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Psylipax

Psylipax is a medicine used to treat the symptoms of schizophrenia in adults who have already started treatment with similar medicines.

Form
Injektioneste, depotsuspensio, esitäytetty ruisku
Strength
150 mg
Active Ingredient
Paliperidone palmitate
Manufacturer
Exeltis Healthcare S.L.

How to Use

Dosage

Your doctor will give you the first dose (150 mg) and second dose (100 mg) in your upper arm about one week apart. After that, you will receive a monthly injection (25-150 mg) in your upper arm or buttock, with the dose adjusted by your doctor as needed.

Method

This medicine is given as a slow, deep injection into a muscle (upper arm or buttock) by a doctor or healthcare professional. Do not inject into a vein or under the skin.

Important

The maximum monthly dose is 150 mg. If you have moderate or severe kidney problems, you should not receive this medicine.

Possible Side Effects

COMMON
  • •Difficulty falling asleep or interrupted sleep.
  • •Flu-like symptoms, urinary tract infection, feeling unwell.
  • •Increased prolactin levels in blood (may cause breast swelling in men, erection problems, or sexual dysfunction; in women, breast discomfort, milk discharge, missed periods).
  • •High blood sugar, weight gain, weight loss, decreased appetite.
  • •Irritability, depression, anxiety.
  • •Parkinsonism (slow movements, stiff muscles, tremors, increased saliva, masked face).
  • •Restlessness, drowsiness, reduced alertness.
  • •Dystonia (slow, involuntary muscle contractions, often in the face, causing abnormal movements of eyes, mouth, tongue, or jaw).
  • •Dizziness.
  • •Dyskinesia (involuntary muscle movements, which can be repetitive, spastic, or jerky).
  • •Tremor.
  • •Headache.
  • •Fast heartbeat.
  • •High blood pressure.
  • •Cough, stuffy nose.
  • •Abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache.
  • •Increased liver enzymes in blood.
  • •Bone or muscle pain, back pain, joint pain.
  • •Missed menstrual periods.
  • •Fever, weakness, tiredness (fatigue).
  • •Injection site reactions (itching, pain, swelling).
RARE
  • •Pneumonia, bronchitis, respiratory infection, sinus infection, bladder infection, ear infection, nail fungal infection, tonsillitis, skin infection.
  • •Decreased white blood cells (including those fighting infections), anemia.
  • •Allergic reaction.
  • •New or worsened diabetes, increased insulin levels.
  • •Increased appetite.
  • •Loss of appetite leading to malnutrition and weight loss.
  • •High triglycerides and cholesterol in blood.
  • •Sleep problems, elevated mood (mania), decreased sex drive, nervousness, nightmares.
  • •Tardive dyskinesia (involuntary, jerky movements of face, tongue, or other body parts).
  • •Fainting, strong urge to move body parts, dizziness when standing, trouble concentrating, speech problems, loss or change of taste, reduced skin sensitivity to pain/touch, tingling, prickling, or numbness.
  • •Blurred vision, eye infection, red eyes, dry eyes.
  • •Spinning sensation (vertigo), ringing in ears, ear pain.
  • •Heart conduction problems (e.g., prolonged QT interval on EKG), fast heartbeat when standing, slow heartbeat, abnormal EKG, fluttering or pounding in chest (palpitations).
  • •Low blood pressure, low blood pressure when standing (may cause faintness, dizziness, or fainting when standing up quickly).
  • •Shortness of breath, sore throat, nosebleed.
  • •Abdominal discomfort, stomach or intestinal inflammation, difficulty swallowing, dry mouth, excessive gas.
  • •Increased liver enzymes (GGT and others) in blood.
  • •Hives, itching, rash, hair loss, eczema, dry skin, skin redness, acne, abscess under skin.
  • •Increased creatine phosphokinase (CPK) in blood (an enzyme released during muscle breakdown).
  • •Muscle cramps, joint stiffness, muscle weakness.
  • •Urinary incontinence, frequent urination, painful urination.
  • •Erectile dysfunction, ejaculation problems, missed or irregular menstrual periods (in women), breast development in men, sexual dysfunction, breast pain, milk discharge from breasts.
  • •Swelling of face, mouth, eyes, or lips, swelling of body, arms, or legs.
  • •Increased body temperature.
  • •Changes in walking.
  • •Chest pain, chest discomfort, feeling unwell.
  • •Hardening of skin.
  • •Falls.
  • •Tick-borne skin infection, scaly itchy scalp or skin.
  • •Increased eosinophils (a type of white blood cell) in blood.
  • •Decreased platelets (blood cells that help stop bleeding).
  • •Head shaking.
  • •Inappropriate secretion of ADH (hormone regulating urine volume).
  • •Sugar in urine.
  • •Life-threatening complications of uncontrolled diabetes.
  • •Low blood sugar.
  • •Excessive water drinking.
  • •Immobility and unresponsiveness while awake (catatonia).
  • •Confusion.
  • •Sleepwalking.
  • •Lack of feelings.
  • •Inability to have an orgasm.
  • •Neuroleptic Malignant Syndrome (confusion, reduced consciousness, high fever, severe muscle stiffness).
  • •Cerebrovascular disorders, including stroke or mini-stroke.
  • •Unresponsiveness to stimuli, loss of consciousness, reduced alertness, seizures, balance problems.
  • •Abnormal coordination.
  • •Glaucoma (increased pressure in the eye).
  • •Eye movement disorders, eye rolling, sensitivity to light, increased tear production, red eyes.
  • •Atrial fibrillation (a type of irregular heartbeat), other heart rhythm disorders.
  • •Blood clots in the lungs (causing chest pain and breathing difficulties).
  • •Redness of face and neck.
  • •Breathing difficulties during sleep (sleep apnea).
  • •Lung congestion, airway congestion, crackling breathing sounds, wheezing.
  • •Pancreatitis, tongue swelling, fecal incontinence, constipation, intestinal obstruction, cracked lips.
  • •Drug rash, skin thickening, dandruff.
  • •Muscle breakdown and muscle pain (rhabdomyolysis).
  • •Joint swelling.
  • •Urinary retention.
  • •Breast discomfort, breast gland enlargement, breast enlargement.
  • •Vaginal discharge.
  • •Priapism (prolonged erection that may require surgery).
  • •Very low body temperature, chills, thirst.
  • •Drug withdrawal syndrome.
  • •Abscess at injection site, deep skin infection, cyst at injection site, bruise at injection site.
  • •Dangerously excessive water intake.
  • •Sleep-related eating disorder.
  • •Coma due to uncontrolled diabetes.
  • •Lack of oxygen in some body parts (due to reduced blood flow).
  • •Rapid, shallow breathing, pneumonia from inhaling food, voice disorders.
  • •Stopped bowel movements, causing obstruction.
  • •Yellowing of skin and eyes (jaundice).
  • •Severe or life-threatening rash with blisters and peeling skin, starting around mouth, nose, eyes, or genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis).
  • •Skin discoloration.
  • •Abnormal postures.
  • •Withdrawal symptoms in newborns of mothers who used Psylipax during pregnancy (irritability, slow/prolonged muscle contractions, tremors, drowsiness, breathing/feeding difficulties, low body temperature).
  • •Skin cell death at injection site, injection site ulcers.

Important Warnings

  • Do not use if you are allergic to paliperidone or risperidone, or any other ingredient in this medicine. Seek immediate medical attention if you have a severe allergic reaction (fever, swelling of mouth/face/tongue/lips, shortness of breath, itching, rash, low blood pressure).
  • Contact your doctor immediately if you develop blood clots, especially in the legs (swelling, pain, redness), as they can travel to the lungs, causing chest pain and breathing difficulties.
  • If you have dementia and experience sudden changes in mental state, sudden weakness or numbness in face/arms/legs, or slurred speech, these could be signs of a stroke. This medicine has not been studied in elderly dementia patients, who may have an increased risk of stroke or death with similar medicines.
  • Seek immediate medical attention if you experience fever, muscle stiffness, sweating, or reduced consciousness (Neuroleptic Malignant Syndrome).
  • If you are a man and have a prolonged or painful erection, seek immediate medical attention (this is called priapism).
Show 9 more warnings
  • Report uncontrolled movements of the tongue, mouth, or face to your doctor, as your treatment may need to be stopped.
  • Inform your eye doctor if you are scheduled for eye surgery, as this medicine can cause complications during cataract surgery.
  • Contact your doctor if you know you have dangerously low levels of certain white blood cells needed to fight infections.
  • This medicine may cause weight gain, which can be harmful to your health, and your weight will be monitored. It may also cause or worsen diabetes, so your doctor will check your blood sugar levels.
  • Tell your doctor about any existing health conditions, such as Parkinson's disease, diabetes, heart problems, kidney or liver issues, or a history of blood clots, as these may worsen with this medicine.
  • Avoid alcohol while using this medicine.
  • Do not use this medicine during pregnancy unless discussed with your doctor, as it can harm the baby. Do not breastfeed while using this medicine, as it can pass into breast milk and harm the baby.
  • This medicine may cause dizziness, severe tiredness, or vision problems, so be careful when driving or operating machinery.
  • This medicine is not for use in children or adolescents under 18 years of age.

Additional Information

ATC Code: N05AX13
→ View Professional Information (PDF)→ View Patient Leaflet (PDF)