Clozapine Accord

Package leaflet: Information for the user

Clozapina Accord 25 mg, 50 mg, 100 mg, 200 mg

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance in Clozapina Accord is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders such as psychosis).
Clozapina Accord 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 not worked or have caused serious side effects that cannot be managed.

For 25 mg, 50 mg and 100 mg tablets only:
Clozapina Accord 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 need to know before taking Clozapina Accord

Do not take Clozapina Accord

• if you are allergic to clozapine or to any of the other ingredients of this medicine (listed in section 6).
• if you are unable to have regular blood tests.
• if you have previously had a low white blood cell count (e.g. leucopenia or agranulocytosis), especially if this was caused by medicines. This does not apply if the low white blood cell count was due to previous chemotherapy.
• if you previously had to stop taking Clozapina Accord because of 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 bone marrow disease or have ever suffered from bone marrow disorders.
• if you have uncontrolled epilepsy (epileptic seizures or convulsions).
• if you have an acute mental disorder caused by alcohol or drugs (e.g. narcotics).
• if you suffer from decreased level of consciousness and severe drowsiness.
• if you suffer from circulatory collapse that may occur following severe shock.
• if you suffer from any severe kidney disease.
• if you suffer from myocarditis (inflammation of the heart muscle).
• if you suffer from any other severe heart disease.
• if you have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, feeling unwell and loss of appetite).
• if you suffer from any other severe liver disease.
• if you suffer from paralytic ileus (your bowel does not function properly and you have severe constipation).
• if you are taking any medicine that impairs bone marrow function.
• if you are taking any medicine that reduces the number of white blood cells in the blood.

If any of the situations described above apply to you, inform your doctor or pharmacist and do not take
Clozapina Accord.
Clozapina Accord must not be administered to unconscious patients or patients in coma.
Warnings and precautions
The safety measures described in this section are very important and must be followed
to minimise the risk of serious, life-threatening side effects.
Talk to your doctor before taking Clozapina Accord if you have or have ever had:

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

Contact your doctor immediately before taking your next dose of Clozapina Accord:

• if you develop signs of cold, fever, flu-like symptoms, sore throat or any other infection. You will need to have a blood test urgently to check whether your symptoms are related to the medicine.
• if you have a sudden and rapid increase in body temperature, and/or muscle rigidity which 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 check 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.
• if you have severe constipation. Your doctor will need to treat this condition to prevent further complications.
• if you develop constipation, abdominal pain, intestinal tenderness, fever, bloating and/or bloody diarrhoea. Your doctor will need to examine you.

Medical checks and blood tests
Before starting this medicine, your doctor will ask about your medical history and will perform a blood test to
ensure that your white blood cell count is normal. This is important because your body needs white blood cells to
fight infections.
Make sure you have blood tests before starting treatment, during treatment and after stopping
treatment with Clozapina Accord.

• Your doctor will tell you exactly when and where to have the blood tests. Clozapina Accord may only be taken if you have a normal blood count.
• This medicine can cause a severe decrease in the number of white blood cells in your 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. Thereafter, 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 once a year, provided no decrease in white blood cells has been detected.
• If there is a decrease in the number of white blood cells, you must stop treatment with clozapine immediately. The white blood cell count must return to normal.
• After stopping treatment with clozapine, you must continue having blood tests for a further 4 weeks in case of complete discontinuation due to haematological reasons (e.g. agranulocytosis), or if the monitoring duration is less than 2 years and/or in the presence of a history of neutropenia that did not lead to treatment discontinuation.

Your doctor will also perform a general physical examination before starting treatment. Your doctor may also perform an
electrocardiogram (ECG) to check your heart, but only if necessary or if you have specific concerns.
If you have liver disorders, you will need regular liver function tests throughout treatment with this medicine.
If you have high blood sugar levels (diabetes), your doctor may need to monitor your blood sugar levels regularly.
This medicine may cause changes in blood lipids. This medicine may cause weight gain. Your doctor may need to monitor your weight and blood lipid levels.
If you already feel dizzy or if this medicine causes dizziness, lightheadedness or fainting, be careful when standing up from a sitting or lying position, as this may increase the risk of falling.
If you are undergoing surgery, or if for any reason you are unable to walk for long periods, talk to your doctor about taking this medicine. You may be at 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, you must not take Clozapina Accord as there is insufficient information on its use in this age group.
Elderly people (aged 60 years or older)
Elderly people (aged 60 years or older) may be more likely to experience the following side effects during treatment with this medicine: weakness or lightheadedness upon changing position, dizziness, rapid heartbeat, difficulty urinating and constipation.
Inform your doctor or pharmacist if you have a condition called dementia.
Other medicines and Clozapina Accord
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription or herbal remedies. It may be necessary to adjust the dose of your medicines or to use different medicines.
Do not take Clozapina Accord together with medicines that impair bone marrow function and/or reduce the number of blood cells produced by the body, such as:

• carbamazepine, a medicine used for epilepsy.
• certain antibiotics: chloramphenicol, sulfonamides such as co-trimoxazole.
• certain painkillers: pyrazolone analgesics such as phenylbutazone.
• penicillamine, a medicine used to treat rheumatic joint inflammation.
• cytotoxic agents, medicines used in chemotherapy.
• injections of long-acting depot antipsychotic medicines.

These medicines increase the risk of developing agranulocytosis (lack of white blood cells).
Taking Clozapina Accord together with another medicine may affect the effect of Clozapina Accord and/or the other medicine. Inform your doctor if you are planning to take, are currently taking (even if treatment is nearly finished) or have recently stopped taking any of the following medicines:

• medicines for depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine and sertraline.
• other antipsychotic medicines used to treat mental disorders, such as perazine.
• benzodiazepines and other medicines used to treat anxiety or sleep disorders.
• narcotics and other medicines that may affect breathing.
• medicines used to control epilepsy such as phenytoin and valproic acid.
• medicines used to treat high or low blood pressure such as adrenaline and noradrenaline.
• warfarin, a medicine used to prevent blood clots.
• antihistamines, medicines used for colds or allergies such as hay fever.
• anticholinergic medicines used to relieve stomach cramps, spasms and 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 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 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 Clozapina Accord and know whether the medicines you are taking are included in this list. Discuss this with them.
Clozapina Accord with food, drinks and alcohol
Do not drink alcohol during treatment with this medicine.
Inform your doctor if you smoke and how frequently you consume caffeine-containing beverages (coffee, tea, cola). Even sudden changes in your smoking habits or caffeine intake may alter the effects of this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy. Inform your doctor or pharmacist immediately if you become pregnant during treatment with Clozapina Accord.
The following symptoms may occur in newborns of mothers who took clozapine during the third trimester (the last three months of pregnancy): tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Some women who take certain medicines for mental disorders have irregular menstrual cycles or no periods at all. If this applies to you, your periods may return when switching from your current medicine to Clozapina Accord. This means you will need to use an effective contraceptive method.
Do not breastfeed during treatment with this medicine. Clozapine, the active substance in Clozapina Accord, may pass into breast milk and affect your baby.
Driving and using machines
This medicine may cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You must not drive or operate machinery while experiencing these symptoms.
Clozapina Accord contains lactose
Clozapina Accord contains lactose. If your doctor or pharmacist has told you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. How to take Clozapina Accord

To minimize the risk of low blood pressure, seizures, and drowsiness, your doctor must gradually increase the dose. Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is important that you do not change the dose or stop treatment with this medicine without first consulting your doctor. Continue taking the tablets unless your doctor tells you otherwise. 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 Accord”).
If the prescribed dose cannot be achieved with a tablet of this strength, other strengths of this medicine are available to achieve the required dose.
25 mg: the tablet can be divided into two equal doses.
100 mg: the tablet can be divided into two equal doses.
200 mg: the score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.

Treatment of schizophrenia
The initial dose is usually 12.5 mg (half a 25 mg tablet) once or twice on the first day, followed by 25 mg once or twice on the second day. Swallow the tablet with water. If well tolerated, your doctor will gradually increase the dose by 25–50 mg at a time over the next 2–3 weeks until reaching a dose of up to 300 mg per day. Afterwards, if necessary, the daily dose may be increased by 50–100 mg at a time every 3–4 days, or preferably at weekly intervals.
The effective daily dose is generally between 200 mg and 450 mg, divided into multiple 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 the daily dose is only 200 mg, you may take it as a single dose in the evening. After taking Clozapina Accord for some time with positive results, your doctor may attempt to reduce the dose.
You should take this medicine for at least 6 months.

For 25 mg, 50 mg, and 100 mg tablets only:
Treatment of severe thought disorders in patients with Parkinson’s disease
The initial dose is usually 12.5 mg (half a 25 mg tablet) in the evening. Take the tablet with water. Your doctor will gradually increase the dose by 12.5 mg at a time, with no more than two increases per week, up to a maximum dose of 50 mg by the end of the second week. Dose increases should be stopped or delayed if you feel weak, drowsy, or confused. To avoid these symptoms, your blood pressure should be monitored 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.
Daily doses of 50 mg should be exceeded only in exceptional cases. The maximum daily dose is 100 mg.
Always take the lowest effective dose for you.

If you take more Clozapina Accord than you should
If you think you have taken too many tablets, or if someone else has taken some of your tablets, contact your doctor immediately or seek urgent medical help.
Symptoms of overdose include:
Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff limbs, hand tremors, seizures (convulsions), increased salivation, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, and difficulty breathing or shallow breathing.

If you forget to take Clozapina Accord
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 the missed dose. Contact your doctor as soon as possible if you have not taken Clozapina Accord for more than 48 hours.

If you stop taking Clozapina Accord
Do not stop treatment with Clozapina Accord 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 symptoms, contact your doctor immediately. These symptoms may be followed by more serious side effects unless you receive appropriate treatment immediately. Your original symptoms may also return. If you need to stop treatment, a gradual reduction of the dose in 12.5 mg steps over one to two weeks is recommended. Your doctor will advise you on how to reduce the daily dose. If you need to stop treatment with Clozapina Accord suddenly, you must be seen by your doctor.
If your doctor decides to restart treatment with this medicine and more than two days have passed since your last dose of Clozapina Accord, you must restart with the initial dose of 12.5 mg.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention:
Immediately inform your doctor before taking your next tablet of Clozapina Accord if you
experience any of the following side effects:

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

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

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

• Signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You 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 stiffness that may lead to unconsciousness (neuroleptic malignant syndrome), as this may indicate a serious adverse reaction requiring immediate treatment.
• Feeling of light-headedness, dizziness, or fainting when standing up from a sitting or lying position, as this may increase the risk of falls.

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

• Signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, and wheezing.
• Severe burning abdominal pain extending 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 function.
• Signs of obesity 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) :

• Painful and prolonged erection of the penis if you are a man. This condition is known as 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).
• Abdominal pain, cramps, bloated abdomen, vomiting, constipation, inability to pass gas—these 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 progress to fulminant hepatic necrosis.
• Nausea, vomiting, fatigue, weight loss—these may be symptoms of kidney inflammation.

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

• Unbearable chest pain, feeling of tightness in the chest, pressure or constriction in the chest (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), which may lead to death. In this case, call for emergency medical help immediately.
• Chest pressure, heaviness, tightness, constriction, burning, or suffocation sensation (signs of inadequate blood and oxygen supply to the heart muscle), which may lead to death. In this case, your doctor will need to check your heart.
• Intermittent sensation in the chest of a “thud”, a “punch”, or an “abnormal beat” (palpitations).
• Rapid and irregular heartbeats (atrial fibrillation). Occasional palpitations, fainting, shortness of breath, or chest discomfort may occur. In this case, your doctor will need to check your heart.
• Symptoms of low blood pressure such as light-headedness, dizziness, fainting, blurred vision, unusual fatigue, cold and sweaty 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.
• Proven or strongly suspected infection with fever or low body temperature, abnormally rapid breathing, rapid heart rate, changes in reactivity and sensitivity, low 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 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 involving replacement of normal liver tissue with scar tissue, leading to loss of liver function, including life-threatening events such as liver failure (which may lead to death), liver injury (damage to liver cells, bile ducts in the liver, or both), and liver transplants.
• Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; bloating, heartburn, nausea, or vomiting, early feeling of fullness (intestinal ulceration of the stomach and/or intestine) which may lead to death.
• Severe abdominal pain worsened by movement, nausea, vomiting including vomiting of blood (or coffee-ground-like liquid); abdomen becomes rigid with rebound tenderness spreading from the perforation site throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or bowel rupture) which may lead to death.
• Constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhoea. This may indicate possible megacolon (bowel enlargement) or intestinal infarction/ischaemia/necrosis which may lead to death. In this case, your doctor will need to examine you.
• Sharp chest pain with shortness of breath, with or without cough.
• New or increased muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disorder (rhabdomyolysis). In this case, your doctor will need to examine you.
• Sudden chest or abdominal pain with shortness of breath, with or without cough or fever.
• Severe and very serious skin reactions have been reported during clozapine use, such as rash with eosinophilia and systemic symptoms (DRESS syndrome). The adverse skin reaction may appear as a rash with or without blisters. Skin irritation, oedema, fever, and flu-like symptoms may occur. DRESS syndrome symptoms usually appear about 2–6 weeks (potentially up to 8 weeks) after starting treatment.

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

Other side effects:

Very common (may affect more than 1 in 10 people)
Drowsiness, dizziness, increased saliva production.

Common (may affect up to 1 in 10 people)
Elevated levels of white blood cells in the blood (leucocytosis), elevated levels of a specific type of white blood cells (eosinophilia), weight gain, blurred vision, headache, tremors, stiffness, restlessness, seizures, spasms, abnormal movements, inability to initiate movements, inability to remain still, changes in ECG, high blood pressure, dizziness or light-headedness upon changing position, nausea (feeling unwell), vomiting, loss of appetite, dry mouth, slightly abnormal results 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 (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), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, 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 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 recording 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), if you are a man, ejaculation disorders where semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), skin rash, red-purple spots, fever or itching due to inflammation of blood vessels, inflammation of the colon causing diarrhoea, abdominal pain, fever, skin colour changes, butterfly-shaped facial rash, joint pain, muscle pain, fever, and fatigue (lupus erythematosus).
Restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by unpleasant sensations during periods of rest, 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 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 Italian Medicines Agency website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clozapine Accord

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

6. Package contents and other information

What Clozapina Accord contains
The active substance is clozapine.
25 mg: Each tablet contains 25 mg of clozapine.
50 mg: Each tablet contains 50 mg of clozapine.
100 mg: Each tablet contains 100 mg of clozapine.
200 mg: Each tablet contains 200 mg of clozapine.

• The other excipients are monohydrate lactose, maize starch, povidone K30, anhydrous colloidal silica, magnesium stearate and talc.

Description of the appearance of Clozapina Accord and package contents
25 mg: tablets of pale yellow to yellow colour, round, approximately 6.0 mm in diameter, film-coating-free,
with "FC" and "1" printed on either side of a break line on one side and smooth on the other side.
50 mg: tablets of pale yellow to yellow colour, round, approximately 8.0 millimetres in diameter, film-coating-free,
with imprint on one side and smooth on the other side.
100 mg: tablets of pale yellow to yellow colour, round, approximately 10.0 mm in diameter, film-coating-free,
with "FC" and "3" printed on either side of a break line on one side and smooth on the other side.
200 mg: film-coating-free tablets of pale yellow to yellow colour, capsule-shaped, approximately 17.0 mm in
length and 8.0 mm in width, with "F" and "C" printed on one side, three break lines, and "7" on the other
side with three break lines.
25 mg: the tablet can be divided into two equal doses.
100 mg: the tablet can be divided into two equal doses.
200 mg: the break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
Clozapina Accord is available in packages with aluminium/PVC/PVDC blisters.
Pack sizes:
25 mg: 7, 14, 28, 30, 40, 50, 100 or 500 tablets
50 mg: 28, 30, 40, 50 or 100 tablets
100 mg: 14, 28, 30, 40, 50, 60, 84, 100 or 500 tablets
200 mg: 40, 100 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturers
Laboratori Fundacio DAU,
C/C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia,
32009, Greece

This medicinal product is authorized in the European Economic Area countries under the following
names:

This patient information leaflet was last approved on: 02/2026.