PSYCLO 100MG TABLET

Manufacturer : SMP-SIGMUND PROMEDICA
Composition : CLOZAPINE-100MG
Dose Form : TABLET
Description : PSYCLO 100MG TAB
Route Of Administration : ORAL
Pack : 10
Out of stock
SKU
PSY0010
₹81.00
Manufacturer : SMP-SIGMUND PROMEDICA
Composition : CLOZAPINE-100MG
Dose Form : TABLET
Description : PSYCLO 100MG TAB
Route Of Administration : ORAL
Pack : 10

Drug Ingredient Information

CLOZAPINE-100MG

CLOZAPINE

Information for patients
Drug Information Clozapine belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis). Clozapine is used to treat people with schizophrenia in whom other medicines have not worked. Schizophrenia is a mental illness which affects how you think, feel and behave.You should only use this medicine if you have tried at least two other medicines to treat schizophrenia before, and these medicines did not work, or caused severe side effects that cannot be treated. Clozapine is also used to treat severe disturbances in the thoughts, emotions and behaviour of people with Parkinson’s disease in whom other medicines have not worked
Drug Alert
Alert if you are allergic (hypersensitive) to clozapine or any of the other ingredients of Clozapine. if you are not able to have regular blood tests. if you have ever been told you have a low white blood cell count (e.g. leucopenia or agranulocytosis), especially if this was caused by medicines. This does not apply if you have had low white blood cell count caused by previous chemotherapy. if you suffer from bone marrow disease or have ever suffered from bone marrow disease. if you use any medicine that stops your bone marrow from working properly. if you use any medicine that reduces the number of white cells in your blood. if you had to stop using Clozapine previously because of severe side effects (e.g. agranulocytosis or heart problems). if you suffer from uncontrolled epilepsy (seizures or fits). if you have an acute mental illness caused by alcohol or drugs (e.g. narcotics). if you suffer from myocarditis (an inflammation of the heart muscle).
Before Consuming the Medicine
Avoid Drug if you are allergic (hypersensitive) to clozapine or any of the other ingredients of Clozapine. if you are not able to have regular blood tests. if you have ever been told you have a low white blood cell count (e.g. leucopenia or agranulocytosis), especially if this was caused by medicines. This does not apply if you have had low white blood cell count caused by previous chemotherapy. if you suffer from bone marrow disease or have ever suffered from bone marrow disease. if you use any medicine that stops your bone marrow from working properly. if you use any medicine that reduces the number of white cells in your blood. if you had to stop using Clozapine previously because of severe side effects (e.g. agranulocytosis or heart problems). if you suffer from uncontrolled epilepsy (seizures or fits). if you have an acute mental illness caused by alcohol or drugs (e.g. narcotics). if you suffer from myocarditis (an inflammation of the heart muscle). - - - - - - - - if you suffer from any other severe heart disease. if you suffer from any severe kidney disease. if you have symptoms of active liver disease such as jaundice (yellow colouring of the skin and eyes, feeling sick and loss of appetite). if you suffer from any other severe liver disease. if you suffer from reduced consciousness and severe drowsiness. if you suffer from circulatory collapse which may occur as a result of severe shock. if you suffer from paralytic ileus (your bowel does not work properly and you have severe constipation). if you are being or have been treated with long-acting depot injections of antipsychotics. If any of the above applies to you, tell your doctor and do not take Clozapine. Clozapine must not be given to anyone who is unconscious or in a coma.
Drug Special Care blood clots or family history of blood clots, as medicines like these have been associated with formation of blood clots. glaucoma (increased pressure in the eye). diabetes. Elevated (sometimes considerably) blood sugar levels, has occurred in patients with or without diabetes mellitus in their medical history (see section 4). prostate problems or difficulty in urinating. any heart, kidney or liver disease. chronic constipation or if you are taking medicines which cause constipation (such as anticholinergics). galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. controlled epilepsy. large intestine diseases. tell your doctor if you have ever had abdominal surgery. if you have had a heart disease or family history of abnormal conduction in the heart called “prolongationof the QT interval”. if you are at risk for having a stroke, for example if you have high blood pressure, cardiovascular problems or blood vessel problems in the brain
Drug Drug Interactions Before you start taking Clozapine, please tell your doctor if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal therapies. You might need to take different amounts of your medicines or to take different medicines. Do not take Clozapine together with medicines that stop the bone marrow from working properly and/or decrease the number of blood cells produced by the body, such as: - - - - - - carbamazepine, a medicine used in epilepsy. certain antibiotics: chloramphenicol, sulphonamides such as co-trimoxazole. certain painkillers: pyrazolone analgesics such as phenylbutazone. penicillamine, a medicine used to treat rheumatic joint inflammation. cytoxic agents, medicines used in chemotherapy. long-acting depot injections of antipsychotic medicines. These medicines increase your risk of developing agranulocytosis (lack of white blood cells). Taking Clozapine may affect how well other medicines work or they might affect how well Clozapine works. Tell your doctor if you are taking any of the following medicines: - - - - - - medicines used to treat depression such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline. other antipsychotic medicines usued to treat mental illnesses. benzodiazepines and other medicines used to treat anxiety or sleep disturbances. narcotics and other medicines which can affect your breathing. medicines used to control epilepsy such as phenytoin and valproic acid. medicines used to treat high or low blood pressure such as adrenaline and noradrenaline. - - - - - - - - - - - warfarin, a medicine used to prevent blood clots. antihistamines, medicines used for colds or allergies such as hay fever. anticholinergic medicines, which are used to relieve stomach cramps, spasms and travel sickness. medicines used to treat Parkinson’s disease. digoxin, a medicine used to treat heart problems. medicines used to treat a fast or irregular heart beat. some medicines used to treat stomach ulcers, such as omeprazole or cimetidine. some antibiotic medicines, such as erythromycin and rifampicin. some medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors, used to treat HIV infections). atropine, a medicine which may be used in some eye drops or cough and cold preparations. adrenaline, a medicine used in emergency situations. This list is not complete. Your doctor and pharmacist have more information on medicines to be careful with or to avoid while taking Clozapine. They will also know if the medicines you are taking belong to the listed groups. Speak to them
Drug Pregnancy Interaction Tell your doctor before using Clozapine if you are pregnant or you think that you might be pregnant. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy. Tell your doctor immediately if you become pregnant during treatment with Clozapine. Some women taking some medicines to treat mental illnesses have irregular or no periods. If you have been affected in this way, your periods might return when your medicine is changed to Clozapine. This means you should use effective contraception.
Drug Breast feeding Interaction Do not breast-feed during treatment with Clozapine. Clozapine, the active substance of Clozapine, may pass into your milk and affect your baby.
Drug Machinery Interaction Clozapine might cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You should not drive or operate machines while you have these symptoms.
Drug More Information Do not drink alcohol during treatment with Clozapine. Tell your doctor if you smoke and how often you have drinks containing caffeine (coffee, tea, cola). Sudden changes in your smoking habits or caffeine drinking habits can also change the effects of Clozapine.
How to take the Medicine
Consumption Info Clozapine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, discuss this with your doctor before taking Clozapine.
Drug quanitty The usual starting dose is 12.5 mg (one half of a 25 mg tablet) once or twice on the first day followed by 25 mg once or twice on the second day. Swallow the tablet with water. If tolerated well, your doctor will then gradually increase the dose in steps of 25-50 mg over the next 2-3 weeks until a dose up to 300 mg per day is reached. Thereafter, if necessary, the daily dose may be increased in steps of 50 to 100 mg half-weekly 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 people might need more. A daily dose of up to 900 mg is allowed. Increased side effects (in particular seizures) are possible at daily doses over 450 mg. Always take the lowest effective dose for you. Most people take part of their dose in the morning and part in the evening. Your doctor will tell you exactly how to divide your daily dose. If your daily dose is only 200 mg, then you can take this as a single dose in the evening. Once you have been taking Clozapine with successful results for some time, your doctor may try you on a lower dose. You will need to take Clozapine for at least 6 months The usual starting dose is 12.5 mg (one half of a 25 mg tablet) in the evening. Swallow the tablet with water. Your doctor will then gradually increase the dose in steps of 12.5 mg, not faster than two steps a week, up to a maximum dose of 50 mg by the end of the second week. Increases in the dosage should be stopped or postponed if you feel faint, light-headed or confused. In order to avoid such symptoms your blood pressure will be measured during the first weeks of treatment. The effective daily dose is usually between 25 mg and 37.5 mg, taken as one 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 effective dose for you
Drug Dose Always take Clozapine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important that you do not change your dose or stop taking Clozapine without asking your doctor first. Continue taking the tablets for as long as your doctor tells you. If you are elderly, your doctor may start you on a lower dose and increase it more gradually because you might be more likely to develop some unwanted side effects (see section 2 “Before you take Clozapine”). If the dose you are prescribed cannot be achieved with this strength tablet, other strengths of this medicinal product are available to achieve the dose.
Excess Drug Consumption If you think that you may have taken too many tablets, or if anyone else takes any of your tablets, contact a doctor immediately or call for emergency medical help. The symptoms of overdose are: Drowsiness, tiredness, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff limbs, trembling hands, seizures (fits), increased production of saliva, widening of the black part of the eye, blurred vision, low blood pressure, collapse, fast or irregular heart beat, shallow or difficult breathing.
Forgot Drug Consumption If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, leave out the forgotten tablets and take the next dose at the right time. Do not take a double dose to make up for a forgotten dose. Contact your doctor as soon as possible if you have not taken any Clozapine for more than 48 hours.
Stop Drug Consumption Do not stop taking Clozapine without asking your doctor, because you might get withdrawal reactions. These reactions include sweating, headache, nausea (feeling sick), vomiting (being sick) and diarrhoea. Your original symptoms might come back. A gradual reduction in dose in steps of 12.5 mg over one to two weeks is recommended, if you have to stop treatment. Your doctor will advise you on how to reduce your daily dose. If you have to stop Clozapine treatment suddenly, you will have to be checked by your doctor. If your doctor decides to re-start the treatment with Clozapine and your last dose of Clozapine was over two days ago, this will be with the starting dose of 12.5 mg. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
General Information if you get signs of a cold, fever, flu-like symptoms, sore throat or any other infection. You will have to have an urgent blood test to check if your symptoms are related to your medicine. if you have a sudden rapid increase in body temperature, rigid muscles which may lead to unconsciousness (neuroleptic malignant syndrome) as you may be experiencing a serious side effect which requires immediate treatment. if you have fast and irregular heart beat, even when you are at rest, palpitations, breathing problems, chest pain or unexplained tiredness. Your doctor will need to check your heart and if necessary refer you to a cardiologist immediately. if you experience nausea (feeling sick), vomiting (being sick) and/or loss of appetite. Your doctor will need to check your liver. if you have severe constipation. Your doctor will have to treat this in order to avoid further complications. Medical check-ups and blood tests Before you start taking Clozapine, your doctor will ask about your medical history and do a blood test to ensure that your white blood cells count is normal. It is important to find this out, as your body needs white blood cells to fight infections Make sure that you have regular blood tests before you start treatment, during treatment and after you stop treatment with Clozapine. - - - - - Your doctor will tell you exactly when and where to have the tests. Clozapine can cause a serious decrease in the number of white cells in your blood (agranulocytosis). Only regular blood tests can tell the doctor if you are at risk of developing agranulocytosis. During the first 18 weeks of treatment, tests are needed once a week. Afterwards, tests are needed at least once a month. If there is a decrease in the number of white blood cells, you will have to stop Clozapine treatment immediately. Your white blood cells should then return to normal. You will need to have blood tests for another 4 weeks after the end of Clozapine treatment. Your doctor will also do a physical examination and may do an electrocardiogram (ECG) to check your heart, but only if these examinations are necessary for you, or if you have any special concerns. If Clozapine makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. If you have to undergo surgery or if for some reason you are unable to walk around for a long time, discuss with your doctor the fact that you are taking Clozapine. You may be at risk of thrombosis (blood clotting within a vein). Children and adolescents under 16 years If you are under 16 years of age you should not use Clozapine as there is not enough information on its use in that age group. Elderly patients Elderly patients may be more likely to have the following side effects during treatment with Clozapine: faintness or light-headedness after changing position, dizziness, fast heart beat, difficulty in passing urine, and constipation. Tell your doctor or pharmacist if you suffer from a condition called dementia
Common Drug Side Effects Low level of white blood cells (leukopenia), high level of white blood cells (leukocytosis), high level of a specific type of white blood cell (eosinophilia), weight gain, blurred vision, headache, trembling, stiffness, restlessness, seizures, convulsions, jerks, abnormal movements, high blood pressure, faintness or light- headedness after changing position, sudden loss of consciousness, nausea (feeling sick), vomiting (being sick), loss of appetite, dry mouth, minor abnormalities in liver function tests, loss of bladder control, difficulty in passing urine, tiredness, fever, increased sweating, raised body temperature, speech disorders (e.g.slurred speech).
Rare Drug Side Effects Low level of red blood cells (anaemia), restlessness, agitation, confusion, delirium, circulatory collapse, irregular heart beat, inflammation of the heart muscle (myocarditis) or the membrane surrounding the heart muscle (pericarditis), fluid collection around the heart (pericardial effusion), difficulty in swallowing (e.g. food going down the wrong way), respiratory tract infection and pneumonia, high level of sugar in the blood, diabetes mellitus, blood clot in the lungs (thromboembolism), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, inflammation of the pancreas leading to severe upper stomach pain, raised levels of an enzyme called creatinine phosphokinase in the blood
Very Rare Drug Side Effects Increase in numbers of blood platelets with possible clotting in the blood vessels, decrease in numbers of blood platelets, uncontrollable movements of mouth/tongue and limbs, obsessive thoughts and compulsive behaviours (obsessive compulsive symptoms), skin reactions, swelling in front of the ear (enlargement of saliva glands), difficulty in breathing, complications due to uncontrolled blood sugar (e.g. coma or ketoacidosis), very high levels of triglycerides or cholesterol in the blood, disorder of the heart muscle (cardiomyopathy), stopped heart beat (cardiac arrest), severe constipation with abdominal pain and stomach cramps caused by obstruction of the bowel (paralytic ileus), swollen abdomen, abdominal pain, severe liver damage (fulminant hepatic necrosis), inflammation of the kidneys, persistent painful erection of the penis, sudden unexplained death
Drug Side Effects Symptoms Blood clots in the vein. In elderly people with dementia, a small increase in the number of people dying has been reported for patients taking antipsychotics compared with those not taking antipsychotics. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist Blood clots in the vein. In elderly people with dementia, a small increase in the number of people dying has been reported for patients taking antipsychotics compared with those not taking antipsychotics. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist Lack of white blood cells (agranulocytosis), neuroleptic malignant syndrome (disorder with high fever, impaired consciousness and muscle stiffness), speech disorders (e.g. stuttering) Tell your doctor immediately before taking the next Clozapine tablet: - - - - - - - if you get signs of a cold, fever, flu-like symptoms, sore throat or any other infection. You will have to have an urgent blood test to check if your symptoms are related to your medicine. if you have a sudden rapid increase in body temperature, rigid muscles which may lead to unconsciousness (neuroleptic malignant syndrome) as you may be experiencing a serious side effect which requires immediate treatment. if you have fast and irregular heart beat, even when you are at rest, palpitations, breathing problems, chest pain or unexplained tiredness. Your doctor will need to check your heart and if necessary refer you to a cardiologist immediately. if you experience nausea (feeling sick), vomiting (being sick) and/or loss of appetite. Your doctor will need to check your liver. if you have severe constipation. Your doctor will have to treat this in order to avoid further complications. if you get signs of a respiratory tract infection or pneumonia such as fever, coughing, difficulty breathing, wheezing. if you get signs of blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Do not use Clozapine after the expiry date which is stated on the blister/bottle and the carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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.

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