INVEGA. 9 mg. 30 tablets. JANSSEN CILAG
INVEGA. 9 mg. 30 tablets. JANSSEN - CILAG
What INVEGA is and what it is used?
INVEGA contains the active substance paliperidone , which belongs to the class of antipsychotic drugs and used to treat schizophrenia in adults and psychotic or manic symptoms of schizoaffective disorder in adults. This drug was not effective for depressive symptoms.
Schizophrenia is a disorder with symptoms such as hearing things , seeing or feeling things that are not there , mistaken beliefs, unusual suspiciousness , becoming withdrawn, incoherent speech and behavior and emotional flatness . People with this disorder may also feel depressed , anxious, guilty, or tense .
Schizoaffective disorder is a psychiatric condition in which a person has a combination of the symptoms of schizophrenia ( such as those listed above ) , together with symptoms of affective disorder (feeling extremely good mood , feelings of sadness, feelings of agitation , forgetfulness , insomnia , talkativeness loss of interest in daily activities , too much or too little sleep, eating too much or too little food, and recurrent thoughts of suicide) .
INVEGA may help relieve the symptoms of your disease and prevent its reoccurrence .
2 . What you should know before taking INVEGA?
Do not take INVEGA
- If you are allergic to paliperidone , risperidone, or to any 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 monitored for the possible switch from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. In elderly patients with dementia , however , who were treated with other similar types of drugs 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 , the symptoms of which include fever 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 know that both conditions can be caused by this type of medicine . , If you know that you had low levels of white blood cells (which may have been or may not be related to other drugs ), if you are diabetic or prone to diabetes .
- If you have heart disease or heart disease treatment that can cause low blood pressure if you have epilepsy.
- If you have difficulty swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
- If you have a disease associated with diarrhea if you have kidney problems, if you have liver problems , if you have prolonged and / or painful erection if difficulty controlling core body temperature or overheating .
- If you have unusually high levels of the hormone prolactin in the blood or if you may have a prolactin- dependent tumors .
- If you or a member of your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
If you have any of these , tell your doctor as he / she may want to adjust your dose or monitor you for a while.
In very rare cases, patients taking INVEGA, observed dangerously low number of certain white blood cells necessary to fight infection in the blood and so your doctor can check the number of white blood cells .
INVEGA can lead to increased weight check . Significant weight gain can have an adverse effect on your health. Your doctor should regularly measure your weight.
In patients taking INVEGA, has seen the emergence of diabetes mellitus or worsening of existing diabetes , so your doctor should examine you for signs of high blood sugar . In patients with established diabetes should regularly monitor the level of glucose in the blood.
Children and adolescents
This medicine is not intended for persons under 18 years of age. Other medicines and INVEGA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines .
It is possible to appear abnormal electrical activity of the heart when this drug is taken with certain heart medications that control heart rhythm or other types of drugs such as antihistamines, antimalarials or other antipsychotics.
Since this drug is acting primarily in the brain , it may cause interactions with other drugs ( or alcohol ) with an effect on the brain due to the additive effect on brain function .
As this medicine can lower blood pressure should be exercised when this drug is taken with other medicines that lower blood pressure. This medicine can reduce the effect of medicines for Parkinson's disease and restless legs syndrome (eg levodopa) .
The effects of this drug may be affected if you are taking medicines that affect the transit time through the gastrointestinal tract ( eg, metoclopramide ) . Reduction of the dose of this medication should be taken into account when this drug is administered simultaneously with valproate.
Concomitant use of oral risperidone and this medicine is not recommended , as the combination of both drugs may increase the side effects .
INVEGA with food, drinks and alcohol
Alcohol should be avoided when taking this medicine. Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine. You should not take this medicine during pregnancy , unless you have discussed this with your doctor. The following symptoms may occur in infants whose mothers used INVEGA in the last trimester ( last three months of pregnancy ): shaking, muscle stiffness and / or weakness , drowsiness , agitation, trouble breathing and feeding difficulty . If your baby develops any of these symptoms contact your doctor . You should not breastfeed when taking this medicine.
Driving and using machines
During treatment with this drug may occur dizziness and vision problems (see section 4 " Possible side effects"). This should be considered in cases where full alertness is required , such as when driving or operating machinery.
Tablet of 3 mg INVEGA contains lactose
The 3 mg tablet of this product contains lactose , a type of sugar . If you are told by a doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. You should not take the 3 mg tablet of this medicine because it contains lactose. However, the tablets of 1,5 mg, 6 mg, 9 mg, or 12 mg of this drug can be administered as they do not contain lactose monohydrate.
3 . How to take INVEGA?
Take this medicine exactly as your doctor has told , pharmacist or nurse and do not stop without first checking with your doctor. Symptoms of your disease may reappear if you stop taking the drug .
The recommended dose is 6 mg once daily, in the morning , but the dosage may be increased or decreased by your doctor 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 medicine should be taken orally , the tablets should be swallowed whole with water or other liquids. They should not be chewed, divided , or crushed.
This medicine should be taken every morning at breakfast or without breakfast , but always in the same way every day. No alternate take this medicine a day with breakfast and without breakfast the next day.
The active ingredient was dissolved paliperidone , once ingested , the tablet shell is ejected from the body as waste .
Patients with kidney problems
Your doctor may adjust the dose of this medicine based on your kidney function. Elderly
Your doctor may reduce the dose of this medicine, if your kidney function is reduced .
If you take more than the dose of INVEGA
Contact your doctor immediately . You may experience sleepiness , fatigue, abnormal body movements, problems with standing and walking, dizziness from low blood pressure and irregular heart rhythm.
If you forget to take INVEGA
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next day after the missed dose. If you miss two or more doses , contact your doctor.
If you stop taking INVEGA
You will lose the effect of the drug. You should not stop this medicine unless your doctor has told you to do this, as your symptoms may reappear. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Immediately tell your doctor if you:
• have 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 .
• have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side , or slurred speech , even for a short period of time. These may be symptoms of a stroke.
• have a fever , muscle stiffness , sweating or a lowered level of consciousness ( a disorder called " Nnevroleptichen malignant syndrome '). You may need urgent medical treatment .
• are a man and have a prolonged and painful erection . This is called priapism . You may need urgent medical treatment .
• have involuntary rhythmic movements of the tongue , mouth and face. It may be necessary to stop treatment with paliperidone.
• you have a severe allergic reaction characterized by fever, swollen mouth, face , lips or tongue , shortness of breath , itching , skin rash and sometimes drop in blood pressure ( reaching " anaphylactic reaction" ) .
Very common: may affect more than 1 in 10 people
• difficulty sleeping or sleeping
• Parkinsonism : this condition may involve delayed or impaired movement, stiffness or muscle tension (making your movements jerky ) , and sometimes even a sense of " freezing " of the movement and followed by the extension. Other signs of parkinsonism include slow shuffling gait, tremor at rest, increased salivation and / or drooling and loss of facial expression, anxiety, drowsiness or loss of attention headaches.
Common side effects may affect up to 1 in 10 people
- Chest infection ( bronchitis ) , cold symptoms , sinus infection , urinary tract infection , flu-like symptoms
- Weight gain, increased appetite , weight loss , decreased appetite excited mood ( mania ) , irritability , depression , anxiety, dystonia : This is a condition in which the monitor is delayed or sustained involuntary muscle contractions . Since dystonia can affect any part of the body ( and lead to abnormal posture ), it often includes the muscles of the face , including the abnormal movements of the eyes, mouth , tongue, jaw or dizziness
- Dyskinesia : This is a condition wherein the observed involuntary muscle movements , and may involve repeated , spastic or twisting movements and twitching tremor (shaking ) blurred vision
- Abnormal electrical impulses of the heart , QT interval of the heart, slow heart rate , rapid heart beat
- Low blood pressure when standing up ( so some people taking INVEGA, may feel sick, dizzy or faint when you stand or sitting) , high blood pressure
- Sore throat, cough , stuffy nose
- Abdominal pain , abdominal discomfort, nausea, vomiting , constipation , diarrhea , indigestion , dry mouth , dental
- Elevated liver transaminases in blood itching, rash
- Bone pain and muscle pain, back pain , joint pain, lack of menstrual periods
- Fever , weakness , fatigue ( tiredness ) .
Uncommon side effects may affect up to 1 in 100 people
- Pneumonia , respiratory infection , urinary bladder infection , ear infection , tonsillitis
- Anemia, low red blood cell count
- Onset or exacerbation of diabetes , high blood sugar , loss of appetite leading to malnutrition and low body weight , increased blood triglycerides ( fats)
- Sleep disturbances , confusion, decreased sex drive , inability to achieve orgasm , nervousness , nightmares
- Convulsions ( fits) , fainting, an irresistible urge to move the body parts, orthostatic dizziness , impaired concentration , difficulty speaking , loss or abnormal sensation of taste , decreased skin sensitivity to pain and touch, numbness, tingling , or hardening skin or eye infection " red eye" dry eyes dizziness ( vertigo), ringing in the ears, ear pain , interruption of impulses between the upper and lower parts of the heart , irregular heartbeat, unusual recording electrical signals from the heart (electrocardiogram or ECG) , feeling fast or strong beat in the chest ( palpitations)
- Low blood pressure
- Shortness of breath , wheezing , nosebleeds
- Swelling of the tongue , an infection of the stomach or intestines, difficulty swallowing , excessive flatulence
- Elevated GGT (a liver enzyme called gamma- glutamyltransferase ) levels, elevated liver enzymes in the blood rash (or " hives " ) , hair loss, acne
- Elevated CPK ( creatine phosphokinase ) levels - an enzyme that is sometimes released during muscle injury , muscle spasms , joint stiffness , joint swelling , muscle weakness , neck pain
- Incontinence (no control ) urine , frequent urination, inability to urinate , pain when urinating erectile dysfunction, ejaculatory dysfunction
- Missed menstrual cycles or other problems with the menstrual cycle ( women) , leakage of milk from the breasts , sexual dysfunction , chest pain , chest discomfort
- Swelling of the face , mouth, eyes or lips, swelling of the body , arms or legs
- Chills, fever
- Change in gait
- Feeling of thirst
- Chest pain , malaise
Rare side effects may affect up to 1 in 1000 people
- Ocular infection , a fungal infection of the nails , skin infection, skin irritation caused by ticks
- Dangerously low levels of certain white blood cells needed to fight infection in your blood
- Reduced number of white blood cells that help protect against infections , decreased white blood cell count , low platelet count ( cells that help blood to clot) , increased number of eosinophils ( a type of white blood cells) in your blood
- A severe allergic reaction , characterized by fever, swelling of the mouth, face, lips or tongue , dyspnea , pruritus , rash , sometimes lowering the blood pressure , allergic response, sugar in urine
INVEGA may increase levels of a hormone called " prolactin " which opens with a blood test ( which can cause , and may not cause symptoms ) . When symptoms of high prolactin, they may include: (men ) breast swelling , difficulty achieving and maintaining an erection, or other disorders of sexual function , ( female ) chest discomfort , leakage of milk from the breasts , missed menstrual cycles or other problems with your monthly cycle inadequate secretion of the hormone that controls the volume urine , life-threatening complications of uncontrolled diabetes , dangerously excessive water intake , low blood sugar , excessive drinking of water , elevated blood cholesterol lack of emotions
Neuroleptic malignant syndrome ( confusion, reduced or loss of consciousness , fever, and severe muscle stiffness)
slow dyskinesia ( twitching or jerking movements of the face, tongue or other parts of the body that you can control ) . Immediately tell your doctor if you experience involuntary rhythmic movements of the tongue , mouth and face . It may be necessary to stop treatment with INVEGA
sudden loss of blood flow to the brain ( stroke or " mini " stroke ), loss of consciousness, balance disorder , coordination abnormal
problems with blood vessels in the brain , coma as a result of uncontrolled diabetes , proofing incentives , low level of consciousness , shaking head glaucoma (increased pressure in the eyeball ) , increased eye sensitivity to light , excessive tearing, redness of the eyes, problems with eye movement , rotating the eye
atrial fibrillation ( abnormal heart beat), fast heart beat on standing
blood clots in the veins especially in the legs ( symptoms include swelling, pain and redness in the leg), which can move around the blood vessels to the lungs causing chest pain and difficulty breathing . If you notice any of these symptoms , seek medical advice immediately .
reduced oxygen level in some parts of the body (due to reduced blood flow ) , flushing
difficulty breathing during sleep ( sleep apnea ) , fast, shallow breathing pneumonia due to inhaling food, airway obstruction , abnormal voice
bowel obstruction , incontinence of feces, very hard stools yellow skin and eyes (jaundice) inflammation of the pancreas
severe allergic reaction with swelling, which can affect the throat and cause breathing difficulties
thickening of the skin , eczema , dry skin, redness , discoloration of the skin, flaking and itchy scalp or skin , dandruff
damage to muscle fibers and muscle pain (rhabdomyolysis ) , unusual posture priapism ( prolonged erection in which you may need surgery ) development of breasts in men , increased glandular breast , breast discharge , vaginal discharge
delayed menstrual cycles , breast enlargement chest discomfort
very low body temperature , decreased body temperature symptoms of withdrawal syndrome.
Not known from the available data can not be estimated
- Pulmonary congestion
- Increased level of insulin (a hormone that controls blood sugar ) in your blood. These adverse reactions have been reported with the use of another drug called risperidone , which is very similar to paliperidone and therefore they can be expected for INVEGA: another type of problems with blood vessels in the brain and rattling sounds in the lungs.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .
5 . How to store INVEGA?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister / bottle and carton after EXP :/ EXP . The expiry date refers to the last day of that month.
Bottles: Do not store above 30 ° C. Keep the bottle tightly closed in order to protect from moisture.
Blisters: Do not store above 30 ° C. Store in the original package to protect from moisture.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does INVEGA?
- The active substance is paliperidone .
Each tablet of INVEGA 1,5 mg prolonged -release tablet contains 1,5 mg paliperidone. Each INVEGA 3 mg prolonged -release tablet contains 3 mg paliperidone. Each INVEGA 6 mg prolonged -release tablet contains 6 mg paliperidone. Each INVEGA 9 mg prolonged -release tablet contains 9 mg paliperidone. Each INVEGA 12 mg prolonged -release tablet contains 12 mg of paliperidone.
Other ingredients are:
Coated tablet core : Polyethylene oxide 200K Sodium chloride Povidone (K29- 32) Stearic acid Butyl hydroxytoluene (E321)
Iron oxide (yellow ) (E172) ( tablet only 3, 12 mg)
Polyethylene oxide 7000K
Iron oxide (red ) (E172)
Polyethylene glycol 3350
Iron oxide ( black) ( E172 ) ( tablet only 1.5 and 9 mg)
Titanium dioxide (E171)
Polyethylene glycol 400 ( tablet only 1.5, 6 , 9 and 12 mg) Iron oxide (yellow ) (E172) ( tablet only 1.5 , 6, 12 mg) Iron oxide (red ) (E172) ( tablet only , 1,5, 6, 9 mg) Lactose monohydrate ( tablet only 3 mg) Triacetin ( tablet only 3 mg) Carnauba wax
Printing ink: Iron oxide (black ) (E172) Propylene glycol Hypromellose
INVEGA looks like and contents of the pack ?
INVEGA prolonged release tablets are capsule-shaped . 1,5 mg tablets are orange- brown and printed with "PAL 1,5", 3 mg tablets are white and printed with "PAL 3 " , 6 mg tablets are beige and printed with "PAL 6 " tablets 9 mg are pink and
printed with "PAL 9" and 12 mg tablets are dark yellow and printed with "PAL 12" . All tablets are available in the following packages :
Bottles: The tablets come in a plastic bottle with a child- plastic cap . Each bottle contains either 30 or 350 tablets. Each bottle contains two silica gel pouches which are provided to absorb moisture and keep the dry tablet . Blisters: The tablets are available in blisters packed in cartons of 14, 28 , 30, 49, 56 and 98 tablets.
Not all pack sizes may be marketed.