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

Use in adults

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 children

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 by mouth, swallowed whole with water or other liquids. Do not chew, break, or crush.

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 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. Telephone: 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 alterations in heartbeats.

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 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 experience any of these symptoms, seek medical advice.

- Dementia and a sudden change in your mental state or sudden weakness or numbness in 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 attack.

- Fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.

- Men who experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.

- Uncontrollable, rhythmic movements of the tongue, mouth, and face. You may need to stop taking this medicine.

- 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 (known as anaphylaxis).

Very common: may affect more than 1 in 10 people

- Difficulty staying or falling 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 then 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.

- Inquietude

- Feeling drowsy or less alert

- Headache

Common: may affect up to 1 in 10 people

- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a urinary tract infection

- Weight gain, increased appetite, weight loss, decreased appetite

- Euphoria (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 most commonly affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.

- Dizziness

- Involuntary movements of the muscles (discinesia)

- Tremors

- Blurred vision

- Abnormal heart rhythms, including irregular heartbeats, abnormal heart conduction, prolonged QT interval, rapid heartbeat, and decreased blood pressure when standing up (resulting in some people feeling weakness, dizziness, or loss of consciousness when standing or sitting suddenly), increased blood pressure

- Sore throat, cough, congestion

- Abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, headache

- Elevated liver enzymes (transaminases) in the blood

- Itching, skin rash

- Muscle or bone pain, back pain, joint pain

- Loss of menstrual periods

- Fever, weakness, fatigue (cansaço)

Uncommon: may affect up to 1 in 100 people

- Pneumonia, respiratory tract infection, urinary tract infection, ear infection, vaginitis

- 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, loss of menstrual periods, or other menstrual cycle problems.

- Diabetes or worsening of diabetes, increased blood sugar, increased circumference of the waist, weight loss, decreased appetite causing malnutrition and weight loss, increased triglycerides in the blood (a type of fat)

- Sleep disorder, confusion, decreased libido, inability to achieve orgasm, nervousness, anxiety

- Tardive dyskinesia (involuntary, uncontrollable movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary movements of the tongue, mouth, or face. You may need to stop taking this medicine.

- 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 sensitivity of the skin 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, abnormal heart activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)

- Decreased blood pressure

- Difficulty breathing, wheezing (silbidos in the chest), bleeding

- Swelling of the 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, acne

- Increased CPK (creatine phosphokinase) in the blood, an enzyme that sometimes leaks from muscle breakdown, muscle spasms, muscle rigidity, 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, sexual dysfunction, breast pain, breast discomfort

- Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs

- Chills, high body temperature

- Change in the way you walk

- Sensation of sedation

- Chest pain, chest discomfort, sensation of malaise

- Falls

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

• Infection of the eyes, fungal infection of the nails, skin infection, skin inflammation caused by bacteria
• Low white blood cell count, a type of white blood cell necessary for combating infections
• Decreased white blood cell count that helps combat infections, increased 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, hives, skin rash, and sometimes decreased blood pressure, anaphylactic reaction
• High blood sugar in the urine
• Incorrect secretion of a hormone that controls urine volume
• Complications of uncontrolled diabetes with a risk to life
• Excessive water intake, low blood sugar, excessive water intake, increased cholesterol in the blood
• Sonambulism
• Loss of emotions
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and muscle rigidity)
• Loss of consciousness, balance, and coordination disorders
• Problems with blood vessels in the brain, coma due to uncontrolled diabetes, response to stimuli, decreased level of consciousness, tremors of the face
• Glaucoma (increased pressure of the eyeball), increased tear production, redness of the eyes, eye movement problems, 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 travel through the blood vessels to the 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
• Pneumonia caused by aspiration of food, respiratory tract congestion, voice disorder
• Intestinal obstruction, fecal incontinence, hard stools, absence of intestinal movement causing obstruction
• Yellow skin and eyes (ictericia)
• Inflammation of the pancreas
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing
• Thickening of the skin, dry skin, redness of the skin, skin discoloration, scaly skin with itching, caspa
• Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (prolonged erection that may require surgical treatment)
• Development of breasts in men, increased breast tissue, milk secretion, vaginal secretion
• Delayed menstrual periods, increased breast size
• 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: sleep-related eating disorder, other types of vascular problems in the brain, and crepitant sounds from the lungs. Other 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 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 then 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

- Inquietude

- Tremors

- Abdominal pain

- Milk secretion in girls

- Swelling of the breasts in boys

- Acne

- Speech problems

- Stomach or intestinal infection

- Hemorrhages

- 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 prospectus. You can also report them directly through the Spanish System for 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 trash.Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Inpalix

• The active ingredient is paliperidone. Each prolonged-release tablet contains 3 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, and propylene glycol.
• Printing ink: shellac, black iron oxide (E172), and propylene glycol.

Appearance of the product and contents of the packaging

Prolonged-release tablets, round, biconvex, white to light gray in color, and marked with “P3” 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/