Paliperidone STADA

Paliperidone Stada is a medicine used for long-term treatment of schizophrenia symptoms in adults.

Form
Injektioneste, depotsuspensio, esitäytetty ruisku
Strength
25 mg
Active Ingredient
Paliperidone palmitate
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

Initial doses are 150 mg and 100 mg, given about one week apart. After that, monthly doses of 25-150 mg are given.

Method

This medicine is given as an injection into the upper arm or buttock muscle by a healthcare professional.

Important

Your doctor will adjust your monthly dose based on your symptoms, with a maximum of 150 mg per injection.

Possible Side Effects

COMMON
  • Difficulty sleeping or interrupted sleep.
  • Flu symptoms, urinary tract infection.
  • Increased prolactin hormone levels (can cause breast swelling, erection issues, or menstrual changes).
  • High blood sugar, weight gain or loss, decreased appetite.
  • Irritability, depression, anxiety.
  • Parkinson-like symptoms (slow movements, stiff muscles, tremors, increased drooling, fixed facial expression).
  • Restlessness, drowsiness, decreased alertness.
  • Dystonia (slow, involuntary muscle contractions, often in the face, eyes, mouth, tongue, or jaw).
  • Dyskinesia (involuntary, repetitive, spastic, or twitching muscle movements).
  • Dizziness, tremor, headache, fast heartbeat, high blood pressure.
  • Cough, stuffy nose.
  • Stomach pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache.
  • Abnormal liver function test results.
  • Muscle pain, back pain, joint pain.
  • Missed menstrual periods.
  • Fever, weakness, tiredness.
  • Injection site reactions (itching, pain, swelling).
RARE
  • Pneumonia, bronchitis, respiratory infection, sinus infection, bladder infection, ear infection, nail fungus, tonsillitis, skin infection.
  • Decreased white blood cells, anemia.
  • Allergic reaction.
  • New or worsened diabetes, increased insulin.
  • Increased appetite, loss of appetite leading to malnutrition and weight loss.
  • High triglycerides, high cholesterol.
  • Sleep disturbances, high mood (mania), decreased sex drive, nervousness, nightmares.
  • Tardive dyskinesia (jerky or uncontrolled movements in the face, tongue, or other body parts – tell your doctor immediately).
  • Fainting, strong urge to move a body part, dizziness when standing up, difficulty concentrating, speech problems, loss/changes in taste, reduced skin sensation, tingling/prickling/numbness.
  • Blurred vision, eye infection, red eyes, dry eyes, spinning sensation (vertigo), ringing in ears, ear pain.
  • Heart rhythm problems (conduction disturbances, prolonged QT interval, fast heart rate when standing, slow heart rate, abnormal EKG, fluttering in chest, low blood pressure, low blood pressure when standing up leading to weakness/dizziness/fainting).
  • Shortness of breath, sore throat, nosebleeds.
  • Stomach discomfort, stomach/intestinal infection, difficulty swallowing, dry mouth, excessive gas.
  • Increased GGT enzyme (liver enzyme) in blood, increased liver enzyme levels in blood.
  • Hives, itching, rash, hair loss, eczema, dry skin, skin redness, acne, pus-filled skin lesions.
  • Increased creatine phosphokinase (CPK) in blood (an enzyme released during muscle breakdown), muscle cramps, stiff joints, muscle weakness.
  • Incontinence, frequent urination, painful urination, erectile dysfunction, ejaculation problems, missed periods, breast development in men, sexual dysfunction, breast pain, milky discharge from breasts.
  • Swelling of face/mouth/eyes/lips/tongue, swelling of body/arms/legs, increased body temperature, changes in walking, chest pain, discomfort in chest, general malaise, hardened skin, falls.
  • Eye inflammation.
  • Skin inflammation from mites, flaky or itchy scalp or skin.
  • Increased eosinophils (a type of white blood cell) in blood, decreased platelets (blood cells that stop bleeding).
  • Head tremor.
  • Inappropriate secretion of hormone that regulates urine volume.
  • Sugar in urine.
  • Life-threatening complications of uncontrolled diabetes.
  • Low blood sugar.
  • Excessive water drinking.
  • Immobility and lack of reaction while awake (catatonia).
  • Confusion, sleepwalking, lack of feelings, inability to achieve orgasm.
  • Malignant neuroleptic syndrome (confusion, reduced consciousness, high fever, severe muscle stiffness), brain blood vessel problems (stroke/mini-stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures, balance disorder.
  • Abnormal coordination.
  • Glaucoma (increased eye pressure).
  • Eye movement disorders, eye rolling, light sensitivity, increased tear production, red eyes.
  • Atrial fibrillation (an abnormal heart rhythm), irregular heartbeat.
  • Blood clot in the lungs causing chest pain and breathing difficulties (seek immediate medical attention).
  • Blood clots in veins, especially in the legs (swelling, pain, redness in legs) (seek immediate medical attention).
  • Flushing (feeling of warmth and redness in the skin).
  • Difficulty breathing during sleep.
  • Fluid/mucus in lungs, blocked airways, crackling breath sounds, wheezing.
  • Pancreatitis, swollen tongue, fecal incontinence, very hard stools, bowel obstruction.
  • Chapped lips.
  • Drug rash on skin, thickening of skin, dandruff.
  • Muscle fiber breakdown and muscle pain (rhabdomyolysis).
  • Joint swelling.
  • Inability to urinate.
  • Breast discomfort, enlarged breasts in men, breast enlargement, vaginal discharge.
  • Priapism (prolonged erection of the penis that may require surgery).
  • Very low body temperature, chills, thirst.
  • Withdrawal symptoms.
  • Pus accumulation from infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.
  • Dangerously low levels of certain white blood cells needed to fight infection.
  • Severe allergic reaction with fever, swelling of mouth/face/lips/tongue, shortness of breath, itching, rash, sometimes low blood pressure.
  • Dangerously excessive water drinking.
  • Sleep-related eating disorder.
  • Coma due to poorly controlled diabetes.
  • Lack of oxygen in some body parts due to reduced blood flow.
  • Rapid, shallow breathing, pneumonia from inhaling food, voice disorders.
  • Cessation of bowel movements, causing obstruction.
  • Yellowing of skin and eyes (jaundice).
  • Severe or life-threatening rash with blisters and peeling skin that may start in/around mouth, nose, eyes, or genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis).
  • Skin discoloration.
  • Abnormal postures.
  • Newborns exposed during pregnancy may have withdrawal symptoms like irritability, muscle stiffness/weakness, tremors, drowsiness, breathing problems, or feeding difficulties.
  • Decreased body temperature.
  • Dead skin cells at injection site, injection site ulcer.

Important Warnings

  • Do not use if you are allergic to paliperidone, risperidone, or any other ingredient in this medicine.
  • This medicine has not been studied in elderly patients with dementia; similar medicines may increase the risk of stroke or death in these patients.
  • Seek immediate medical attention if you experience blood clots, especially in the legs (swelling, pain, redness), which can travel to the lungs (chest pain, breathing difficulties).
  • Seek immediate medical attention if you have fever, stiff muscles, sweating, or a reduced level of consciousness (Neuroleptic Malignant Syndrome).
  • Seek immediate medical attention if you have a severe allergic reaction (fever, swelling of mouth/face/lips/tongue, difficulty breathing, itching, rash, low blood pressure).
Show 6 more warnings
  • Do not use this medicine during pregnancy without consulting your doctor.
  • Do not breastfeed while using this medicine.
  • This medicine may cause dizziness, severe tiredness, or vision problems; avoid driving or operating machinery if affected.
  • Inform your doctor about any existing health conditions, especially heart problems, epilepsy, kidney/liver issues, Parkinson's disease, or diabetes, as the medicine may affect these.
  • This medicine may cause weight gain or affect blood sugar levels; regular monitoring by your doctor is important.
  • If you are having eye surgery, tell your eye doctor that you are using this medicine, as it can affect your pupils.