CLOZAPINA 25 mg Coated Tablet

Зміст інструкції

1. CLOZAPINA DOC Generici 25 mg tablets, 100 mg tablets
   1. What is CLOZAPINA DOC Generici and what is it used for
   2. What you need to know before taking CLOZAPINA DOC Generici
   3. How to take CLOZAPINA DOC Generici
   4. Possible side effects
   5. How to store CLOZAPINA DOC Generici
   6. Package Contents and Other Information

CLOZAPINA DOC Generici 25 mg tablets, 100 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it containsimportant
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CLOZAPINA DOC Generici is and what it is used for
• 2. What you need to know before you take CLOZAPINA DOC Generici
• 3. How to take CLOZAPINA DOC Generici
• 4. Possible side effects
• 5. How to store CLOZAPINA DOC Generici
• 6. Contents of the pack and other information

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

The active ingredient of CLOZAPINA DOC Generici is clozapine, which belongs to a group of medicines
called antipsychotics (medicines that are used to treat specific mental disorders such as psychoses).
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 you think, how you feel and how you
behave. You must only use this medicine 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 serious side effects that cannot be treated.
CLOZAPINA DOC Generici is also used to treat severe disorders of thought, emotions and
behaviour in people with Parkinson's disease in whom 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 any of the other ingredients of this medicine (listed in section 6).
• If you cannot have regular blood tests.
• If you have previously been found to have a low number of white blood cells (e.g. leucopenia or agranulocytosis), especially if this was caused by medicines. This does not apply to you if the low number of white blood cells was caused by previous chemotherapy.
• If you have had to stop taking CLOZAPINA DOC Generici in the past 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 disease of the bone marrow or have ever suffered from bone marrow diseases.
• If you suffer from uncontrolled epilepsy (seizures or convulsions).
• If you suffer from an acute mental illness caused by alcohol or drugs (e.g. narcotics).
• If you suffer from decreased state of consciousness and severe drowsiness.
• If you suffer from circulatory collapse that can occur following a 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 serious liver disease.
• If you suffer from paralytic ileus (your intestines are not working properly and you have severe constipation).
• If you are using any medicine that prevents the bone marrow from working properly.
• If you are using any medicine that reduces the number of white blood cells in the blood.

If any of the situations described above apply to you, tell your doctor or pharmacist and do not take
CLOZAPINA DOC Generici.
CLOZAPINA DOC Generici should not be given to people who are unconscious or in
a coma.

Warnings and precautions
The safety measures described in this paragraph are very important and must berespected
to minimize the risk of serious side effects that are life-threatening.
Before starting treatment with CLOZAPINA DOC Generici,tell your doctor if you suffer or have ever
suffered from:

• blood clots or have a family history of blood clots, as medicines like these have been associated with blood clot formation.
• glaucoma (increased pressure in the eye).
• diabetes. In patients with or without a history of diabetes mellitus, high (sometimes even significantly) blood sugar levels have occurred (see section 4).
• problems with the prostate 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.
• tell your doctor if you have ever had abdominal surgery.
• if you have had a heart disorder or have a family history of a known cardiac conduction abnormality called “prolongation of the QT interval”.
• if you are at risk of having a stroke, for example if you suffer from high blood pressure, cardiovascular problems or if you have problems with the blood vessels in the brain.

Immediately inform your doctor before taking the next tablet of CLOZAPINA DOC
Generici:

• if you experience signs of cold, fever, flu-like symptoms, sore throat or any otherinfection.You will need to have an urgent blood test to check if the symptoms you are experiencing are related to the medicine.
• if you have a sudden and rapid increase in body temperature, muscle stiffness that can lead to a state of unconsciousness (neuroleptic malignant syndrome), as there is a possibility that a serious side effect is occurring that requires immediate treatment.
• if you have a fast and irregular heartbeateven at rest, palpitations, breathing problems, chest painor unexplained fatigue. The doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
• if you experience nausea (feeling unwell), vomitingand/or loss of appetite. The doctor will need to check your liver.
• if you have severe constipation. The doctor will need to treat this condition to avoid further complications.

Clinical checks and blood tests
Before starting to take this medicine, your doctor will ask you about your medical history and will
give you a blood test to make sure your white blood cell count is normal. It is important
to know this, because the body needs white blood cells to fight infections.

Make sure you have blood tests done regularly before starting treatment, during the
treatment and after stopping treatment with CLOZAPINA DOC Generici.

• The doctor will tell you exactly when and where to have the tests. CLOZAPINA DOC Generici can only be taken if the number of blood cells 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 tell the doctor if you are at risk of developing agranulocytosis.
• During the first 18 weeks of treatment, blood tests must be done once a week. Afterwards, blood tests must be done at least once a month.
• If there is a decrease in the number of white blood cells, you must stop taking clozapine immediately. The number of white blood cells must then return to normal.
• After stopping treatment with clozapine, you must have blood tests for another 4 weeks.

The doctor will also give you a general check-up before starting treatment. The doctor may also give you an
electrocardiogram (ECG) to check your heart, but only if necessary or if you have any particular concerns
about it.
If you suffer from liver disorders, you will need to have regular tests of liver function as long as you are
being treated with this medicine.
If you have high blood sugar levels (diabetes), your doctor may need to check
your blood sugar levels regularly.
This medicine can cause changes in blood fats. This medicine can cause weight gain. Your doctor may need to check your weight and blood fat levels.
If this medicine causes you to feel lightheaded, dizzy or faint, be
careful when getting up from a sitting or lying position.
If you need to have surgery or if for some reason you are unable to walk for a long time, talk
to your doctor about the fact that you are taking this medicine. You may be at risk of thrombosis
(formation of blood clots in the veins).

Children and adolescents under 16 years of age
If you are under 16 years of age, you should not take CLOZAPINA DOC Generici as there is not enough information
about its use in this age group.

Elderly people (aged 60 years or over)
Elderly people (aged 60 years or over) may be more likely to experience the
following side effects during treatment with this medicine: weakness or feeling lightheaded after changing position, dizziness, fast heartbeat, difficulty urinating and constipation.
Tell your doctor or pharmacist if you suffer from a condition called dementia.

Other medicines and CLOZAPINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines, including those without a prescription or herbal remedies. It may be necessary
to change the dose of your medicines or take different medicines.

Do not take CLOZAPINA DOC Generici together with medicines that prevent the bone marrow from
functioningproperly and/or decrease the number of blood cells produced by the body, such as:

• carbamazepine, a medicine used for epilepsy.
• some antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
• some painkillers: pyrazolone analgesics, such as phenylbutazone.
• penicillamine, a medicine used to treat rheumatoid inflammation of the joints.
• cytotoxic agents, medicines used for chemotherapy.
• depot long-acting antipsychotic injections.

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

Taking CLOZAPINA DOC Generici with another medicine can affect the effect of
CLOZAPINA DOC Generici and/or the other medicine. Tell your doctor if you intend to take,
if you are taking (even ifthe treatment is almost finished) or if you have recently stopped taking
any of thefollowing medicines:

• medicines for the treatment of 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 can 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, which are 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.
• some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
• some antibiotics, such as erythromycin and rifampicin.
• some medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors, used to treat HIV infections).
• atropine, a medicine that can be used in some eye drops or cough and cold remedies.
• 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 to be avoided while taking CLOZAPINA DOC Generici, and they also know if
the medicines you are taking are among those described in the list. Talk to them.

Taking CLOZAPINA DOC Generici with food, drinks and alcohol
Do not drink alcohol while being treated with this medicine.
Tell your doctor if you smoke and how often you drink beverages containing caffeine (coffee, tea, cola). Even
sudden changes in your smoking habits or caffeine intake can change
the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. The doctor will discuss with you
the benefits and possible risks of using this medicine during pregnancy. Tell your doctor or pharmacist immediately
if you become pregnant while taking CLOZAPINA DOC Generici.
The following symptoms may occur in newborns of mothers who have taken clozapine during the last
trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby develops any of these
symptoms, contact your doctor.
Some women who take certain medicines to treat mental disorders have irregular menstrual cycles or
do not have menstrual cycles. If this is your case, your periods may return when you switch from
the medicine you are taking to CLOZAPINA DOC Generici. This means you will need to use an effective
method of contraception.
Do not breastfeed while taking this medicine. Clozapine, the active ingredient of
CLOZAPINA DOC Generici, can pass into breast milk and have effects on your baby.

Driving and using machines
This medicine can cause fatigue, drowsiness and seizures, especially at the beginning of treatment.
You should not drive vehicles or use machines while experiencing these symptoms.

CLOZAPINA DOC Generici contains lactose.
CLOZAPINA DOC Generici contains lactose. If your doctor or pharmacist has told you that you have
an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take CLOZAPINA DOC Generici

To minimise the risk of low blood pressure, seizures and
drowsiness, the doctor must increase the dose gradually. Always take this medicine exactly as your doctor has
told you. If you have doubts, consult your doctor or pharmacist.
It is important that you do not change the dose or stop treatment with this medicine without first having
consulted your doctor. Continue taking the tablets until otherwise indicated by your doctor. If you are 60
years old or over 60 years old, your doctor may start treatment with a lower dose and increase it more
gradually, as some undesirable effects may be more likely to occur (see
paragraph 2 “What you need to know before taking CLOZAPINA DOC Generici”).
If the dose prescribed for you cannot be obtained with the tablet of this dosage, other dosages of this medicine
are available to reach the 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) one or two times a day on the first
day, followed by 25 mg one or two times a day on the second day. Swallow the tablet with water. If
well tolerated, the 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. 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 mg and 450 mg, divided into several single doses throughout
the day. Some people may need a higher dose. A dose of up to 900 mg per day is permitted. An increase in
undesirable effects (particularly seizures) is possible 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. The doctor will tell you exactly how to divide the
daily dose. If the daily dose is only 200 mg, you can take it as a single dose in the evening. After
taking CLOZAPINA DOC Generici for some time with positive results, the doctor may try to
lower the dose. You will need to 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. The doctor will gradually increase the dose by 12.5 mg at a time, with a maximum of 2 increases per
week, up to a maximum dose of 50 mg by the end of the second week. Increases in dosage
should be interrupted or postponed if you feel weak, dizzy or confused. To avoid these symptoms, you should
measure 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 takes some of your tablets, contact
your doctor immediately or call for urgent medical assistance.
Symptoms of overdose are:
drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations,
agitation, incoherent speech, stiff limbs, hand tremors, seizures (convulsions), increased
salivation, enlargement of the black part of the eye, blurred vision, low blood pressure,
collapse, fast or irregular heartbeat, difficulty 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 the 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 missed 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 have
withdrawal reactions. These reactions include sweating, headache, nausea (feeling unwell), vomiting and diarrhoea. If any of these signs occur, seek immediate medical attention. These signs may befollowed by more serious side effects unless you are immediately given appropriate treatment.Your original symptoms may reappear. If you need
to stop treatment, a gradual reduction of the dose in fractions of 12.5 mg is recommended
over one/two weeks. The doctor will advise you on how to reduce the daily dose. If you need to stop
treatment suddenly, you should be monitored by your doctor.
If the doctor decides to restart treatment with this medicine and more than two
days have passed since the last dose of CLOZAPINA DOC Generici, you should start again with the starting dose of
12.5 mg.
If you have any doubts about using this medicine, ask 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.
Tell your doctor immediately before taking the next tablet of CLOZAPINA DOC
Generici:
Very common( may affect more than 1 in 10 people):

• if you have severe constipation. Your doctor will need to treat this condition to avoid further complications. Common( may affect up to 1 in 10 people):
• if you develop signs of a cold, fever, flu-like symptoms, sore throat or any other infection.You will need to have an urgent blood test to check if the symptoms you are experiencing are related to the medicine.
• if you experience seizures.

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

• if you have a sudden and rapid increase in body temperature, muscle stiffness that can lead to unconsciousness (neuroleptic malignant syndrome), as there is a possibility that a serious side effect is occurring that requires immediate treatment.

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

• if you develop signs of respiratory or lung infection such as fever, cough, difficulty breathing, wheezing.
• if you have nausea (feeling sick), vomitingand/or loss of appetite. Your doctor will need to check your liver.

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 heartbeateven when you are at rest, palpitations, breathing problems, chest painor unexplained fatigue. Your doctor will need to check your heart and, if necessary, will 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 persistent erection of the penis. This condition is known as priapism. If you experience an erection that lasts for more than 4 hours you may need immediate medical treatment to avoid further complications. Not known(frequency cannot be estimated from the available data):
• if you experience unbearable chest pain, a feeling of pressure in the chest, pressure or tightness in the chest (chest pain can radiate to the left arm, jaw, neck and upper abdomen), shortness of breath, sweating, weakness, dizziness, nausea, vomiting and palpitations (symptoms of a heart attack). In this case, call immediately for urgent medical assistance.
• if you experience chest pressure, heaviness, tightness, burning or a feeling of suffocation (signs of insufficient blood and oxygen supply to the heart muscle). In this case, your doctor will need to check your heart.
• if you develop signs of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing.
• if you experience excessive sweating, headache, nausea, vomiting and diarrhea (symptoms of cholinergic syndrome).
• if there is a severe decrease in the amount of urine (sign of kidney failure).
• if you experience an allergic reaction (swelling mainly of the face, mouth and throat, but also of the tongue, which can cause itching or pain).

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

Other side effects:
Very common( may affect more than 1 in 10 people):
Sleepiness, dizziness, fast heartbeat, increased saliva production.

Common( may affect up to 1 in 10 people):
High levels of white blood cells in the blood (leukocytosis), high 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 feeling lightheaded after changing position, sudden loss of consciousness, nausea (feeling sick), vomiting, loss of appetite, dry mouth, slightly altered values in 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 (anemia), restlessness, agitation, confusion, delirium, circulatory collapse, irregular heartbeat, inflammation of the heart muscle (myocarditis) or the membrane surrounding the heart muscle (pericarditis), fluid retention around the heart (pericardial effusion), difficulty swallowing (e.g. food goes down the wrong way), high levels of sugar in the blood, diabetes mellitus, blood clots in the lungs (pulmonary thromboembolism), inflammation of the liver (hepatitis), liver disease that causes yellowing of the skin/dark urine/itching, inflammation of the pancreas causing severe upper abdominal pain, increased levels in the blood 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, decreased number of platelets in the blood, uncontrolled movements of the mouth, tongue and limbs, obsessive thoughts and repetitive compulsive behaviors (obsessive/compulsive symptoms), skin reactions, swelling of the front of the ears (enlargement of the salivary glands), difficulty breathing, complications due to uncontrolled blood sugar levels (e.g. coma or ketoacidosis), very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cardiac arrest (cardiac arrest), severe constipation with abdominal pain and stomach cramps caused by intestinal obstruction (paralytic ileus), swollen abdomen, abdominal pain, severe liver damage (fulminant hepatic necrosis), kidney inflammation, sudden unexplained death.

Not known(frequency cannot be estimated from the available data)
Liver disorders including: fatty liver disease, death of liver cells, toxicity/damage to the liver, liver disorders involving the replacement of normal liver tissue with scar tissue causing loss of function: these include hepatic events that can lead to life-threatening consequences such as liver failure (which can lead to death), liver damage (injury to liver cells, bile duct in the liver or both) and liver transplant, changes in the tracing performed with the brain wave apparatus (electroencephalogram/ECG), diarrhea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle spasms, muscle pain, stuffy nose, night-time urine loss, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), uncontrolled flexion of the body to one side (pleurototonia), if you are a male, disorders of ejaculation, in which sperm enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), skin rash, reddish-purple spots, fever or itching due to inflammation of blood vessels, inflammation of the colon causing diarrhea, abdominal pain, fever, change in skin color, "butterfly" rash on the face, joint pain, muscle pain, fever and fatigue (lupus erythematosus).
In elderly people with dementia, a small increase in the number of deaths has been reported among patients taking antipsychotics compared to those who were not taking them.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CLOZAPINA DOC Generici

This medicine does not require any particular storage conditions.
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 package and on the blister after “Scad”. 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 in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What CLOZAPINA DOC Generici contains
The active ingredient 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 ingredients are lactose monohydrate, corn starch, povidone K 30, anhydrous colloidal silica, magnesium
stearate and talc.

Description of the appearance of CLOZAPINA DOC Generici and package contents
CLOZAPINA DOC Generici 25 mg: tablet of colour from pale yellow to yellow, round, approximately 6.0 mm
in diameter, uncoated, with imprinted on one side “FC” and “1” on either side of a fracture line, smooth on
the opposite side.
CLOZAPINA DOC Generici 100 mg: tablet of colour from pale yellow to yellow, round, approximately 10.0
mm in diameter, uncoated, with imprinted on one side “FC” and “3” on either side of a fracture line, 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 Aluminium-PVC/PVDC blisters.
Packs:
25 mg: 28 tablets in blisters
100 mg: 28 tablets in blisters.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer

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

This medicinal product is authorised in the Member States of the European Economic Area with thefollowing
names:
Italy: CLOZAPINA DOC Generici