INPALIX 9 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Inpalix 9 mg prolonged-release tablets EFG

paliperidone

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, 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 Inpalix and what is it used for
2. What you need to know before taking Inpalix
3. How to take Inpalix
4. Possible side effects
5. Storage of Inpalix
6. Package contents and additional information

1. What is Inpalix and what is it used for

Paliperidone contains the active substance paliperidone, which belongs to the class of antipsychotic medications.

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

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such as hearing, seeing, or feeling things that do not exist, having false beliefs, being abnormally suspicious, being withdrawn, having disorganized speech, and a flattening of behavior and emotions.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

Paliperidone is also used to treat schizoaffective disorder in adults.

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

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

2. What you need to know before taking Inpalix

Do not takepaliperidone

• if you are allergic to paliperidone, risperidone, 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 paliperidone.

• Patient with schizoaffective disorder treated with this medication should be closely monitored for a possible shift from manic to depressive symptoms.
• This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with similar medications may have an increased risk of stroke or death (see section 4, Possible side effects).
• if you have Parkinson's disease or dementia.
• if you have ever been diagnosed with a condition whose symptoms are high 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 can be caused by this type of medication.

• if you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• if you are diabetic or have a tendency to diabetes.
• if you have heart disease or are being treated for heart conditions that may make you more prone to a decrease in blood pressure.
• if you have epilepsy.
• if you have a swallowing disorder, stomach, or intestinal disorder that reduces your ability to swallow food or digest it with normal intestinal movements.
• if you have diseases associated with diarrhea.
• if you have kidney problems.
• if you have liver problems.
• if you have a prolonged and/or painful erection.
• if you have difficulty controlling your body temperature or are overheated.
• if you have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• if you or someone in your family has a history of blood clots, as antipsychotics are associated with the formation of blood clots.

If you have any of these diseases, please consult your doctor, as it may be necessary to adjust your dose or keep you under observation for a period of time.

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

Paliperidone 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 paliperidone, diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed. Your doctor should check for signs of high 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 center 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 taking this medication.

Children andadolescents

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

Paliperidone 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 paliperidone is safe or effective in this age group.

Othermedicines and paliperidone

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

Abnormalities in heart function may appear when taking this medication with other medications for heart rhythm control or other medications such as antihistamines, antimalarials, or antipsychotics.

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

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

This medication may reduce the effect of medications for Parkinson's disease and restless legs syndrome (e.g., levodopa).

The effects of this medication may be affected if you take medications that influence the speed of intestinal movement (e.g., metoclopramide).

A reduction in the dose of this medication should be considered when administered with valproate.

The use of oral risperidone with this medication is not recommended, as this combination may cause an increase in side effects.

Taking paliperidone withalcohol

You should avoid consuming alcohol during treatment with this medication.

Pregnancy andbreastfeeding

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 newborns of mothers who have been treated with paliperidone in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

You should not breastfeed your child while taking this medication.

Driving and usingmachines

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

Warnings about excipients

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

3. How to take Inpalix

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult 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 the 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 medication works for you.

Use inadolescents

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 paliperidone

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 morning 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, paliperidone, is dissolved once swallowed, and the tablet coating is eliminated from the body through the feces.

Patients 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 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 medication and the amount ingested. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and changes in heart rhythm.

If you forget to take paliperidone

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 taking paliperidone

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 your symptoms may return.

If you have any further 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:

• You have blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These can be signs of a stroke
• You have fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment
• You are a man and experience a prolonged or painful erection. It is known as priapism. You may need immediate medical treatment
• You experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw paliperidone
• You 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 staying or falling asleep
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tension in the muscles (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
• Restlessness
• Feeling drowsy or less alert/awake
• Headache

Common: 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 condition that involves slow or continuous involuntary contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw
• Dizziness
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• Tremors
• Blurred vision
• Interruption of conduction between the upper and lower parts of the heart, anomalies in the electrical conduction of the heart, prolongation of the QT interval in the heart, slow heartbeat, rapid heartbeat
• Decrease in blood pressure when standing up (as a consequence, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly), increased blood pressure
• Sore throat, cough, nasal congestion
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Increase in liver transaminases in the blood
• Itching, skin rash
• Bone or muscle pain, back pain, joint pain
• Loss of menstrual periods
• Fever, weakness, fatigue (tiredness)

Uncommon: 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
• Diabetes or worsening of diabetes, increased blood sugar, increased waist circumference, loss of appetite that causes malnutrition and weight loss, increased triglycerides in the blood (a type of fat)
• Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares
• Tardive dyskinesia (involuntary, uncontrollable movements of the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to withdraw paliperidone
• Seizures (epileptic fits), fainting, restlessness that causes movement of parts of the body, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased sensitivity of the skin to pain or touch, tingling, pinching, or numbness of the skin
• Hypersensitivity of the eyes to light, eye infection or "red eye", dry eyes
• Feeling that everything is spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, anomaly in the electrical activity of the heart (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations)
• Decrease in blood pressure
• Difficulty breathing, wheezing (whistling in the chest), nasal bleeding
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence

• Increase in GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increase in liver enzymes in blood
• Hives (or "urticaria"), hair loss, eczema, acne
• Increase in CPK (creatine phosphokinase) in blood, an enzyme that is sometimes released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence (loss of control), frequent urination, inability to pass urine, pain when urinating
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods or other problems with the cycle (women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort
• Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
• Chills, increased body temperature
• Change in gait
• Feeling of thirst
• Chest pain, chest discomfort, feeling of discomfort
• Falls

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

• Eye infection, fungal infection of the nails, skin infection, skin inflammation caused by mites
• Dangerously low number of a type of white blood cells in the blood necessary to fight infections
• Decrease in a type of white blood cells in the blood that help fight infections, increase in eosinophils (a type of white blood cell) in the blood
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, 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 potential
• Excessive water intake, decreased blood sugar, excessive water intake, increased 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 pressure in the eyeball), increased tearing, redness of the eyes, problems with eye movement, eye rotation
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat when standing up
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately
• Decrease in oxygen in parts of the body (due to decreased blood flow), flushing
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing
• Pneumonia caused by aspiration of food, congestion of the airways, voice disorder
• Intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement that causes obstruction
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing
• Thickening of the skin, dryness of the skin, redness of the skin, discoloration of the skin, scaly and itchy skin or scalp, dandruff
• Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (a prolonged erection that may require surgical treatment)
• Development of breasts in men, breast enlargement, milk secretion from the breasts, vaginal discharge
• Delayed menstrual periods, breast enlargement
• Very low body temperature, decreased body temperature
• Withdrawal symptoms from the medicine

Unknown: frequency cannot be estimated from the available data

• Lung congestion
• Increase in 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: eating disorders related to sleep, other types of problems with the blood vessels in the brain, and crackling sounds in the lungs. Eye problems may also appear during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

Additional adverse effects in adolescents

Adolescents generally experienced similar adverse effects to those found in adults, except for the following adverse effects that were detected more frequently:

• Feeling drowsy or less alert/awake
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tension in the muscles (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
• 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)
• Feeling 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Inpalix

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

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture.

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

Medicines should not be disposed of through wastewater or household waste. 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 Inpalix

• The active ingredient is paliperidone. Each prolonged-release tablet contains 9 mg of paliperidone.
• The other ingredients are:

• Core of the tablet: macrogol, butylhydroxytoluene (E321), povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, and red iron oxide (E172).

• Coated tablets (intermediate): hydroxypropylcellulose.
• Semipermeable coating: cellulose acetate and macrogol.
• Coating: hypromellose, titanium dioxide (E170), talc, propylene glycol, and red iron oxide.
• Printing ink: shellac, black iron oxide (E172), and propylene glycol.

Appearance of the product and package contents

Prolonged-release tablets, round, biconvex, pink, and marked with "P9" on one side.

They come in aluminum blister packs (oPA/Al/PVC)/aluminum, in packs of 28 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Date of the last revision of this leaflet: 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/