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Neurology - Muscle

CLOZAREM

Clozapine Tablets 25 mg
Clozapine Tablets 100 mg

1. WHAT CLOZAREM IS AND WHAT IT IS USED FOR
Clozarem belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis).
Clozarem 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 already tried at least two other antipsychotic medicines, including one of the newer atypical antipsychotics, to treat schizophrenia, and these medicines did not work, or caused severe side effects that cannot be treated.
Clozarem 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.


2. BEFORE YOU TAKE CLOZAREM
Do not take Clozarem:
· If you are hypersensitive (allergic) to clozapine or to any of the ingredients of the product.
· If you are unable to undergo 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 or have ever suffered from impaired bone marrow function.
· 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 Clozarem previously because of severe side effects (e.g. agranulocytosis or heart problems).
· If you suffer from uncontrolled epilepsy (seizures or fits). P18-0507RPILECY3-02 11
· 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 Clozarem.
Clozarem must not be given to anyone who is unconscious or in a coma.
Take special care with Clozarem:
The safety measures mentioned in this section are very important. You must comply with them to minimise the risk of serious life-threatening side effects. Before you start treatment with Clozarem, tell your doctor if you suffer from or have ever suffered from:
· 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 out 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 are at risk for having a stroke, for example if you have high blood pressure, cardiovascular problems or blood vessel problems in the brain.
Tell your doctor immediately before taking the next Clozarem 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.
· Ifyou 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.
P18-0507RPILECY3-02 12
· 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 Clozarem, 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 Clozarem.
· Your doctor will tell you exactly when and where to have the tests. Clozarem may only be taken if you have a normal blood count.
· Clozarem 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 Clozarem 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 Clozarem treatment. Your doctor will also do a physical examination before starting treatment. Your doctor may do an electrocardiogram (ECG) to check your heart, but only if this is necessary for you, or if you have any special concerns.
If you have a liver disorder you will have regular liver function tests as long as you continue to take Clozarem. If you suffer from high levels of sugar in the blood (diabetes) your doctor may regularly check your level of sugar in the blood. Clozarem may cause alteration in blood lipids. Clozarem may cause weight gain. Your doctor may monitor your weight and blood lipid level.
If Clozarem 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 Clozarem. 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 Clozarem as there is not enough information on its use in that age group.
Older people (aged 60 years and over)
Older people (aged 60 years and over) may be more likely to have the following side effects during treatment with Clozarem: faintness or light-headedness after changing position, dizziness, fast heartbeat, difficulty in passing urine, and constipation.
Tell your doctor or pharmacist if you suffer from a condition called dementia. Taking other medicine:
Before you start taking Clozarem, 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 Clozarem 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. P18-0507RPILECY3-02 13
· 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 Clozarem may affect how well other medicines work or they might affect how well Clozarem
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 used 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.
· 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 Clozarem. They will also know if the medicines you are taking belong to the listed groups. Speak to them.
Taking Clozarem with food and drink Do not drink alcohol during treatment with Clozarem. 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 Clozarem.
Pregnancy and breast-feeding
Tell your doctor before using Clozarem 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 Clozarem. The following symptoms may occur in newborn babies, of mothers that have used Clozarem in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. 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 Clozarem. This means you should use effective contraception. Do not breast-feed during treatment with Clozarem. Clozapine, the active substance of Clozarem, may
pass into your milk and affect your baby.
Driving and using machines:
P18-0507RPILECY3-02 14
Clozarem might cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You should not drive or operate machines while you have these symptoms. Important information about some of the ingredients of Clozarem:
Clozarem 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 Clozarem.


3. HOW TO TAKE CLOZAREM
In order to minimise the risk of low blood pressure, seizures and drowsiness it is necessary that your doctor increases your dose gradually. Always take Clozarem 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 Clozarem without asking your doctor first. Continue taking the tablets for as long as your doctor tells you. If you are 60 years or older, your doctor may start you on a lower dose and increase it more gradually because you might be more likely to develop. 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.
Treatment of schizophrenia. 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 Clozarem with successful results for some time, your doctor may try you on a lower dose. You will need to take Clozarem 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.

If you take more Clozarem than you should:
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.


If you forget to take Clozarem:
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 Clozarem for more than 48 hours.

 

If you stop taking Clozarem:
Do not stop taking Clozarem without asking your doctor, because you might get withdrawal reactions. These reactions include sweating, headache, nausea (feeling sick), vomiting (being sick) and diarrhoea. If you have any of the above signs, tell your doctor straight away. These signs may be followed by more serious side effects unless you are treated immediately. 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 Clozarem treatment suddenly, you will have to be checked by your doctor. If your doctor decides to re-start the treatment with Clozarem and your last dose of Clozarem 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.


4. POSSIBLE SIDE EFFECTS
Like all medicines Clozarem can cause side effects, although not everybody gets them. Some side effects can be serious and need immediate medical attention: Tell your doctor immediately before taking the next Clozarem 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 experience crushing chest pain, sensation of chest tightness, pressure or squeezing (chest pain may radiate to the left arm, jaw, neck and upper abdomen), shortness of breath, sweating, weakness, light headedness, nausea, vomiting and palpitations (symptoms of heart attack). You should seek emergency medical treatment immediately.
· 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 chest pressure, heaviness, tightness, squeezing, burning or choking sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your doctor will need to check your heart.
· 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.
· If you experience profuse sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic syndrome).
· If you experience severely decreased urine output (sign of kidney failure).
· If you experience seizures.
· If you are a man and experience persistent painful erection of the penis. This is called priapism. If you have an erection which lasts more than 4 hours immediate medical treatment may be needed in order to avoid further complications. All possible side effects are listed under headings of frequency:
Very common (affects more than 1 in 10 people):
Drowsiness, dizziness, fast heart beat, constipation, increased production of saliva.
Common (affects up to 1 in 10 people):
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, inability to initiate movement, inability to remain motionless, 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).
Uncommon (affects up to 1 in 100 people):
Lack of white blood cells (agranulocytosis), neuroleptic malignant syndrome (disorder with high fever, impaired consciousness and muscle stiffness), speech disorders (e.g. stuttering).
Rare (affects up to 1 in 1,000 people):
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 (affects up to 1 in 10,000 people):
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 repetitive 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 (priapism), sudden unexplained death. Unknown (frequency cannot be estimated from the available data) Blood clots in the vein, profuse sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic syndrome), crushing chest pain, shortness of breath (symptoms of heart attack), chest pressure or heaviness (signs of insufficient blood flow and oxygen to the heart muscle), severely decreased urine output (sign of kidney failure), liver disorders including fatty liver disease, death of liver cells, liver toxicity/injury, liver disorders that involve replacement of normal liver tissue with scar tissue leading to loss of liver function, including those liver events leading to life-threatening consequences such as liver failure (which may lead to death), liver injury (injury of liver cells, bile duct in the liver, or both) and liver transplant, changes in brain waves machine (electroencephalogram/EEG), diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle spasms, muscle pain, stuffy nose, nocturnal bedwetting. 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In case you have purchased or been given the product in the Republic of Cyprus you can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Pharmaceutical Services
Ministry of Health
CY-1475
Fax: + 357 22608649
Website: www.moh.gov.cy/phs

 

5. HOW TO STORE CLOZAREM
Keep out of the reach and sight of children
Expiry date:
Do not use Clozarem after the expiry date stated on the inner and outer packaging.
Storage Conditions:
Store below 25°C, away from light and moisture.
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.

 

6. FURTHER INFORMATION
What Clozarem contains:
· The active substance is Clozapine 25 mg or 100 mg.
· The other ingredients are Microcrystalline Cellulose, Lactose, Maize Starch, Povidone, Sodium Starch Glycollate, Magnesium Stearate and Talc.

 

Pack sizes:
Clozarem 25 mg Tablets: This product is available in pack sizes of 20, 30, 40, 50, 60, 100 and 1000 tablets.
Clozarem 100 mg Tablets: This product is available in pack sizes of 50 and 1000 tablets.
Not all pack sizes may be marketed.

 

CY MA Holder / Manufacturer:
Remedica Ltd
Aharnon Str., Limassol Industrial Estate,
3056 Limassol,
Cyprus

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