Clozapine STADA
Clozapine Stada is a medicine for schizophrenia when other treatments haven't helped, and for severe thinking, feeling, and behavior issues in Parkinson's disease.
Form
tabletti
Strength
25 mg
Active Ingredient
Clozapine
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For schizophrenia, the usual starting dose is 12.5 mg (half of a 25 mg tablet) once or twice on the first day, increasing slowly to 300 mg daily; typical daily dose is 200-450 mg split into several doses. For Parkinson's related problems, the usual starting dose is 12.5 mg in the evening, increasing slowly to a maximum of 50 mg daily; typical dose is 25-37.5 mg as a single evening dose.
Method
Take orally. Swallow the tablet with water.
Important
The maximum daily dose for Clozapine Stada is 900 mg.
Possible Side Effects
COMMON
- •Drowsiness
- •Dizziness
- •Increased saliva production
- •Severe constipation (requires medical treatment)
- •Fast heart rate
- •High white blood cell count (leukocytosis)
- •High count of a specific type of white blood cells (eosinophilia)
- •Weight gain
- •Blurred vision
- •Headache
- •Tremors
- •Stiffness
- •Restlessness
- •Seizures
- •Muscle twitching
- •Abnormal movements
- •Difficulty initiating movement
- •Difficulty staying still
- •Changes in ECG (electrocardiogram)
- •High blood pressure
- •Weakness or strange, unreal feeling after changing position (increased risk of falls)
- •Nausea
- •Vomiting
- •Loss of appetite
- •Dry mouth
- •Minor abnormalities in liver function tests
- •Urinary incontinence
- •Difficulty urinating
- •Fatigue
- •Fever
- •Increased sweating
- •Increased body temperature
- •Speech disorder (e.g., slurred speech)
- •Signs of a cold, fever, flu-like symptoms, sore throat, or other signs of infection (requires urgent blood test)
- •Sudden fainting or loss of consciousness with muscle weakness (syncope)
RARE
- •Lack of white blood cells (agranulocytosis)
- •Speech disorder (e.g., stuttering)
- •Sudden rapid increase in body temperature, muscle stiffness, which can lead to unconsciousness (neuroleptic malignant syndrome)
- •Strange, unreal feeling, dizziness or fainting when getting up from a sitting or lying position (increased risk of falls)
- •Symptoms suggesting respiratory infection or pneumonia, such as fever, cough, difficulty breathing, wheezing
- •Severe, burning upper abdominal pain due to pancreatitis, radiating to the back, accompanied by nausea and vomiting
- •Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse)
- •Difficulty swallowing (which may cause food to go down the wrong way)
- •Nausea, vomiting, and/or loss of appetite (doctor must check your liver)
- •Signs of weight gain or increased obesity
- •Breathing pauses during sleep, possibly with snoring
- •Low red blood cell count (anemia)
- •Restlessness, agitation, confusion, delirium
- •Irregular heartbeat
- •Inflammation of the heart muscle (myocarditis) or heart sac (pericarditis), fluid accumulation around the heart
- •High blood sugar, diabetes mellitus
- •Blood clots in the lungs (thromboembolism)
- •Liver inflammation (hepatitis), liver disease causing yellow skin/dark urine/itching
- •Elevated creatine kinase in blood
- •Fast or irregular heart rate, even at rest, palpitations, difficulty breathing, chest pain, or unexplained tiredness (doctor must examine heart)
- •Persistent painful erection of the penis in men (priapism). If an erection lasts more than four hours, immediate medical treatment is needed.
- •Spontaneous bleeding or bruising, which may indicate a decrease in platelet count
- •Symptoms due to poor blood sugar control (such as nausea or vomiting, abdominal pain, severe thirst, excessive urination, disorientation, or confusion)
- •Abdominal pain, cramps, abdominal swelling, vomiting, constipation, and difficulty passing gas, which may be signs and symptoms of bowel obstruction
- •Loss of appetite, abdominal swelling, abdominal pain, yellow skin, severe weakness, and general malaise (may indicate liver disease leading to acute liver failure)
- •Nausea, vomiting, fatigue, or weight loss (may be symptoms of kidney inflammation)
- •Increased platelet count with risk of blood clots
- •Involuntary movements of the mouth/tongue and limbs
- •Obsessive thoughts and repetitive compulsive behavior (symptoms of obsessive-compulsive disorder)
- •Skin reactions, swelling in front of the ear (enlargement of the parotid gland)
- •Difficulty breathing
- •Very high blood triglyceride or cholesterol levels
- •Heart muscle disease (cardiomyopathy)
- •Cardiac arrest
- •Sudden unexplained death
- •Severe chest pain, tightness, pressure, or squeezing sensation in the chest (chest pain may radiate to the left arm, jaw, neck, and upper abdomen), shortness of breath, sweating, weakness, confusion, nausea, vomiting, and palpitations (symptoms of heart attack), which can be fatal. Seek immediate medical attention.
- •Pressure, heaviness, squeezing, burning, or choking sensation in the chest (signs of insufficient blood flow and oxygen to the heart muscle), which can be fatal. Your heart must be examined by a doctor.
- •Intermittent throbbing, pulsating or fluttering sensation in the chest (palpitations)
- •Rapid and irregular heartbeats (atrial fibrillation). Occasionally, palpitations, fainting, shortness of breath, or chest discomfort may occur. Your heart must be examined by a doctor.
- •Symptoms of low blood pressure such as dizziness, lightheadedness, fainting, blurred vision, unusual fatigue, cold clammy skin, or nausea
- •Symptoms indicating blood clots, especially in the leg veins (swelling, pain, and redness). These may travel to the lungs, causing chest pain and difficulty breathing.
- •Confirmed or strong suspicion of infection with fever or low body temperature, abnormally rapid breathing, fast heart rate, altered responsiveness and level of consciousness, decreased blood pressure (sepsis)
- •Excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome)
- •Significantly reduced urine output (sign of kidney failure)
- •Allergic reaction (swelling primarily of the face, mouth and throat, and tongue swelling, which may be itchy or painful)
- •Diarrhea due to large intestine inflammation, abdominal pain, fever, changes in skin color, 'butterfly rash' on face, joint pain, muscle pain, fever, and weakness (lupus)
- •Restless legs syndrome (an irresistible urge to move the legs or arms, usually accompanied by unpleasant sensations during rest. It occurs especially in the evening or at night, and movement temporarily relieves it).
- •Changes in EEG, diarrhea, uncomfortable feeling in stomach, heartburn, abdominal pain after meals, muscle weakness, muscle cramps, muscle pain, nasal congestion, bedwetting, sudden uncontrolled increase in blood pressure (pseudopheochromocytoma), uncontrolled turning of the body to one side (pleurothotonus), ejaculation disorder in men where semen enters the bladder instead of exiting through the penis (dry orgasm or retrograde ejaculation); rash, purplish red spots, fever or itching due to vasculitis.
Important Warnings
- Do not take if you are allergic to clozapine or any other ingredients.
- Do not take if you cannot have regular blood tests.
- Do not take if you have previously had a low white blood cell count (e.g., leukopenia or agranulocytosis), especially if caused by medicines, unless due to cancer treatment.
- Do not take if clozapine treatment was previously stopped due to serious side effects (e.g., agranulocytosis or heart problems).
- Do not take if you are being treated or have been treated with long-acting antipsychotic injections.
Show 24 more warnings
- Do not take if you have or have had a bone marrow disease.
- Do not take if you have uncontrolled epilepsy (seizures).
- Do not take if you have an acute mental illness caused by alcohol or drugs.
- Do not take if you have reduced consciousness and severe drowsiness.
- Do not take if you have circulatory collapse, which can occur after severe shock.
- Do not take if you have severe kidney disease.
- Do not take if you have myocarditis (inflammation of the heart muscle).
- Do not take if you have any other severe heart disease.
- Do not take if you have symptoms of active liver disease, such as yellow skin and eyes, nausea, and loss of appetite.
- Do not take if you have any other severe liver disease.
- Do not take if you have paralytic ileus (paralysis of the bowel and severe constipation).
- Do not take if you are using medicines that prevent normal bone marrow function.
- Do not take if you are using medicines that reduce the number of white blood cells.
- Do not give Clozapine Stada to unconscious or comatose individuals.
- Contact your doctor immediately if you have signs of a cold or fever, flu-like symptoms, sore throat, or other signs of infection. You will need an urgent blood test.
- Contact your doctor immediately if you experience a sudden high fever and/or muscle stiffness that can lead to unconsciousness (neuroleptic malignant syndrome). This is a serious side effect requiring immediate treatment.
- Contact your doctor immediately if your heart rate is fast and irregular, even at rest, or if you have palpitations, difficulty breathing, chest pain, or unexplained tiredness. Your heart needs to be checked, and you might be referred to a heart specialist.
- Contact your doctor if you experience nausea, vomiting, and/or loss of appetite. Your liver must be checked.
- Contact your doctor if you have severe constipation. This needs medical treatment to prevent other complications.
- Contact your doctor if you experience constipation, abdominal pain, tenderness in the abdomen, fever, swelling, and/or bloody diarrhea. You need to be examined.
- Do not drink alcohol during Clozapine Stada treatment.
- Do not use Clozapine Stada if you are under 16 years old.
- Do not breastfeed during Clozapine Stada treatment.
- Clozapine Stada can cause fatigue, drowsiness, and seizures, especially at the beginning of treatment. If you experience these symptoms, do not drive or operate machinery.