PALIPERIDONE ALTER 3 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Paliperidona Alter 3 mg prolonged-release tablets EFG

Paliperidona Alter 6 mg prolonged-release tablets EFG

Paliperidona Alter 9 mg prolonged-release tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Paliperidona Alter 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as hearing, seeing, or feeling things that do not exist, having false beliefs, having more than normal distrust, being withdrawn, speaking incoherently, and planning behavior and emotionality. 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 various symptoms of schizophrenia (listed in the previous paragraph) in addition to mood disorder symptoms (feelings of euphoria, sadness, agitation, distraction, insomnia, verbosity, loss of interest in daily activities, excessive or insufficient sleep, excessive or insufficient food intake, and recurring thoughts of suicide).

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

2. What you need to know before taking Paliperidona Alter

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, pharmacist, or nurse before starting to take paliperidona.

• Patient with schizoaffective disorder treated with this medication should be closely monitored for a possible change from manic symptoms to depressive symptoms.

Controlled by a possible change of 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 disease whose symptoms are elevated 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 know 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).

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 diseases that may make you more prone to a reduction 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 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 related to 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 while.

Because it has been rarely observed in patients treated with paliperidona 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 eye damage. 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.

Othermedicaments and paliperidona

Tell your doctor or pharmacist if you are using or have recently used other medications.

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 mainly 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 it.

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.

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 taking 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, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, you should contact your doctor.

You should not take this medication during breastfeeding.

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 Alter contains sodium

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

3. How to take Paliperidona Alter

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist, or nurse.

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 case of schizophrenia or 6 mg to 12 mg once daily in 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 in the same way every day. Do not alternate between taking the medication 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 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 drowsiness, fatigue, abnormal body movements, problems standing and walking, dizziness due to low 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 stop 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, pharmacist, 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:

• Presents 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
• Has dementia and presents a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or has difficulty speaking even for a short period. They can be signs of a stroke
• Presents fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). May need immediate medical treatment
• Is a man and presents a prolonged or painful erection. It is known as priapism. May need immediate medical treatment
• Presents involuntary rhythmic movements of the tongue, mouth, and face. May require withdrawal of paliperidone
• Presents 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 frequent: may affect more than 1 in 10 patients

• Difficulty staying or falling asleep
• Parkinsonism: This disease can include slow or altered movement, feeling of stiffness or muscle tension (making sudden 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.

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• Feeling drowsy or less attentive
• Headache

Frequent Adverse Effects: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, nose infection, urinary tract infection, feeling like having the flu
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: It is a disease 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 muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness
• Discinesia: This disease involves involuntary muscle movements and can include repetitive, spasmodic, or twisting movements, or spasms
• Tremors (agitation)
• Blurred vision
• Disruption 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 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
• Loss of menstrual periods
• Fever, weakness, fatigue (tiredness)

Infrequent 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

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

Discinesia tardía (involuntary spasmodic movements that cannot be controlled in 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. Withdrawal of paliperidone may be necessary

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, an enzyme that is sometimes released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain

Incontinence (loss of control) of urine, frequent urination, inability to pass urine, pain when urinating

• Sexual 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, an increase in body temperature
• Change in gait
• Sensation 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

Number of white blood cells in the blood dangerously low, 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, skin 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, decrease in blood sugar, excessive water intake, increase in cholesterol in the blood
• Sleepwalking
• Absence 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 eye pressure), 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 suffer from any of these symptoms, seek medical help immediately.
• Decrease in oxygen in parts of the body (due to decreased blood flow), flushing
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing
• Pneumonia caused by aspiration of food, congestion of the respiratory tract, voice disorder

Intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement that causes obstruction

• Yellow color 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
• Rupture of muscle fibers and muscle pain (rhabdomyolysis), anomaly in posture
• Priapism (a prolonged erection that may require surgical treatment)
• Development of breasts in men, breast enlargement, milk secretion from the breasts, vaginal secretion
• 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

• Lung congestion
• 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, and lung crackling sounds. 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 presented 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 can include slow or altered movement, feeling of stiffness or muscle tension (making sudden 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects that do not appear in this prospectus. 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 Alter

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

Do not use this medicine after the expiration date that appears on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Blister packs: Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, 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 Alter

The active ingredient is paliperidone.

Each 3 mg prolonged-release tablet of Paliperidona Alter contains 3 mg of paliperidone.

Each 6 mg prolonged-release tablet of Paliperidona Alter contains 6 mg of paliperidone.

Each 9 mg prolonged-release tablet of Paliperidona Alter contains 9 mg of paliperidone.

The other components are:

Core

Macrogol 200,000, macrogol 700,000, butylhydroxytoluene, povidone K30, sodium chloride, microcrystalline cellulose PH102, magnesium stearate, red iron oxide (E172).

Intermediate tablet coating

Hydroxypropylcellulose

Semi-permeable coating

Cellulose acetate, macrogol 4000 Ph.Eur

Coating

Hypromellose 6CP, titanium dioxide, talc, propylene glycol, red iron oxide (E172) (for the 9 mg dose), yellow iron oxide (for the 6 mg dose)

Printing ink

Shellac, black iron oxide (E172).

Appearance of the Product and Package Contents

The 3 mg prolonged-release tablets of Paliperidona Alter are round, biconvex tablets with a white to grayish color and a possible irregular surface, printed with the mark P3 on one side of the tablet.

The 6 mg prolonged-release tablets of Paliperidona Alter are round, biconvex tablets with a yellowish-brown color and a possible irregular surface, printed with the mark P6 on one side of the tablet.

The 9 mg prolonged-release tablets of Paliperidona Alter are round, biconvex tablets with a pink color and a possible irregular surface, printed with the mark P9 on one side of the tablet.

The tablets are provided in blister packs packaged in cartons of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Date of the Last Revision of this Prospectus:July 2018

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