Invega 3 mg Tablets

What INVEGA is

INVEGA contains the active substance paliperidone. This belongs to a group of medicines called central nervous system depressants.

What INVEGA is used for

Schizophrenia

INVEGA belongs to the class of antipsychotic medicines and is used to treat schizophrenia in adults (> 18 years) and in adolescents (12 – 17 years of age). Schizophrenia is a mental illness with symptoms such as disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). INVEGA is not for treating people with schizophrenia who are younger than 12 years old.

Schizoaffective disorder

INVEGA is used to treat schizoaffective disorder in adults (18 years of age and older), used either alone or with other medicines that are also used to treat depression and/or other mood disorders. This is a condition in which the patient has episodes of elevated mood (mania) or low mood (depression) in addition to symptoms of schizophrenia. INVEGA is not for treating people with schizoaffective disorder who are younger than 18 years old. The safety and efficacy beyond 6 weeks have not yet been established.

Do not use INVEGA:

• if you are hypersensitive (allergic) to paliperidone, or to any of the other ingredients of INVEGA, or to risperidone (listed in section 6). Hypersensitivity can be recognised for instance by skin rash, itching, shortness of breath or swollen face. If any of these occur, contact your doctor straight away.
• if you have loss of kidney function.
• if you have a disorder that reduces your ability to pass food through your digestive system.
• if you have dementia (i.e. decline of reasoning, memory and other mental abilities).
• if you have Parkinson’s disease (i.e. deterioration of certain nerve systems, which affects your movement, balance and muscle control).
• if you are younger than 12 years old.

Warnings and precautions

Take special care with INVEGA

• INVEGA has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
• if you have ever been diagnosed with a condition whose symptoms include high 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 both of these conditions may be caused by this type of medicine.
• if you are diabetic (high blood sugar) or prone to diabetes.
• if you have heart disease or heart disease treatment or treatment for high blood pressure that makes you prone to low blood pressure; or are prone to drop in blood pressure or feeling dizzy when you stand up from lying or sitting position.
• if you have epilepsy (fits).
• if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• if you have diseases associated with diarrhoea.
• if you have a decrease of kidney function as you may need a lower dosage.
• if you have a decrease of liver function.
• if you have prolonged and/or painful erection.
• if you have difficulty controlling core body temperature or overheating.
• if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots. Blood clots in the lungs and legs have been seen in patients taking INVEGA. Blood clots in the lungs can be fatal.
• if you have a history of heart rate disturbances, or congenital long QT syndrome or in concomitant use with medicines known to prolong the QT interval.
• If you have or have had low white blood cell counts in your blood. Let your doctor know right away if you develop fever or infection while being treated with INVEGA.
• patients with schizoaffective disorder treated with INVEGA should be carefully monitored for a potential switch from manic to depressive symptoms.

Weight gain has been seen in patients receiving INVEGA. You doctor may monitor your body weight while you are being treated with INVEGA.

Children and adolescents

INVEGA is not for use in children and adolescents under 12 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. 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.

Other medicines and INVEGA

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Since INVEGA can make you sleepy or drowsy, care should be taken when INVEGA is taken with other medicines that can also cause sleepiness or drowsiness. Since INVEGA 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 INVEGA can lower blood pressure, care should be taken when INVEGA is taken with other medicines that lower blood pressure. INVEGA can reduce the effect of medicines against Parkinson’s disease and restless legs syndrome (e.g. levodopa).

Do not share medicines prescribed for you with any other person. Always take INVEGA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with INVEGA will last. Do not stop treatment early because your symptoms may return. If you have the impression that the effect of INVEGA is too strong or too weak, tell your doctor or pharmacist.

How and when to take INVEGA

INVEGA should be taken every morning with or without food. Always take INVEGA in the fasting state or always take INVEGA with breakfast. Do not alternate between administration in the fasting state or in the fed state. INVEGA must be taken by mouth, swallowed whole with water or other liquids. It must not be chewed, broken, or crushed. The active ingredient, paliperidone, dissolves once swallowed, and the tablet shell is passed out of the body as waste.

Your doctor will decide on the dose that is most suitable for you.

How much to take

For adults (18 years of age and older) with schizophrenia: The usual dose is 6 mg once a day taken in the morning, but the dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day.

For adolescents (12 to 17 years of age) with schizophrenia: The usual dose is 3 mg once a day taken in the morning, but the dose may be increased by your doctor within the range of 6 mg to 12 mg once a day.

For adults (18 years of age and older) with schizoaffective disorder: The usual dose is 6 mg once a day taken in the morning, but the dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day. INVEGA is not approved for treating schizoaffective disorder in patients younger than 18 years of age.

If you take more INVEGA than you should

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. Irregular heartbeats have been reported with overdose. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take INVEGA

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.

If you stop taking INVEGA

You should not stop INVEGA unless told to do so by your doctor as your symptoms may return. If you have any further questions on the use of this product, ask your doctor or pharmacist.

INVEGA can have side effects

Not all side effects reported for INVEGA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking INVEGA, please consult your doctor, pharmacist or other healthcare provider for advice.

Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction’) can occur. If this occurs, seek medical attention immediately.

In elderly patients with dementia, INVEGA has been associated with side effects including sudden weakness or numbness of the face, arms, or legs, instances of slurred speech, or blurred vision. These symptoms may be associated with stroke. If any of these occur, even for a short period of time, seek medical attention immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling sleepy or less alert; headache
• Common cold symptoms; sinus infection
• Weight gain; increased appetite
• Difficulty falling or staying asleep; elated mood (mania); irritability; depression; anxiety
• Parkinsonism (this condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and then restarting. Other symptoms of Parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face.
• Dystonia (this is a condition involving slow or sustained involuntary contraction of muscles. While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dyskinesia (this is a condition involving involuntary muscle movements, and can include repetitive, spastic, or writhing movements, or twitching)
• Restlessness; dizziness; problems with speech; tremor (shaking)
• Blurry vision
• Abnormal electric conduction of the heart; prolongation of the QT interval from your heart; rapid heart rate
• Low blood pressure upon standing (consequently, some people taking INVEGA may feel faint, dizzy, or may pass out when they stand up or sit up suddenly); high blood pressure
• Cough; stuffy nose
• Abdominal pain or discomfort; vomiting; nausea; constipation; diarrhoea; indigestion; dry mouth; toothache
• Itching
• Bone or muscle ache; back pain
• Fever; weakness; fatigue (tiredness)

Less frequent:

• Infection of the chest (bronchitis); infection of the breathing passages; urinary tract infection; ear infection; tonsillitis; feeling like you have the flu
• Anaemia
• High blood sugar; weight loss; loss of appetite resulting in malnutrition and low body weight; increased or decreased appetite; high blood triglycerides (a fat)
• Sleep disorder; inability to reach orgasm; nightmares
• Convulsion (fits); fainting; a restless urge to move parts of your body; dizziness upon standing; loss or abnormal sense of taste; reduced sensation of skin to pain and touch
• Eye infection or “pink eye”; dry eye; increased tears
• Ear pain
• An interruption in conduction between the upper and lower parts of the heart; slow heart rate; irregular heartbeat; abnormal electrical tracing of the heart (electrocardiogram or ECG); a fluttering or pounding feeling in your chest (palpitations)
• Low blood pressure (i.e. dizziness and lightheadedness and a tendency to faint)
• Shortness of breath; wheezing; sore throat; nosebleeds
• Stomach or intestinal infection; difficulty swallowing; excessive passing of gas or wind
• Increased liver enzymes in your blood
• Rash; dry skin; acne; dandruff
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is released with muscle breakdown; muscle spasms; joint swelling; muscle weakness; neck pain; joint pain
• Incontinence (lack of control) of urine; frequent passing of urine; inability to pass urine; pain when passing urine
• Erectile dysfunction; loss of menstrual periods; leakage of milk from the breasts; breast discomfort
• Swelling of the face, mouth, eyes, or lips; swelling of the body, arms, or legs; an increase in body temperature; feeling thirsty; chest discomfort
• Fall
• Bladder infection; fungal infection of the nails; infection of the skin; skin inflammation caused by mites
• Decrease in the type of white blood cells that help you protect against infection; white blood cell count decreased; decrease in platelets (blood cells that help you stop bleeding); decrease in red blood cells.

INVEGA can raise your levels of a hormone called “prolactin” found on a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, they may include: (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.

Dangerously excessive intake of water; low blood sugar; diabetes or worsening of diabetes; increased cholesterol in your blood.

Not moving or responding while awake (catatonia); sleep related eating disorder; sleep walking; decreased sexual drive; tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. Withdrawal of INVEGA may be needed.

Sudden loss of blood supply to brain (stroke or “mini” stroke); loss of consciousness; disturbance in attention; a sensation of tingling, pricking, or numbness of skin.

Oversensitivity of the eyes to light; sensation of spinning (vertigo); ringing in the ears; atrial fibrillation (an abnormal heart rhythm); decreased oxygen in parts of your body (because of decreased blood flow); flushing; trouble breathing during sleep (sleep apnea); fast, shallow breathing; a blockage in the bowels; swollen tongue; stool incontinence; chapped lips; serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing; hair loss; eczema; skin redness; skin discoloration; joint stiffness; ejaculation disorder; missed menstrual periods or other problems with your cycle (females); development of breasts in men; sexual dysfunction; enlargement of the gland in your breasts; discharge from the breasts; vaginal discharge; chills; a change in the way you walk; lack of bowel muscle movements that cause blockage; eye problems during cataract surgery. 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 INVEGA.

Frequency not known:

• 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 or toxic epidermal necrolysis).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of INVEGA.

Keep all medicines out of the reach of children. Do not store above 30 ° C. Protect from moisture. Bottles: Keep the bottle tightly closed to protect from moisture. Blisters: Keep tablets in the original package (i.e. blisters) to protect from moisture until required for use. Do not use INVEGA after the expiry date which is stated on the blister/bottle and carton after {MM/YYYY}. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (i.e. toilets).