Package Insert: Information for the Patient

Paliperidone Teva 3 mg Extended-Release Tablets EFG

Paliperidone Teva 6 mg Extended-Release Tablets EFG

Paliperidone Teva 9 mg Extended-Release Tablets EFG

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Paliperidone Teva contains the active ingredient paliperidone which belongs to the class ofmedicamentosantipsicóticos.

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

Schizophrenia is a disorder that causes symptoms that include hearing, seeing or feeling things thatdonotexist, holding false beliefs, having an abnormal distrust, withdrawing into oneself,speaking incoherently and flattening of behavior and emotion. People with this disorder may also feeldepressed,anxious,guiltyoranxious.

Paliperidone is also used to treat schizoaffective disorder in adults.

Schizoaffective disorder is a mental condition in which the person experiences several of the symptoms of schizophrenia (listed in the previous paragraph) in addition to symptoms of mood disorder (feeling of euphoria, sadness, agitation, being distracted, insomnia, excessive or reduced speech, loss of interest in daily activities, excessive or reduced sleep, excessive or reduced food intake, and recurring thoughts ofsuicidio).

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

Do not takepaliperidone

-if you are allergic to paliperidone, risperidone, or any of the other ingredients in thismedicine(listed in section6).

Warnings andprecautions

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

• Patients with schizoaffective disorder treated with this medication should be closely monitored for a potential change from manic symptoms to depressive symptoms.
• This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with similar medications, may have an increased risk of stroke or death (see section 4, Possible side effects)
• if you have Parkinson's disease or dementia.
• if you have ever been diagnosed with a condition whose symptoms are high temperature and muscle rigidity (also known as neuroleptic malignant syndrome).
• if you have ever experienced abnormal movements of the tongue or face (tardive dyskinesia). You should know that these two conditions may be caused by this type of medication.
• if you have had low white blood cell counts in the past (which may or may not have been caused by other medications)
• if you are diabetic or have a tendency to develop diabetes.
• if you have any heart disease or 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 disorders of swallowing, stomach, or intestines that reduce your ability to swallow food or digest it normally.
• if you have diseases associated with diarrhea.
• if you have kidney problems.
• if you have liver problems.
• if you have a prolonged and painful erection.
• if you have difficulty controlling your body temperature or are overheated.
• if you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• if you or a family member has a history of blood clots, as antipsychotics are related to blood clot formation.

If you have any of these conditions, please consult your doctor as it may benecesaryto adjust your dose or keep you under observation for atime.

Because, in very rare cases, a dangerously low number of a type of white blood cells necessary to fight infections in the blood has been observed in patients treated with paliperidone, your doctor may check the number of white blood cells.

Paliperidone may cause you to gain weight. A significant weight gain canafectarnegatively on your health. Your doctor will regularly monitor yourweight.

In patients treated with paliperidone, diabetes mellitus or worsening of 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 cataract surgery, the pupil (the small 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 thatyou are taking thismedicine.

Children andadolescents

Paliperidone should not be administered to children and adolescents under 15 years of age for the treatment ofschizophrenia.

Paliperidone should not be administered to children and adolescents under 18 years of age for the treatment ofschizoaffectivedisorder.

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

Othermedicines and paliperidone

Inform your doctor or pharmacist if you are using, have used recently, or may take othermedicaments.

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

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

This medication may lower blood pressure, so you should be careful if you take this medication with other medications that also lowerbloodpressure.

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.,metoclopramida).

Consider reducing the dose of this medication when it is administered withvalproato.

It is not recommended to use oral risperidone with this medication as thiscombinationmayincreaseanindersideeffects.

Paliperidone should be used with caution with medications that increase the activity of the central nervous system (psycho-stimulants such as metilphenidato).

Paliperidone and alcohol

You should avoid consuming alcohol during treatment with thismedicine.

Pregnancy andlactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking thismedicine.

You should not take this medication during pregnancy unless you have discussed it with yourmédico.

The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone in the last trimester of pregnancy (last three months of pregnancy):templor,rigidenessand/ormuscularweaknesssomnolencesstresspirestonalbreathingdifficultytobreathe. If your baby develops any of these symptoms, you should contact yourmédico.

You should not breastfeed your baby while taking this medication.

Driving and use ofmachinery

During treatment with this medication, dizziness and vision problems (see section 4, Possible side effects) may occur. This should be taken into account when requiring high attention, for example, when driving or operatingmachinery.

Paliperidone Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which may be considered as “sodium-free”.

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

Use in adultsaduls

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

Use in adolescents and childrencents

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

This medication should be taken orally, swallowed whole with water or other liquids. Do not chew, divide, or crush it.

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 than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested. You may experience drowsiness, dizziness, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and cardiac rhythm alterations.

If you forgot to take paliperidone

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

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, pharmacist, or nurse.

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 adviceimmediately.

•dementia and a sudden change in mental state or sudden weaknessornumbness of the face, arms, or legs, especially on one side, or difficulty speaking even for a short period of time. These may be signs of a heart attackcerbral

•fever, muscle stiffness, sweating, or a decrease in level ofconsciousness(a condition known as “Neuroleptic Malignant Syndrome”). You may needtreatmentomedical

•men and experience a prolonged or painful erection. This is known as priapism.You may need medical treatmentimmediately.

•involuntary rhythmic movements of the tongue, mouth, and face. You may need toretirepaliperidona

•severe allergic reaction characterized by fever, swelling of the mouth, face,lipsorlenguadificultad respiratoria, picores, erupción cutánea, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction).

Very common (may affect more than 1 in 10pacients)

• difficulty staying or remainingdormint
• parkinsonism: This disease may include slow or altered movement, sensation ofrigidityortirantenessof the muscles (making sudden movements) and sometimes a sensation of “freezing” of the movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, tremor whiledescansa,aumentofsalivaand/orbabearingandlossofexpressivityoftheface
• inquietud
• feeling drowsy or lessatent
• abdominal pain

Common side effects (may affect up to 1 in 10pacients)

• chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, feeling as if you havegripe
• weight gain, increased appetite, weight loss, decreasedapetite
• euphoria (mania), irritability, depression,ansiedad
• dystonia: This disease involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia most commonly affects the facial muscles, includingabnormalmovementsoftheeyes,mouth,lenguaormandibulary
• dizziness
• discinesia: This disease involves involuntary muscle movements and mayincludemovementsrepetitive,spasmodic,orespasms
• tremor(agitación)
• blurred vision
• interrupted conduction between the upper and lower parts of the heart, anomalies in heart electrical conduction, prolonged QT interval in the heart, heart rate, rapid heart rate of thecorazón
• decrease in blood pressure when standing (as a result, some people who take paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting suddenly), increase in bloodarterial
• throat pain, cough, nasal congestion
• abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• increase in liver transaminases in thesangre
• itching, skin rash
• bone or muscle pain, back pain, joint pain
• loss of menstrual periods
• fever, weakness, fatigue(cansancio)

Uncommon side effects (may affect up to 1 in 100pacients)

• lung infection, respiratory tract infection, urinary tract infection, ear infection, angina
• decrease in white blood cells, decrease in platelets(células

• of the blood that help stop bleeding), anemia, decrease in red blood cells in thesangre
• Paliperidone may increase levels of a hormone called “prolactin” that is detected inlosanalysofblood(whichmayornotcausesymptoms). When symptoms of increased prolactin appear, they may include: (in men) breast swelling, difficulty getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, milk secretion by the breasts, loss of menstrual periods, or other menstrual cycle problems
• diabetes or worsening of diabetes, increased blood sugar, increased perimeter of thecinturaaumented,lossofapetitethatcausesmalnutritionanddisminutedweight
• sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness,pesadillas
• late discinesia (spasms or involuntary movements that cannot be controlled in theface,lenguaorothereartsofthebody. Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. You may need toretirepaliperidona
• seizures (epileptic crises), fainting, restlessness that causes movement ofpartsofthebody,dizzineswhenstandingup,alterationoftheheart,problemswithoustandingup,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,disminutedlevelopmentary,dism5. Conservation of Paliperidone Teva

  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 and blister after CAD or EXP. The expiration date is the last day of the month indicated.

  Store in the original packaging to protect it from moisture.

  This medication does not require special temperature conditions for its conservation.

  Medicines should not be disposed of through drains or trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

  6. Contents of the packaging and additional information

  Composition of Paliperidone Teva

  • The active ingredient is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg or 9 mg of paliperidone.
  • The other components are macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate,iron oxide red (E172), hydroxypropylcellulose and cellulose acetate in the tablet core and hypromellose, titanium dioxide (E171), talc and propylene glycol in the coating and lacquer, iron oxide black (E172) and propylene glycol in the printing ink.

  Appearance of the product and contents of the package

  3 mg: Prolonged-release tablets, round, biconvex, white to off-white, with possible uneven surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9mm.

  6 mg: Prolonged-release tablets, round, biconvex, yellowish-brown, with possible uneven surface and printed with the mark P6 on one side of the tablet. Diameter: approximately 9mm.

  9 mg: Prolonged-release tablets, round, biconvex, pale pink, with possible uneven surface and printed with the mark P9 on one side of the tablet. Diameter: approximately 9mm.

  Paliperidone Teva is available in boxes containing:

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

  Not all package sizes may be marketed.

  Holder of the marketing authorization and manufacturer responsible

  Holder of the marketing authorization:

  Teva B.V.

  Swensweg 5

  Haarlem 2031GA

  Netherlands

  Manufacturer responsible:

  KRKA, d.d., Novo mesto

  Šmarješka cesta 6

  8501

  Slovenia

  O

  Laboratoria Qualiphar NV (Qualiphar NV)

  Rijksweg 9

  2880 Bornem

  Belgium

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

  Teva Pharma, S.L.U.

  c/ Anabel Segura 11, Edificio Albatros B, 1ª planta, Alcobendas,

  28108 Madrid (Spain)

  Last review date of thisleaflet:November 2024

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

  Composition of Paliperidone Teva

  • The active ingredient is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg or 9 mg of paliperidone.
  • The other components are macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate,iron oxide red (E172), hydroxypropylcellulose and cellulose acetate in the tablet core and hypromellose, titanium dioxide (E171), talc and propylene glycol in the coating and lacquer, iron oxide black (E172) and propylene glycol in the printing ink. See section 2. “Paliperidone Teva contains sodium”.

  Appearance of the product and contents of the package

  3 mg: Prolonged-release tablets, round, biconvex, white to off-white, with possible uneven surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9mm.

  6 mg: Prolonged-release tablets, round, biconvex, yellowish-brown, with possible uneven surface and printed with the mark P6 on one side of the tablet. Diameter: approximately 9mm.

  9 mg: Prolonged-release tablets, round, biconvex, pale pink, with possible uneven surface and printed with the mark P9 on one side of the tablet. Diameter: approximately 9mm.

  Paliperidone Teva is available in boxes containing:

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

  Not all package sizes may be marketed.

  Holder of the marketing authorization and manufacturer responsible

  Holder of the marketing authorization:

  Teva B.V.

  Swensweg 5

  Haarlem 2031GA

  Netherlands

  Manufacturer responsible:

  KRKA, d.d., Novo mesto

  Šmarješka cesta 6

  8501

  Slovenia

  Ó

  Teva Pharma, S.L.U.

  C/ C, nº 4. Polígono Industrial Malpica

  50016 Zaragoza

  Spain

  O

  Laboratoria Qualiphar NV (Qualiphar NV)

  Rijksweg 9

  2880 Bornem

  Belgium

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

  Teva Pharma, S.L.U.

  c/ Anabel Segura 11, Edificio Albatros B, 1ª planta, Alcobendas,

  28108 Madrid (Spain)

  Last review date of thisleaflet:May 2019

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