Invega 9 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 further 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, because it may harm them.
- If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are 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 adverse 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 medicines 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 mistrust, social withdrawal, disorganized speech, and blunted 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 a person experiences several of the symptoms of schizophrenia (listed in the paragraph above), as well as mood disorder symptoms (feelings of euphoria or sadness, agitation, distractibility, insomnia, pressured speech, loss of interest in daily activities, excessive or insufficient sleep, excessive or poor food intake, and recurrent thoughts of suicide).
INVEGA may help relieve the symptoms of your illness and 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 taking 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 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 characterized by high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
- if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).
- You should be aware that these disorders may be caused by this type of medicine.
- if you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
- if you have diabetes or are prone to diabetes.
- if you have heart disease or are being treated for heart conditions that may make you more susceptible to a drop in blood pressure.
- if you have epilepsy.
- if you have a swallowing disorder, or stomach or intestinal problems that reduce 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 are overheated.
- if you have abnormally high levels of the hormone prolactin in your 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 dose adjustment or monitoring may be necessary.
Because a dangerously low number of a type of white blood cells needed to fight infections has been observed very rarely 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 center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become flaccid 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 may be pregnant, or are planning 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): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.
You should 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 have an intolerance to certain sugars, talk to them 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 administration instructions for this medicine 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 dosage range of 3 mg to 12 mg once daily in the case of schizophrenia, or 6 mg to 12 mg once daily in the case of 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, either 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 according to your kidney function.
Elderly patients
Your doctor may reduce your medicine dose 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 standing or walking, dizziness due to low blood pressure, and changes in heartbeat.
If you forget to take INVEGA
Do not take a double dose to make up for missed doses. If you miss a dose, 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 this medicine, as you will lose the medicine's effects. You should not stop taking this medicine unless instructed by your doctor, since 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 of 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 state 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 decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required
- you are a man and have a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required
- you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary
- you have 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 feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling 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, euphoria (mania), irritability, depression, anxiety
- dystonia: A condition involving involuntary, slow, or continuous muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia often affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
- dizziness
- dyskinesia: A condition involving involuntary muscle movements, which may include repetitive, spasmodic, or twisting movements, or spasms
- tremor (agitation)
- blurred vision
- conduction disturbances between the upper and lower parts of the heart, abnormalities in the heart's electrical conduction, QT interval prolongation in the heart, slow heartbeat, rapid heartbeat
- decreased 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 the blood
- itching, skin rash
- bone or muscle pain, back pain, joint pain
- loss 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" detected 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, loss 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 decreased body weight, increased triglycerides in the blood (a type of fat)
- sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares
- tardive dyskinesia (involuntary spasms or 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 disturbances, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin
- light sensitivity of the eyes, 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
- swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence, increased GGT (an enzyme in the liver 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, painful urination
- erectile dysfunction, ejaculation disorder
- loss 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 swelling
- 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 nail infection, skin infection, skin inflammation caused by mites
- dangerously low number of a type of white blood cells needed to fight infections
- decreased number 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 difficulties, itching, skin rash, and sometimes drop in blood pressure, allergic reaction
- sugar in the urine
- inappropriate secretion of a hormone that controls 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 the blood vessels of the brain, coma due to uncontrolled diabetes, unresponsiveness to stimuli, decreased level of consciousness, head agitation
- glaucoma (increased pressure in the eyeball), increased tearing, redness of the eyes, 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.
- decreased oxygen in parts of the body (due to reduced blood flow), flushing
- breathing problems during sleep (sleep apnea), rapid, shallow breathing
- pneumonia caused by aspiration of 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)
- inflammation of the pancreas
- severe allergic reaction with swelling, which may affect the throat causing breathing difficulties
- thickening of the skin, dry skin, redness of the skin, skin discoloration, scaly and itchy skin or scalp, dandruff
- muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
- priapism (a prolonged erection that may require surgical treatment)
- breast development in men, enlarged mammary glands, milk secretion from the breasts, vaginal secretion
- delayed menstrual periods, enlarged breasts
- very low body temperature, decreased body temperature
- medication 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 occurred with the use of another medicine called risperidone, which is very similar to paliperidone; therefore, they are also expected to occur with INVEGA: sleep-related eating disorder, other types of blood vessel problems in the brain, and crackling lung sounds. 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 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 feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling 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 triglycerides in blood (a type of fat)
- sensation of movement (vertigo).
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed 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 outer carton following EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers 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 coating:
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
Iron 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:
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 printed with "PAL 3", the 6 mg tablets are beige and printed with "PAL 6", the 9 mg tablets are pink and printed with "PAL 9", and the 12 mg tablets are dark yellow and printed with "PAL12". All tablets are marketed in the following pack sizes:
- Bottles: Tablets are supplied in plastic bottles with child-resistant closures. 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: 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 about this medicinal product can be requested 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. Telephone: +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 | |
| Suomi/Finland JANSSEN-CILAG OY Puh/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