Prospect: Information for the User

INVEGA 3 mg prolonged-release tablets

INVEGA 6 mg prolonged-release tablets

INVEGA 9 mg prolonged-release tablets

INVEGA 12 mg prolonged-release tablets

Paliperidone

Read this prospect carefully before starting to take the medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1. What INVEGA is and for what it is used

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

3. How to take INVEGA

4. Possible adverse effects

5. Storage of INVEGA

6. Contents of the pack and additional information

INVEGA contains the active ingredient paliperidone, which belongs to the class of antipsychotic medications.

INVEGA is used to treat schizophrenia in adults and adolescents 15 years of age and older.

Schizophrenia is a disorder that causes symptoms that include hearing, seeing, or feeling things that do not exist, holding false beliefs, having an abnormal distrust, becoming withdrawn, speaking incoherently, and flattening of behavior and emotions. People with this disorder may also feel depressed, anxious, guilty, or tense.

INVEGA is also used to treat schizoaffective disorder in adults.

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

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

Do not take INVEGA

-if you are allergic to paliperidone, risperidone, or any of the other components of this medication (listed in section 6)

Warnings and precautions

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

• Patients with schizoaffective disorder treated with this medication should be closely monitored for any change in manic symptoms to depressive symptoms.
• This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia 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 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 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 are receiving treatment for heart conditions 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 keep you under observation for a period of time.

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

INVEGA 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 INVEGA, diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed. 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 dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, be sure to inform your ophthalmologist that you are taking this medication.

Children and adolescents

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

INVEGA 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 INVEGA is safe or effective in this age group.

INVEGA with other medications

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

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, or antipsychotics.

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 on brain function.

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

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., metoclopramide).

Reduction of this medication dose should be considered when this medication is administered with valproate.

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

INVEGA with alcohol

You should avoid consuming alcohol during treatment with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 paliperidone in the last three months of pregnancy (last trimester of pregnancy): tremor, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

You should not take this medication during breastfeeding.

Driving and operating machinery

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

The 3 mg INVEGA tablet contains lactose

The 3 mg tablet of this medication contains lactose, a type of sugar. If your doctor has told you that you are intolerant to some sugars, speak with them before taking this medication.

INVEGA contains sodium

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

Follow exactly the administration instructions for this medication as indicated by 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 the case of schizophrenia or 6 mg to 12 mg once a day in the case of schizoaffective disorder. This depends on how well the medication works for you.

Use in adolescents

The recommended starting dose for the treatment of schizophrenia in adolescents 15 years of age or older is 3 mg once a day taken in the morning.

For adolescents weighing 51 kg or more, the dose may be increased within the interval of 6 mg to 12 mg once a day.

For adolescents weighing less than 51 kg, the dose may 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 INVEGA

This medication should be taken by mouth, 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 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 through the feces.

Patients with kidney problems

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

Seniors

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

If you take more INVEGA than you should

Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and alterations in heartbeats.

If you forgot to take INVEGA

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 treatment with INVEGA

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 symptoms may recur.

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 will experience them.

Inform your doctor immediately if:

• You experience 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 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 it's difficult for you to speak even for a short period of time. These may be signs of a stroke
• You experience fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment
• You experience involuntary rhythmic movements of the tongue, mouth, and face. You may need to have paliperidone withdrawn
• 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 patients

• Difficulty staying or falling asleep
• Parkinsonism: This disease may include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, trembling while resting, increased saliva and/or drooling, and loss of facial expression.
• Restlessness
• Feeling drowsy or less attentive
• Headache

Common side effects:may affect up to 1 in 10 patients

• Chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, feeling like having the flu
• Weight gain, increased appetite, weight loss, decreased appetite, euphoria (mania), irritability, depression, anxiety
• Dystonia: A disease 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 jaw.
• Dizziness
• Discinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• Tremor (agitation)
• Blurred vision
• Abnormal heart rhythm, heart conduction anomalies, prolonged QT interval in the heart, slow heart rate, rapid heart rate
• Decreased blood pressure when standing (as a result, some people who take INVEGA may feel weakness, dizziness, or loss of consciousness when standing 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 enzymes in the blood
• Itching, skin rash
• Muscle or bone pain, back pain, joint pain
• Loss of menstrual periods
• Fever, weakness, fatigue (tiredness).

Rare side effects: may affect up to 1 in 100 patients

• Pneumonia, respiratory tract infection, urinary tract infection, ear infection, tonsillitis
• Decreased white blood cell count, decreased platelet count (a type of blood cell that helps stop bleeding), anemia, decreased red blood cell count
• INVEGA may increase levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When prolactin symptoms appear, they may include: (in men) breast swelling, difficulty having 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 waist circumference, loss of appetite leading to malnutrition and weight loss, increased triglycerides in the blood (a type of fat)
• Sleep disorder, confusion, decreased sex drive, inability to achieve orgasm, nervousness, nightmares
• 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 have INVEGA withdrawn.
• Seizures (epileptic crises), fainting, an abnormal restlessness that causes 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, feeling of pins and needles, or numbness of the skin
• Light sensitivity of the eyes, eye infection, or "red eye," dry eyes
• Feeling of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, abnormal heart activity (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure
• Labored breathing, gasping, nasal 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
• Rashes (or "urticaria"), hair loss, eczema, acne
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence, frequent urination, inability to urinate, painful urination
• Sexual dysfunction, ejaculation disorder
• Loss of menstrual periods or other menstrual cycle problems (women), milk secretion, sexual dysfunction, breast pain, breast discomfort
• Swollen face, mouth, eyes, or lips, swollen body, arms, or legs
• Chills, increased body temperature
• Change in gait
• Feeling thirsty
• Chest pain, chest discomfort, feeling unwell
• Falls.

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

• Infection of the eyes, fungal infection of the nails, skin infection, skin inflammation caused by mites
• Pelviclymphopenia (a dangerously low count of a type of white blood cell necessary for fighting infections)
• Decreased count of a type of white blood cell that helps fight 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, allergic reaction
• Glucose in the urine
• Incorrect secretion of a hormone that controls urine volume
• Life-threatening complications of uncontrolled diabetes
• Excessive water intake, decreased blood sugar, excessive water intake, increased blood cholesterol
• Somnambulism
• Apathy
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle stiffness)
• Loss of consciousness, balance disorder, abnormal coordination
• Brain vessel problems, coma due to uncontrolled diabetes, no response to stimuli, decreased level of consciousness, head agitation
• Glaucoma (increased pressure in the eyeball), increased tear production, eye redness, eye movement problems, eye rotation
• Atrial fibrillation (abnormal heart rhythm), rapid heart rate 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 immediately.
• Decreased 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, respiratory tract congestion, voice disorder
• Intestinal obstruction, fecal incontinence, hard stools, absence of intestinal movement causing obstruction
• Yellow skin and eyes (jaundice)
• Pancreatitis
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing
• Thickening of the skin, dry skin, skin redness, skin discoloration, scaly skin with itching, dandruff
• 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 tissue
• Very low body temperature, decreased body temperature
• Withdrawal symptoms from the medication.

Unknown: their frequency cannot be estimated from available data

• Pulmonary congestion
• 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 INVEGA: eating disorder related to sleep, other types of brain vessel problems, and crepitant lung sounds. 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 INVEGA. 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 attentive

•Parkinsonism: This disease may include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, trembling while resting, increased saliva and/or drooling, and loss of facial expression.

• Weight gain

• Common cold symptoms

• Restlessness

• Tremor (agitation)

• Abdominal pain

• Milk secretion by the breasts in girls

• Swollen breasts in boys

• Acne

• Speech problems

• Stomach or intestinal infection

• Nasal bleeding

• Ear infection

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

• Feeling of spinning (vertigo).

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.Mby 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.

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

Bottles: Do not store at a temperature above 30°C. Keep the bottle perfectly closed to protect it from humidity.

Blister packs: Do not store at a temperature above 30°C. Store in the original packaging to protect it from humidity.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of INVEGA

The active ingredient is paliperidone.

Each prolonged-release tablet of 3 mg of INVEGA contains 3 mg of paliperidone.

Each prolonged-release tablet of 6 mg of INVEGA contains 6 mg of paliperidone.

Each prolonged-release tablet of 9 mg of INVEGA contains 9 mg of paliperidone.

Each prolonged-release tablet of 12 mg of INVEGA contains 12 mg of paliperidone.

The other components are:

Tablet core:

Polysorbate 80

Sodium chloride Povidone (K29-32)

Stearic acid

BHT (E321)

Iron oxide (Yellow) (E172) (only in 3 and 12 mg tablets)

Polysorbate 80

Iron oxide (Red) (E172)

Hydroxyethyl cellulose

Poloxamer 3350

Cellulose acetate

Iron oxide (Black) (E172) (only in 9 mg tablets)

Colored coating: Hypromellose

Titanium dioxide (E171)

Poloxamer 400 (only in 6, 9 and 12 mg tablets)

Iron oxide (Yellow) (E172) (only in 6 and 12 mg tablets)

Iron oxide (Red) (E172) (only in 6 and 9 mg tablets)

Lactose monohydrate (only in 3 mg tablets)

Triacetin (only in 3 mg tablets)

Carnauba wax

Printing ink:

Iron oxide (Black) (E172) Propylene glycol

Hypromellose

Appearance of the product and contents of the pack

INVEGA prolonged-release tablets are capsule-shaped. The 3 mg tablets are white and engraved with “PAL 3”, the 6 mg tablets are beige and engraved with “PAL 6”, the 9 mg tablets are pink and engraved with “PAL 9”, the 12 mg tablets are dark yellow and engraved with “PAL12”. All tablets are available in the following pack sizes:

Only some pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen-Cilag SpA Via C. Janssen

04100 Borgo San Michele

Latina

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency

http://www.ema.europa.eu