Paliperidone CINFA 3 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

paliperidona cinfa 3 mg prolonged-release tablets EFG

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What paliperidona cinfa is and what it is used for
2. What you need to know before taking paliperidona cinfa
3. How to take paliperidona cinfa
4. Possible side effects
5. How to store paliperidona cinfa
6. Contents of the pack and other information

1. What paliperidona cinfa is and what it is used for

Paliperidona contains the active substance paliperidona, which belongs to the class of medicines known as antipsychotics.

Paliperidona is used to treat schizophrenia in adults and adolescents from the age of 15 years.

Schizophrenia is a disorder that causes symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive distrust, withdrawal into oneself, disorganized speech, and blunted behavior and emotional expression. 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 in which a person experiences several of the symptoms of schizophrenia (listed in the paragraph above) as well as mood disorder symptoms (feelings of euphoria or sadness, agitation, distractibility, insomnia, pressured speech, loss of interest in daily activities, excessive or reduced sleep, excessive or reduced food intake, and recurrent thoughts of suicide).

Paliperidona can help relieve the symptoms of your illness and prevent them from returning.

2. What you need to know before taking paliperidona cinfa

Do not take paliperidona cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before taking paliperidona cinfa

• Patients with schizoaffective disorder treated with this medicine should be closely monitored for possible changes from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other 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 characterized by high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
• If you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).

You should be aware that these two disorders may be caused by this type of medicine.

• If you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• If you have diabetes or are prone to diabetes.
• If you have heart disease or are being treated for heart conditions that may make you more susceptible to low blood pressure.
• If you have epilepsy.
• If you have any swallowing, stomach, or intestinal disorder that reduces your ability to swallow food or digest it with normal intestinal movements.
• If you have conditions associated with diarrhea.
• If you have kidney problems.
• If you have liver problems.
• If you experience prolonged and/or painful erection.
• If you have difficulty controlling your body temperature or feel overheated.
• If you have abnormally high levels of the hormone prolactin in your blood or have a tumor that may be prolactin-dependent.
• If you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, please consult your doctor, as dose adjustment or monitoring may be necessary.

Because, very rarely, patients treated with paliperidone have developed a dangerously low number of a type of white blood cells needed to fight infections, your doctor may check your white blood cell count.

Paliperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients treated with paliperidone. Your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as required. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

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

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

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

Other medicines and paliperidona cinfa

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

Abnormalities in heart electrical function may occur when this medicine is taken together with other medicines used to control heart rhythm or other medicines such as antihistamines, antimalarials, or antipsychotics.

Since this medicine acts mainly in the brain, it may interact with other medicines (or alcohol) that also act on the brain, due to additive effects on brain function.

This medicine may lower blood pressure, so caution is needed if you take it together with other medicines that also lower blood pressure.

This medicine may reduce the effect of medicines used for Parkinson’s disease and restless legs syndrome (e.g., levodopa).

The effects of this medicine may be altered if you take medicines that affect intestinal motility (e.g., metoclopramide).

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

The use of oral risperidone together with this medicine is not recommended, as this combination may lead to an increase in adverse effects.

Paliperidone should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Taking paliperidona cinfa with alcohol

You should avoid alcohol consumption during treatment with this medicine.

Pregnancy and breastfeeding

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

Do not take this medicine during pregnancy unless discussed with your doctor. The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.

Do not take this medicine during breastfeeding.

Driving and using machines

Paliperidone may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Paliperidona cinfa contains sodium

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

3. How to take paliperidona cinfa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Use in adults

The recommended dose for adults is 6 mg once daily in the morning. Your doctor may increase or decrease your dose 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 medicine 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 taken in the morning.

For adolescents weighing 51 kg or more, the dose may be increased within the range of 6 mg to 12 mg once daily.

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

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

How and when to take paliperidona cinfa

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

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

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

Patients with kidney problems

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

Elderly patients

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

If you take more paliperidona cinfa than you should

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

If you forget to take paliperidona cinfa

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

If you stop taking paliperidona cinfa

Do not stop taking this medicine, as you will lose the medicine's effects. You should not stop taking this medicine unless instructed by your doctor, as symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if:

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through 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 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 time. These may be signs of a stroke.
• You develop a high fever, muscle stiffness, sweating, or a decreased level of consciousness (a condition known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• You experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• You have 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 common: may affect more than 1 in 10 patients

• Difficulty falling or staying asleep
• Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of “freezing” of movement that then restarts. Other signs of parkinsonism include shuffling while walking slowly, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Restlessness
• Feeling drowsy or less alert
• Headache

Common: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, nasal infection, urinary tract infection, feeling as if you have the flu
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: A condition involving involuntary, slow or continuous muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia often affects facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• Dizziness
• Dyskinesia: A condition involving involuntary muscle movements, which may include repetitive, spasmodic or twisting movements or spasms.
• Tremor (agitation)
• Blurred vision
• Impaired conduction between upper and lower parts of the heart, abnormalities in the heart’s electrical conduction, QT interval prolongation in the heart, slow heartbeat, rapid heartbeat
• Decreased blood pressure upon standing (as a result, some people taking paliperidona may feel weak, dizzy or lose consciousness when standing 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
• Absence of menstrual periods
• Fever, weakness, fatigue (tiredness)

Uncommon: may affect up to 1 in 100 patients

• Pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells
• Paliperidone may increase levels of a hormone called “prolactin” detectable in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin may include: (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other menstrual cycle problems
• Diabetes or worsening of diabetes, increased blood sugar, increased waist circumference, loss of appetite leading to malnutrition and decreased body weight, increased blood triglycerides (a type of fat)
• Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares
• Tardive dyskinesia (spasms or uncontrollable spasmodic movements of the face, tongue or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• Seizures (epileptic fits), fainting, restlessness causing body movements, dizziness upon standing, attention disturbances, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling or numbness of the skin
• Light sensitivity of the eyes, eye infection or “red eye,” dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, abnormal electrical activity of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure
• Labored breathing, gasping, nosebleeds
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence
• Increased GGT (a liver enzyme called gamma-glutamyl transferase) in blood, increased liver enzymes in blood
• Hives (or “urticaria”), hair loss, eczema, acne
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence (loss of control), frequent urination, inability to pass urine, pain during urination
• Erectile dysfunction, ejaculation disorder
• Absence of menstrual periods or other cycle problems (in women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort
• Swelling of the face, mouth, eyes or lips, body swelling, arms or legs
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst
• Chest pain, chest discomfort, feeling unwell
• Falls

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

• Eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• Dangerously low levels of a type of white blood cells needed to fight infections
• Decreased levels of a type of white blood cell that helps fight infections, increased eosinophils (a type of white blood cell) in 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 urine
• Inappropriate secretion of a hormone controlling urine volume
• Life-threatening complications of uncontrolled diabetes
• Dangerously excessive water intake, decreased blood sugar, excessive water intake, increased blood cholesterol
• Sleepwalking
• 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 disorder, abnormal coordination
• Problems in brain blood vessels, coma due to uncontrolled diabetes, unresponsiveness to stimuli, decreased level of consciousness, head agitation
• Glaucoma (increased pressure in the eyeball), increased tearing, eye redness, eye movement problems, eye rolling
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat upon standing
• Blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If you experience any of these symptoms, seek immediate medical help.
• Decreased oxygen in parts of the body (due to reduced blood flow), flushing
• Breathing problems during sleep (sleep apnea), rapid shallow breathing
• Pneumonia caused by aspiration of food, respiratory congestion, voice disorder
• Intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement leading to obstruction
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis (inflammation of the pancreas)
• Severe allergic reaction with swelling, which may affect the throat causing breathing difficulties
• Skin thickening, dry skin, red skin, skin discoloration, scaly and itchy skin or scalp, dandruff
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), postural abnormalities
• Priapism (a prolonged erection that may require surgical treatment)
• Breast development in males, enlarged mammary glands, milk secretion from the breasts, vaginal secretion
• Delayed menstrual periods, breast enlargement
• Very low body temperature, decreased body temperature
• Medication withdrawal symptoms

Not known: frequency cannot be estimated from available data

• Lung congestion
• Increased insulin (a hormone that controls blood sugar levels) in blood

The following adverse effects have been reported with the use of another medicine called risperidone, which is very similar to paliperidone, and therefore may also be expected with paliperidone: sleep-related eating disorder, other types of brain blood vessel problems, crackling lung sounds, and severe or life-threatening skin rash with blisters and peeling skin that may start inside and around the mouth, nose, eyes and genitals and spread to other body areas (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis). Eye problems may also occur during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you need 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 adverse effects similar to those seen in adults, except for the following effects, which were more frequently observed:

• Feeling drowsy or less alert
• Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of “freezing” of movement that then restarts. Other signs of parkinsonism include shuffling while walking slowly, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Weight gain
• Symptoms of common cold
• Restlessness
• Tremor (agitation)
• Stomach pain
• Milk secretion from the breasts in girls
• Breast swelling in boys
• Acne
• Speech problems
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High blood triglycerides (a type of fat)
• Sensation of movement (vertigo)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of paliperidone cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of paliperidona cinfa

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

Appearance of the product and contents of the pack

White to off-white film-coated tablets, round, biconvex, possibly with an uneven surface, marked with "P3" on one side. Approximate diameter 9 mm.

• Paliperidona cinfa is available in packs 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 single-dose perforated blisters marked with the days of the week (calendar pack).

Only certain pack sizes may be 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 most recent revision of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/85826/P_85826.html

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