Clozapine 100 mg. 50 tablets

1. What Clozapine is and what it is used for

The active substance in Clozapine is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders such as psychosis).

Clozapine is used to treat people with schizophrenia for whom other medicines have not worked.

Schizophrenia is a mental illness that affects your thinking, emotional reactions and behavior. You should only use this medicine if you have already tried treatment with at least two other antipsychotic medicines, including one of the new atypical antipsychotics, to treat schizophrenia, and they did not work, or caused severe side effects that cannot be be treated.

Clozapine is also used to treat thought, emotional and behavioral disturbances in people with Parkinson's disease when other types of treatment have failed.

2. What you need to know before you take Clozapine

Do not take Clozapine:

if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6);

if you are unable to undergo regular blood tests;

if you have been told that you have a low white blood cell count (leukopenia and agranulocytosis), especially if this was caused by medicines. This does not apply if you have had a low blood cell count after chemotherapy.

if you have previously had to stop taking Clozapine Accord for severe side effects (eg agranulocytosis or a heart problem);

if you are being treated or have been treated with antipsychotics in the form of long-acting depot injections;

if you suffer from or have previously suffered from bone marrow disease;

if you suffer from uncontrolled epilepsy (fits or seizures);

if you have an acute mental illness caused by the use of alcohol or other substances (eg drugs);

if you suffer from blurred consciousness and severe drowsiness;

if you suffer from circulatory collapse, which can occur as a result of severe shock;

if you suffer from severe kidney disease;

if you suffer from myocarditis (inflammation of the heart muscle);

if you suffer from any other serious heart disease;

if you have symptoms of active liver disease, such as jaundice (yellowing of the skin and eyes, nausea and loss of appetite);

if you suffer from any other severe liver disease;

if you suffer from paralytic ileus (your bowels do not work properly and you are severely constipated);

if you are taking any medicine that suppresses bone marrow function;

if you are using any medicine that reduces the number of white blood cells in your blood.

If any of the above applies to you, tell your doctor or pharmacist and do not take Clozapine Accord.

Warnings and precautions

The safety precautions mentioned in this section are very important. You must comply with them to reduce the risk of serious life-threatening side effects.

Talk to your doctor before taking Clozapine Accord if you have or have ever had:

blood clots or have a family history of blood clots, as this type of medicine is associated with blood clots;

glaucoma (increased intraocular pressure);

diabetes. Elevated (sometimes significantly) blood sugar levels are observed in patients with or without diabetes mellitus in their medical history (see section 4);

prostate problems or difficulty urinating;

any heart, kidney or liver disease;

chronic constipation or if you are taking medicines that cause constipation (such as anticholinergic medicines);

galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;

controlled epilepsy;

diseases of the colon;

abdominal surgery;

heart disease or a family history of impaired cardiac conduction called "QT prolongation";

risk of having a stroke, for example if you have high blood pressure, cardiovascular problems or problems with blood vessels in the brain.

Tell your doctor immediately before taking the next Clozapine Accord tablet:

if you get cold symptoms, fever, flu-like symptoms, sore throat or other infection. You should have an urgent blood test to check if your symptoms are related to your medicine;

if you experience a sudden and rapid increase in temperature and/or muscle stiffness that may lead to loss of consciousness (neuroleptic malignant syndrome), as you may be experiencing a serious side effect that requires immediate treatment;

if you have a fast and irregular heartbeat even when you are at rest, palpitations, trouble breathing, chest pain or unexplained tiredness. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately;

you have nausea (feeling sick) or vomiting, and/or loss of appetite. Your doctor will need to check

your liver;

if you have severe constipation. Your doctor will need to prescribe treatment to avoid further complications;

if you have constipation, abdominal pain, abdominal pain, fever, stomach swelling and/or bloody diarrhoea. Your doctor should examine you.

Medical examinations and blood tests

Before you start taking this medicine, your doctor will ask about your medical history and order blood tests to make sure your white blood cell count is normal. This is important to know because your body needs white blood cells to fight infections.

Make sure you have regular blood tests before, during and after stopping treatment with Clozapine Accord.

Your doctor will tell you exactly when and where to do the tests. Clozapine Accord can only be taken if you have a normal blood count.

This medicine can cause a serious decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can show the doctor if you are at risk of developing agranulocytosis.

During the first 18 weeks of treatment, it is necessary to do tests once a week. After that, examinations are required at least once a month.

If a decrease in the number of white blood cells is detected, treatment with clozapine should be stopped immediately. Your white blood cell count should then return to normal.

Blood tests should be done for another 4 weeks after the end of clozapine treatment.

Before starting treatment, your doctor will also perform a physical examination. He may do an electrocardiogram (ECG) to check the condition of your heart, but only if this is necessary or if you have a particular concern.

If you have a liver disorder while taking the medicine you will have regular liver function tests.

If you have high blood sugar (diabetes), your doctor may check it regularly.

This medicine may cause changes in blood lipids. This medicine may cause weight gain. Your doctor may monitor your weight and the level of lipids in your blood.

If you feel dizzy, or if this medicine makes you feel dizzy, light-headed or sick, be careful when getting up from a sitting or lying position, as this may increase the chance of falling.

If you are about to have surgery or for some reason your mobility is limited for a long time, discuss with your doctor the fact that you are taking clozapine. You may be at increased risk of thromboembolism (formation of a blood clot in the veins).

Children and adolescents under 16 years of age

If you are under 16 years of age you should not use Clozapine Accord as there is not enough information on its use in this age group.

Old age (60 and over)

Elderly patients (60 years and older) may be more susceptible to the following side effects during treatment with clozapine: feeling sick or dizzy when changing body position, dizziness, rapid heart rate, urinary retention or constipation.

Tell your doctor or pharmacist if you have a condition called dementia.

Other medicines and Clozapine Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over-the-counter medications or herbal therapies. It may be necessary to take different amounts of the drugs or to take other drugs.

Do not take Clozapine Accord with medicines that prevent the bone marrow from working normally and/or reduce the number of blood cells produced by the body, such as:

carbamazepine, a medicine used for epilepsy;

some antibiotics: chloramphenicol, sulfonamides, such as co-trimoxazole;

some pain relievers: pyrazolone analgesics, such as phenylbutazone;

penicillamine, a medicine used to treat rheumatic arthritis;

cytotoxic agents, drugs used in chemotherapy;

long-acting depot injections of antipsychotic drugs.

These drugs increase the risk of developing agranulocytosis (lack of white blood cells).

Concomitant use of Clozapine Accord with another drug may affect the action of Clozapine Accord and/or the other drug. Tell your doctor if you plan to take, if you are taking (even if the course of treatment is coming to an end) or if you have recently stopped taking any of the following medicines:

drugs used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAOIs, citalopram, paroxetine, fluoxetine, and sertraline;

other antipsychotic medicines used to treat mental illness, such as perazine;

benzodiazepines and other drugs used to treat anxiety or sleep disturbances;

narcotics and other medications that 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 norepinephrine;

warfarin, a medicine used to prevent blood clots;

antihistamines, medicines used for colds or allergies, such as hay fever;

anticholinergic drugs, which are used to relieve stomach pain, cramps, and seasickness;

medicines used to treat Parkinson's disease;

digoxin, a medicine used to treat heart problems;

medicines used to treat a fast or irregular heartbeat;

certain medicines used to treat stomach ulcers, such as omeprazole or cimetidine;

certain antibiotics, such as erythromycin and rifampicin;

certain medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infections);

atropine, a medicine that can be used in some eye drops or cough and cold medicines;

adrenaline, a drug used in emergency situations;

hormonal contraceptives (birth control pills).

This list is not exhaustive. Your doctor and pharmacist have more information about medicines to watch out for or avoid while taking Clozapine Accord. Also, they know if the medicines you are taking belong to the listed groups. Talk to them.

Clozapine Accord with food, drink and alcohol

You should not drink alcohol during treatment with this medicine.

Tell your doctor if you smoke and how often you drink caffeinated beverages (coffee, tea, cola). Sudden changes in your smoking habits and consumption of drinks containing caffeine may also change the effects of clozapine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy. Tell your doctor or pharmacist immediately if you become pregnant during treatment with Clozapine Accord.

The following symptoms may occur in newborn babies whose mothers used clozapine in the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, you may need to contact your doctor.

Some women who take certain medications to treat mental health problems

bleeding, no period, or irregular periods. If you have been affected in this way, it is possible that your cycle will resume when you switch to Clozapine Accord. This means you must use effective contraception.

Do not breast-feed during treatment with this medicine. Clozapine, the active ingredient in Clozapine Accord, can pass into breast milk and affect your baby.

Driving and using machines

This drug may cause fatigue, drowsiness, and seizures, especially at the beginning of treatment. You should not drive or operate machinery while you have these symptoms.

Clozapine Accord contains lactose

Clozapine Accord contains lactose. If your doctor or pharmacist has told you that you have an intolerance to some sugars, consult your doctor or pharmacist before taking this medicine.

3. How to take Clozapine Accord

To minimize the risk of low blood pressure, fainting and drowsiness, your doctor should increase your dose gradually. Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

It is important not to change your dose or stop taking this medicine without first talking to your doctor. Keep taking the tablets for as long as your doctor tells you. If you are 60 years of age or older, your doctor may give you a lower starting dose to be increased gradually because you may be more likely to develop some unwanted side effects (see section 2 "Before you take Clozapine Accord" ).

If the dose you have been prescribed cannot be achieved with this concentration of tablets, other tablets are available with a concentration of the medicinal product that is more suitable for achieving the dose.

The tablet can be divided into two equal doses.

Treatment of schizophrenia

The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice a day on the first day, followed by 25 mg once or twice a day on the second day. If it is well tolerated, your doctor will then gradually increase the dose in steps of 25-50 mg over the next 2-3 weeks, until you reach a dose of 300 mg per day. Thereafter, if necessary, the daily dose may be increased in steps of up to 100 mg at semi-weekly or, preferably, weekly intervals.

The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses per day. Some people may need a higher dose. A daily dose of up to 900 mg is permissible. At daily doses above 450 mg, increased side effects (especially convulsions) are possible. Always take the lowest dose that is effective for you. Most people take part of their daily dose in the morning and the other part in the evening. Your doctor will tell you exactly how to divide your daily dose. If your daily dose is only 200 mg, you can take it in the evening as a single dose. After you have been taking Clozapine Accord with success for a while, your doctor may recommend that you try a lower dose. You will need to take the medicine 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 in steps of 12.5 mg, no more often than twice a week, up to a maximum dose of 50 mg by the end of the second week. Increasing the dose should be stopped or delayed if you feel weak, dizzy or confused. 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, as a single dose in the evening. Doses of 50 mg daily should only be exceeded in exceptional cases. The maximum daily dose is 100 mg. Always take the lowest dose that is effective for you.

If you have taken more Clozapine Accord than you should

If you think you may have taken too many tablets, or if someone else takes some of your tablets, contact a doctor immediately or seek emergency medical help.

Symptoms of overdose are:

Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations, agitation, slurred speech, stiff limbs, trembling hands, seizures (seizures), increased salivation, dilated pupils, blurred vision, low blood pressure, collapse, fast or irregular heartbeat, shallow or difficult breathing.

If you forget to take Clozapine Accord

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next one at the correct time. Do not take a double dose to make up for a missed dose. Contact your doctor as soon as possible if you have not taken Clozapine Accord for more than 48 hours.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

signs of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing.

severe, burning pain in the upper part of the abdomen, passing to the back, accompanied by nausea and vomiting due to inflammation of the pancreas.

sharp pain in the chest or abdomen, accompanied by shortness of breath, with or without cough or fever.

extremely intense and serious skin reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with clozapine. The adverse skin reaction may appear as a rash with or without blisters. Skin irritation, swelling and fever and flu-like symptoms may occur. Symptoms of DRESS syndrome usually appear approximately 2-6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above applies to you, tell your doctor immediately before taking the next Clozapine Accord tablet.

Other side effects:

Very common (may affect more than 1 in 10 people):

Drowsiness, dizziness, increased salivation.

Common (may affect up to 1 in 10 people):

High level of white blood cells (leukocytosis), high level of a certain type of white blood cell (eosinophilia), weight gain, blurred vision, headache, tremors, stiffness, restlessness, convulsions, spasms, unusual movements, inability to start moving, inability to stay still, EKG changes, high blood pressure, feeling sick or dizzy after changing position, nausea (feeling sick), vomiting, loss of appetite, dry mouth, minor abnormalities in liver function tests, loss of urinary control bladder, difficulty urinating, tiredness, fever, increased sweating, increased body temperature, speech disorders (eg slurred speech).

Uncommon (may affect up to 1 in 100 people):

Low levels of white blood cells (agranulocytosis), speech disorders (eg stuttering).

Rare (may affect up to 1 in 1,000 people):

Low level of red blood cells (anaemia), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), collection of fluid around the heart (pericardial effusion), high blood sugar, diabetes mellitus, blood clot in the lungs (thromboembolism), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, increased levels of the enzyme creatinine phosphokinase in the blood .

Very rare (may affect up to 1 in 10,000 people):

An increase in the number of platelets in the blood, with possible clotting in the blood vessels, uncontrollable movements of the mouth/tongue and limbs, obsessive thoughts and repetitive actions (obsessive-compulsive symptoms), skin reactions, swelling in the area in front of the ear (increased saliva gland), difficulty breathing, very high levels of triglycerides and cholesterol in the blood, disorder of the heart muscle (cardiomyopathy), stopping the heart (cardiac arrest), sudden unexplained death.

Not known (frequency cannot be estimated from the available data)

Changes in brain waves (electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, stuffy nose, bedwetting, sudden, uncontrollable increase in blood pressure (pseudopheochromocytoma), uncontrolled bending n

and the body on one side (pleurototonus), impaired ejaculation in men, in which sperm enter the bladder instead of ejaculating through the penis (dry orgasm or retrograde ejaculation), rash, purple-red spots, fever or itching due to inflammation of the blood vessels vessels, inflammation of the large intestine leading to diarrhoea, abdominal pain, fever, skin color change, "butterfly" rash on the face, joint pain, muscle pain, high fever and fatigue (lupus erythematosus), restless legs syndrome ( an overwhelming urge to move the legs or arms, usually accompanied by a feeling of discomfort at rest, especially in the evening or at night, which is temporarily relieved by movement).

In elderly people with dementia, a small increase in mortality has been reported in patients taking antipsychotics compared to those not taking antipsychotics.

5. How to store Clozapine Accord

This medicine does not require special storage conditions.

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date corresponds to the last day of the specified month.

Do not use this medicine if you notice that the package is damaged or shows signs of tampering.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Clozapine Accord contains

The active substance is clozapine.

Each tablet contains 100 mg of clozapine.

The other ingredients are: lactose monohydrate, corn starch, povidone K30, colloidal anhydrous silica, magnesium stearate and talc.

What Clozapine Accord looks like and contents of the pack

Pale yellow to yellow, round, uncoated tablet, approximately 10.0 mm in diameter, debossed with “FC” and “3” on both sides of the score and plain on the other side.

The tablet can be divided into two equal doses.

Clozapine Accord tablets are available packed in aluminum - PVC/PVDC blisters.

Types of packaging:

14, 28, 30, 40, 50, 60, 84, 100 or 500 tablets