Invega 6 mg prolonged-release tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: 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 the entire leaflet carefully before you start 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the 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 a class of medications called antipsychotics.
INVEGA is used to treat schizophrenia in adults and adolescents aged 15 years and older.
Schizophrenia is a disorder that causes symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive distrust, social withdrawal, incoherent speech, and blunted behavior and emotional expression. 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 several of the symptoms of schizophrenia (listed in the previous paragraph) along with mood disorder symptoms (feelings of euphoria, sadness, agitation, distractibility, insomnia, pressured speech, loss of interest in everyday activities, excessive or insufficient sleep, excessive or reduced food intake, and recurrent thoughts of suicide).
INVEGA can help relieve the symptoms of your illness and help prevent them from returning.
2. What you need to know before taking INVEGA
Do not take INVEGA
- if you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting INVEGA.
- Patients with schizoaffective disorder treated with this medicine should be closely monitored for possible changes 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 medicines 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 whose symptoms include 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 disorders may be caused by this type of medicine.
- if you have previously had low levels of white blood cells in the blood (which may or may not have been caused by other medicines).
- if you are diabetic or have a tendency towards diabetes.
- if you have heart disease or are being treated for heart conditions that may make you more prone to low blood pressure.
- if you have epilepsy.
- if you have a swallowing, stomach, or intestinal disorder that reduces your ability to swallow food or digest it with normal intestinal movements.
- 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 body temperature or feel overheated.
- if you have abnormally high levels of prolactin hormone in the blood or if you have a tumor that may be prolactin-dependent.
- if you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.
If you have any of these conditions, please consult your doctor, as a dose adjustment or monitoring may be necessary.
Because a dangerously low number of a type of white blood cells needed to fight infections in the blood has been observed in very rare cases in patients treated with INVEGA, your doctor may check your white blood cell count.
INVEGA may cause weight gain. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.
Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients treated with INVEGA. Your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.
During eye surgery for lens clouding (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.
Children and adolescents
INVEGA must not be given to children and adolescents under 15 years of age for the treatment of schizophrenia.
INVEGA must not be given 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.
Taking INVEGA with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Abnormalities in heart electrical function may occur when this medicine is taken together with other medicines used to control heart rhythm or other medicines such as antihistamines, antimalarials, or antipsychotics.
Since this medicine acts mainly in the brain, it may interact with other medicines (or alcohol) that also act on the brain, due to additive effects on brain function.
This medicine may lower blood pressure, so caution is needed if you take it together with other medicines that also lower blood pressure.
This medicine may reduce the effect of medicines used for Parkinson's disease and restless legs syndrome (e.g., levodopa).
The effects of this medicine may be altered if you take medicines that affect intestinal motility (e.g., metoclopramide).
Dose reduction of this medicine should be considered when administered concomitantly with valproate.
The use of oral risperidone together with this medicine is not recommended, as this combination may lead to an increase in adverse effects.
INVEGA and alcohol
You should avoid alcohol consumption during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take this medicine during pregnancy unless discussed with your doctor.
The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone during the last trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
You must not take this medicine while breastfeeding.
Driving and using machines
During treatment with this medicine, dizziness and vision problems may occur (see section 4, Possible side effects). This should be taken into account when maximum attention is required, for example, when driving or operating machinery.
The 3 mg INVEGA tablet contains lactose
The 3 mg tablet of this medicine contains lactose, a type of sugar. If your doctor has told you that you cannot tolerate certain sugars, talk to him or her before taking this medicine.
INVEGA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.
3. How to take INVEGA
Follow exactly the instructions for using this medicine as given by your doctor, pharmacist, or nurse.
Use in adults
The recommended dose in adults is 6 mg once daily in the morning. Your doctor may increase or decrease it within the dose range of 3 mg to 12 mg once daily for schizophrenia, or 6 mg to 12 mg once daily for schizoaffective disorder. This depends on how well the medicine works for you.
Use in adolescents
The recommended starting dose for the 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 to 6 mg once daily.
Your doctor will decide how much you should take. The amount you take depends on how well the medicine works for you.
How and when to take INVEGA
This medicine should be taken by mouth, swallowed whole with water or other liquids. It must not be chewed, broken, or crushed.
This medicine should be taken in the morning with breakfast or on an empty stomach, but always in the same way every day. Do not alternate between taking the medicine one day with breakfast and the next day on an empty stomach.
The active substance, paliperidone, dissolves once swallowed, and the tablet coating is eliminated from the body through the feces.
Patients with kidney problems
Your doctor may adjust your dose of this medicine depending on your kidney function.
Elderly patients
Your doctor may reduce your dose of medicine if your kidney function is reduced.
If you take more INVEGA than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, and changes in heart rhythm.
If you forget to take INVEGA
Do not take a double dose to make up for missed doses. If you miss a dose, take your next dose the following day. If you miss two or more doses, contact your doctor.
If you stop taking INVEGA
Do not stop taking this medicine, as you will lose the medicine's effects. You should not stop taking this medicine unless your doctor tells you to, as your symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Tell your doctor immediately if:
- you develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through 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 mental status or sudden weakness or numbness of the face, arms or legs, especially on one side, or have difficulty speaking even for a short period. These may be signs of a stroke
- you develop fever, muscle stiffness, sweating or a decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required
- you are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed
- you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary
- you develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction").
Very common: may affect more than 1 in 10 patients
- difficulty falling or staying asleep
- parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" sensation in movement that later restarts. Other signs of parkinsonism include shuffling slow gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.
- restlessness
- feeling drowsy or less alert
- headache.
Common adverse effects: may affect up to 1 in 10 patients
- chest infection (bronchitis), symptoms of a common cold, nasal infection, urinary tract infection, feeling as if you have the flu
- weight gain, increased appetite, weight loss, decreased appetite, mania, irritability, depression, anxiety
- dystonia: A condition involving involuntary, slow or sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal movements of the eyes, mouth, tongue or jaw.
- dizziness
- dyskinesia: A condition involving involuntary muscle movements and may include repetitive, spasmodic or twisting movements, or spasms
- tremor (agitation)
- blurred vision
- conduction block between the upper and lower chambers of the heart, abnormalities in the heart's electrical conduction, QT interval prolongation on the electrocardiogram, slow heartbeat, rapid heartbeat
- drop in blood pressure upon standing (as a result, some people taking INVEGA may feel weak, dizzy or faint when standing up or sitting up suddenly), increased blood pressure
- sore throat, cough, nasal congestion
- abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
- increased liver transaminases in blood
- itching, skin rash
- bone or muscle pain, back pain, joint pain
- absence of menstrual periods
- fever, weakness, fatigue (tiredness).
Uncommon adverse effects: may affect up to 1 in 100 patients
- pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
- decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells
- INVEGA may increase levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of elevated prolactin occur, they may include: (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, absence of menstrual periods or other cycle problems.
- diabetes or worsening of diabetes, increased blood sugar, increased waist circumference, loss of appetite leading to malnutrition and reduced body weight, increased blood triglycerides (a type of fat)
- sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares
- tardive dyskinesia (spasms or uncontrollable spasmodic movements of the face, tongue or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of INVEGA may be necessary.
- seizures (epileptic fits), fainting, restlessness causing body movements, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, reduced skin sensitivity to pain or touch, tingling, prickling or numbness of the skin
- eye sensitivity to light, eye infection or "red eye", dry eyes
- sensation of spinning (vertigo), ringing in the ears, ear pain
- irregular heartbeat, abnormal electrical activity of the heart (electrocardiogram or ECG), fluttering or pounding sensation in the chest (palpitations)
- decreased blood pressure
- shortness of breath, gasping, nosebleeds
- tongue swelling, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence, increased GGT (a liver enzyme called gamma-glutamyl transferase) in blood, increased liver enzymes in blood
- hives (or "urticaria"), hair loss, eczema, acne
- increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
- urinary incontinence (loss of control), frequent urination, inability to pass urine, pain when urinating
- erectile dysfunction, ejaculation disorder
- absence of menstrual periods or other cycle problems (women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort
- swelling of the face, mouth, eyes or lips, body swelling, arms or legs
- chills, increased body temperature
- change in walking pattern
- feeling thirsty
- chest pain, chest discomfort, feeling unwell
- falls.
Rare adverse effects: may affect up to 1 in 1,000 patients
- eye infection, fungal infection of the nails, skin infection, skin inflammation caused by mites
- dangerously low count of a type of white blood cells needed to fight infections
- decreased count of a type of white blood cells that help fight infections, increased eosinophils (a type of white blood cell) in blood
- severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, breathing difficulty, itching, skin rash and sometimes drop in blood pressure, allergic reaction
- sugar in urine
- inappropriate secretion of a hormone controlling urine volume
- life-threatening complications of uncontrolled diabetes
- dangerously excessive water intake, low blood sugar, excessive water intake, increased blood cholesterol
- sleepwalking
- absence of emotions
- neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle rigidity)
- loss of consciousness, balance disorder, abnormal coordination
- problems in brain blood vessels, coma due to uncontrolled diabetes, unresponsiveness to stimuli, decreased level of consciousness, head agitation
- glaucoma (increased pressure in the eyeball), increased tearing, eye redness, eye movement problems, eye rolling
- atrial fibrillation (abnormal heart rhythm), rapid heartbeat upon standing
- blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
- reduced oxygen supply to parts of the body (due to reduced blood flow), flushing
- breathing problems during sleep (sleep apnea), rapid, shallow breathing
- aspiration pneumonia (caused by inhaling food), respiratory congestion, voice disorder
- intestinal obstruction, fecal incontinence, very hard stools, absence of intestinal movement leading to obstruction
- yellowing of the skin and eyes (jaundice)
- pancreatitis (inflammation of the pancreas)
- severe allergic reaction with swelling, which may affect the throat causing breathing difficulty
- skin thickening, dry skin, skin redness, skin discoloration, scaly and itchy skin or scalp, dandruff
- muscle fiber breakdown and muscle pain (rhabdomyolysis), postural abnormality
- priapism (a prolonged erection that may require surgical treatment)
- breast development in males, enlarged mammary glands, milk secretion from breasts, vaginal discharge
- delayed menstrual periods, breast enlargement
- very low body temperature, decreased body temperature
- drug withdrawal symptoms.
Not known: frequency cannot be estimated from available data
- lung congestion
- increased insulin (a hormone that controls blood sugar levels) in blood.
The following adverse effects have been reported with the use of another medicine called risperidone, which is very similar to paliperidone, and therefore may also be expected with INVEGA: sleep-related eating disorder, other types of brain blood vessel problems, and crackling lung sounds. Eye problems may also occur during cataract surgery. During cataract surgery, a disturbance 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 medicine.
Additional adverse effects in adolescents
Adolescents generally experienced adverse effects similar to those seen in adults, except for the following effects, which occurred more frequently:
- feeling drowsy or less alert
- parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" sensation in movement that later restarts. Other signs of parkinsonism include shuffling slow gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.
- weight gain
- symptoms of common cold
- restlessness
- tremor (agitation)
- stomach pain
- milk secretion from the breasts in girls
- breast swelling in boys
- acne
- speech problems
- stomach or intestinal infection
- nosebleeds
- ear infection
- high blood triglycerides (a type of fat)
- sensation of movement (vertigo).
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 is the last day of the month indicated.
Bottles: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.
Blister packs: Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of INVEGA
The active substance is paliperidone.
Each 3 mg prolonged-release tablet of INVEGA contains 3 mg of paliperidone.
Each 6 mg prolonged-release tablet of INVEGA contains 6 mg of paliperidone.
Each 9 mg prolonged-release tablet of INVEGA contains 9 mg of paliperidone.
Each 12 mg prolonged-release tablet of INVEGA contains 12 mg of paliperidone.
The other components are:
Tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Ferric oxide (Yellow) (E172) (only in 3 mg and 12 mg tablets)
Polyethylene oxide 7000K
Ferric oxide (Red) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate
Ferric oxide (Black) (E172) (only in 9 mg tablets)
Coloured coating: Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (only in 6 mg, 9 mg and 12 mg tablets)
Ferric oxide (Yellow) (E172) (only in 6 mg and 12 mg tablets)
Ferric 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:
Ferric 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 marked with "PAL 3", the 6 mg tablets are beige and marked with "PAL 6", the 9 mg tablets are pink and marked with "PAL 9", and the 12 mg tablets are dark yellow and marked with "PAL12". All tablets are available in the following pack sizes:
- Bottles: The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 30 tablets or 350 tablets. Each bottle contains two silica gel desiccant packets to protect the tablets from moisture and keep them dry.
- Blister packs: The tablets are supplied in blister packs contained in cartons of 14, 28, 30, 49, 56 and 98 tablets.
Only certain pack sizes may be commercially available.
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
More information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:
| Lithuania UAB “JOHNSON & JOHNSON” Tel: +370 5 278 68 88 | |
| Luxembourg/Luxemburg Janssen-Cilag NV Tel: +32 14 64 94 11 | |
| Hungary JANSSEN-CILAG Ltd. Tel.: +36 1 884 2858 | |
| Malta AM MANGION LTD. Tel: +356 2397 6000 | |
| Netherlands JANSSEN-CILAG B.V. Tel: +31 76 711 1111 | |
| Norway JANSSEN-CILAG AS Tel: +47 24 12 65 00 | |
Greece JANSSEN-CILAG Φαρμακευτική Α.Ε.Β.Ε. Tel: +30 210 80 90 000 | Austria Janssen-Cilag Pharma GmbH Tel: +43 1 610 300 | |
| Poland JANSSEN–CILAG Polska Sp. z o.o. Tel.: +48 22 237 60 00 | |
| Portugal Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600 | |
| Romania Johnson & Johnson Romania SRL Tel: +40 21 207 1800 | |
| Slovenia Johnson & Johnson d.o.o. Tel: +386 1 401 18 00 | |
| Slovak Republic Johnson & Johnson, s.r.o. Tel: +421 232 408 400 | |
| Finland/Suomi JANSSEN-CILAG OY Tel: +358 207 531 300 | |
| Sweden JANSSEN-CILAG AB Tel: +46 8 626 50 00 | |
| United Kingdom JANSSEN-CILAG Ltd. Tel: +44 1 494 567 444 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu