerously low count of a type of white blood cell necessary for combating infections.

- Decreased count of a type of white blood cell that helps 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, hives, skin rash, and sometimes decreased blood pressure, anaphylactic reaction.

- Sugar in the urine.

- Inappropriate secretion of a hormone that controls urine volume.

- Complications of uncontrolled diabetes with a risk to life.

- Dangerously excessive water intake, decreased blood sugar, excessive water intake, increased blood cholesterol.

- Somnambulism.

- Lack of movement or response while awake (catatonia).

- Absence of emotions.

- Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle rigidity).

- Loss of consciousness, balance disorder, coordination abnormality.

- Problems in the blood vessels of the brain, coma due to uncontrolled diabetes, decreased response to stimuli, decreased level of consciousness, agitation.

- Glaucoma (increased pressure of the eyeball), increased tear production, eye redness, eye movement problems, 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 travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.

- Decreased oxygen in parts of the body (due to decreased blood flow), flushing.

- Respiratory problems during sleep (sleep apnea), rapid breathing, superficial breathing.

- Pneumonia 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 (ictericia).

- Inflammation of the pancreas.

- Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing.

- Thickening of the skin, dry skin, skin redness, skin discoloration, scaly skin with itching, caspa.

- Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal posture.

- Priapism (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.

- Symptoms of withdrawal from the medication.

Unknown: their frequency cannot be estimated from the available data:

- Respiratory congestion.

- Increased 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: sleep-related eating disorder, other types of blood vessel problems in the brain, crepitant sounds from the lungs, and severe or fatal skin rash with blisters and peeling of the skin that can start in the mouth, nose, eyes, and genitals and spread to other parts of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis). Other eye problems may also appear 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 attentive.

- Parkinsonism: This disease may 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 descending stairs, increased saliva and/or drooling, and loss of facial expression.

- Weight gain.

- Common cold symptoms.

- Incontinence (loss of bladder control), frequent urination, inability to urinate, painful urination.

- Euphoria (mania), irritability, depression, anxiety.

- Dystonia: A disease that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.

- Dizziness.

- Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.

- Tremor (agitation).

- Abdominal pain.

- Milk secretion from the breasts in girls.

- Swelling of the breasts in boys.

- Acne.

- Speech problems.

- Gastrointestinal infection or intestinal infection.

- Hemorrhages.

- Ear infection.

- High triglycerides in the blood (a type of fat).

- Sensation of movement (vertigo).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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 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 disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of paliperidone cinfa

• The active ingredient is paliperidone. Each prolonged-release paliperidone cinfa 3 mg tablet 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 tablet core, 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 contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible person for manufacturing

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2024

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

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

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