Clozapine Doc Generici: detailed information

Package leaflet: Information for the user

CLOZAPINE DOC Generici 25 mg tablets, 100 mg tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CLOZAPINA DOC Generici is and what it is used for

The active substance of CLOZAPINA DOC Generici is clozapine, which belongs to a group of medicines
called antipsychotics (medicines used to treat specific mental disorders such as psychosis).
CLOZAPINA DOC Generici 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 been ineffective or have caused severe side effects that cannot be managed.
CLOZAPINA DOC Generici 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 need to know before taking CLOZAPINA DOC Generici

Do not take CLOZAPINA DOC Generici

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. leucopenia or agranulocytosis), especially if this was caused by medications. This does not apply if the low white blood cell count was due to previous chemotherapy.
If you previously had to stop taking CLOZAPINA DOC Generici 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 suffer from a bone marrow disorder or have ever had bone marrow disorders.
If you suffer from 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 are experiencing circulatory collapse that may occur following severe shock.
If you suffer from any 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, feeling unwell, and loss of appetite).
If you suffer from any other severe liver disease.
If you suffer from paralytic ileus (your intestine is not functioning 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 above situations apply to you, inform your doctor or pharmacist and do not take
CLOZAPINA DOC Generici.
CLOZAPINA DOC Generici must not be administered to individuals 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 DOC Generici, inform your doctor if you suffer or have ever suffered from:

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 (sometimes markedly elevated) blood sugar levels 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 a family history of a cardiac 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 cerebrovascular disease.
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking CLOZAPINA DOC Generici. This medicine can cause serious skin reactions. Stop taking clozapine and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions.

Inform your doctor immediately before taking the next tablet of CLOZAPINA DOC Generici:

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 experience 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 have a fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor will need to examine 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 function.
if you have severe constipation. Your doctor will need to treat this condition to prevent further complications.
if you develop constipation, abdominal pain, intestinal tenderness, fever, bloating, and/or bloody diarrhoea. Your doctor will need to examine you.
if you develop signs and symptoms of appendicitis; these may include severe and worsening abdominal pain starting near the navel and moving to the lower right abdomen, worsening with movement or coughing, or when pressure is applied to the area. Other signs may include constipation, abdominal bloating, malaise, low-grade fever, vomiting, loss of appetite, or diarrhoea. You will need to seek urgent medical evaluation.

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 DOC Generici.

Your doctor will tell you exactly when and where to have the tests. CLOZAPINA DOC Generici may only be taken if your blood cell count is normal.
This medicine can cause a serious 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 are required once a week. Afterwards, tests are needed at least once a month for the following 34 weeks.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then annually, provided no decrease in white blood cell count has occurred.
If there is a decrease in white blood cell count, you must stop treatment with clozapine immediately. The white blood cell count should then return to normal.
You will need to continue blood tests for another 4 weeks after stopping CLOZAPINA DOC Generici if treatment is discontinued completely for hematological reasons (i.e. agranulocytosis), or if monitoring duration is < 2 years and/or if you have a history of neutropenia that did not lead to treatment discontinuation.

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 disorders, you will need regular liver function tests throughout treatment with 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 dizzy, or if this medicine causes dizziness, lightheadedness, or fainting, be careful when standing up from a sitting or lying position, as this may increase the risk of falling.
If you are scheduled for surgery or for any reason are unable to walk for prolonged periods, inform your doctor that you are 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, you must not take CLOZAPINA DOC Generici, as there is insufficient information on its use in this age group.
Elderly people (aged 60 years or older)
Elderly people (aged 60 years or older) may be more likely to experience the following side effects during treatment with this medicine: weakness or lightheadedness upon changing position, dizziness, fast heartbeat, difficulty urinating, and constipation.
Inform your doctor or pharmacist if you suffer from a condition called dementia.
Other medicines and CLOZAPINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines or herbal remedies. Your doctor may need to adjust the dose of your medicines or prescribe different ones.
Do not take CLOZAPINA DOC Generici 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 co-trimoxazole.
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 DOC Generici together with another medicine may affect the action of CLOZAPINA DOC Generici 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 clots.
antihistamines, medicines used for colds or allergies such as hay fever.
anticholinergic medicines, used to relieve stomach cramps, spasms, and motion 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 cold and cough preparations.
adrenaline, a medicine used in emergency situations.
hormonal contraceptives (birth control pills).

This list is not exhaustive. Your doctor and pharmacist have more information about medicines to be taken with caution or avoided during treatment with CLOZAPINA DOC Generici, and they can also advise whether any medicines you are taking belong to those listed. Discuss this with them.
Taking CLOZAPINA DOC Generici 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). Even sudden changes in smoking habits or caffeine intake may alter the effects of this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 immediately if you become pregnant while being treated with CLOZAPINA DOC Generici.
The following symptoms may occur in newborns of mothers who took clozapine during the third trimester (the last three months of pregnancy): tremor, muscle rigidity 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 menstrual cycles or no periods at all. If this applies to you, your periods may return when switching from your current medicine to CLOZAPINA DOC Generici. This means you will need to use an effective contraceptive method.
Do not breastfeed while taking this medicine. Clozapine, the active substance in CLOZAPINA DOC Generici, can pass into breast milk and may 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 DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take CLOZAPINA DOC Generici

To minimize the risk of low blood pressure, seizures, and drowsiness, your doctor must gradually increase the dose. Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is important that you do not 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 need to know before taking CLOZAPINA DOC Generici”).
If the prescribed dose cannot be achieved with the available tablet strength, other strengths of this medicine are available to reach the required dose.
25 mg: the tablet can be divided into two equal doses.
100 mg: the tablet can be divided into two equal doses.

Treatment of schizophrenia
The initial dose is usually 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 dose of 300 mg per day. Afterwards, 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 mg and 450 mg, divided into multiple single doses per day. Some individuals may require a higher dose. A daily dose of up to 900 mg is permitted. However, an increase in side effects (particularly seizures) may occur 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, it may be taken as a single dose in the evening. After taking CLOZAPINA DOC Generici for some time with positive results, your doctor may attempt to reduce the dose. You should take this medicine for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson’s disease
The initial dose is usually 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 no more than two increases per week, up to a maximum dose of 50 mg by the end of the second week. Dose increases should be paused or delayed if you feel weak, drowsy, or confused. To avoid these symptoms, you should monitor your blood pressure during the first weeks of treatment.
The effective daily dose is generally between 25 mg and 37.5 mg, taken as a single 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 CLOZAPINA DOC Generici than you should
If you think you have taken too many tablets, or if someone else has taken 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 CLOZAPINA DOC Generici
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 correct time. Do not take a double dose to make up for the forgotten dose. Contact your doctor as soon as possible if you have not taken CLOZAPINA DOC Generici for more than 48 hours.

If you stop taking CLOZAPINA DOC Generici
Do not stop treatment with CLOZAPINA DOC Generici without consulting your doctor, as you may experience withdrawal symptoms. These may include sweating, headache, nausea (feeling unwell), vomiting, and diarrhoea. If any of these signs occur, contact your doctor immediately. These signs may be followed by more serious adverse 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 CLOZAPINA DOC Generici abruptly, 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 CLOZAPINA DOC Generici, you must restart treatment at 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 everyone experiences them.
Some side effects can be serious and require immediate medical attention.
Contact your doctor immediately before taking your next tablet of CLOZAPINA DOC Generici if you experience any of the following side effects:

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

Severe constipation. Your doctor will need to treat this condition to prevent further complications.
Fast heartbeat.

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

Signs of cold, fever, flu-like symptoms, sore throat or any other infection. You must urgently have a blood test to check whether your symptoms are related to this medicine.
Seizures.
Sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

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

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.
Feeling of light-headedness, dizziness or fainting when standing up from sitting or lying down, as this may increase the risk of falls.

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

Signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, wheezing.
Severe abdominal pain and burning pain in the upper abdomen, radiating to the back, accompanied by nausea and vomiting due to inflammation of the pancreas.
Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
Difficulty swallowing (which may cause aspiration of food).
Nausea (feeling unwell), vomiting and/or loss of appetite. Your doctor will need to check your liver.
Obesity or worsening of obesity.
Breathing interruption, 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):

Fast and 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.

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

If you are a man and experience episodes of painful, persistent penile erection. This condition is known as priapism. If an erection lasts more than 4 hours, you may need immediate medical treatment to avoid further complications.
Spontaneous bleeding or appearance of bruises, which may be signs of a reduced platelet count in the blood.
Symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation or confusion).
Abdominal pain, cramps, bloating, vomiting, constipation, inability to pass gas—these may be signs and symptoms of intestinal obstruction.
Loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness and malaise. These symptoms may indicate the onset of liver disease that could lead to fulminant hepatic necrosis.
Nausea, vomiting, fatigue, weight loss—these may be symptoms of kidney inflammation.

Not known (frequency cannot be determined from available data):

Unbearable chest pain, feeling of pressure, tightness or constriction in the chest (chest pain may radiate to the left arm, jaw, neck, or 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 for emergency medical help immediately.
Chest pressure, heaviness, tightness, oppression, burning or choking sensation (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.
Intermittent sensation in the chest of a "thud", "punch" or "abnormal beat" (palpitations).
Fast 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.
Symptoms of low blood pressure such as light-headedness, dizziness, fainting, blurred vision, unusual fatigue, cold and clammy skin, or nausea.
Signs of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), with clots possibly traveling through blood vessels to the lungs, causing chest pain and difficulty breathing.
Proven or strongly suspected infection with fever or abnormally low body temperature, abnormally rapid breathing, fast heart rate, changes in reactivity and sensitivity, drop in blood pressure (sepsis).
Excessive sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic syndrome).
Severe reduction in urine output (a sign of kidney failure).
Allergic reaction (swelling mainly of the face, mouth and throat, but also of the tongue, possibly causing itching or pain).
Loss of appetite, bloating, 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 life-threatening liver events such as liver failure (which may lead to death), liver injury (damage to liver cells, bile ducts in the liver, or both), and liver transplants.
Burning 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.
Severe abdominal pain worsened by movement, nausea, vomiting including vomiting blood (or coffee-ground-like material); the abdomen becomes rigid with rebound tenderness spreading from the perforation site throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) which may lead to death.
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.
Sudden chest pain with shortness of breath, with or without cough.
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.
Acute chest or abdominal pain with shortness of breath, with or without cough or fever.
Severe and very intense skin reactions have been reported during clozapine use, such as rash with eosinophilia and systemic symptoms (DRESS syndrome). The adverse skin reaction may appear as a rash with or without blisters. Skin irritation, oedema, fever and flu-like symptoms may occur. DRESS syndrome symptoms usually appear about 2–6 weeks (potentially up to 8 weeks) after starting treatment.
Inflammation of the appendix (appendicitis).

If any of the conditions described above affect you, consult your doctor immediately before taking your next tablet of CLOZAPINA DOC Generici.

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 count (leucocytosis), elevated levels of a specific 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 tracing, high blood pressure, weakness or light-headedness upon 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):
Absence 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), inability to rest, 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), liver inflammation (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 blood clot formation 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 determined from available data):
Changes observed on electroencephalogram (EEG), diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden uncontrolled increase in blood pressure (pseudopheochromocytoma), uncontrolled curvature of the body to one side (pleurothotonus), in males, ejaculation disorders where semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), skin rash, red-purple 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 rest periods, especially in the evening or at night, and temporarily relieved by movement), blood tumour (haematological malignancy).

A small increased risk of developing blood tumours has been observed in patients taking clozapine, particularly with longer-term treatment.
Symptoms may include:

Unexplained fever
Swollen glands
Persistent infections during treatment
Weight loss
Extreme tiredness
Redness
Night sweats
Tendency to bruise easily or bleed excessively.

In elderly patients with dementia, a slightly increased 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CLOZAPINE DOC Generici

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 carton and blister after “Exp”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or shows 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 DOC Generici contains
The active substance is clozapine.
CLOZAPINA DOC Generici 25 mg: each tablet contains 25 mg of clozapine.
CLOZAPINA DOC Generici 100 mg: each tablet contains 100 mg of clozapine.
The other components are monohydrate lactose, maize starch, povidone K 30, anhydrous colloidal silica, magnesium stearate and talc.

Description of the appearance of CLOZAPINA DOC Generici and contents of the pack
CLOZAPINA DOC Generici 25 mg: tablet of pale yellow to yellow colour, round, approximately 6.0 mm in diameter, uncoated, with "FC" and "1" printed on either side of a break line on one side, smooth on the opposite side.
CLOZAPINA DOC Generici 100 mg: tablet of pale yellow to yellow colour, round, approximately 10.0 mm in diameter, uncoated, with "FC" and "3" printed on either side of a break line on one side, smooth on the opposite side.
25 mg: the tablet can be divided into two equal doses.
100 mg: the tablet can be divided into two equal doses.
CLOZAPINA DOC Generici is available in aluminum-PVC/PVDC blisters.
Pack sizes:
25 mg: 28 tablets in blister
100 mg: 28 tablets in blister.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer

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

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Italy: CLOZAPINA DOC Generici