PALIPERIDONE TAD 9 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Paliperidona TAD3 mg prolonged-release tablets EFG

Paliperidona TAD6 mg prolonged-release tablets EFG

Paliperidona TAD9 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Paliperidona contains the active substance paliperidona, which belongs to the class of antipsychotic medications.

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

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such as hearing, seeing, or feeling things that do not exist, having false beliefs, being abnormally suspicious, being withdrawn, having disorganized speech, and a flattening of behavior and emotions.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

Paliperidona is also used to treat schizoaffective disorder in adults.

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

Paliperidona can help alleviate the symptoms of your illness and prevent them from recurring.

2. Before taking Paliperidona TAD

Do not takepaliperidona

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

Warnings andprecautions

Consult your doctor or pharmacist before starting to take paliperidona.

• Patient with schizoaffective disorder treated with this medication should be closely monitored for a possible shift from manic 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 be aware 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 conditions that may make you more prone to a decrease in blood pressure.
• if you have epilepsy.
• if you have a swallowing disorder, stomach, 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 it has been observed in very rare cases in patients treated with paliperidona that there is a dangerously low number of a type of white blood cells necessary to fight infections in the blood, your doctor may check the number of white blood cells.

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, and your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

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

Children andadolescentes

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

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Anomalies in heart function may appear 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 it, due to the sum of effects 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 the speed of intestinal movement (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 cause an increase in side effects.

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

Taking paliperidona withalcohol

You should avoid consuming alcohol during treatment with this medication.

Pregnancy andlactation

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, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

You should not breastfeed while taking this medication.

Driving and usingmachines

During treatment with this medication, dizziness and vision problems may occur (see section 4, possible side effects). This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Paliperidona TAD contains sodium

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

3. How to take Paliperidona TAD

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use inadults

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

Use inadolescentes

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

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 mornings with breakfast or on an empty stomach, but each day in the same way. 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.

Patient with kidney problems

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

Elderly patients

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

If you take more paliperidona than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested. You may experience somnolence, fatigue, abnormal body movements, problems standing and walking, dizziness due to decreased blood pressure, and cardiac arrhythmias.

If you forget to take paliperidona

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 interrupt treatment with paliperidona

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

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

4. Possible Adverse Effects

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

Report immediately to your doctorif:

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

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

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

Common adverse effects: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, 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: It is a condition 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 facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremors (agitation)
• Blurred vision
• Interruption 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 up 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 adverse effects: 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 in the blood.
• Paliperidone may increase the levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include: (in men) breast swelling, difficulty having or maintaining erections or other sexual dysfunctions, (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods or other problems with the cycle.
• Diabetes or worsening of diabetes, increased sugar in the blood, 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.
• Tardive dyskinesia (involuntary, uncontrollable spasms or 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. It may be necessary to withdraw paliperidone.
• Seizures (epileptic fits), fainting, restlessness that causes movement of parts of the body, dizziness when standing up, attention disturbance, speech problems, loss or alteration of taste, decreased sensitivity of the skin to pain or touch, sensation of tingling, pinching, or numbness of the skin.
• Hypersensitivity of the eyes to light, eye infection or "red eye", dry eyes.
• Sensation that everything is spinning (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.
• Difficulty breathing, wheezing (whistling in the chest), nasal bleeding.
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence.
• Increase in GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increase in liver enzymes in blood.
• Hives (or "urticaria"), hair loss, eczema, acne.
• Increase in CPK (creatine phosphokinase) in blood, an enzyme that is sometimes released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain.
• Urinary incontinence (loss of control), frequent urination, inability to pass urine, pain when urinating.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstrual periods or other problems with the cycle (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 gait.
• Feeling of thirst.
• Chest pain, chest discomfort, feeling of discomfort.
• Falls.

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

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

• Dangerously low number of a type of white blood cells in the blood necessary to fight infections.
• Decrease in a type of white blood cells in the blood that help fight infections, 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, 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 risks.
• Excessive water intake, decreased sugar in the blood, excessive water intake, increased cholesterol in the blood.
• Sleepwalking.
• Not moving or not responding while being awake (catatonia).
• Lack of emotions.
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness).
• Loss of consciousness, balance disorder, abnormal coordination.
• Problems in the blood vessels of the brain, coma due to uncontrolled diabetes, unresponsive to stimuli, decreased level of consciousness, head tremors.
• Glaucoma (increased pressure in 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 circulate through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
• Decrease in oxygen in parts of the body (due to decreased blood flow), flushing.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pneumonia caused by aspiration of food, congestion of the airways, voice disorder.
• Intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement that causes obstruction.
• Yellowing of the skin and eyes (jaundice).
• Pancreatitis.
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing.
• Thickening of the skin, dryness of the skin, redness of the skin, discoloration of the skin, scaly and itchy skin or scalp, dandruff.
• Breakdown 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 discharge.
• Delayed menstrual periods, breast enlargement.
• Very low body temperature, decreased body temperature.
• Withdrawal symptoms from the medicine.

Unknown frequency: cannot be estimated from available data

• Congestion of the lungs.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.

The following adverse effects have appeared with the use of another medicine called risperidone, which is very similar to paliperidone, so it is also expected to appear with paliperidone: sleep-related eating disorder, other types of cerebrovascular problems, crackling sounds in the lungs, and severe or fatal rash with blisters and peeling of the skin 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 medicine.

Additional adverse effects in adolescents

Adolescents generally experienced 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 may include slow or altered movement, feeling of stiffness or muscle tension (making jerky movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors while resting, increased saliva and/or drooling, and loss of facial expressiveness.
• Weight gain.
• Common cold symptoms.
• Restlessness.
• Tremors (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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Paliperidona TAD

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

Do not use this medicine 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.

This medicine does not require any special storage temperature.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paliperidona TAD

• The active ingredient is paliperidone.
• Each prolonged-release tablet contains 3 mg, 6 mg, or 9 mg of paliperidone.

• The other components are:

Core: macrogol 200,000, macrogol 7,000,000, macrogol 4000, hydroxybutyltoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose, and cellulose acetate.

Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) - only for 6 mg tablets, and red iron oxide (E172) - only for 9 mg tablets.

Printed ink: shellac, black iron oxide (E172), and propylene glycol. See section 2 "Paliperidona TAD contains sodium".

Appearance of the product and package contents

3 mg: Film-coated tablets, biconvex, round, white to grayish-white in color with a possible irregular surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9 mm.

6 mg: Film-coated tablets, biconvex, round, yellowish-brown in color with a possible irregular surface and printed with the mark P6 on one side of the tablet. Diameter: approximately 9 mm.

9 mg: Film-coated tablets, biconvex, round, light pink in color with a possible irregular surface and printed with the mark P9 on one side of the tablet. Diameter: approximately 9 mm.

Paliperidona TAD is available in packages of 14x1, 28x1, and 56x1 prolonged-release tablets in unit-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA d.d. Novo mesto

Smarjeska cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 2024

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