Paliperidone ratiopharm
This medicine helps control the symptoms of schizophrenia and prevents them from returning.
Form
injektioneste, depotsuspensio
Strength
150 mg
Active Ingredient
Paliperidone palmitate
Manufacturer
ratiopharm GmbH
How to Use
Dosage
The first injection (150 mg) and second injection (100 mg) are given in your upper arm about one week apart. After that, you will receive an injection (25–150 mg) in your upper arm or buttock once a month. Your doctor may adjust your monthly dose based on your symptoms.
Method
This medicine is given to you by your doctor or other healthcare professional as an injection into a muscle (usually your upper arm or buttock). It should not be given into a vein or under the skin.
Important
The highest amount you can get in one monthly injection is 150 mg. Your doctor will decide your dose.
Possible Side Effects
COMMON
- •Difficulty falling asleep or interrupted sleep.
- •Flu-like symptoms, urinary tract infection, or generally feeling unwell.
- •Increased levels of a hormone called prolactin in your blood (may cause breast swelling/pain, milk leakage, sexual problems for men/women, or missed periods for women).
- •High blood sugar, weight gain, weight loss, or decreased appetite.
- •Irritability, depression, or anxiety.
- •Parkinsonism: slow movements, stiff muscles, jerking movements, shuffling walk, shaking, increased saliva/drooling, or a mask-like face.
- •Restlessness, drowsiness, or feeling less alert.
- •Dystonia: slow or long-lasting involuntary muscle spasms (can affect any body part, but often facial muscles causing abnormal eye, mouth, tongue, or jaw movements).
- •Dizziness.
- •Dyskinesia: uncontrolled muscle movements that can be repetitive, spastic, twisting, or jerking.
- •Shaking (tremor).
- •Headache.
- •Fast heart rate.
- •High blood pressure.
- •Cough or stuffy nose.
- •Stomach pain, vomiting, nausea, constipation, diarrhea, indigestion, or toothache.
- •Increased liver enzyme levels in your blood.
- •Bone or muscle pain, back pain, or joint pain.
- •Missed menstrual period.
- •Fever, feeling weak, or tiredness.
- •Reaction at the injection site (itching, pain, or swelling).
- •Lung infection (pneumonia, bronchitis), airway infection, sinus infection, bladder infection, ear infection, nail fungus, sore throat, or skin infection.
- •Decrease in white blood cells (which help fight infections) or anemia.
- •Allergic reaction.
- •New or worsening diabetes, or increased insulin levels in your blood.
- •Increased appetite.
- •Loss of appetite leading to poor nutrition and weight loss.
- •High levels of triglycerides (fats) or cholesterol in your blood.
- •Sleep disturbance, elevated mood (mania), decreased sex drive, nervousness, or nightmares.
- •Tardive dyskinesia: uncontrolled, twitching movements of the face, tongue, or other body parts.
- •Fainting, restless urge to move parts of your body, dizziness when standing up, trouble concentrating, speech problems, loss/change of taste, reduced sensation to touch/pain, tingling/numbness of the skin.
- •Blurred vision, eye infection, red eyes, or dry eyes.
- •Spinning sensation (vertigo), ringing in the ears, or ear pain.
- •Heart conduction problems (electrical signals in the heart), prolonged QT interval, fast heart rate when standing up, slow heart rate, abnormal heart signals (ECG), or fluttering/pounding in the chest.
- •Low blood pressure, especially when standing up quickly (may cause weakness, dizziness, or fainting).
- •Shortness of breath, sore throat, or nosebleed.
- •Stomach discomfort, stomach or bowel infection, difficulty swallowing, dry mouth, or gas.
- •Increased GGT or other liver enzyme levels in your blood.
- •Hives (nettle rash), itching, rash, hair loss, eczema, dry skin, red skin, acne, or pus under the skin.
- •Increased CPK levels in your blood (a sign of muscle breakdown).
- •Muscle spasms, stiff joints, or muscle weakness.
- •Leaking urine, frequent urination, or painful urination.
- •Erectile dysfunction (difficulty getting/keeping an erection), ejaculation problems, missed or irregular periods (women), breast development in men, sexual problems, breast pain, or milk leakage from breasts.
- •Swelling of the face, mouth, eyes, lips, tongue, body, arms, or legs.
- •Increased body temperature.
- •Change in walking style.
- •Chest pain, chest discomfort, or generally feeling unwell.
- •Hardening of the skin.
- •Falls.
RARE
- •Eye inflammation.
- •Skin inflammation caused by mites, flaky and itchy scalp or skin.
- •Increase in eosinophils (a type of white blood cell) in your blood.
- •Decrease in platelets (blood cells that help stop bleeding).
- •Head shaking.
- •Inappropriate secretion of a hormone that regulates urine volume.
- •Sugar in urine.
- •Life-threatening complications from uncontrolled diabetes.
- •Low blood sugar.
- •Drinking too much water.
- •Catatonia (immobility and lack of response while awake).
- •Confusion.
- •Sleepwalking.
- •Lack of emotions.
- •Inability to orgasm.
- •Severe neuroleptic malignant syndrome (confusion, reduced consciousness, high fever, severe muscle stiffness), brain blood vessel problems (including stroke), unresponsiveness to stimuli, loss of consciousness, seizures, or balance problems.
- •Abnormal coordination.
- •Glaucoma (high pressure inside the eye).
- •Eye movement problems, rolling eyes, light sensitivity, increased tear production, or red eyes.
- •Atrial fibrillation (a type of irregular heartbeat) or other heart rhythm disorders.
- •Blood clot in the lungs causing chest pain and breathing difficulties. Seek medical help immediately if you notice these symptoms.
- •Blood clot in veins, especially in the legs (swelling, pain, redness). Seek medical help immediately if you notice these symptoms.
- •Redness in the face and neck (flushing).
- •Breathing problems during sleep (sleep apnea).
- •Lung congestion, airway congestion.
- •Crackling breathing sounds, wheezing.
- •Pancreatitis (inflammation of the pancreas), swollen tongue, inability to control bowel movements, or very hard stools.
- •Bowel obstruction.
- •Chapped lips.
- •Drug rash, skin thickening, or dandruff.
- •Muscle fiber breakdown and muscle pain (rhabdomyolysis).
- •Joint swelling.
- •Inability to urinate.
- •Breast discomfort, breast enlargement, or vaginal discharge.
- •Priapism (prolonged erection requiring surgery).
- •Very low body temperature, chills, or feeling thirsty.
- •Withdrawal symptoms.
- •Pus accumulation from injection site infection, deep skin infection, injection site cyst, or injection site bruising.
- •Dangerously low levels of certain white blood cells needed to protect against infection.
- •Severe allergic reactions with fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes low blood pressure.
- •Dangerously excessive intake of water.
- •Sleep-related eating disorder.
- •Coma due to uncontrolled diabetes.
- •Reduced oxygen supply to parts of the body (due to reduced blood flow).
- •Fast shallow breathing, pneumonia due to inhaling food, or voice disorder.
- •Lack of bowel muscle movements (causing blockage).
- •Yellowing of the skin and eyes (jaundice).
- •Severe or life-threatening skin rash with blistering and peeling skin (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- •Severe allergic reaction with swelling that can affect the throat and lead to breathing difficulties.
- •Skin discoloration.
- •Abnormal posture.
- •Newborns whose mothers used Paliperidone ratiopharm during pregnancy may have side effects or withdrawal symptoms such as irritability, stiff/prolonged muscle contractions, tremors, drowsiness, breathing problems, or feeding difficulties.
- •Decreased body temperature.
- •Skin cell death at the injection site or an injection site sore.
Important Warnings
- If you get blood clots, especially in your legs (swelling, pain, redness), or if they travel to your lungs causing chest pain and breathing problems, tell your doctor right away.
- If you have dementia and suddenly feel confused, or have sudden weakness/numbness on one side of your face, arms, or legs, or slurred speech, even for a short time, tell your doctor right away as these could be signs of a stroke.
- If you get a fever, very stiff muscles, sweating, or become less alert/unconscious (a serious condition called neuroleptic malignant syndrome), tell your doctor right away.
- If you are a man and have an erection that lasts a long time (more than 4 hours) or is painful, get medical help right away. This is called priapism.
- If you have uncontrolled, rhythmic movements of your tongue, mouth, or face, tell your doctor. They might need to stop your medicine.
Show 3 more warnings
- If you have a severe allergic reaction with symptoms like fever, swelling of your mouth, face, lips, or tongue, trouble breathing, itching, rash, or low blood pressure, get medical help right away.
- If you need eye surgery, especially for cataracts, tell your eye doctor you are taking this medicine. It can cause problems with your eye during the surgery.
- If you know you have a very low number of certain white blood cells that fight infections, tell your doctor right away.