Paliperidone Sandoz
Paliperidone Sandoz contains paliperidone and is used for long-term treatment of schizophrenia in adults after their condition has been stabilized.
Form
Injektioneste, depotsuspensio, esitäytetty ruisku
Strength
50 mg
Active Ingredient
Paliperidone palmitate
Manufacturer
Sandoz A/S
How to Use
Dosage
The first dose (150 mg) and second dose (100 mg) are given about one week apart. After that, you will receive an injection of 25-150 mg once a month.
Method
This medicine is given by your doctor or another healthcare professional as an injection into your upper arm or buttock.
Important
The maximum single maintenance dose is 150 mg, given once a month.
Possible Side Effects
COMMON
- •Difficulty falling asleep or staying asleep
- •Flu-like symptoms, urinary tract infection
- •High prolactin levels in blood (may or may not cause symptoms)
- •High blood sugar, weight gain, weight loss, decreased appetite
- •Irritability, depression, anxiety
- •Parkinsonism (slow or stiff movements, tremors)
- •Restlessness, drowsiness or feeling less alert
- •Dystonia (slow, lasting involuntary muscle contractions, often in the face, eyes, mouth, or jaw)
- •Dizziness, uncontrolled muscle movements (dyskinesia), tremor, headache
- •Fast heartbeat, high blood pressure
- •Cough, stuffy nose
- •Stomach pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
- •Increased liver enzymes in blood
- •Bone or muscle pain, back pain, joint pain
- •Missed periods
- •Fever, weakness, tiredness
- •Injection site reactions like itching, pain, or swelling
RARE
- •Lung inflammation, bronchitis, respiratory tract infection, sinus infection, ear infection, skin infection, tonsillitis, nail fungus
- •Decreased white blood cells, anemia
- •Allergic reaction
- •Diabetes or worsening diabetes, increased insulin in blood
- •Increased appetite, loss of appetite leading to malnutrition or weight loss
- •High triglycerides and cholesterol in blood
- •Sleep disturbances, elevated mood (mania), decreased sex drive, nervousness, nightmares
- •Tardive dyskinesia (involuntary, jerky movements of the face, tongue, or other body parts)
- •Fainting, restless legs, dizziness when standing up, attention problems, speech difficulties, loss or change of taste, reduced sensation, tingling or numbness in skin
- •Blurred vision, eye infection, dry eyes
- •Vertigo (spinning sensation), ringing in ears, ear pain
- •Heart rhythm problems (e.g., fast heart rate when standing, slow heart rate, abnormal EKG, palpitations)
- •Low blood pressure, low blood pressure when standing up
- •Shortness of breath, sore throat, nosebleed
- •Abdominal discomfort, stomach or intestinal inflammation, difficulty swallowing, dry mouth, excessive gas
- •Increased liver enzymes in blood
- •Hives, itching, rash, hair loss, eczema, dry skin, skin redness, acne, abscess under skin
- •Increased CPK in blood (an enzyme released when muscles break down)
- •Muscle cramps, joint stiffness, muscle weakness
- •Urinary incontinence, frequent or painful urination
- •Erectile dysfunction, ejaculation problems, menstrual cycle changes or missed periods in women, breast development in men, sexual dysfunction, breast pain, breast milk leakage
- •Swelling of the face, mouth, eyes, lips, body, arms, or legs
- •Increased body temperature, changes in gait (walking), chest pain, breast discomfort, malaise, skin hardening, falls
- •Skin inflammation caused by mites, flaky or itchy scalp or skin
- •Increased white blood cells called eosinophils in blood, decreased platelets (cells that help blood clot)
- •Head tremors
- •Inappropriate secretion of a hormone that controls urine volume, sugar in urine
- •Life-threatening complications of uncontrolled diabetes, low blood sugar
- •Excessive water drinking
- •Catatonia (immobility and lack of response while awake), confusion, sleepwalking, lack of feelings, inability to have an orgasm
- •Malignant neuroleptic syndrome (confusion, reduced consciousness, high fever, severe muscle stiffness)
- •Brain blood vessel disorders (including stroke or mini-stroke), lack of response to stimuli, loss of consciousness, low consciousness, seizures, balance disorders, abnormal coordination
- •Glaucoma (increased eye pressure), eye movement problems, eye rolling, light sensitivity, increased tearing, red eyes
- •Atrial fibrillation (irregular heartbeat), irregular heart rhythm
- •Blood clots in the lungs (pulmonary embolism) causing chest pain and breathing difficulties
- •Blood clots in veins, especially in legs (swelling, pain, redness)
- •Flushing (feeling of warmth and redness in the skin), sleep apnea (difficulty breathing during sleep)
- •Lung congestion, airway congestion, wheezing, crackling sounds in lungs
- •Pancreatitis, swollen tongue, fecal incontinence, very hard stool, bowel obstruction
- •Chapped lips
- •Drug rash, thickened skin, dandruff, rhabdomyolysis (muscle fiber breakdown and pain)
- •Joint swelling, urinary retention (inability to urinate)
- •Breast discomfort, breast enlargement (men/women), nipple discharge, vaginal discharge, priapism (prolonged erection that may need surgery)
- •Very low body temperature, chills, thirst, drug withdrawal syndrome
- •Injection site abscess, deep skin inflammation, cyst, bruising
- •Dangerous excessive water intake, sleep-related eating disorder
- •Coma due to uncontrolled diabetes, lack of oxygen in parts of the body
- •Fast, shallow breathing, pneumonia from inhaling food, voice disorders, stopped bowel movements
- •Yellowing of the skin and eyes (jaundice)
- •Severe or life-threatening skin rash with blisters and peeling skin (Stevens-Johnson syndrome or toxic epidermal necrolysis)
- •Skin discoloration, abnormal posture
- •Side effects or withdrawal symptoms in newborns whose mothers took Paliperidone Sandoz during pregnancy (irritability, stiff or prolonged muscle contractions, tremors, drowsiness, breathing problems, feeding difficulties, low body temperature)
- •Dead skin cells or a wound at the injection site
Important Warnings
- Contact your doctor immediately if you have blood clots, especially in your legs (swelling, pain, redness), as they can move to the lungs causing chest pain and breathing difficulties.
- Contact your doctor immediately if you experience stroke-like symptoms such as sudden changes in mental state, weakness or numbness in the face, arms, or legs, or slurred speech.
- Contact your doctor immediately if you have a high fever, stiff muscles, sweating, or confusion (called neuroleptic malignant syndrome).
- Contact your doctor immediately if you are a man and experience a prolonged, painful erection.
- Contact your doctor immediately if you experience involuntary movements of your tongue, mouth, or face; treatment with paliperidone may need to stop.
Show 3 more warnings
- Contact your doctor immediately if you have a severe allergic reaction with symptoms like fever, swelling of your mouth, face, lips, or tongue, difficulty breathing, itching, rash, or low blood pressure.
- Inform your eye doctor if you are scheduled for eye surgery, especially for cataracts, as this medicine can affect your eyes during the procedure.
- Inform your doctor if you know you have dangerously low levels of certain white blood cells needed to fight infections.