Package leaflet: Information for the patient

CLOZAPINE HEXAL 25 mg Tablets, 100 mg Tablets

Generic 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 other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT CLOZAPINE HEXAL IS AND WHAT IT IS USED FOR

The active substance of Clozapine Hexal is clozapine, which belongs to a group of medicines called
antipsychotics (used to treat specific mental disorders such as psychosis).
Clozapine Hexal 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 antipsychotics 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.
Clozapine Hexal is also used to treat severe disorders of thought, emotions, and behaviour in people with Parkinson's disease when other medicines have not worked.

2. WHAT YOU SHOULD KNOW BEFORE TAKING CLOZAPINE HEXAL

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

If you are in any of the situations described above, inform your doctor and do not take Clozapine Hexal.
Clozapine Hexal must not be administered to unconscious patients or those in a coma.
Warnings and precautions
The safety measures described in this section are very important. You must follow them to minimize
the risk of serious side effects that could endanger your life.
Before starting treatment with Clozapine Hexal, inform your doctor if you suffer or have 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 inside the eye)
diabetes. Elevated (sometimes even markedly) blood sugar levels have been observed in patients with or without a history of diabetes mellitus (see section 4)
prostate problems or difficulty urinating
any heart, kidney, or liver disorder
chronic constipation or if you are taking medicines that cause constipation (such as anticholinergics)
galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
controlled epilepsy
disorders of the large intestine
abdominal surgery

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heart disorder or family history of a cardiac conduction abnormality known as "QT interval prolongation"
risk of stroke, for example if you have high blood pressure, cardiovascular disorders, or cerebrovascular problems.

Inform your doctor immediately before taking your next tablet of Clozapine Hexal if:

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

Medical visits and blood tests
Before starting treatment with Clozapine Hexal, your doctor will ask you 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 Clozapine Hexal.

Your doctor will tell you exactly when and where to have the tests. Clozapine Hexal may only be taken if your blood cell count is normal.
Clozapine Hexal 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 whether 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 has occurred.
If your white blood cell count decreases, you must stop treatment with Clozapine Hexal immediately. The white blood cell count should then return to normal.
After stopping treatment with Clozapine Hexal, you must continue to have blood tests for an additional 4 weeks. Blood tests must continue for 4 weeks after stopping Clozapine Hexal, especially if treatment was discontinued completely for hematological 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 medical examination before starting treatment. Your doctor may perform
an electrocardiogram (ECG) to check your heart, but only if necessary or if you have specific concerns.
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If you have liver disorders, you will need regular liver function tests for as long as you are taking Clozapine Hexal.
If you have high blood sugar levels (diabetes), your doctor may regularly monitor your blood sugar levels.
Clozapine Hexal may cause changes in blood lipids. Clozapine Hexal may cause weight gain. Your doctor may monitor your weight and blood lipid levels.
If Clozapine Hexal causes dizziness, lightheadedness, or fainting, be careful when standing up from a sitting or lying position.
If you are undergoing surgery or for any reason are unable to walk for long periods, inform your doctor that you are taking Clozapine Hexal. In these cases, you may be at risk of thrombosis (blood clots in the veins).
Children and adolescents under 16 years of age
If you are under 16 years of age, do not take Clozapine Hexal, as there is insufficient information on
its use in this age group.
Elderly patients (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 Clozapine Hexal: fainting or lightheadedness upon changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation. Inform your doctor or pharmacist if you have a condition called dementia.
Other medicines and Clozapine Hexal
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 preparations.
It may be necessary to adjust the dose of these medicines or to use different medicines.
Do not take Clozapine Hexal 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 drugs, medicines used for chemotherapy
injections of long-acting depot antipsychotic medicines. These medicines increase the risk of developing agranulocytosis (lack of white blood cells).

Taking Clozapine Hexal together with another medicine may affect the effect of Clozapine Hexal
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:
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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 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 gastric 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 present in certain eye drops or 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 Clozapine Hexal. They also know whether the medicines you are taking belong to the listed groups. Please consult your doctor or pharmacist.
Taking Clozapine Hexal with food and drinks
Do not consume alcohol during treatment with Clozapine Hexal.
Inform your doctor if you smoke and how frequently you consume caffeine-containing beverages (coffee, tea, Coca-Cola). Sudden changes in smoking or caffeine consumption habits may also alter the effects of Clozapine Hexal.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will discuss with you the benefits and potential risks of taking this medicine during pregnancy. Inform your doctor immediately if you become pregnant while taking Clozapine Hexal.
The following symptoms may occur in newborns whose mothers used Clozapine Hexal during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Some women taking certain medicines for mental disorders may not have periods or may have irregular periods. If this applies to you, your periods may return
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when switching from your current medicine to Clozapine Hexal treatment. This means you must use appropriate contraceptive measures.
Do not breastfeed while taking Clozapine Hexal. Clozapine, the active substance in Clozapine Hexal, may pass into breast milk and affect the baby.
Driving and using machines
Clozapine Hexal may cause fatigue, drowsiness, and seizures, especially at the beginning of treatment. You must not drive or operate machinery when experiencing these symptoms.
Clozapine Hexal contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE CLOZAPINE HEXAL

To minimize the risk of low blood pressure, seizures, and drowsiness, your doctor must gradually increase the dose. Always take Clozapine Hexal 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 Clozapine Hexal without first consulting your doctor. Continue taking the tablets until your doctor advises otherwise.
If you are 60 years of age or older, your doctor may start you on a lower dose and increase it gradually, as certain side effects may be more likely to occur (see section 2 “Before taking Clozapine Hexal”).

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. If well tolerated, your doctor will gradually increase the dose by 25–50 mg over the next 2–3 weeks until reaching a daily dose of 300 mg. Thereafter, if necessary, the daily dose may be increased in steps of 50–100 mg every half week or, preferably, at weekly intervals.
The effective daily dose is generally between 200 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. Higher doses (daily doses exceeding 450 mg) may lead to an increased risk of adverse effects (particularly epileptic seizures). Always carry 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 your daily dose is only 200 mg, you may take this as a single dose in the evening. After taking Clozapine Hexal for some time with good results, your doctor may attempt to reduce the dose. You should take Clozapine Hexal 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. Your doctor will gradually increase the dose by 12.5 mg at a time, with no more than 2 increases per week, up to a maximum dose of 50 mg by the end of the second week. Dose increases must be interrupted or delayed if you feel weak, confused, or lightheaded. To avoid these symptoms, you should monitor your blood pressure during the first weeks of treatment.
The effective daily dose is generally between 25 and 37.5 mg, taken as a single evening dose. In exceptional cases, the daily dose may exceed 50 mg. The maximum daily dose is 100 mg. Always take the lowest effective dose for you.

Method of administration
For oral use. Swallow the tablet with water. Clozapine Hexal may be taken before, during, or after meals.

If you take more Clozapine Hexal than you should
Contact your doctor immediately or call for urgent medical assistance if you think you have taken too many tablets, or if someone else has taken some of your tablets.
Symptoms of overdose include:
drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations, agitation, slurred speech, joint stiffness, hand tremors, epileptic seizures (convulsions), increased saliva production, dilation of the black part of the eye (pupils), vision disturbances, low blood pressure, collapse, rapid or irregular heartbeat, and difficult or shallow breathing.

If you forget to take Clozapine Hexal
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 a forgotten dose. Contact your doctor as soon as possible if you have not taken Clozapine Hexal for more than 48 hours.

If you stop taking Clozapine Hexal
Do not stop treatment with Clozapine Hexal without consulting your doctor, as you may experience withdrawal reactions. These reactions may include sweating, headache, nausea (feeling unwell), vomiting (feeling sick), and diarrhea.
If you experience any of these signs, contact your doctor immediately. These signs may be followed by more serious adverse effects if you do not receive immediate appropriate treatment.
The original symptoms may reappear. If you need to stop treatment, a gradual reduction of the dose by 12.5 mg increments over one to two weeks is recommended. Your doctor will advise you on how to reduce the daily dose. If you must stop treatment with Clozapine Hexal suddenly, you should be monitored by your doctor.
If your doctor decides to restart treatment with Clozapine Hexal and more than two days have passed since your last dose, you must restart with a dose of 12.5 mg.

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

4. POSSIBLE ADVERSE EFFECTS

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Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some adverse effects can be serious and require immediate medical attention.
Contact your doctor immediately before taking your next tablet of Clozapina Hexal
if any of the following occur:
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 type of infection. You will need to urgently have a blood test to check whether your symptoms are related to the medicine.
Seizures
Sudden fainting or sudden loss of consciousness with muscle weakness (syncope)

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

Sudden and rapid increase in body temperature, muscle rigidity that may lead to loss of consciousness (neuroleptic malignant syndrome): this may indicate a serious adverse effect requiring immediate treatment.
Dizziness, lightheadedness, or fainting when standing up from a sitting or lying position, which may increase your risk of falling.

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

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

Painful and prolonged erection of the penis, if you are male. This is called priapism. If you experience an erection lasting more than 4 hours, you may require immediate medical treatment to avoid further complications.
Spontaneous bleeding or bruising, which may be signs of a reduced number of platelets in the blood.
Symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation or confusion)

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Abdominal pain, cramps, bloated abdomen, vomiting, constipation and inability to pass gas, which may be signs and symptoms of intestinal obstruction.
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 may progress to fulminant hepatic necrosis.
Nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

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

Unbearable chest pain, feeling of pressure, tightness or constriction in the chest (chest pain may radiate to the left arm, jaw, neck and upper abdomen), shortness of breath, sweating, weakness, lightheadedness, nausea, vomiting and palpitations (symptoms of a heart attack) which may lead to death: in this case, call immediately for emergency medical assistance
Chest pressure, heaviness, tightness, constriction, burning or suffocating 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
Pulsating sensation, strong, intermittent pounding heartbeat (palpitations)
Rapid and irregular heartbeats (atrial fibrillation). Occasional palpitations, fainting, shortness of breath or chest discomfort may occur. Your doctor will need to check your heart.
Symptoms related to low blood pressure such as lightheadedness, dizziness, blurred vision, unusual tiredness, 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 that may travel through blood vessels to the lungs and cause chest pain and breathing difficulties
Confirmed or strongly suspected infection with fever or abnormally low body temperature, abnormally rapid breathing, fast heartbeat, changes in responsiveness and awareness, decreased blood pressure (sepsis).
Excessive sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic syndrome)
Severe reduction in urine output (sign of kidney failure)
Allergic reaction (swelling, especially of the face, mouth and throat, but also swelling of the tongue, which may cause itching or pain).
Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness and malaise. This could indicate possible liver disorders leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including potentially life-threatening liver events, consequences such as liver failure (which may lead to death), liver damage (liver cell or bile duct injury, or both) and liver transplantation.
Burning 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, sensation of early fullness (intestinal ulceration of stomach and/or intestine) – which may lead to death.
Severe abdominal pain worsened by movement, nausea, vomiting including vomiting of blood (or coffee-ground-like material); the abdomen becomes rigid with tenderness (rebound) spreading from the perforation site throughout the abdomen; fever and/or chills (perforation of stomach and/or intestine or ruptured bowel) which may lead to death.
Constipation, abdominal pain, abdominal tenderness, fever, swelling, bloody diarrhoea. This may indicate megacolon (bowel enlargement) or intestinal infarction/ischemia/necrosis which could lead to death. Your doctor will need to check you.
Sudden chest pain with shortness of breath, with or without cough.
Increased or new muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you. FI_CLOZAPINE_HEXAL
Sudden chest pain with shortness of breath, with or without cough or fever.
During clozapine use, extremely severe and serious skin reactions have been reported, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Skin adverse reactions may appear as rashes with or without blisters. Skin irritation, swelling and fever and flu-like symptoms may occur. DRESS syndrome symptoms usually appear approximately 2–6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above reactions occur, inform your doctor immediately
before taking your next tablet of Clozapina Hexal.
Other adverse 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 levels of white blood cells in the blood (leukocytosis), elevated levels of specific types 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 electrocardiogram (ECG) pattern, high blood pressure, feeling unwell or mild mental confusion after changing position, nausea (feeling sick), vomiting (being sick), 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),
liver inflammation (hepatitis), liver diseases 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 (salivary gland enlargement), breathing difficulties, very high levels of cholesterol and triglycerides in the blood, heart muscle disease (cardiomyopathy), cessation of heartbeat (cardiac arrest), unexplained sudden death.
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Not known (frequency cannot be estimated from the available data)
Electroencephalogram (EEG) abnormalities, diarrhoea, stomach discomfort, heartburn, stomach discomfort after meals, muscle weakness, muscle spasms, muscle pain, nasal congestion, bedwetting at night, sudden and 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, facial "butterfly" 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).
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 adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CLOZAPINE HEXAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister/ bottle and carton after the word “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Clozapina Hexal contains
The active substance is clozapine.
Each tablet contains 25 mg of clozapine.
Each tablet contains 100 mg of clozapine.
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The other ingredients are monohydrate lactose, maize starch, anhydrous colloidal silica, sodium lauryl sulfate, povidone (K25), microcrystalline cellulose, sodium carboxymethylstarch (type A) and magnesium stearate.

Description of the appearance of Clozapina Hexal and pack contents
25 mg:
The tablets are round, light yellow in colour, with a score line and the imprint “C 25”.
100 mg:
The tablets are round, light yellow in colour, with a clover-shaped indentation.
Clozapina Hexal tablets are contained in PVC/aluminum or PP/aluminum blister strips or in HDPE bottles with PE screw caps and are packaged in cardboard cartons.

Pack sizes:
Blister packs: 20, 28, 30, 40, 50, 60 (100 mg only), 84, 98, 100, 10 x 50 and 100 x 50.
10 x 50 and 100 x 50 for hospital use only.
Bottles (for hospital use): 250 and 500 (25 mg and 100 mg only).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana (Slovenia)
Lek Pharmaceuticals d.d., Trimlini 2d, 9220 Lendava (Slovenia)

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Belgium
Clozapine Sandoz 25 mg tabletten
Clozapine Sandoz 50 mg tabletten
Clozapine Sandoz 100 mg tabletten

Denmark
Clozapin “Hexal”

Italy
CLOZAPINA HEXAL
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Netherlands
Clozapine Sandoz 25, tabletten 25 mg
Clozapine Sandoz 50, tabletten 50 mg
Clozapine Sandoz 100, tabletten 100 mg

Norway
Clozapin HEXAL 25 mg tabletter
Clozapina HEXAL 100 mg tabletter
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