Clozapine Aurobindo: detailed information

Patient Information Leaflet: Information for the patient

Clozapine Aurobindo 25 mg tablets, 100 mg tablets

Generic medicine
Please read this entire leaflet carefully before you start 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

The active substance of Clozapina Aurobindo is clozapine, which belongs to a group of medicines called
antipsychotics (medicines used to treat specific mental disorders such as psychosis).
Clozapina Aurobindo is used to treat people with schizophrenia who have not benefited from other
medicines. Schizophrenia is a mental illness that affects the way a person thinks, feels, and behaves. You should use this medicine only after having tried at least two other antipsychotic medicines for the treatment of schizophrenia, including one of the more recent atypical antipsychotics, and only if these medicines have been ineffective or have caused serious side effects that cannot be managed.
Clozapina Aurobindo 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 Clozapina Aurobindo

Do not take Clozapina Aurobindo:

if you are allergic to clozapine or to any of the other ingredients of 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 this was caused by medicines. This does not apply to you if the low
white blood cell count was due to previous chemotherapy.
you previously had to stop taking Clozapina Aurobindo due to serious adverse effects (e.g. agranulocytosis or heart problems).
you are or have been treated with long-acting depot antipsychotic injections.
you suffer from or have ever suffered from a bone marrow disorder.
you have uncontrolled epilepsy (epileptic seizures or convulsions).
you suffer from 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 severe heart disease.
you have symptoms of active liver disease, such as jaundice (yellowing of the skin and eyes, feeling unwell and loss of appetite).
you suffer from any other severe liver disease.
you suffer from paralytic ileus (your bowel does not function properly and you have severe constipation).
you are taking any medicine that prevents the bone marrow from functioning properly.
you are taking any medicine that reduces the number of white blood cells in the blood.

If any of these situations apply to you, inform your doctor and do not take Clozapina Aurobindo.
Clozapina Aurobindo must not be administered to unconscious individuals or those in a coma.

Warnings and precautions

The safety measures described in this section are very important and must be followed to minimize the risk of serious, life-threatening adverse effects.

Before starting treatment with Clozapina Aurobindo, inform your doctor if you suffer from or have ever suffered from:

Blood clots or a family history of blood clots, as medicines like this have been associated with blood clot formation.
Glaucoma (increased pressure in the eye).
Diabetes. High blood sugar levels (sometimes markedly elevated) have occurred in patients with or without a history of diabetes mellitus (see section 4).
Prostate problems or difficulty urinating.
Any heart, kidney or liver disease.
Chronic constipation, or if you are taking medicines that cause constipation (such as anticholinergics).
Galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption.
Controlled epilepsy.
Diseases of the large intestine.
Abdominal surgery.
If you have had a heart disorder or a family history of a cardiac conduction abnormality known as “QT interval prolongation”.
If you are at risk of stroke, for example if you have high blood pressure, cardiovascular problems or cerebrovascular disorders.

Contact your doctor immediately before taking your next tablet of Clozapina Aurobindo:

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

Clinical monitoring and blood tests

Before starting Clozapina Aurobindo, your doctor will review your medical history and perform a blood test to ensure your white blood cell count is normal. This is important because your body needs white blood cells to fight infections.

Make sure you have regular blood tests before starting treatment,
during treatment, and after stopping treatment with Clozapina Aurobindo.

Your doctor will tell you exactly when and where to have the blood tests. Clozapina Aurobindo may only be taken if your blood cell count 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 help your doctor determine if you are at risk of developing agranulocytosis.
During the first 18 weeks of treatment, blood tests must be performed weekly. After this period, blood tests must be performed at least once a month.
If your white blood cell count decreases, you must stop taking Clozapina Aurobindo immediately. Your white blood cell count must return to normal.
After stopping treatment with Clozapina Aurobindo, you must continue having blood tests for another 4 weeks. Your doctor will also perform a general physical examination before starting treatment. Your doctor may also perform an electrocardiogram (ECG) to check your heart, but only if necessary or if you have specific concerns. If you have liver disorders, you must have regular liver function tests throughout treatment with Clozapina Aurobindo. If you have high blood sugar levels (diabetes), your doctor may need to monitor your blood sugar levels regularly. Clozapina Aurobindo may cause changes in blood lipids. Clozapina Aurobindo may cause weight gain. Your doctor may need to monitor your weight and blood lipid levels.

If you have previously experienced or currently experience dizziness, lightheadedness or fainting while taking Clozapina Aurobindo, be careful when standing up from a sitting or lying position, as this may increase your risk of falling.
If you are scheduled for surgery or for any reason are unable to walk for prolonged periods, inform your doctor that you are taking Clozapina Aurobindo. You may be at increased risk of thrombosis (blood clot formation in the veins).

Children and adolescents under 16 years of age

If you are under 16 years of age, do not take Clozapina Aurobindo, as there is insufficient information on its use in this age group.

Elderly people (aged 60 years or older)

Elderly people (aged 60 years or older) may be more likely to experience the following adverse effects during treatment with Clozapina Aurobindo: weakness or lightheadedness upon changing position, dizziness, rapid heartbeat, difficulty urinating and constipation.
Inform your doctor or pharmacist if you suffer from a condition called dementia.

Other medicines and Clozapina Aurobindo

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines or herbal remedies. It may be necessary to adjust the dose of your medicines or switch to different medicines.

Do not take Clozapina Aurobindo 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 in epilepsy.
certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
certain painkillers: pyrazolone analgesics such as phenylbutazone.
penicillamine, a medicine used to treat rheumatic joint inflammation.
cytotoxic agents, medicines used in chemotherapy.
injections of long-acting depot antipsychotic medicines.

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

Taking Clozapina Aurobindo together with another medicine may affect the effect of Clozapina Aurobindo and/or the other medicine. Inform your doctor if you intend to take, are currently taking (even if treatment is nearly finished) or have recently stopped taking any of the following medicines:

medicines for depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine and sertraline.
other antipsychotic medicines used to treat mental disorders, such as perazine.
benzodiazepines and other medicines used to treat anxiety or sleep disorders.
narcotics and other medicines that may affect breathing.
medicines used to control epilepsy, such as phenytoin and valproic acid.
medicines used to treat high or low blood pressure, such as adrenaline and noradrenaline.
warfarin, a medicine used to prevent blood clot formation.
antihistamines, medicines used for colds or allergies such as hay fever.
anticholinergic medicines, used to relieve stomach cramps, spasms and motion sickness.
medicines used to treat Parkinson's disease.
digoxin, a medicine used to treat heart problems.
medicines used to treat a fast or irregular heartbeat.
certain medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
certain antibiotics, such as erythromycin and rifampicin.
certain medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infections).
atropine, a medicine that may be used in certain eye drops or cold and cough preparations.
adrenaline, a medicine used in emergency situations.
hormonal contraceptives (birth control pills).

This list is not complete. Your doctor and pharmacist have more information about medicines that should be taken with caution or avoided during treatment with Clozapina Aurobindo. They also know whether the medicines you are taking belong to those listed. Discuss this with them.

Clozapina Aurobindo with food, drinks and alcohol

Do not drink alcohol during treatment with Clozapina Aurobindo.
Inform your doctor if you smoke and how frequently you consume caffeine-containing beverages (coffee, tea, cola). Sudden changes in smoking or caffeine consumption habits may alter the effects of Clozapina Aurobindo.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy.
Inform your doctor promptly if you become pregnant during treatment with Clozapina Aurobindo.

The following symptoms may occur in newborns of mothers who took Clozapina Aurobindo during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Some women who take certain medicines for mental disorders have irregular or absent menstrual cycles. If this applies to you, your periods may return when switching from your current medicine to Clozapina Aurobindo. This means you will need to use an effective contraceptive method.

Do not breastfeed during treatment with Clozapina Aurobindo. Clozapine, the active substance in Clozapina Aurobindo, can pass into breast milk and may affect your baby.

Driving and using machines

Clozapina Aurobindo may cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You must not drive or operate machinery while experiencing these symptoms.

Clozapina Aurobindo contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Clozapina Aurobindo

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

Treatment of schizophrenia
The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice daily on the first day, followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If well tolerated, your doctor will gradually increase the dose by 25–50 mg at a time over the next 2–3 weeks until a daily dose of 300 mg is reached.
Thereafter, 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 multiple individual doses per day.
Some individuals may require a higher dose. A daily dose of up to 900 mg is permitted. However, there may be an increased risk of side effects (particularly seizures) with daily doses exceeding 450 mg. Always take the lowest effective dose for you. Most people take part of the dose in the morning and part in the evening. Your doctor will tell you exactly how to divide the daily dose. If your daily dose is only 200 mg, you may take it as a single dose in the evening. After you have taken Clozapina Aurobindo for some time with positive results, your doctor may attempt to reduce the dose. You should take Clozapina Aurobindo 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. Take the tablet with water. Your doctor will gradually increase the dose by 12.5 mg at a time, with a maximum of two increases per week, up to a maximum dose of 50 mg by the end of the second week. Dose increases must be stopped or delayed if you feel weak, drowsy, or confused. To avoid these symptoms, you should monitor your blood pressure during the first weeks of treatment.
The effective daily dose is generally between 25 mg and 37.5 mg, taken as a single evening dose. Doses of 50 mg per day should only be exceeded in exceptional cases. The maximum daily dose is 100 mg. Always take the lowest effective dose for you.

If you take more 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 seek urgent medical help.
Symptoms of overdose include:
Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff limbs, hand tremors, seizures (convulsions), increased salivation, dilation of the black part of the eye (pupil), blurred vision, low blood pressure, collapse, fast or irregular heartbeat, and difficulty breathing 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 your next dose, do not take the missed dose and take the next dose at the regular 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 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 experience withdrawal symptoms.
These symptoms include sweating, headache, nausea (feeling unwell), vomiting, and diarrhoea.
If you experience any of these signs, contact your doctor immediately. These signs may be followed by more serious side effects unless you receive appropriate medical treatment promptly. The original symptoms may reappear. If you need to stop treatment, a gradual reduction of the dose in steps of 12.5 mg over one to two weeks is recommended. Your doctor will advise you on how to reduce your daily dose. If you need to stop treatment with Clozapina Aurobindo abruptly, you must be monitored by your doctor.
If your doctor decides to restart treatment with Clozapina Aurobindo and more than two days have passed since your last dose, you must restart with the initial dose of 12.5 mg.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention:
Contact your doctor immediately before taking your next tablet of Clozapine Aurobindo if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

Signs of cold, fever, flu-like symptoms, sore throat or any other infection. You must urgently have a blood test to check whether your symptoms are related to the medicine.
Epileptic 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 unconsciousness (neuroleptic malignant syndrome), as this may indicate a serious adverse reaction requiring immediate treatment.
Light-headedness, dizziness or fainting when standing up from a sitting or lying position, as this may increase the risk of falling.

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

Signs of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing.
Severe burning pain in the upper abdomen spreading to the back, accompanied by nausea and vomiting due to inflammation of the pancreas.
Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
Difficulty swallowing (which may cause food aspiration).
Nausea (feeling unwell), vomiting and/or loss of appetite. Your doctor will need to monitor your liver.
Signs of becoming obese or worsening obesity.
Breathing interruption with or without snoring during sleep.

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

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

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

If you are a man and experience episodes of painful, prolonged penile erection. This condition is known as priapism. If an erection lasts longer than 4 hours, you may require immediate medical treatment to avoid further complications.
Spontaneous bleeding or bruising, which could 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).
Abdominal pain, cramps, bloated abdomen, vomiting, constipation and failure 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 could lead 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 (the chest pain may radiate to the left arm, jaw, neck and upper abdomen), shortness of breath, sweating, weakness, light-headedness, nausea, vomiting and palpitations (symptoms of a heart attack). In this case, call immediately for emergency medical assistance.
Chest pressure, heaviness, tightness, constriction, burning or suffocating sensation (signs of insufficient blood and oxygen supply to the heart muscle). In this case, your doctor will need to check your heart.
Intermittent "pounding", "pulsating" or "fluttering" sensation in the chest (palpitations).
Fast and irregular heartbeat (atrial fibrillation). Occasional palpitations, fainting, shortness of breath or chest discomfort may occur. Your doctor must check your heart.
Symptoms of low blood pressure such as feeling of emptiness in the head, dizziness, fainting, 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), which may travel through 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, 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 (a 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 could indicate possible liver disorders involving replacement of normal liver tissue with scar tissue, leading to loss of liver function, including liver events that may result in potentially fatal outcomes such as liver failure (which may lead to death), liver damage (liver cell damage, bile duct damage in the liver or both) and liver transplantation.
Constipation, abdominal pain, abdominal tenderness, fever, bloating, diarrhoea with blood. This could indicate possible megacolon (enlargement of the intestine) or intestinal infarction/ischaemia. Your doctor will need to examine you.
Sudden chest pain with shortness of breath, with or without cough.
Sudden increase or new onset of muscle weakness, muscle spasms, muscle pain. This could indicate a possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you.
Sudden chest or abdominal pain with shortness of breath, with or without cough or fever.

If any of the situations described above apply to you, consult your doctor immediately before taking the next dose of Clozapine Aurobindo.

Other side effects:

Very common: may affect more than 1 in 10 people

Drowsiness, dizziness, fast heartbeat, increased saliva production.

Common: may affect up to 1 in 10 people

High levels of white blood cells in the blood (leucocytosis), 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 light-headedness after changing position, sudden loss of consciousness, nausea (feeling unwell), vomiting, loss of appetite, dry mouth, slightly abnormal liver function tests, loss of bladder control, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g. slurred speech).

Uncommon: may affect up to 1 in 100 people

Absence of white blood cells in the blood (agranulocytosis), speech disorders (e.g. stuttering).

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

Low levels of red blood cells in the blood (anaemia), 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), high blood sugar levels, diabetes mellitus, blood clots in the lungs (thromboembolism), liver inflammation (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, increased blood levels of an enzyme called creatine phosphokinase.

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

Increased number of platelets in the blood with possible blood clot formation in blood vessels, uncontrolled movements of the mouth, tongue and limbs, obsessive thoughts and repetitive compulsive behaviours (obsessive/compulsive symptoms), skin reactions, swelling of the front part of the ears (enlargement of the salivary glands), breathing difficulties, very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cessation of heartbeat (cardiac arrest), unexplained sudden death.

Not known: frequency cannot be estimated from the available data

Changes in the tracing performed with brain wave equipment (electroencephalogram/EEG), diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal loss of urine, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), uncontrollable bending of the body to one side (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, change in skin colour, butterfly-shaped facial rash, joint pain, muscle pain, fever and fatigue (lupus erythematosus).

In elderly patients with dementia, a small increase in the number of deaths has been reported among patients taking antipsychotics compared to those not taking them.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 stated on the label, the carton and the blister pack after "Exp." The expiry date refers to the last day of that month.
Store below 30 °C.
Do not use this medicine if you notice any changes in the appearance of the tablets.
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. Package contents and other information

What Clozapina Aurobindo contains:

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

Description of the appearance of Clozapina Aurobindo and the contents of the pack:
Tablet.
Clozapina Aurobindo 25 mg tablets:
Pale yellow, round, flat-faced, uncoated tablets with bevelled edges, marked with "C" and "Z" separated by a breakline 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, marked with "C" and "Z" separated by a breakline 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.
Pack sizes:
Blister pack: 28 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the
following names:
Italy: Clozapina Aurobindo
Portugal: Clozapina Ritisca