Leaflet: Information for the user

paliperidone cinfa 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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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,incoherent speech and flattening of behavior and emotions. 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, verbosity,lossof interest in daily activities, excessive or insufficient sleep, excessive or insufficient food intake,recurrentthoughts ofsuicidedio).

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 medicine (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 medicine should be closely monitored for any change in 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 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 fever 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 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 develop diabetes.
• If you have any heart disease or if you are receiving treatment for heart diseases that may make you more prone to a drop 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/or 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 related to blood clot formation.

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 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, 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 old for the treatment of schizophrenia.

Paliperidone should not be administered to children and adolescents under 18 years old 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 cinfa

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 heart rhythm control 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 lower blood pressure, so you should 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 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 this medicine is administered with valproate.

The use of oral risperidone with this medicine is not recommended 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 (psychoestimulants such as methylphenidate).

Paliperidone cinfa and alcohol

You should avoid consuming alcohol during treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using 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 three months of pregnancy (last trimester of pregnancy): 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 medicine 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 disease, 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 medicine.

Paliperidone cinfa contains sodium

This medicine 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 your doctor.médico. In case of doubt, consult your doctor or pharmacist again.

Use inadults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or reduce 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 inadolescentsandchildren

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 cinfa

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

This medication should be taken in the mornings with breakfast or on an empty stomach, but in the same way every day. 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 intestines.

Patients with kidney problems

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

Patients of advanced age

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

If you take more paliperidone cinfa 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, confusion, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and alterations in heartbeats.

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 the next dose the next day. If you forget two or more doses, contact your doctor.

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 doubts 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 medical treatment.

- 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 later 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.

- Inquietude.

- Feeling drowsy or less attentive.

- Headache.

Common: may affect up to 1 in 10 patients:

- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat.

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

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

- Dystonia: This disease involves involuntary slow or continuous contraction of the muscles. 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.

- Involuntary movements of the muscles.

- 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).

- Increased GGT (a liver enzyme called gamma-glutamiltransferase) 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, muscle rigidity, joint swelling, muscle weakness, muscle pain.

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

- Erectile dysfunction, sexual dysfunction.

- Menstrual irregularities or other problems with the cycle (women), milk secretion by the breasts, sexual dysfunction, breast pain, breast tenderness.

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

- Chills, high body temperature.

- Change in the way you walk.

- Feeling sedated.

- Chest pain, chest discomfort, feeling of malaise.

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 number of a type of white blood cell necessary for infections.

- Decreased number 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 a decrease in blood pressure (i.e., anaphylactic reaction).

- Sugar in the urine.

- Inappropriate secretion of a hormone that controls urine volume.

- Complications of uncontrolled diabetes with a risk to life.

- Excessively excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood.

- Somnambulism.

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

- Absence of emotions.

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

- Loss of consciousness, balance, coordination abnormalities.

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

- Glaucoma (increased pressure of the eyeball), increased tearing, redness of the eyes, 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 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, congestion of the respiratory tract, 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, redness of the skin, skin or scalp scaly and itchy, eczema.

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

- Priapism (a prolonged erection that may require surgical treatment).

- Development of breasts in men, increased breast tissue, milk secretion by the breasts, vaginal secretion.

- Delayed menstrual periods, increased breast tissue.

- Very low body temperature, decreased body temperature.

- Symptoms of withdrawal from the medication.

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

- Congestion of the lungs.

- 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: eating disorder related to sleep, other types of problems with blood vessels in the brain, crepitant sounds of the lungs, and severe or fatal skin rash with blisters and peeling of the skin that can start in the inside and around 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 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 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 later 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.

- Symptoms of a common cold.

- Inquietude.

- Trembling (agitation).

- Stomach pain.

- Milk secretion by the breasts in girls.

- Swelling of the breasts in boys.

- Acne.

- Speech problems.

- Stomach infection or intestinal infection.

- Hemorrhages.

- Ear infection.

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

- Feeling 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 prospectus. You can also report them directly through the Spanish System for the 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 package

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

Only some package 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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