Package leaflet: Information for the user

INVEGA 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets, 12 mg prolonged-release tablets

Paliperidone
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What INVEGA is and what it is used for
What you need to know before taking INVEGA
How to take INVEGA
Possible side effects
How to store INVEGA
Contents of the pack and other information

1. What INVEGA is and what it is used for

INVEGA contains the active substance paliperidone, which belongs to the class of antipsychotic medicines.
INVEGA is used for the treatment of schizophrenia in adults and adolescents from the age of 15 years.
Schizophrenia is a disorder whose symptoms include hearing sounds or voices, seeing or perceiving things that are not present, having false beliefs or being unusually suspicious, tendency to withdraw, disorganized speech, and behavioral and emotional flattening. 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 a person experiences a combination of schizophrenia symptoms (as described above) together with mood-related symptoms (such as excitement, sadness, agitation, distractibility, drowsiness, talkativeness, loss of interest in daily activities, sleeping too much or too little, eating too much or too little, and recurrent suicidal thoughts).
INVEGA can help relieve the symptoms of the illness and prevent their recurrence.

2. What you should know before taking INVEGA

Do not take INVEGA

if you are allergic to paliperidone, risperidone, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking INVEGA. Patients with schizoaffective disorder treated with this medicine should be closely monitored for a potential shift from manic to depressive symptoms.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other similar types of medicines may be at 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 include increased 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 both of these conditions may be caused by this type of drug.
If you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
If you have diabetes or are predisposed to diabetes.
If you have heart disease or are taking medication for heart disease that tends to lower your blood pressure.
If you have epilepsy.
If you have swallowing difficulties, or stomach or intestinal disorders that reduce your ability to swallow or move food normally through the intestines.
If you have conditions associated with diarrhea.
If you have kidney problems.
If you have liver problems.
If you experience prolonged and/or painful erection.
If you have difficulty regulating your internal body temperature or are exposed to excessive heat.
If you have abnormally high levels of the hormone prolactin in your blood or if you may have a prolactin-dependent tumour.
If you or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines have been associated with blood clot formation.

If you have any of these conditions, consult your doctor so they can assess whether
dose adjustment or monitoring over a period of time is necessary.
Since a dangerously low count of a certain type of white blood cells needed to fight infections in the
blood has been observed very rarely in patients taking INVEGA, your doctor may check your white blood cell count.
INVEGA may cause weight gain. Significant weight gain can negatively affect health. Your doctor should regularly monitor your body weight.
Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking INVEGA, your doctor should check for high blood sugar levels. Blood glucose levels should be regularly monitored in patients with pre-existing diabetes mellitus.
During cataract surgery (clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could cause eye damage. If you are planning eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.
Children and adolescents
INVEGA must not be used in children and adolescents under 15 years of age for the treatment of
schizophrenia.
INVEGA must not be used in children and adolescents under 18 years of age for the
treatment of schizoaffective disorder.
This is because it is not known whether INVEGA is safe or effective in these age groups.
Other medicines and INVEGA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
When this medicine is taken together with certain heart medications that regulate heart rhythm or other medicines such as antihistamines, antimalarials, or other antipsychotics, abnormalities in the heart's electrical function may occur.
Since this medicine acts primarily on the brain, interactions may occur with other medicines (or alcohol) that act on the brain, due to additive effects on brain function.
Since this medicine may lower blood pressure, be cautious when taking it together with other medicines that also lower blood pressure.
This medicine may reduce the effect of medicines used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa).
The effects of this medicine may be altered if you are taking medicines that affect the speed of intestinal movement (e.g., metoclopramide).
Consider a dose reduction of this medicine when it is administered concomitantly with valproate.
Concomitant use of oral risperidone with this medicine is not recommended, as combining these two medicines could lead to increased side effects.
INVEGA should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
INVEGA and alcohol
Avoid consuming alcohol while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy unless you have discussed it with your doctor. The following symptoms may occur in newborns of mothers who have used paliperidone during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Avoid breastfeeding while taking this medicine.
Driving and using machines
While being treated with this medicine, dizziness and vision problems may occur (see section 4, Possible side effects). This should be taken into account when full alertness is required, for example when driving a car or operating machinery.
The 3 mg INVEGA tablets contain lactose
The 3 mg tablets of this medicine contain lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
INVEGA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take INVEGA

Take this medicine exactly as instructed by your doctor, pharmacist, or nurse.
Use in adults
The recommended dose for adults is 6 mg once daily, taken in the morning. Your doctor may increase or decrease your dose within the range of 3 mg to 12 mg once daily for schizophrenia, or from 6 mg to 12 mg once daily for schizoaffective disorder. This depends on how the medicine works for you.
Use in adolescents
The recommended initial dose for treatment of schizophrenia in adolescents aged 15 years and older is 3 mg once daily, taken in the morning.
For adolescents weighing 51 kg or more, the dose may be increased within the range of 6 mg to 12 mg once daily.
For adolescents weighing less than 51 kg, the dose may be increased up to 6 mg once daily.
Your doctor will determine the appropriate dose for you. The dose you take depends on how the medicine works for you.
How and when to take INVEGA
This medicine must be taken orally; the tablet should be swallowed whole with water or other liquid. It must not be chewed, divided, or crushed.
This medicine should be taken every morning with breakfast or on an empty stomach, but always in the same way each day. Do not alternate taking the medicine one day on an empty stomach and the next day with food.
The active ingredient, paliperidone, dissolves after swallowing, while the tablet shell is eliminated from the body as waste.
Patients with kidney problems
Based on your kidney function, your doctor may adjust the dose of this medicine.
Elderly patients
Your doctor may reduce the dose of this medicine if you have reduced kidney function.
If you take more INVEGA than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty maintaining an upright posture and walking, dizziness due to low blood pressure, and abnormal heartbeats.
If you forget to take INVEGA
Do not take a double dose to make up for the missed dose. If you miss one tablet, take the next dose the following day. If you miss two or more doses, contact your doctor.
If you stop taking INVEGA
Do not stop taking INVEGA, as you will lose the medicine's beneficial effects. You should not discontinue treatment unless instructed by your doctor, because symptoms may return.
If you have any further questions about how to take this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:

You think you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
You have dementia and notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes incomprehensible, even for a short time. These may be signs of a stroke.
You have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
You are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be required.
You experience involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to discontinue paliperidone.
You experience a severe allergic reaction, characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (corresponding to an “anaphylactic reaction”).

Very common: may affect more than 1 in 10 users

Difficulty falling asleep or staying asleep
Parkinsonism. This condition may include: slow or impaired body movements, feeling of muscle stiffness or tension (causing jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow walking with shuffling of the feet, resting tremor, increased saliva and/or drooling, and loss of facial expression
Restlessness
Drowsiness or reduced alertness
Headache

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

Chest infection (bronchitis), symptoms of common cold, sinusitis, urinary tract infection, feeling as if you have the flu
Weight gain, increased appetite, weight loss, decreased appetite
Elevated mood (mania), irritability, depression, anxiety
Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves facial muscles, including abnormal movements of the eyes, mouth, tongue or jaw.
Dizziness
Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, spastic or writhing movements or spasms.
Tremor
Blurred vision
Interruption of cardiac conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation of the heart, slow heart rate, fast heart rate
Low blood pressure when standing up (as a result, some patients taking INVEGA may feel faint, dizzy or may faint when standing up or sitting down suddenly), high blood pressure
Sore throat, cough, stuffy nose
Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache
Increased liver transaminases in the blood
Itching, skin rash
Bone or muscle pain, back pain, joint pain
Loss of menstrual cycle
Fever, weakness, fatigue

Uncommon side effects: may affect up to 1 in 100 users

Pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
Decreased white blood cell count, decreased platelets (blood cells that help stop bleeding), anaemia, decreased red blood cells in the blood
INVEGA may increase levels of a hormone called “prolactin” found in blood tests (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, they may include: (in males) breast swelling, difficulty achieving or maintaining erection or other sexual dysfunctions, (in females) breast discomfort, milk discharge from the breast, loss of menstrual cycle or other menstrual problems
Diabetes or worsening of diabetes, high blood sugar levels, increased abdominal circumference, loss of appetite resulting in malnutrition and low body weight, elevated triglyceride levels (a fat)
Sleep disorders, confusion, reduced sexual drive, inability to achieve orgasm, nervousness, nightmares
Tardive dyskinesia (spasms or jerky, uncontrollable movements of the face, tongue or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop taking INVEGA
Seizures (epileptic fits), fainting, urgent need to move a part of the body, dizziness when standing up, attention disturbance, language problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin
Light sensitivity of the eyes, eye infection or “slightly red”, dry eyes
Sensation of spinning (vertigo), ringing in the ears, ear pain
Irregular heartbeat, abnormal heart electrical trace (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations)
Low blood pressure
Shortness of breath, wheezing, nosebleeds
Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas or air
Increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
Skin rash (or hives), hair loss, eczema, acne
Increased CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when there is muscle damage, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
Urinary incontinence (lack of control), frequent urination, inability to urinate, pain during urination
Erectile dysfunction, ejaculation disorders
Loss of menstrual cycle or menstrual problems (females), milk discharge from the breasts, sexual dysfunction, breast pain, breast discomfort
Swelling of the face, mouth, eyes or lips, body swelling, arms or legs swelling
Chills, increased body temperature
Change in the way of walking
Feeling thirsty
Chest pain, chest discomfort, feeling unwell
Falls

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

Eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
Dangerously low number of a certain type of white blood cells in the blood needed to fight infections
Decrease in a type of white blood cells in the blood that protects the body from infections, increase in eosinophils (a type of white blood cell)
Severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure, allergic reaction
Sugar in urine
Inappropriate secretion of the hormone controlling urine volume
Complications leading to life-threatening danger due to uncontrolled diabetes
Dangerously excessive water intake, decreased blood sugar, excessive water drinking, increased blood cholesterol
Sleepwalking
Absence of movements or responses when awake (catatonia)
Lack of emotion
Neuroleptic Malignant Syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity)
Loss of consciousness, balance disorders, abnormal coordination
Problems with brain blood vessels, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, head tremor
Glaucoma (increased pressure within the eyeball), increased tearing, redness of the eyes, eye movement problems, rolling of the eyes backward
Atrial fibrillation (an abnormal heart rhythm), rapid heartbeat when standing up
Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
Decreased oxygen levels in parts of the body (due to reduced blood flow), hot flushes
Breathing problems during sleep (sleep apnoea), rapid and shallow breathing
Pneumonia caused by inhalation of food, respiratory congestion, voice problems
Intestinal obstruction, faecal incontinence, hard stools, lack of intestinal muscle movement causing blockage
Yellowing of the skin and eyes (jaundice)
Inflammation of the pancreas
Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
Thickening of the skin, dry skin, skin redness, skin colour changes, scaly and itchy scalp or skin, dandruff
Muscle fibre breakdown and muscle pain (rhabdomyolysis), abnormal posture
Priapism (a prolonged penile erection that may require surgical treatment)
Breast development in males, enlargement of breast glands, milk discharge from breasts, vaginal discharge
Delayed menstrual cycle, breast enlargement
Very low body temperature, a decrease in body temperature
Medication withdrawal symptoms

Not known: frequency cannot be estimated from the available data

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

The following side effects have been observed with the use of another medicine called risperidone, which is very similar to paliperidone, so these effects may also be expected with INVEGA:
sleep-related eating disorder, other types of brain blood vessel problems, crackling lung sounds and severe or life-threatening skin rash with blisters and skin peeling that may start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis). 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 INVEGA. If you are scheduled for cataract surgery, make sure to inform your doctor if you are taking or have taken this medicine.

Other side effects in adolescents
The side effects generally experienced by adolescents are similar to those observed in adults, except for the following which have been observed more commonly:

Feeling sleepy or less alert
Parkinsonism: this condition may include: slow or impaired movements, feeling of muscle stiffness or tension (causing jerky movements) and sometimes also a sensation of movement starting and stopping. Other signs of parkinsonism include slow walking with shuffling of the feet, resting tremor, increased saliva and/or drooling and loss of facial expression
Weight gain
Symptoms of common cold
Restlessness
Tremor
Stomach ache
Milk discharge from the breast in girls
Breast swelling in boys
Acne
Language problems
Stomach or intestinal infection
Nosebleeds
Ear infection
High levels of triglycerides (a fat) in the blood
Sensation of spinning (dizziness)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INVEGA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/ bottle and carton after EXP. The expiry date refers to the last day of the month.
Bottles: Do not store above 30 °C. Keep the bottle tightly closed to protect the medicine from moisture.
Blister: Do not store above 30 °C. Keep the blister in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INVEGA contains
The active substance is paliperidone.
Each prolonged-release tablet of INVEGA 3 mg contains 3 mg of paliperidone.
Each prolonged-release tablet of INVEGA 6 mg contains 6 mg of paliperidone.
Each prolonged-release tablet of INVEGA 9 mg contains 9 mg of paliperidone.
Each prolonged-release tablet of INVEGA 12 mg contains 12 mg of paliperidone.

The other components are:
Tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butylated hydroxytoluene (E321)
Iron oxide (yellow) (E172) (only in 3 mg and 12 mg tablets)
Polyethylene oxide 7000K
Iron oxide (red) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate
Iron oxide (black) (E172) (only in 9 mg tablets)

Film coating:
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (only in 6 mg, 9 mg, and 12 mg tablets)
Iron oxide (yellow) (E172) (only in 6 mg and 12 mg tablets)
Iron oxide (red) (E172) (only in 6 mg 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

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

Bottles: tablets are supplied in white plastic bottles with child-resistant closures. Each bottle contains 30 tablets or 350 tablets. Each bottle contains two silica gel desiccant packets to absorb moisture and keep the tablets dry.
Blister packs: tablets are supplied in blisters packed in cartons containing 14, 28, 49, 56, or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA
Via C. Janssen
04100 Borgo San Michele
Latina
Italy

For further information on INVEGA, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Tel: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 45 94 82 82 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tel: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tel: +357 22 207 700 Tel: +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Latvijā Janssen Sciences Ireland UC
Tel: +371 6789 3561 Tel: +44 1 494 567 444
[email protected] [email protected]

This Patient Information Leaflet was last reviewed MM/YYYY

Other sources of information:
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Invega