25 mg tablets and 100 mg clozapine tablets
What Leponex is and what it is used for
The active substance in Leponex is clozapine which belongs to a group of medicines called antipsychotic medicines, which are used to treat specific mental conditions e.g. psychos.
leponex is used to treat patients with schizophrenia for whom other medicines have not worked satisfactorily.
Schizophrenia is a mental illness, which affects how you think, feel, and behave. You should only take this medicine if you have already tried at least two other antipsychotic drugs, including one of the newer so-called atypical antipsychotic drugs, to treat schizophrenia and none of these drugs have worked satisfactorily or caused serious untreatable side effects.
leponex is also used to treat severe mental, emotional and behavioral disorders in people with Parkinson’s disease for whom other medicines have not worked.
What you need to know before you take Leponex
Do not take Leponex if you:
- is allergic (hypersensitive) to clozapine or to any of the ingredients of Leponex (listed in section 6).
- do not have the opportunity to participate in regular blood tests.
- have previously been informed that you have low white blood cell count (eg leukopenia or agranulocytosis ), especially if this has been caused by other medicines.This does not apply if you have low blood cell counts as a result of previous cancer treatment ( chemotherapy ).
- have previously discontinued the use of Leponex due to serious side effects (eg agranulocytosis and heart problems).
- treated with or have been treated with long-acting depot injections of antipsychotic drugs.
- has or has had impaired bone marrow function.
- have uncontrolled epilepsy (seizures and seizures).
- have an acute mental illness caused by alcohol or drugs (eg drugs).
- has decreased consciousness and pronounced drowsiness.
- has had a collapse of the blood circulation, which can occur as a result of severe shock .
- have severe kidney disease.
- have inflammation of the heart muscle ( myocarditis ).
- have any other serious heart disease.
- have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, nausea or poor appetite).
- have another serious liver disease.
- if your bowel is not functioning normally and you have severe constipation (paralytic ileus ).
- use drugs that prevent your bone marrow from functioning normally.
- Take any medicine that reduces the number of white blood cells in your blood.
If any of the above apply to you, tell your doctor and do not take Leponex.
leponex must not be given to anyone who is unconscious or in a coma.
Warnings and cautions
The safety precautions in this section are very important. You must follow them to minimize the risk of serious life-threatening side effects.
Before treatment with Leponex, tell your doctor if you have or have had:
- blood clots or if someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
- glaucoma (increased pressure in the eye)
- diabetes . Elevated blood sugar level (sometimes very elevated), have occurred both in patients with preexisting diabetes or without previous diabetes (see section 4)
- prostate problems or difficulty urinating
- heart, kidney or liver disease
- chronic constipation or if you are taking medicines that can cause constipation (such as anticholinergics)
- galactose intolerance, total lactate deficiency or lack of glucose- galactose uptake
- controlled epilepsy
- colon disease
- underwent any abdominal surgery
- a heart disease or if someone in your family has had disorders of the cardiac conduction system called ” QT prolongation “,
- an increased risk of stroke , if you have high blood pressure , cardiovascular problems or disease in the blood vessels of the brain, for example .
Tell your doctor immediately before taking the next Leponex tablet if you:
- get signs of cold, fever, flu-like symptoms, sore throat or any other infection . You will then immediately need to take a blood sample to check if your symptoms are related to your medicine.
- has a sudden rapid increase in body temperature and stiff muscles that can lead to unconsciousness. It can be a serious side effect (malignant neuroleptic syndrome) that requires immediate treatment.
- have rapid and irregular heartbeats , even at rest, palpitations, difficulty breathing, chest pain or unexplained fatigue . Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.
- is nauseous, vomits and / or has a lack of appetite . Then your doctor needs to check your liver.
- have severe constipation . Your doctor will treat this to avoid later complications.
- have constipation, abdominal pain, abdominal tenderness, fever, bloating and / or bloody diarrhea . Your doctor will need to examine you.
Medical and blood tests
Before starting treatment with Leponex, your doctor will ask you about your medical history and take a blood test to make sure that your white blood cell count is normal. It is important to find out this because your body needs white blood cells to fight your infection.
Make sure you have regular blood tests before starting treatment, during treatment, and after stopping treatment with Leponex.
- Your doctor will carefully inform you when and where to take a blood test. Leponex should only be taken if you have a normal number of blood cells .
- Leponex can cause a large decrease in the number of white blood cells in your blood ( agranulocytosis ).
- Only regular blood tests can tell your doctor if you are at risk of developing agranulocytosis .
- During the first 18 weeks of treatment, blood tests are performed once a week. Later, blood tests are taken at least once a month.
- If there is a decrease in the number of white blood cells , you must stop the Leponex treatment immediately. Your white blood cells will return to normal.
- You will need to have a new blood test 4 weeks after stopping Leponex treatment.
Your doctor will also examine you before you start treatment. Your doctor may take an ECG to examine your heart, but only if it is considered necessary or if you have special concerns.
If you have impaired liver function, you will need regular liver function tests while you are taking Leponex.
If you suffer from high blood sugar levels ( diabetes ), your doctor may need to check your blood sugar levels regularly.
leponex can cause changes in blood fats. leponex can lead to weight gain. Your doctor may need to check your weight and blood fats.
If you already feel dizzy or if Leponex makes you dizzy, dizzy, or faint, be careful when standing up from a sitting or lying position as these may increase the risk of falling.
If you need surgery or if for some reason you can not walk for a long time, discuss with your doctor the fact that you are taking Leponex. You are at risk of getting a blood clot in a vein ( thrombosis ).
Children and adolescents under 16 years
If you are under 16 years of age, do not take Leponex, as there is not enough information on its use in this age group.
Elderly people (60 years and older)
Elderly people (60 years and older) are more likely to get the following side effects during treatment with Leponex: Fainting or dizziness in the head after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.
Tell your doctor or pharmacist if you suffer from dementia.
Other medicines and Leponex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and natural remedies. You may need to take a different amount of your medicine or take other medicines.
Do not take Leponex with medicines that prevent the bone marrow from functioning normally and/or reducing the number of blood cells produced by the body, such as:
- carbamazepine, a medicine used to treat epilepsy
- certain antibiotics: chloramphenicol, sulfonamide (eg co-trimazole)
- certain painkillers: pyrazolone analgesics such as phenylbutazone
- penicillamine, a drug used to treat rheumatic arthritis
- cytotoxic agents, drugs used in chemotherapy
- long-acting depot injections of antipsychotic drugs
These medicines increase your risk of developing agranulocytosis (lack of white blood cells ).
Treatment with Leponex with other medicines may affect how well Leponex and/or the other medicines work. Tell your doctor if you are planning to take, if you are taking (even if your treatment is about to end) or if you have recently taken any of the following medicines:
- drugs used to treat depression e.g. lithium, fluvoxamine, tricyclic antidepressants , MAO inhibitors , citalopram , paroxetine , fluoxetine and sertraline
- other antipsychotic drugs to treat mental illness, such as perazine
- benzodiazepines and other medicines used to treat anxiety and difficulty sleeping
- drugs and other drugs that may affect breathing
- drugs that control epilepsy such as phenytoin and valproic acid
- drugs used to treat high or low blood pressure such as adrenaline and norepinephrine
- warfarin , a drug used to prevent blood clots
- antihistamines , medicines used for allergies such as hay fever
- anticholinergic drugs, which are used to relieve stomach cramps, spasms and motion sickness
- drugs used in Parkinson’s disease
- digoxin , a drug used in heart problems
- drugs used to treat fast or irregular heartbeat
- some medicines used to treat stomach ulcers , such as omeprazole or cimetidine
- some antibiotics , such as erythromycin and rifampicin
- some medicines used to treat fungal infections (such as ketoconazole ) or viral infections (eg protease inhibitors , used to treat HIV infections)
- atropine, a drug that can be used in certain eye drops or in cough and cold products
- adrenaline , a drug used in emergencies
- hormonal contraceptives.
This list is not complete. Your doctor and pharmacist have more information about the medicines that you should be careful of or avoid when taking Leponex. They also know if the medicines you are currently taking are on the list of medicines. Talk to them.
Taking Leponex with food and drink
Do not drink alcohol during treatment with Leponex.
Tell your doctor if you smoke and how often you drink caffeinated beverages (coffee, tea, and Coca-cola). Sudden changes in your smoking or caffeine habits can also change the effect of Leponex.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss the benefits and possible risks for you of using this medicine during pregnancy. Tell your doctor immediately if you become pregnant during treatment with Leponex.
The following symptoms may occur in newborns of mothers who have used Leponex during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.
Some women who take medication to treat mental illness have irregular periods or none at all. If you have been affected in this way, your periods may return when you are treated with Leponex. This means that you must use an effective contraceptive method.
Do not breastfeed during treatment with Leponex. Clozapine, the active substance in Leponex, may pass into your breast milk and affect your baby.
Driving and using machines
Do not drive or use any tools or machines as Leponex may cause fatigue, drowsiness, and cramps, especially at the beginning of treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Leponex contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Leponex.
How to take Leponex
To reduce the risk of low blood pressure, seizures, and drowsiness, it is necessary for your doctor to increase the dose gradually. Always take Leponex exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
You mustn’t change your dose or stop taking Leponex without consulting your doctor first.
Keep taking the tablets for as long as your doctor tells you to. If you are 60 years of age or older, your doctor may start with the lower dose and gradually increase it as you are at greater risk of developing any side effects (See section 2 “What you need to know before taking Leponex”).
If the dose one you have been prescribed cannot be achieved with this strength on the tablet, there are other strengths of this medicine that may make it possible to achieve dose one.
Treatment of schizophrenia
The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice on the first day followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If you tolerate this well, your doctor will gradually increase the dose one by one in 25 mg-50 mg over the next 2-3 weeks until a dose of 300 mg per day is reached. Thereafter, if necessary, the daily dose may be increased in increments of 50 to 100 mg twice a week or preferably at weekly intervals.
The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses per day. Some patients may need a higher dose. A daily dose of up to 900 mg is allowed. Increased side effects (especially seizures) may occur with daily doses above 450 mg. Always take the lowest dose that is effective for you. Most people take part of their dose in the morning and the other part in the evening. Your doctor will tell you exactly how to distribute the daily dose. About your daily dose of only 200 mg, you can take it as a single dose in the evening. Once you have taken Leponex with good results for some period, your doctor may try a lower dose. You need to take Leponex for at least 6 months.
Treatment of severe thought disorders in patients with Parkinson’s disease
The usual starting dose is 12.5 mg (half a 25 mg tablet) in the evening. Swallow the tablet with water.
Your doctor will then gradually increase the dose one step by 12.5 mg, not faster than 2 steps in a week, all the way up to a maximum dose of 50 mg at the end of the second week. Increases in dosage should be discontinued or postponed if you feel dizzy, dizzy, or confused. To avoid such symptoms, your blood pressure will be measured during the first few weeks of treatment.
The effective dose is usually between 25 mg and 37.5 mg, it is taken as a dose in the evening. Doses of 50 mg per day should only be exceeded in exceptional cases. The maximum daily dose is 100 mg. Always take the lowest dose that is effective for you.
Possible side effects
Like all medicines, Leponex can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention:
Tell your doctor immediately before taking the next Leponex tablet if you experience any of the following:
Very common ( may affect more than 1 user in 10 ):
- severe constipation . Your doctor will treat this to avoid further complications.
- fast heartbeat.
Common ( may affect up to 1 in 10 people ):
- signs of cold, fever, flu-like symptoms, sore throat or any other infection . Then you will need to take a blood test quickly to check if your symptoms are related to your medicine.
- seizures.
- suddenly faints or loses consciousness at the same time as you become muscle weak ( syncope ).
Uncommon ( may affect up to 1 in 100 people ):
- a sudden rapid increase in body temperature, stiff muscles, which can lead to unconsciousness (malignant neuroleptic syndrome) as this can be a serious side effect that requires immediate treatment.
- dizzy, dizzy or faint when standing up from a sitting or lying position as these may increase the risk of falling.
Rare ( may affect up to 1 in 1,000 people ):
- signs of respiratory infection or pneumonia such as fever, cough, difficulty breathing or wheezing.
- severe, burning, pain in the upper abdomen extending to the back as well as nausea and vomiting (due to inflammation of the pancreas).
- faints and / or becomes muscle weak due to a sharp drop in blood pressure.
- difficulty swallowing (which may cause you to put food in the trachea).
- nausea, vomiting and / or loss of appetite . In these cases, your doctor needs to check your liver.
- signs of becoming overweight or increasing obesity.
- respiratory arrest with or without snoring during sleep.
Rare ( may affect up to 1 in 1,000 people ) or Very rare ( may affect up to 1 in 10,000 users ):
- rapid and irregular heartbeat even at rest, palpitations, difficulty breathing, chest pain or unexplained fatigue . Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.
Very rare ( may affect up to 1 in 10,000 people ):
- persistent painful erection of the penis, if you are a man. This is called priapism. If you have an erection that lasts for more than 4 hours, immediate medical treatment may be necessary to avoid further complications.
- spontaneous bleeding or bruising, which may be a sign of decreased platelet count .
- symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, stomach pain, increased thirst, urination abnormally and often, confusion).
- stomach pain, cramps, bloated stomach, vomiting, constipation and problems with gas in the gastrointestinal tract which may be signs and symptoms of intestinal obstruction (intestinal obstruction).
- poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness and malaise. These symptoms may be a sign that you have started to develop a liver disease that can lead to cell death in the liver ( fulminant liver necrosis).
- nausea, vomiting, fatigue, weight loss that may be symptoms of inflammation of the kidneys.
Has been reported ( occurs in an unknown number of users ):
- oppressive chest pain, feeling of tightness in the chest (chest pain may radiate to the left arm, jaw, neck and upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting and palpitations (signs of heart attack), which may be life-threatening. Seek emergency medical treatment immediately.
- pressure over the chest, heaviness, tightness, burning or suffocating sensation (signs of insufficient blood flow and oxygen to the heart muscle), which can be life-threatening. Your doctor will need to check your heart.
- periodic “throbbing”, “throbbing” or “fluttering” sensation in the chest (palpitations).
- rapid and irregular heartbeat ( atrial fibrillation ). It can cause symptoms such as temporary palpitations, fainting, shortness of breath or chest pain. Your doctor will need to check your heart.
- symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual tiredness, cold and damp / sticky skin and nausea.
- signs of blood clots in the veins, especially in the legs, (symptoms are swelling, pain and redness of the legs), which can be transported via the blood vessels to the lungs and cause chest pain and difficulty breathing.
- diagnosed or suspected infection together with fever or low body temperature, abnormally fast breathing, fast heart rate, altered alertness and consciousness, drop in blood pressure (symptoms of sepsis ).
- heavy sweating, headache, nausea, vomiting and diarrhea (symptoms of cholinergic syndrome).
- severely decreased urine production (signs of kidney failure ).
- allergic reaction (swelling mainly of the face, mouth and throat, as well as the tongue, which may be itchy or painful).
- poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness and malaise. It can be a sign of a kind of liver disease which means that normal liver tissue is replaced with scar tissue. This leads to reduced liver function, including liver effects that have life-threatening consequences such as liver failure (which can lead to death), liver damage (damage to liver cells, bile ducts in the liver or both) and liver transplantation.
- burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages; tar-like, black, or bloody stools; bloating, heartburn, nausea or vomiting, early feeling of satiety (intestinal ulcers in the stomach and / or intestines), which can be life-threatening.
- severe abdominal pain aggravated by movement; nausea, vomiting, including bloody vomiting (coffee-like); tense abdomen with residual tenderness spreading across the abdomen; fever and / or chills (broken stomach or intestines), which can be life-threatening.
- constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may indicate a possible megacolon (enlargement of the intestines) or a blood clot in the blood vessels of the intestines (intestinal infarction / ischemia / necrosis), which can be life-threatening. Your doctor will need to examine you.
- sharp chest pain with shortness of breath with or without cough
- increased or new muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disease ( rhabdomyolysis ). Your doctor will need to examine you.
- sharp chest or abdominal pain with shortness of breath and with or without cough or fever.
- Extremely intense and severe skin reactions, such as rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with clozapine. Side effect can manifest itself as a rash with or without blisters. Skin irritation, edema , fever and flu-like symptoms may occur. Symptoms of DRESS syndrome usually occur about 2-6 weeks (possibly up to 8 weeks) after starting treatment.
If you get any of these side effects, talk to your doctor immediately before taking your next Leponex tablet.
Other side effects are
Very common ( may affect more than 1 user in 10 ):
Drowsiness, dizziness, increased saliva flow.
Common ( may affect up to 1 in 10 people ):
Increased white blood cell count ( leukocytosis ), increased number of a specific type of white blood cell count ( eosinophilia ), weight gain, blurred vision, headache, tremors, stiffness, internal anxiety, twitching of arms and legs, muscle twitching, abnormal movements, inability to initiate movement, inability to remain immobile, changes in ECG, high blood pressure, fainting when getting up quickly, nausea, vomiting, loss of appetite, dry mouth, slightly elevated values in liver tests, urinary incontinence, difficulty urinating, fatigue, fever, sweating, increased body temperature (speech difficulties, speech difficulties eg slurred speech).
Uncommon ( may affect up to 1 in 100 people ):
Decreased white blood cell count ( agranulocytosis ), speech difficulties (eg stuttering).
Rare ( may affect up to 1 in 1,000 people ):
Reduced number of red cells ( anemia ), restlessness, excitement, confusion, irregular heartbeat, inflammation of the heart muscle ( myocarditis ) or membrane surrounding the heart muscle (pericarditis), fluid retention around the pericardial sac (pericardial effusion), high blood sugar levels in the blood, diabetes mellitus, blood clots in the lungs ( thromboembolism ), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin / dark urine/itching, elevated levels of an enzyme called creatinine phosphokinase in the blood.
Very rare ( may affect up to 1 in 10,000 people ):
Increased numbers of platelets with the risk of blood clots, involuntary twitching of the arms and legs, obsessive thoughts and compulsive repetitive behavior (signs of obsessive-compulsive disorder), skin reactions, swelling in front of the ear (enlargement of the parotid glands), difficulty in breathing, very high levels of triglycerides you or cholesterol in the blood, heart muscle disease ( cardiomyopathy ), cardiac arrest, sudden unexplained death.
Has been reported ( occurs in an unknown number of users ) :
Changes in brain activity (seen on electroencephalogram / EEC), diarrhea, stomach pain, heartburn, stomach pain after the meal, muscle weakness, muscle cramps, muscle aches, nasal congestion, nocturnal bedwetting, sudden, uncontrollable increase in blood pressure (pseudopheochromocytoma) ( pleurothotonus), disturbed ejaculation in men which means that semen enters the bladder instead of ejaculation through the penis (dry orgasm or retrograde ejaculation), rash, purplish-red spots, fever or itching due to inflammation of blood vessels, inflammation in the colon that causes diarrhea, abdominal pain, fever, changes in skin color, redness of the face, joint pain, muscle aches, fever and fatigue (lupus erythematosus ). Restless legs syndrome ( compulsive need to move your legs or arms. This is usually accompanied by unpleasant sensations during times of rest, especially in the evening or at night, and is temporarily relieved by movement).
In the elderly with dementia, a small increase in the number of deaths has been reported for patients who have been treated with antipsychotics compared with those who have not been treated.
How to store Leponex
- Keep this medicine out of the sight and reach of children.
- Do not use Leponex after the expiry date which is stated on the blister / jar and carton. The expiration date is the last day of the specified month.
- No special storage instructions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is clozapine. Each tablet contains 25 mg clozapine resp. 100 mg clozapine.
- The other ingredients are magnesium stearate, colloidal silicic acid, povidone K30, talc, corn starch, lactose monohydrate .
What the medicine looks like and contents of the pack
Both strengths of Leponex are available in PVC / PVDC / aluminum or PVC / PE / PVDC / aluminum blister packs containing 7, 14, 20, 28, 30, 40, 50, 60, 84, 98, 100, 500 (10×50) or 5000 ( 100×50) tablets.
PVC / PVDC / Aluminum or PVC / PE / PVDC / Aluminum, perforated single-dose blister containing 7 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 40 x 1, 50 x 1, 60 x 1, 84 x 1.98 x 1, 100 x 1, 500 (10 x 50 x 1) and 5000 (100 x 50 x 1) tablets and in white plastic jars containing 100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer:
Mylan Hungary Kft.
Mylan UTC 1
Komárom 2900
Hungary
Alternative manufacturers
McDermott Laboratories Limited T / A Gerard Laboratories T / A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland