Package leaflet: Information for the user

Clozapine Teva 25 mg tablets, 100 mg tablets, 200 mg tablets

clozapine
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Clozapine Teva is and what it is used for
What you need to know before taking Clozapine Teva
How to take Clozapine Teva
Possible side effects
How to store Clozapine Teva
Contents of the pack and other information

1. What Clozapina Teva is and what it is used for

The active substance of Clozapina Teva is clozapine, which belongs to a group of medicines
called antipsychotics (medicines used to treat specific mental disorders such as psychosis).
Clozapina Teva is used to treat people with schizophrenia who have not benefited from other
medicines.
Schizophrenia is a mental illness that affects the way a person thinks, feels, and behaves. You should use this medicine only after having tried at least two other antipsychotic medicines for the treatment of schizophrenia, including one of the more recent atypical antipsychotics, and only if these medicines have not worked or have caused severe side effects that cannot be managed.
For
Clozapina Teva 25 mg tablets
Clozapina Teva 100 mg tablets only:
Clozapina Teva is also used to treat severe disturbances of thought, emotions, and behaviour in people with Parkinson's disease when other medicines have not worked.

2. What you should know before taking Clozapina Teva

Do not take Clozapina Teva

If you are allergic to clozapine or to any of the other ingredients of this medicine (listed in section 6).
If you are unable to undergo regular blood tests.
If you have previously had a low white blood cell count (e.g. leukopenia or agranulocytosis), especially if this was caused by medicines. This does not apply if the low white blood cell count was due to previous chemotherapy.
If you previously had to stop taking Clozapina Teva due to serious side effects (e.g. agranulocytosis or heart problems).
If you are or have been treated with long-acting depot antipsychotic injections.
If you have a bone marrow disorder or have ever had bone marrow disorders.
If you have uncontrolled epilepsy (epileptic seizures or convulsions).
If you have an acute mental disorder caused by alcohol or drugs (e.g. narcotics).
If you suffer from decreased level of consciousness and severe drowsiness.
If you have circulatory collapse that may occur following severe shock.
If you have any severe kidney disease.
If you have myocarditis (inflammation of the heart muscle).
If you have any other severe heart disease.
If you have symptoms of active liver disease, such as jaundice (yellowing of the skin and eyes, feeling unwell and loss of appetite).
If you have any other severe liver disease.
If you have paralytic ileus (your bowel does not function properly and you have severe constipation).
If you are taking any medicine that impairs bone marrow function.
If you are taking any medicine that reduces the number of white blood cells in the blood.

If any of the situations described above apply to you, inform your doctor or pharmacist and do not
take Clozapina Teva.
Clozapina Teva must not be administered to people who are unconscious or in a coma.
Warnings and precautions
The safety measures described in this section are very important and must be followed to
minimize the risk of serious, life-threatening side effects.
Before starting treatment with Clozapina Teva, inform your doctor if you have or have ever had:

Blood clots or a family history of blood clots, as medicines like this have been associated with blood clot formation.
Glaucoma (increased pressure in the eye).
Diabetes. High blood sugar levels (sometimes markedly elevated) have occurred in patients with or without a history of diabetes mellitus (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 anticholinergics).
Galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption.
Controlled epilepsy.
Diseases of the large intestine.
Inform your doctor if you have ever had abdominal surgery.
If you have had a heart disorder or have a family history of a heart conduction abnormality known as “QT interval prolongation”.
If you are at risk of stroke, for example if you have high blood pressure, cardiovascular problems or problems with blood vessels in the brain.

Inform your doctor immediately before taking your next dose of Clozapina Teva:

If you develop signs of cold, fever, flu-like symptoms, sore throat or any other infection. You will need to have a blood test urgently to check whether your symptoms are related to the medicine.
If you have a sudden and rapid increase in body temperature, muscle stiffness that may lead to unconsciousness (neuroleptic malignant syndrome), as this may indicate a serious side effect requiring immediate treatment.
If you have a fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
If you experience nausea (feeling unwell), vomiting and/or loss of appetite. Your doctor will need to check your liver.
If you have severe constipation. Your doctor will need to treat this condition to prevent further complications.
If you develop constipation, abdominal pain, abdominal tenderness, fever, swelling and/or bloody diarrhoea. Your doctor will need to examine you.

Clinical monitoring and blood tests
Before starting this medicine, your doctor will ask about your medical history and perform a blood test to ensure your white blood cell count is normal. This is important because your body needs white blood cells to fight infections.
Make sure you have regular blood tests before starting treatment,
during treatment and after stopping treatment with Clozapina Teva.

Your doctor will tell you exactly when and where to have the blood tests. Clozapina Teva may only be taken if your blood cell count is normal.
This medicine can cause a severe decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can help your doctor determine if you are at risk of developing agranulocytosis (see section 4).
During the first 18 weeks of treatment, blood tests must be performed once a week. Afterwards, blood tests must be performed at least once a month for the following 34 weeks.
After 12 months of treatment, blood tests must be performed every 12 weeks for one year, and then annually, provided no decrease in white blood cell count occurs within the month.
If there is a decrease in white blood cell count, you must stop treatment with clozapine immediately. The white blood cell count must then return to normal.
After stopping treatment with Clozapina Teva, you must continue blood tests for another 4 weeks if treatment was completely discontinued for haematological reasons (i.e. agranulocytosis), or if monitoring duration was less than 2 years and/or if you have a history of neutropenia that did not lead to discontinuation of treatment.

Your doctor will also perform a general physical examination before starting treatment. Your doctor may
also perform an electrocardiogram (ECG) to check your heart, but only if necessary or if you have
specific concerns.
If you have liver problems, you will need regular liver function tests for as long as you are taking this
medicine.
If you have high blood sugar levels (diabetes), your doctor may need to monitor your blood sugar levels regularly.
This medicine may cause changes in blood lipids. This medicine may cause weight gain. Your doctor may need to monitor your weight and blood lipid levels.
If you already feel or this medicine causes you to feel dizzy, lightheaded or faint, be careful when standing up from a sitting or lying position, as this may increase the risk of falls.
If you are scheduled for surgery or for any reason cannot walk for long periods, talk to your doctor about taking this medicine. You may be at risk of thrombosis (blood clot formation in veins).
Children and adolescents under 16 years of age
If you are under 16 years of age, do not take Clozapina Teva, as there is insufficient information on its use in this age group.
Elderly (aged 60 years or older)
Elderly patients (aged 60 years or older) may be more likely to experience the following side effects during treatment with this medicine: weakness or lightheadedness after changing position, dizziness, fast heartbeat, difficulty urinating and constipation.
Inform your doctor or pharmacist if you have a condition called dementia.
Other medicines and Clozapina Teva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription or herbal remedies. It may be necessary to adjust the dose of your medicines or to take different medicines.
Do not take Clozapina Teva together with medicines that impair bone marrow function and/or reduce the number of blood cells produced by the body, such as:

Carbamazepine, a medicine used for epilepsy.
Certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
Certain painkillers: pyrazolone analgesics such as phenylbutazone.
Penicillamine, a medicine used to treat rheumatic joint inflammation.
Cytotoxic agents, medicines used in chemotherapy.
Injections of long-acting depot antipsychotic medicines.

These medicines increase the risk of developing agranulocytosis (lack of white blood cells).
Taking Clozapina Teva together with another medicine may affect the effect of Clozapina Teva and/or the other medicine. Inform your doctor if you intend to take, are currently taking (even if treatment is nearly finished) or have recently stopped taking any of the following medicines:

Medicines for depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine and sertraline.
Other antipsychotic medicines used to treat mental disorders, such as perazine.
Benzodiazepines and other medicines used to treat anxiety or sleep disorders.
Narcotics and other medicines that may affect 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 clot formation.
Antihistamines, medicines used for colds or allergies such as hay fever.
Anticholinergic medicines, 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 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 may be used in certain eye drops or in cough and cold preparations.
Adrenaline, a medicine used in emergency situations.
Hormonal contraceptives (birth control pills).

This list is not complete. Your doctor and pharmacist have more information about medicines that should be taken with caution or avoided during treatment with Clozapina Teva, and know whether the medicines you are taking belong to those listed. Discuss this with them.
Taking Clozapina Teva with food, drinks and alcohol
Do not drink alcohol during treatment with this medicine.
Inform your doctor if you smoke and how frequently you consume caffeine-containing beverages (coffee, tea, cola). Sudden changes in smoking habits or caffeine intake may alter the effects of this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy.
Inform your doctor or pharmacist promptly if you become pregnant during treatment with Clozapina Teva.
The following symptoms may occur in newborns of mothers who took clozapine during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Some women who take certain medicines for mental disorders have irregular or absent menstrual cycles. If this applies to you, your periods may return when switching from your current medicine to Clozapina Teva. This means you will need to use an effective contraceptive method.
Do not breastfeed while taking this medicine. Clozapine, the active substance in Clozapina Teva, may pass into breast milk and affect your baby.
Driving and using machines
This medicine may cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You must not drive or operate machinery while experiencing these symptoms.
Clozapina Teva contains lactose
Clozapina Teva contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Clozapine Teva

To minimize the risk of low blood pressure, seizures,
and drowsiness, your doctor must gradually increase the dose. Take this medicine
exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is important not to change the dose or stop treatment with this medicine without first
consulting your doctor. Continue taking the tablets unless otherwise instructed by your doctor.
If you are 60 years of age or older, your doctor may start you on a lower dose and increase it more gradually,
as certain side effects may occur more frequently (see section 2 “What you should know before taking Clozapine Teva”).
If the prescribed dose cannot be achieved with a tablet of this strength, other strengths of this medicine are
available to reach the required dose.

Clozapine Teva 25 mg tablets
The tablet may be divided into two equal doses.

Clozapine Teva 100 mg tablets
The tablet may be divided into two equal doses.

Clozapine Teva 200 mg tablets
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.

Treatment of schizophrenia
The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice daily on the first day, followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If well tolerated, your doctor will gradually increase the dose by 25–50 mg at a time over the next 2–3 weeks until reaching a daily dose of 300 mg. Subsequently, if necessary, the daily dose may be increased by 50–100 mg at a time every 3–4 days, or preferably at weekly intervals.
The effective daily dose is generally between 200 and 450 mg, divided into several individual doses per day. Some individuals may require a higher dose. A daily dose of up to 900 mg is permitted. However, there may be an increased risk of side effects (particularly seizures) with daily doses exceeding 450 mg. Always take the lowest effective dose for you. Most people take part of the dose in the morning and part in the evening. Your doctor will tell you exactly how to divide the daily dose. If the daily dose is only 200 mg, you may take it as a single dose in the evening. After taking Clozapine Teva for some time with positive results, your doctor may attempt to reduce the dose. You should continue taking this medicine for at least 6 months.

For Clozapine Teva 25 mg tablets and Clozapine Teva 100 mg tablets only:

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. Take the tablet with water. Your doctor will gradually increase the dose by 12.5 mg at a time, with a maximum of two increases per week, until reaching a maximum dose of 50 mg by the end of the second week. Dose increases should be stopped or delayed if you feel weak, drowsy, or confused. To avoid these symptoms, your blood pressure should be monitored during the first weeks of treatment.
The effective daily dose is generally between 25 mg and 37.5 mg, taken as a single evening dose. 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 Clozapine Teva than you should
If you think you have taken too many tablets, or if someone else takes some of your tablets, contact your doctor immediately or seek urgent medical help.
Symptoms of overdose include:
Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff limbs, hand tremors, seizures (convulsions), increased saliva production, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, and difficulty breathing or shallow breathing.

If you forget to take Clozapine Teva
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and take the next dose at the usual 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 Teva for more than 48 hours.

If you stop taking Clozapine Teva
Do not stop treatment with Clozapine Teva without consulting your doctor, as you may experience withdrawal reactions. These reactions may include sweating, headache, nausea (feeling unwell), vomiting, and diarrhoea. If you experience any of these symptoms, contact your doctor immediately. These symptoms may be followed by more serious side effects unless you receive appropriate treatment promptly. The original symptoms may also return.
If you need to stop treatment, a gradual reduction of the dose in 12.5 mg steps over one to two weeks is recommended. Your doctor will advise you on how to reduce your daily dose. If you must stop treatment with Clozapine Teva suddenly, you should be monitored by your doctor.
If your doctor decides to restart treatment with this medicine and more than two days have passed since your last dose of Clozapine Teva, you must restart with the initial dose of 12.5 mg.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention.
Contact your doctor immediately before taking your next tablet of Clozapina Teva if you experience:
Very common (may affect more than 1 in 10 people) :

if you have severe constipation . Your doctor will need to treat this condition to prevent further complications.
if you have a fast heartbeat.

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

if you develop signs of cold, fever, flu-like symptoms, sore throat or any other infection . You will need to urgently have a blood test to check whether your symptoms are related to the medicine.
if you have epileptic seizures.
if you experience sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

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

if you have a sudden and rapid increase in body temperature, muscle rigidity that may lead to unconsciousness (neuroleptic malignant syndrome), as this may indicate a serious adverse reaction requiring immediate treatment.
if you feel light-headed, dizzy or faint when getting up from a sitting or lying position, as this may increase your risk of falling.

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

if you develop signs of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, or wheezing.
if you have severe pain and burning in the upper abdomen spreading to the back, accompanied by nausea and vomiting, due to inflammation of the pancreas.
if you experience fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
if you have difficulty swallowing (which may cause food aspiration).
if you have nausea (feeling unwell), vomiting and/or loss of appetite . Your doctor will need to check your liver.
if you show a tendency to become obese or to gain weight.
if breathing stops, 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 people) :

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

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

if you are a man and suffer from episodes of painful and prolonged penile erection. This condition is known as priapism. If you have an erection lasting more than 4 hours, you may require immediate medical treatment to avoid further complications.
if you have spontaneous bleeding or bruising, which may be signs of a decreased number of platelets in the blood.
if you experience symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation or confusion).
if you have abdominal pain, cramps, bloated abdomen, vomiting, constipation, inability to pass gas, which may be signs and symptoms of intestinal obstruction.
if you experience loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness and malaise. These symptoms may indicate the onset of a liver disorder that could lead to fulminant hepatic necrosis.
if you have nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

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

if you experience unbearable chest pain, tightness, pressure or squeezing in the chest (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 a heart attack) which may lead to death. In this case, call immediately for urgent medical assistance.
if you feel chest pressure, heaviness, tightness, constriction, burning or suffocation (signs of inadequate blood and oxygen supply to the heart muscle) which may lead to death. In this case, your doctor will need to check your heart.
if you feel intermittent sensations in the chest such as a “thump”, a “punch” or an “abnormal heartbeat” (palpitations).
if you have rapid and irregular heartbeats (atrial fibrillation). Occasional palpitations, fainting, shortness of breath or chest discomfort may occur. In this case, your doctor will need to check your heart.
if you experience symptoms of low blood pressure such as light-headedness, dizziness, fainting, blurred vision, unusual tiredness, cold and sweaty skin or nausea.
if you develop signs of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing.
if you develop a confirmed or strongly suspected infection with fever or low body temperature, abnormally rapid breathing, fast heart rate, changes in reactivity and sensitivity, low blood pressure (sepsis).
if you experience excessive sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic syndrome).
if you have a severe decrease in the amount of urine (a sign of kidney failure).
if you experience an allergic reaction (swelling mainly of the face, mouth and throat, but also of the tongue, which may cause itching or pain).
if you have loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness and malaise. This may indicate possible liver disorders involving replacement of normal liver tissue with scar tissue leading to loss of liver function, including liver events that may lead to life-threatening consequences such as liver failure (which may lead to death), liver injury (damage to liver cells, bile ducts in the liver, or both), and liver transplant.
if you feel burning and pain in the upper abdomen, particularly between meals, early in the morning or after drinking acidic beverages; tarry, black or bloody stools; bloating, heartburn, nausea or vomiting, early feeling of fullness (intestinal ulceration of the stomach and/or intestine) which may lead to death.
if you experience severe abdominal pain worsened by movement, nausea, vomiting including vomiting blood (or coffee-ground-like liquid); the abdomen becomes rigid with rebound tenderness spreading from the perforation site through the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) which may lead to death.
if you have constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhoea. This may indicate possible megacolon (enlargement of the intestine) or intestinal infarction/ischemia/necrosis which may lead to death. In this case, your doctor will need to examine you.
if you feel acute chest pain with shortness of breath, with or without cough.
if you develop new or increased muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disorder (rhabdomyolysis). In this case, your doctor will need to examine you.
if you feel acute chest or abdominal pain with shortness of breath, with or without cough or fever.
extremely severe and serious skin reactions, such as rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported during the use of Clozapina Teva. The adverse skin reaction may appear as a rash with or without blisters. Skin irritation, swelling, fever and flu-like symptoms may occur. Symptoms of DRESS syndrome usually appear about 2–6 weeks (potentially up to 8 weeks) after starting treatment.

If any of the situations described above apply to you, consult your doctor immediately before taking the next tablet of Clozapina Teva.
Other side effects:
Very common (may affect more than 1 in 10 people) :
Drowsiness, dizziness, increased saliva production.
Common (may affect up to 1 in 10 people) :
Elevated white blood cell levels (leukocytosis), elevated levels of a particular type of white blood cells (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, restlessness, seizures, spasms, abnormal movements, inability to initiate movements, inability to remain still, changes in ECG, high blood pressure, fainting or light-headedness after changing position, nausea (feeling unwell), vomiting, loss of appetite, dry mouth, slightly abnormal liver function tests, loss of bladder control, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g. slurred speech).
Uncommon (may affect up to 1 in 100 people) :
Lack of white blood cells in the blood (agranulocytosis), speech disorders (e.g. stuttering).
Rare (may affect up to 1 in 1,000 people) :
Low levels of red blood cells in the blood (anaemia), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), fluid accumulation around the heart (pericardial effusion), elevated blood sugar levels, diabetes mellitus, blood clots in the lungs (thromboembolism), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, increased blood levels of an enzyme called creatine phosphokinase.
Very rare (may affect up to 1 in 10,000 people) :
Increased number of platelets in the blood with possible formation of clots in blood vessels, uncontrolled movements of the mouth, tongue and limbs, obsessive thoughts and repetitive compulsive behaviours (obsessive/compulsive symptoms), skin reactions, swelling of the front part of the ears (enlargement of salivary glands), breathing difficulties, very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cessation of heartbeat (cardiac arrest), unexplained sudden death.
Not known (frequency cannot be estimated from the available data) :
Changes in the recording performed with brain wave equipment (electroencephalogram/EEG), diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal loss of urine, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), uncontrollable bending of the body to one side (pleurosthotonos), if you are a male, ejaculation disorders where semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), skin rash, purple-red spots, fever or itching due to inflammation of blood vessels, inflammation of the colon causing diarrhoea, abdominal pain, fever, skin colour changes, butterfly-shaped facial rash, joint pain, muscle pain, fever and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by unpleasant sensations during periods of rest, especially in the evening or at night, temporarily relieved by movement).
In elderly patients with dementia, a small increase in the number of deaths has been reported among patients taking antipsychotics compared to those not taking them.
Reporting of side effects .
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clozapina Teva

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack or blister after
"Exp." The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is damaged or if there are any signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Clozapina Teva Contains
The active substance is clozapine.
Clozapina Teva 25 mg tablets
Each tablet contains 25 mg of clozapine.
Clozapina Teva 100 mg tablets
Each tablet contains 100 mg of clozapine.
Clozapina Teva 200 mg tablets
Each tablet contains 200 mg of clozapine.
The other components are monohydrate lactose, maize starch, povidone K30, anhydrous colloidal silica,
magnesium stearate and talc.

Description of the Appearance of Clozapina Teva and Package Contents
Clozapina Teva 25 mg tablets
Pale yellow to yellow, round, uncoated tablet, approximately 6.0 mm in diameter, with "FC" and "1" imprinted on either side of a break line on one side, and smooth on the opposite side.
The tablet can be divided into two equal doses.

Clozapina Teva 100 mg tablets
Pale yellow to yellow, round, uncoated tablet, approximately 10.0 mm in diameter, with "FC" and "3" imprinted on either side of a break line on one side, and smooth on the opposite side.
The tablet can be divided into two equal doses.

Clozapina Teva 200 mg tablets
Uncoated, pale yellow to yellow, capsule-shaped tablets, approximately 17 mm long and 8 mm wide, with "FC" and "C" imprinted on one side with three break lines, and "7" imprinted on the other side with three break lines.
The score line on the tablet is only intended to facilitate breaking for ease of swallowing and is not intended for dividing the tablet into equal doses.

Clozapina Teva is available in aluminum PVC/PVDC blisters.
Pack sizes:
Clozapina Teva 25 mg tablets
7, 14, 20, 28, 30, 50, 60, 100 or 500 tablets in blister packs
Clozapina Teva 100 mg tablets
14, 28, 30, 50, 60, 84, 100 or 500 tablets in blister packs
Clozapina Teva 200 mg tablets
100 tablets in blister packs

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna 4, 20123 Milan, Italy

Manufacturer
Laboratori Fundació DAU - C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 – Spain