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The product code(s) for this leaflet is: PLGB 00242/0684.
INVEGA 3 mg, 6 mg and 9 mg prolonged-release tablets
INVEGA 3 mg prolonged-release tablets
INVEGA 6 mg prolonged-release tablets
INVEGA 9 mg prolonged-release tablets
Paliperidone
What is in this leaflet:
1. What INVEGA is and what it is used for
2. What you need to know before you take INVEGA
3. How to take INVEGA
4. Possible side effects
5. How to store INVEGA
6. Contents of the pack and other information
INVEGA contains the active substance paliperidone which belongs to the class of antipsychotic medicines.
INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older.
Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness. 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 listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).
INVEGA can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Talk to your doctor, pharmacist or nurse before taking INVEGA.
If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose or monitor you for a while.
As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking INVEGA, your doctor may check your white blood cell counts.
INVEGA may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor should regularly measure your body weight.
As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking INVEGA, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
INVEGA is not for use in children and adolescents under 15 years for the treatment of schizophrenia.
INVEGA is not for use in children and adolescents who are under 18 years for the treatment of schizoaffective disorder.
This is because it is not known if INVEGA is safe or effective in these age groups.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Abnormalities of electrical function in the heart may occur when this medicine is taken with certain heart medicines that control heart rhythm, or some other types of medicines such as antihistamines, antimalarials, or other antipsychotics.
Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.
Since this medicine can lower blood pressure, care should be taken when this medicine is taken with other medicines that lower blood pressure.
This medicine can reduce the effect of medicines against Parkinson’s disease and restless legs syndrome (e.g., levodopa).
The effects of this medicine may be affected if you are taking medicines that affect the speed of movement in the gut (e.g., metoclopramide).
Dosage reduction for this medicine should be considered when this medicine is co-administered with valproate.
The use of oral risperidone together with this medicine is not recommended as the combination of the two medicines may lead to increased side effects.
INVEGA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Alcohol should be avoided when taking this medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy unless this has been discussed with your doctor. The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
You should not breastfeed when taking this medicine.
Dizziness and vision problems may occur during treatment with this medicine (see section 4, possible side effects). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
The 3 mg tablet of this medicine contains lactose, a type of sugar. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Take this medicine exactly as the doctor, pharmacist or nurse has told you to.
The recommended dose in adults is 6 mg once a day taken in the morning. The dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day for schizophrenia or 6 mg to 12 mg once a day for schizoaffective disorder. This depends on how well the medicine works for you.
The recommended starting dose for treating schizophrenia in adolescents 15 years and 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 range 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 give you. The amount you take depends on how well the medicine works for you.
This medicine must be taken by mouth, swallowed whole with water or other liquids. It must not be chewed, broken, or crushed.
This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day. Do not alternate between taking this medicine with breakfast one day and without having breakfast the next day.
The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is passed out of the body as waste.
Your doctor may adjust your dose of this medicine based upon your kidney function.
Your doctor may reduce your dose of medicine if your kidney function is reduced.
Contact your doctor right away. You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose on the day following the missed dose. If you miss two or more doses, contact your doctor.
Do not stop taking this medicine since you will lose the effects of the medicine. You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
Rare side effects: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
The following side effects have been seen with the use of another medicine called risperidone that is very similar to paliperidone, so these can also be expected with INVEGA: sleep-related eating disorder, other types of blood vessel problems in the brain, crackly lung sounds, and severe or life-threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome/toxic epidermal necrolysis). Eye problems during cataract surgery may also occur. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken INVEGA. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.
Adolescents generally experienced side effects that were similar to those seen in adults except the following side effects were seen more commonly:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP. The expiry date refers to the last day of that month.
Blisters: Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is paliperidone
Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone.
The other ingredients are:
Coated tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Ferric Oxide (Yellow) (E172) (3 tablet only)
Polyethylene Oxide 7000K
Ferric Oxide (Red) (E172)
Hydroxyethyl Cellulose
Polyethylene glycol 3350
Cellulose acetate
Iron oxide (Black) (E172) (9 mg tablet only)
Colour overcoat:
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (6 and 9 tablet only)
Ferric Oxide (Yellow) (E172) (6 tablet only)
Ferric Oxide (Red) (E172) ( 6, 9 mg tablet only)
Lactose monohydrate (3 mg tablet only)
Triacetin (3 mg tablet only)
Carnauba wax
Printing ink:
Iron oxide (Black) (E172)
Propylene glycol
Hypromellose
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”, and the 9 mg tablets are pink and printed with “PAL 9”. All tablets are available in the following pack sizes:
Not all pack sizes may be marketed.
For information in large print, tape, CD or Braille, telephone 0800 7318450
This leaflet was last revised in 01/2025.