CLOZAPINA 25 mg Coated Tablets

Содержание инструкции

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

Clozapina Aurobindo 25 mg tablets, 100 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

The active ingredient of Clozapina Aurobindo is clozapine, which belongs to a group of medicines called
antipsychotics (medicines that are used to treat specific mental disorders such as psychoses).
Clozapina Aurobindo is used to treat people with schizophrenia who have not benefited from other
medicines. Schizophrenia is a mental illness that influences 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 Aurobindo 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 Aurobindo

Do not take Clozapina Aurobindo:
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 Aurobindo 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 bone marrow disease or have ever suffered from a bone marrow disease.
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 serious 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 functioning properly.
if you are using any medicine that reduces the number of white blood cells in the blood.
If any of these apply to you, tell your doctor and do not take Clozapina Aurobindo.
Clozapina Aurobindo must not be given to people who are unconscious or in a coma.

Warnings and precautions
The safety measures described in this section are very important and must be
respected to minimize the risk of serious, life-threatening side effects.
Before starting treatment with Clozapina Aurobindo, 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. High levels of blood sugar (sometimes even very high) have occurred in patients with or without a history of diabetes mellitus (see section 4).
• Problems with the prostate or difficulty urinating.
• Any disease of the heart, kidneys or liver.
• 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.
• 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 tell your doctor before taking the next Clozapina
Aurobindo tablet:

• If you develop signs of a cold, fever, flu-like symptoms, sore throator 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 stiffnessthat 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 sick), 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.
• If you have constipation, abdominal pain, abdominal tenderness, fever, bloatingand/or diarrhea with blood present.The doctor will need to examine you.

Clinical checks and blood tests
Before you start taking Clozapina Aurobindo, your doctor will ask about your medical history and
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 regularly before starting treatment,
during treatment and after stopping treatment with Clozapina Aurobindo.

• The doctor will tell you exactly when and where to have the blood tests. Clozapina Aurobindo can only be taken if the number of blood cells is normal.
• Clozapina Aurobindo can cause a severe 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 the number of white blood cells decreases, you must stop taking Clozapina Aurobindo immediately. The number of white blood cells must then return to normal.
• After stopping treatment with Clozapina Aurobindo, you should 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. If you suffer from liver problems, you should have regular liver function tests while being treated with Clozapina Aurobindo. If you have high blood sugar levels (diabetes), your doctor may need to check your blood sugar levels regularly. Clozapina Aurobindo can cause changes in blood fats. Clozapina Aurobindo can cause weight gain. The doctor may need to check your weight and blood fat levels.

If you have previously suffered or if this medicine causes you to feel lightheaded, dizzy or
faint, be careful when getting up from a sitting or lying position as it may increase
the risk of falling.
If you are going to have surgery or if for any reason you are unable to walk for a long time, talk
to your doctor about the fact that you are taking Clozapina Aurobindo. 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 Aurobindo 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 Clozapina Aurobindo: 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 Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available 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 Aurobindo with medicines that prevent the bone marrow from
functioning properly 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 co-trimoxazole.
• some pain relievers: pyrazolone analgesics such as phenylbutazone.
• penicillamine, a medicine used to treat rheumatic inflammation of the joints.
• cytotoxic agents, 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 Clozapina Aurobindo with another medicine can affect the effect of
Clozapina Aurobindo and/or the other medicine. Tell your doctor if you intend to take, if
you are taking (even if the treatment is almost finished) or if you have recently stopped
taking any of the following 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 the medicines to
be taken with caution or to be avoided while taking Clozapina Aurobindo. They also know if the
medicines you are taking are among those described in the list. Talk to them.

Clozapina Aurobindo with food, drinks and alcohol
Do not drink alcohol while taking Clozapina Aurobindo.
Tell your doctor if you smoke and how often you drink beverages containing caffeine (coffee, tea, cola). Even
sudden changes in smoking habits or caffeine intake can change the effects of Clozapina Aurobindo.

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 immediately if you become pregnant while taking Clozapina Aurobindo.
The following symptoms may occur in newborns of mothers who have taken Clozapina Aurobindo 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 periods or do not
have periods at all. If this is the case, your periods may return when you switch from
the medicine you are taking to Clozapina Aurobindo. This means you will need to use an effective
method of contraception.
Do not breastfeed while taking Clozapina Aurobindo. Clozapine, the active ingredient of
Clozapina Aurobindo, can pass into breast milk and have effects on your baby.

Driving and using machines
Clozapina Aurobindo can cause fatigue, drowsiness and seizures, especially at the beginning of
treatment. You should not drive vehicles or use machines while you experience these symptoms.

Clozapina Aurobindo contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Clozapina Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
ask your doctor or pharmacist.
To minimize the risk of low blood pressure, seizures and
drowsiness, it is necessary for the doctor to increase the dose gradually. Take Clozapina Aurobindo
exactly as your doctor has told you. If you have any doubts ask your doctor or pharmacist.
It is important that you do not change the dose or stop treatment with Clozapina Aurobindo without first
consulting your doctor. Continue to take 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 side effects may be more likely to occur
(see section 2 “What you need to know before you take Clozapina Aurobindo”).
If the dose prescribed for you cannot be obtained with the tablet of this dosage, there are
other dosages of this medicine available to reach the dose.

Treatment of schizophrenia
The initial dose is usually 12.5 mg (half a 25 mg tablet) once or twice a day on the first
day, followed by 25 mg once or twice a day on the second day. 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
to reach a dose of 300 mg per day.
Subsequently, if necessary, the daily dose may be increased by 50-100 mg at a time every half
week or, preferably, at weekly intervals.
The effective daily dose is generally between 200 mg and 450 mg, divided into several single doses
per day.
Some people may need a higher dose. A dose of up to 900 mg per day is permitted. An increase in undesirable effects (in particular seizures) is possible with daily doses
greater than 450 mg. Always take the lowest effective dose for you. Most people take
a portion of the dose in the morning and a portion in the evening. Your doctor will tell you exactly how to divide the dose
daily. If the daily dose is only 200 mg, you can take it as a single dose in the evening. After having
taken Clozapina Aurobindo for some time with positive results, your doctor may attempt to lower the
dose. You should take Clozapina Aurobindo 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 two increases per
week, up to a maximum dose of 50 mg by the end of the second week. Dose increases 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 few 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 Aurobindo 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.
The symptoms of overdose are:
Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations,
agitation, incoherent speech, stiff limbs, trembling hands, 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 Aurobindo
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 forgotten dose and take the next dose at the exact 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 Aurobindo for more than 48 hours.

If you stop taking Clozapina Aurobindo
Do not stop treatment with Clozapina Aurobindo without consulting your doctor, as you may have
withdrawal reactions.
These reactions include sweating, headache, nausea (feeling unwell), vomiting and diarrhea.

If any of these signs occur, seek immediate medical attention. These signs
may be followed by more serious side effects unless you are immediately
subjected to appropriate treatment.The original symptoms may reappear. If you need to stop
treatment, a gradual reduction of the dose in fractions of 12.5 mg over one/two
weeks is recommended. The doctor will advise you on how to reduce the daily dose. If you need to stop Clozapina Aurobindo treatment suddenly, you should have a medical check-up.
If the doctor decides to restart treatment with Clozapina Aurobindo and more than
two days have passed since the last intake of Clozapina Aurobindo, you should start again with the starting dose
of 12.5 mg.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects may be serious and require immediate medical attention:
Immediately inform your doctor before taking the next Clozapina
Aurobindo tablet 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 avoid 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 will need to have an urgent blood test to check if the symptoms you are experiencing 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 can lead to
a state of unconsciousness (neuroleptic malignant syndrome), because there is a possibility that a
serious side effect is occurring that requires immediate treatment.
dizziness, lightheadedness, or fainting when getting up from a sitting or
lying position as it may increase the risk of falling.

Rare: may affect up to 1 in 1,000 people
signs of respiratory tract or pneumonia infection, such as fever, cough, difficulty breathing,
wheezing.
severe, burning, pain in the upper abdomen that extends 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 can cause food to be inhaled).

nausea (feeling unwell), vomitingand/or loss of appetite. Your doctor will need
to check your liver.
signs of becoming obese or increased obesity.
interruption of breathing with or without snoring during sleep.

Rare: may affect up to 1 in 1,000 peopleor Very rare: may affect up to 1 in
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 immediately refer you to a cardiologist.

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

• if you are a man and experience 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.
• spontaneous bleeding or bruising, which may be signs of a decrease in the 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).
• 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 be signs that you are beginning to develop a liver disorder that can lead to fulminant hepatic necrosis.
• nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Not known: frequency cannot be estimated based on available data
unbearable chest pain, feeling of pressure in the chest, tightness or constriction in the chest (the
chest pain may 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
emergency medical assistance.
chest pressure, heaviness, tightness, constriction, burning, or feeling of suffocation
(signs of insufficient blood and oxygen supply to the heart muscle). In this case, the
doctor will need to check your heart.
intermittent sensation of "pounding", "throbbing", or "fluttering" in the chest (palpitations).
rapid and irregular heartbeat (atrial fibrillation). Occasional heart palpitations, fainting, shortness of breath, or chest discomfort may occur. The doctor will need to check your
heart.
symptoms of low blood pressure such as feeling lightheaded, 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), which may move through the blood vessels to the
lungs, causing chest pain and difficulty breathing.
confirmed or strongly suspected infection associated with fever or low body temperature,
abnormally rapid breathing, accelerated heartbeat, change in reactivity and
awareness, decreased blood pressure (sepsis).
profuse sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
severe decrease in the amount of urine (sign of kidney failure).
allergic reaction (swelling mainly of the face, mouth, and throat, but also 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 may indicate possible liver disorders that involve the replacement
of normal liver tissue with scar tissue leading to loss of liver function, including those liver events that can lead to potentially fatal consequences such as
liver failure (which can lead to death), liver damage (damage to the liver cells, bile duct in the liver or both) and liver transplantation.
constipation, abdominal pain, abdominal tenderness, fever, swelling, diarrhea with the presence of
blood. This may indicate possible megacolon (enlargement of the intestine) or intestinal infarction/ischemia. The doctor will need to examine you.
acute chest pain with shortness of breath and with or without cough.
increase or new muscle weakness, muscle spasms, muscle pain. This may
indicate a possible muscle disorder (rhabdomyolysis). The doctor will need to examine you.
acute chest pain or abdominal pain with shortness of breath and with or without cough or fever.
If any of the situations described above applies to you, consult your doctor immediately before
taking the next Clozapina Aurobindo tablet.

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

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, rigidity, restlessness, seizures,
spasms, abnormal movements, inability to initiate movements, inability to remain still, changes
in the ECG, high blood pressure, feeling faint or lightheaded after changing
position, sudden loss of consciousness, nausea (feeling unwell), 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, irregular
heartbeat, inflammation of the heart muscle (myocarditis) or the membrane surrounding the
heart muscle (pericarditis), fluid buildup around the heart (pericardial effusion), high levels of
sugars in the blood, diabetes mellitus, blood clots in the lungs (pulmonary thromboembolism), inflammation of the
liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, increased in
the blood levels of an enzyme called creatine phosphokinase.

Very rare: may affect up to 1 in 10,000 people
Increased number of platelets in the blood with possible formation of clots in blood vessels,
uncontrollable 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, very high levels of triglycerides or cholesterol
in the blood, heart muscle disease (cardiomyopathy), cardiac arrest (cardiac arrest),
sudden unexplained death.

Not known: frequency cannot be estimated based on available data
Changes in the tracing performed with the brain wave apparatus
(electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, stomach discomfort after
a meal, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal urine loss,
sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), involuntary
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-shaped rash on the face, joint pain, muscle pain, 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, please tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa . By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Clozapina Aurobindo

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 label, on the carton and on the blister
after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30  C.
Do not use this medicine if you notice any change in the appearance of the tablets.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Clozapina Aurobindo contains:

• The active ingredient is clozapine. Each tablet contains 25 mg of clozapine. Each tablet contains 100 mg of clozapine.
• The other ingredients are: lactose monohydrate, corn starch, povidone (K-30), anhydrous colloidal silica, talc and magnesium stearate.

Description of the appearance of Clozapina Aurobindo and package contents:
Tablet.
Clozapina Aurobindo 25 mg tablets:
Pale yellow, round, flat-faced, uncoated tablets with bevelled edges, imprinted with “C”
and “Z” separated by a break line on one side and “25” on the other side.
The tablet can be divided into two equal doses.
Clozapina Aurobindo 100 mg tablets:
Pale yellow, round, flat-faced, uncoated tablets with bevelled edges, imprinted with “C”
and “Z” separated by a break line on one side and “100” on the other side.
The tablet can be divided into two equal doses.
Clozapina Aurobindo tablets are available in blister packs.
Packs:
Blister pack: 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Clozapina Aurobindo
Portugal: Clozapina Ritisca