Leaflet: information for the user

Inpalix 6 mg prolonged-release tablets EFG

paliperidone

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

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

1. What Inpalix is and for what it is used

2. What you need to know before starting to take Inpalix

3. How to take Inpalix

4. Possible side effects

5. Storage of Inpalix

6. Contents of the pack and additional information

Paliperidone 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include hearing, seeing or feeling things thatdonotexist, holding false beliefs, having an abnormal distrust, becoming withdrawn, speaking incoherently and flattening of behavior and emotion. People with this disorder may also feel depressed, anxious, guilty ortense.

Paliperidone is also used to treat schizoaffective disorder inadultos.

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, verbosity, loss of interest in daily activities, excessive or inadequate sleep, excessive or inadequate food intake, and recurring thoughts ofsuicidio).

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

Do not takepaliperidone

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

Warnings andprecautions

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

• Patients with schizoaffective disorder treated with this medicine should be closely monitored for a potential change from manic symptoms to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other medicines may have an increased risk of stroke or death (see section 4, Possible Adverse Effects).
• if you have Parkinson's disease orDemencia.
• 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 ofmedicamentos.
• if you have had low levels of white blood cells in the past (which may or may not have been caused by othermedicamentos)
• if you are diabetic or have a tendency todiabetes.
• if you have any heart disease or if you are receiving treatment for heart diseases that may make you more prone to a reduction in bloodarterial.
• if you haveepilepsia.
• if you have any swallowing disorder, stomach disorder, or intestinal disorder that reduces your ability to swallow food or digest it with normal intestinalmovements.
• if you have diseases associated withdiarrea.
• if you have problems withriñón.
• if you have problems withhígado.
• if you have a prolonged erection and/ordolorosa.
• if you have difficulty controlling your body temperature or areacalorado.
• if you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent onprolactina.
• if you or a family member has a history of blood clots, as antipsychotics are associated with the formation ofcoágulos.

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.

Due to the fact that 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 whiteblancas.

Paliperidone may cause you to gain weight. Significant weight gain can have a negative impact on your health. Your doctor will regularly monitor yourpeso.

In patients treated with paliperidone, diabetes mellitus or worsening of pre-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 cataract surgery, 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 damage to the eye.Siyou are planning to have eye surgery, please inform your ophthalmologist that you are taking thismedicine.

Children andadolescents

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

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

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

Othermedicines and paliperidone

Please inform your doctor or pharmacist if you are using or have recently usedother medicamentos.

Abnormalities in heart function may occur when this medicine is taken with other medicines for heart rhythm control or other medicines such as antihistamines, antimalarials, orantipsicóticos.

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

This medicine may reduce blood pressure, so you should be careful if you take this medicine with other medicines that alsoreducebloodpressure.

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

The effects of this medicine may be affected if you take medicines that influence the speed of intestinalmovements(e.g.,metoclopramida).

Reduction of this medicine dose should be considered when administered withvalproato.

The use of oral risperidone with this medicine is not recommended as this combination may cause an increase in adverseeffects.

Paliperidone withalcohol

You should avoid consuming alcohol during treatment with thismedicine.

Pregnancy andlactation

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

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

The following symptoms may occur in newborn babies, from mothers who have been treated with paliperidone in the last trimester of pregnancy (last three months of your pregnancy):temblor,rigidez and/or weakness, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, please contact yourmédico.

You should not breastfeed your child while taking this medicine.

Driving and use ofmachinery

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

Warnings about excipients

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

Follow exactly the administration instructions of this medication as indicated by yourmedico. In case of doubt, consult your doctor,pharmaceuticoroenfermero.

Use inadults

The recommended dose in adults is 6 mg once a day in the morning. Your doctormaybeadjustingthedosedowithinthedosageof3mgto12mgonceadayincaseofschizophreniao6mgto12mgonceadayincaseofschizoafectivedependingonhowwellitworksforyyourselforhospitalpatient.

Use inadolescents

The initial recommended 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 range of 6 mg to12mg 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 wellthemedicationworksforyyourselforhospitalpatient.

How and when to take paliperidone

This medication should be taken by mouth, swallowed whole with water or other liquids. Do notmasticate, break, orbreakd.

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 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 thehealthys.

Patients with kidney problems

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

Renal impairment

Your doctor may reduce your medication dose if your kidney function isreduced.

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,sleepinessiancansing, abnormalmovements, problemsforpermancingtostandorwalking, mareaoduetotothereductionoftheheartlatitdes.

If you forget 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 questions 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 notice 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 trouble speaking even for a short period of time. These may be signs of a heart attack.
• You develop 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, skin rash, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction).

Very common: may affect more than 1 in 10 people

• Difficulty staying or remaining asleep
• Parkinsonism: This condition may 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 the feet, tremors 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

• Chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, feeling like you have a lump in your throat
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: A condition that involves involuntary slow or continuous muscle contraction. 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
• Discinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• Tremor
• Blurred vision
• Abnormal heart rhythm, anomalies in heart electrical conduction, prolonged QT interval in the heart, irregular heartbeat, rapid heartbeat
• Decreased blood pressure when standing (as a result, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting suddenly), increased blood pressure
• Sore throat, cough, congestion
• Abdominal pain, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, 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
• Pelvic inflammatory disease
• Decreased white blood cell count, decreased platelet count (a type of blood cell that helps stop bleeding), anemia, decreased red blood cell count

• Paliperidone may increase 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 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 circumference of the waist, loss of appetite causing malnutrition and weight loss, increased triglycerides in the blood (a type of fat)
• Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, anxiety
• Discinesia tardía (involuntary spasms or movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. You may need to discontinue treatment.
• Seizures (epileptic crises), fainting, restlessness causing movement of parts of the body, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of pins and needles, numbness, or tingling of the skin
• Increased sensitivity of the eyes to light, eye infection, or "red eye," dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, anomaly in heart electrical activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure
• Difficulty breathing, wheezing (whistling sounds in the chest), bleeding
• Swollen tongue, stomach or intestinal infection, difficulty swallowing, excessive gas or flatulence
• Increased GGT (a liver enzyme called gamma-glutamiltransferase) in the blood, increased liver enzymes in the blood
• Hives (urticaria), hair loss, eczema
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that sometimes is released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, muscle pain
• Urinary incontinence, frequent urination, inability to urinate, painful urination
• Erectile dysfunction, sexual dysfunction
• Loss of menstrual periods or other menstrual cycle problems (women), milk secretion by the breasts, breast discomfort, breast pain
• Swollen face, mouth, eyes, or lips, swollen body, arms, or legs
• Chills, low body temperature
• Changes in behavior
• Sensation of sedation
• Chest pain, chest discomfort, sensation of malaise
• Falls

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 they are also expected to appear with paliperidone: sleep-related eating disorder, other types of cerebrovascular problems, and lung crackles.

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 in adolescents:

Feeling drowsy or less alert

Parkinsonism: This condition may 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 the feet, tremors while descending stairs, increased saliva and/or drooling, and loss of facial expression.

Weight gain

Common cold symptoms

Insomnia

Tremor

Abdominal pain

Milk secretion by the breasts in girls

Swollen breasts in boys

Eczema

Speech problems

Stomach or intestinal infection

Bleeding

Ear infection

High triglycerides in the blood (a type of fat)

Sensation of movement (vertigo)

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if the side effects do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 drop-off 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 6 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 yellow iron oxide (E172).
• Printing ink: shellac, black iron oxide (E172), and propylene glycol.

Appearance of the product and content of the container

Prolonged-release tablets, round, biconvex, yellowish-brown in color, and marked with “P6” on one face.

Presented in aluminum blisters (oPA/Al/PVC)/aluminum, in containers 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/