Paliperidone Teva-Ratiopharm 3 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Paliperidona Teva-ratiopharm 3 mg prolonged-release tablets EFG

Paliperidona Teva-ratiopharm 6 mg prolonged-release tablets EFG

Paliperidona Teva-ratiopharm 9 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. 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 pass it on to other people, even if they have the same symptoms as you, because it may 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 Teva-ratiopharm is and what it is used for
2. What you need to know before taking Paliperidona Teva-ratiopharm
3. How to take Paliperidona Teva-ratiopharm
4. Possible side effects
5. How to store Paliperidona Teva-ratiopharm
6. Contents of the pack and other information

1. What Paliperidone Teva-ratiopharm is and what it is used for

Paliperidone Teva-ratiopharm contains the active substance paliperidone, which belongs to the class of medications known as antipsychotics.

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

Schizophrenia is a disorder that causes symptoms including hearing, seeing, or feeling things that do not exist, having false beliefs, excessive distrust, social withdrawal, disorganized speech, and flattened behavior and emotional expression. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidone 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 previous paragraph) as well as mood disorder symptoms (feelings of euphoria, sadness, agitation, distractibility, insomnia, pressured speech, loss of interest in daily activities, excessive or insufficient sleep, excessive or reduced food intake, and recurrent thoughts of suicide).

Paliperidone may help relieve the symptoms of your illness and help prevent them from returning.

2. What you need to know before taking Paliperidona Teva-ratiopharm

Do not take paliperidone

• 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 paliperidone.

• 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 causing symptoms of 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 disorders may be caused by this type of medicine.
• if you have previously had low levels of white blood cells in your blood (whether or not this was 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 a swallowing disorder, or 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 a prolonged and/or painful erection.
• if you have difficulty regulating body temperature or are overheated.
• if you have abnormally high levels of prolactin hormone in your blood or if you 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 a dose adjustment or monitoring may be necessary.

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

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

Diabetes mellitus has been observed or pre-existing diabetes mellitus has worsened 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 clouding of the lens (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 flaccid 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 paliperidone

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

Abnormalities in the heart's 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 on 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 you should be cautious if taking it 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 paliperidone with alcohol

You should avoid drinking alcohol 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 taking this medicine.

Do not take this medicine during pregnancy unless you have discussed it with your doctor.

The following symptoms may occur in newborn babies whose mothers were treated with paliperidone during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

You must not breastfeed while taking this medicine.

Driving and using machines

During treatment with this medicine, 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 Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is considered "sodium-free".

3. How to take Paliperidone Teva-ratiopharm

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. 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 dosing range of 3 mg to 12 mg once daily for schizophrenia, or 6 mg to 12 mg once daily for 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 you should be given. The dose you receive depends on how well the medicine works for you.

How and when to take paliperidone

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

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

The active substance, paliperidone, 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 depending on your kidney function.

Elderly patients

Your doctor may reduce your medicine dose if you have reduced kidney function.

If you take more paliperidone 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. Telephone: 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 reduced blood pressure, and changes in heartbeat.

If you forget to take paliperidone

Do not take a double dose to make up for forgotten 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 paliperidone

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, pharmacist, or nurse.

4. Possible adverse effects

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

Tell 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 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 of time. These may be signs of a stroke
• you develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required
• you are a man and have 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 feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" in movement that later restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• restlessness
• feeling drowsy or less alert
• 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 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
• disruption in conduction between the upper and lower parts of the heart, abnormalities in the heart's electrical conduction, QT interval prolongation on the electrocardiogram, slow heartbeat, rapid heartbeat
• drop in blood pressure upon standing (as a result, some people taking paliperidone may feel weak, dizzy, or faint when standing 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
• absence 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, 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). When symptoms of elevated prolactin occur, they may include: (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk discharge 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 (involuntary spasms or 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 movement of body parts, 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
• eye sensitivity to light, 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
• shortness of breath, gasping, nosebleeds
• swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence
• increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• hives (or “urticaria”), hair loss, eczema, acne
• increased CPK (creatine phosphokinase) in blood, a muscle enzyme sometimes released during muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• urinary incontinence (loss of bladder control), frequent urination, inability to pass urine, painful urination
• erectile dysfunction, ejaculation disorder
• absence of menstrual periods or other cycle problems (women), milk discharge from the breasts, sexual dysfunction, breast pain, breast discomfort
• swelling of the face, mouth, eyes, or lips, body swelling, arms or legs swelling
• chills, increased body temperature
• change in walking pattern
• feeling of thirst
• chest pain, chest discomfort, feeling unwell
• falls

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

• eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• dangerously low count of a type of white blood cells needed to fight infections
• decreased count of a type of white blood cells that help 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, breathing difficulty, itching, skin rash, and sometimes drop in blood pressure, allergic reaction
• sugar in the urine
• inappropriate secretion of a hormone controlling urine volume
• life-threatening complications of uncontrolled diabetes
• dangerously excessive water intake, low 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 swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulty. If you experience any of these symptoms, seek medical help immediately.
• decreased oxygen supply to 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, airway congestion, voice disorder
• intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement leading to obstruction
• yellowing of the skin and eyes (jaundice)
• inflammation of the pancreas
• severe allergic reaction with swelling, which may affect the throat causing breathing difficulty
• thickening of the skin, dry skin, skin redness, skin discoloration, scaly and itchy scalp or skin, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
• priapism (a prolonged erection that may require surgical treatment)
• breast development in men, enlarged mammary glands, milk discharge from breasts, vaginal discharge
• 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: other types of brain blood vessel problems, crackling lung sounds, and severe or potentially life-threatening skin rash with blisters and skin peeling that may start in the mouth, nose, eyes, and genitals and around them 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 occurred more frequently:

• feeling drowsy or less alert
• parkinsonism: This condition may include slow or altered movement, a feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" in movement that later restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• weight gain
• symptoms of common cold
• restlessness
• tremor (agitation)
• stomach pain
• milk discharge 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 effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can 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 Teva-ratiopharm

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

Do not use this medicine after the expiry date which is stated on the carton and blister after CAD or EXP. The expiry date refers to 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 conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paliperidona Teva-ratiopharm

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

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; hypromellose, titanium dioxide (E171), talc and propylene glycol in the coating; and lacquer, black iron oxide (E172) and propylene glycol in the printing ink.

Appearance of the product and contents of the pack

3 mg: Round, biconvex, film-coated tablets, white to greyish white, with a possibly uneven surface, printed with the mark P3 on one side of the tablet. Diameter: approximately 9 mm.

6 mg: Round, biconvex, film-coated tablets, brownish yellow, with a possibly uneven surface, printed with the mark P6 on one side of the tablet. Diameter: approximately 9 mm.

9 mg: Round, biconvex, film-coated tablets, light pink, with a possibly uneven surface, printed with the mark P9 on one side of the tablet. Diameter: approximately 9 mm.

Paliperidona Teva-ratiopharm is available in packs containing:

10x1, 14x1, 28x1, 30x1, 56x1, 98x1, 112x1 or 196x1 prolonged-release tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

Haarlem 2031GA

The Netherlands

Manufacturer:

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501

Slovenia

Or

Teva Pharma, S.L.U.

C/ C, nº 4. Polígono Industrial Malpica

50016 Zaragoza

Spain

Or

Laboratoria Qualiphar NV (Qualiphar NV)

Rijksweg 9

2880 Bornem

Belgium

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B, 1st floor, Alcobendas,

28108 Madrid (Spain)

Date of the most recent revision of this leaflet: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://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 packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83112/P_83112.html

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