Do not takepaliperidone

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

Warnings andprecautions

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

• Patients with schizoaffective disorder treated with this medication should be closely monitored for a change in 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 characterized by elevated body 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 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 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 decrease in blood pressure.
• if you have epilepsy.
• if you have any swallowing, stomach, or intestinal disorders 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 be necessary to adjust your dose or monitor you for a period of time.

Because very rarely, patients treated with paliperidone have been observed to have 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.

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 existing diabetes mellitus has been observed. Your doctor should check for signs of increased blood sugar.Inpatients 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 dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage.Since you are planning to have eye surgery, be sure to inform your ophthalmologist that you 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 the safety and efficacy of paliperidone in this age group are unknown.

Othermedicines and paliperidone

Inform your doctor or pharmacist if you are using or have recently usedother medicaments.

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 onbrainfunction.

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

This medication may reduce the effect of medications for Parkinson's disease and restless leg 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 thiscombinationmayprovokeanincreasedeffectsadverses.

Paliperidone and alcohol

You should avoid consuming alcohol during treatment with thismedicine.

Pregnancy andlactation

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

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 paliperidone in the last trimester of pregnancy (last three months of pregnancy):templor,rigidenessand/ordebility,somnolence,agitation,predicatin,and/ordifficultyinfeding.Ifyyorbabydevelopdevenanyofthesesymptoms,pleasecontactyyordoctor.

You should not breastfeed your baby while taking this medication.

Driving anduse ofmachinery

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

Warnings about excipients

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

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

Use inadults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or reduce 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 inadolescents and children

The recommended starting dose for the treatment of schizophrenia in adolescents from 15 years of age 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 by mouth, swallowed whole with water or other liquids. Do not chew, break or crush it.

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

The active ingredient, paliperidone, dissolves once swallowed, and the coating of the tablet is eliminated from the body by the kidneys.

Patients with kidney problems

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

Patients with liver problems

Your doctor may reduce your medication dose if your liver function is reduced.

Overdose

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, confusion, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure and cardiac arrhythmias.

Missed dose

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.

Discontinuation of 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 recur.

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, although not everyone gets them.

Inform your doctor immediately if you experience any of the following:

• You develop blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.
• You experience dementia and a sudden change in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or you have difficulty speaking even for a short period of time. These may be signs of a heart attack.
• You experience fever, muscle stiffness, sweating, or a decrease in your level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.
• You experience involuntary rhythmic movements of your tongue, mouth, and face. You may need to discontinue treatment.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, and sometimes a decrease in blood pressure (known as anaphylaxis).

Very common: may affect more than 1 in 10 people.

• Difficulty staying or remaining asleep.
• Parkinsonism: This condition can include slow or altered movement, a feeling of stiffness or tension in the muscles (causing jerky movements) and sometimes a feeling of "freezing" of movement that later resumes. Other signs of parkinsonism include walking slowly dragging your feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.
• Insomnia.
• Feeling drowsy or less alert.
• Headache.

Common: may affect up to 1 in 10 people.

• You experience a chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, or feel like you have a lump in your throat.
• A weight gain, increased appetite, weight loss, decreased appetite, euforia (mania), irritability, depression, anxiety.
• Dystonia: This condition involves involuntary slow or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.
• Dizziness.
• You experience involuntary movements of the muscles, known as dyskinesia. This condition can include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor.
• Blurred vision.
• You experience irregular heartbeats, anomalies in heart conduction, prolonged QT interval in the heart, rapid heartbeat, or palpitations.
• You experience a decrease in blood pressure when standing (as a result, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing or sitting suddenly), increased blood pressure.
• Sore throat, cough, congestion.
• You experience abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, or headache.
• Increased liver enzymes in the blood.
• Itching, skin rash.
• Muscle or bone pain, back pain, joint pain.
• Loss of menstrual periods.
• Fever, weakness, fatigue.

Rare: may affect up to 1 in 1,000 people.

• Eye infection, fungal infection of the nails, skin infection, inflammation of the skin caused by bacteria.
• You experience a dangerously low number of a type of white blood cell necessary for fighting infections.
• You experience a decrease in a type of white blood cell that helps fight infections, an increase in eosinophils (a type of white blood cell) in the blood.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, and sometimes a decrease in blood pressure (known as anaphylaxis).
• High blood sugar.
• Incorrect secretion of a hormone that controls urine volume.
• Complications of uncontrolled diabetes with a risk to life.
• You experience excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood.
• Sonambulism.
• Loss of emotions.
• You experience a severe form of Neuroleptic Malignant Syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness).
• Loss of consciousness, balance, coordination disorder.
• You experience problems with blood vessels in the brain, coma due to uncontrolled diabetes, decreased response to stimuli, decreased level of consciousness, tremors of the face.
• Glaucoma (increased pressure in the eyeball), increased tear production, redness of the eyes, problems with eye movement, eye rotation.
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat when standing.
• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.
• Decreased oxygen in parts of the body (due to decreased blood flow), flushing.
• Respiratory problems during sleep (sleep apnea), rapid breathing, superficial breathing.
• Chest congestion, voice disorder.
• Obstruction of the intestine, fecal incontinence, hard stools, absence of intestinal movement causing obstruction.
• Yellow skin and eyes (ictericia).
• Inflammation of the pancreas.
• You experience a severe allergic reaction with swelling, which can affect the throat, causing difficulty breathing.
• Thickening of the skin, dry skin, redness of the skin, skin or scalp discoloration, scaly skin with itching.
• Muscle fiber rupture and muscle pain (rhabdomyolysis), anomaly in the posture.
• Priapism (a prolonged erection that may require surgical treatment).
• Development of breasts in men, increased breast tissue, milk secretion by the breasts, vaginal secretion.
• Delayed menstrual periods, increased breast tissue.
• Low body temperature, decreased body temperature.
• Withdrawal symptoms from the medication.

Unknown: their frequency cannot be estimated from the available data.

Congestion of the lungs.

Increased insulin (a hormone that controls blood sugar levels) in the blood.

The following side effects have appeared with the use of another medication 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 blood vessel problems in the brain, and crepitant sounds from the lungs. Other 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 medication.

Additional side effects in adolescents.

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

Feeling drowsy or less alert.

Parkinsonism: This condition can include slow or altered movement, a feeling of stiffness or tension in the muscles (causing jerky movements) and sometimes a feeling of "freezing" of movement that later resumes. Other signs of parkinsonism include walking slowly dragging your feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.

Weight gain.

Common cold symptoms.

Insomnia.

Tremor.

Headache.

Leakage of milk from the breasts in girls.

Swelling of the breasts in boys.

Acne.

Speech problems.

Stomach or intestinal infection.

Nosebleeds.

Ear infection.

High triglycerides in the blood (a type of fat).

Sensation of movement (vertigo).

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

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

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

Medications should not be disposed of through drains or in the trash.Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Inpalix

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

• Tablet core: macrogol, butylhydroxytoluene (E321), povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, and red iron oxide (E172).

• Polymer-coated tablets (intermediate): hydroxypropylcellulose.
• Permeable 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 contents of the packaging

Prolonged-release tablets, round, biconvex, pink in color, and marked with “P9” on one face.

Presented in aluminum blisters (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

Responsible for manufacturing

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Last review date of this leaflet: July 2018.

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