Package Insert: Information for the Patient

Nemea 100 mg Tablets EFG

Clozapine

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

The active ingredient of Nemea is clozapine, which belongs to a group of medications called antipsychotics (also known as neuroleptics and used to treat specific mental disorders such as psychosis).

Clozapine is used to treat patients with schizophrenia when the use of other medications has not been effective. Schizophrenia is a mental illness that involves disturbances in thought, emotional reactions, and behavioral disturbances. You can only use this medication if you have already tried at least two other antipsychotic medications, including one of the new atypical antipsychotics for treating schizophrenia, and these medications do not respond, or cause severe adverse reactions that cannot be treated.

Clozapine is also indicated for treating severe thought disturbances, emotional reactions, and behavioral disturbances that occur in Parkinson's disease, when other medications have not been effective.

Follow carefully all the instructions given to you by your doctor.

Do not take Nemea

• if you are allergic to clozapine or any of the other components of this medication (listed in section 6).
• if you will not be able to have blood tests performed periodically.
• if you have ever been told that you have a low white blood cell count (e.g. leucopenia or agranulocytosis), especially if it was caused by other medications. This does not apply if you had a low white blood cell count caused by previous chemotherapy.
• if you previously had to stop taking Nemea because it caused severe adverse reactions (e.g. agranulocytosis or heart problems).
• if you are being or have been treated with long-acting depot injections of antipsychotics.
• if you have or have had bone marrow disease.
• if you have uncontrolled epilepsy (seizures or attacks).
• if you have had severe mental disorders caused by alcohol or other medications (e.g. narcotics).
• if you have episodes of loss of consciousness and a strong feeling of sleep that is difficult to control.
• if you have circulatory collapse that can occur as a result of severe shock.
• if you have severe kidney disease.
• if you have myocarditis (inflammation of the heart muscle).
• if you have other severe heart disease.
• if you have symptoms or active liver disease such as jaundice (yellowing of the skin and eyes, feeling unwell, and loss of appetite).
• if you have other severe liver disease.
• if you have paralytic ileus (intestinal obstruction, your intestines do not function correctly and you have severe constipation).
• if you are taking a medication that prevents your bone marrow from functioning correctly.
• if you are taking a medication that reduces the number of white blood cells in your blood.

If you have any of the above circumstances, inform your doctor and do not take Nemea. Nemea should not be administered to anyone who is unconscious or in a coma.

Warnings and precautions

The safety measures mentioned in this section are very important. You must comply with them to minimize the risk of severe adverse reactions that can be life-threatening.

Before starting treatment with Nemea, inform your doctor if you have or have had any of the following circumstances:

- blood clots or a family history of blood clots, as this type of medication has been associated with blood clot formation.

- glaucoma (elevated eye pressure).

- diabetes. In patients with or without a medical history of diabetes mellitus (see section 4), elevated blood glucose levels (sometimes significantly) have been reported.

- prostate problems or difficulty urinating.

- any heart, kidney, or liver disease.

- chronic constipation or taking medications that cause constipation (such as anticholinergics).

- lactose intolerance, total lactase deficiency, or malabsorption of glucose-galactose.

- controlled epilepsy.

- intestinal diseases.

- abdominal surgery.

- a heart disease or family history of abnormal heart conduction called "prolongation of the QT interval."

- risk of stroke, for example if you have high blood pressure, cardiovascular problems, or problems with blood vessels in the brain.

Immediately before taking the next dose of Nemea tablets, inform your doctor if:

- you have signs offlu, fever, symptoms similar to the flu, sore throat, or any other infection. You will need to have an urgent blood test to see if these symptoms are related to the medication.

- you have a sudden increase in body temperature, muscle stiffness that can lead to altered consciousness (neuroleptic malignant syndrome), as it may be a severe adverse reaction that requires immediate treatment.

- you haverapid and irregular heart rate, even when at rest,palpitations, breathing problems, chest pain, or unusual fatigue. Your doctor will need to check your heart and, if necessary, refer you to a cardiologist immediately.

- you havenausea (feeling of dizziness), vomiting (you feel dizzy)and/orloss of appetite. Your doctor will need to examine your liver.

- you havesevere constipation. Your doctor will need to treat you to prevent other complications.

- you experienceconstipation, abdominal pain, abdominal sensitivity, fever, abdominal distension, and/ordiarrhea with blood. Your doctor will need to examine you.

Medical examinations and blood tests

Before starting treatment with Nemea, your doctor will ask you about your medical history and perform a blood test to ensure that your white blood cell count is normal. It is essential to know this, as you need white blood cells to fight infections.

Make sure you have regular blood tests performed before, during, and after completing treatment with Nemea.

- Your doctor will inform you exactly when and where these tests will be performed. You can only take Nemea if you have a normal blood count.

- Nemea can cause a severe decrease in white blood cells in your blood (agranulocytosis). Only with regular blood tests can your doctor know if you are at risk of developing agranulocytosis.

- This test should be performed weekly during the first 18 weeks of treatment with Nemea and, after that, at least once a month.

- If there is a decrease in the number of white blood cells, you must stop taking Nemea immediately. Your white blood cells should return to normal values.

- Blood tests should be performed for 4 weeks after completing treatment with Nemea.

Before starting treatment, your doctor will also perform a physical examination. Your doctor may perform an electrocardiogram (ECG) to check your heart, but only if necessary for you or if you have any special concerns.

If you have liver abnormalities, you will have periodic tests of liver function during treatment with Nemea.

If you have elevated blood glucose levels (diabetes), your doctor may perform periodic checks of your blood glucose levels.

Nemea can alter your blood lipid levels. Nemea can cause weight gain. Your doctor may monitor your weight and lipid levels.

If you have mild headache pain, dizziness, or weakness, or if Nemea makes you feel this way, be careful when getting up from a sitting or lying position, as this can increase the risk of falls.

If you need to undergo surgery or are unable to walk for a long period of time for any reason, inform your doctor that you are taking Nemea. You may be at risk of developing blood clots (blood clots in a vein).

Children and adolescents under 16 years

If you are under 16 years old, you should not take Nemea as there is not enough information available for its use in this age group.

Use in elderly patients (60 years and older)

Elderly patients may be more susceptible to the following adverse effects during treatment with Nemea: mild headache or dizziness after changing position, dizziness, rapid heart rate, urinary retention, and constipation.

Inform your doctor or pharmacist if you have a disease called dementia.

Use of Nemea with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, even those purchased without a prescription or herbal treatments. You may need to take different amounts of your medications or different medications.

Do not take Nemea with other medications that prevent the correct functioning of the bone marrow and/or reduce the number of blood cells produced by the body, such as:

- carbamazepine, a medication used to treat epilepsy.

- certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.

- certain pain medications: analgesics in the pyrazolone group such as phenylbutazone.

- penicillamine, a medication used to treat rheumatoid arthritis inflammation.

- cytotoxic agents, medications used in chemotherapy.

- long-acting depot injections of antipsychotic medications.

These medications increase your risk of developing agranulocytosis (severe decrease in white blood cells).

Taking Nemea with other medications may affect the correct action of Nemea and/or other medications. Inform your doctor if you intend to take, are taking (even if the treatment is about to end), or have recently stopped taking any of the following medications:

- medications used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.

- other antipsychotic medications used to treat mental illnesses, such as perazine.

- benzodiazepines and other medications used to treat anxiety or sleep disorders.

- narcotics and other medications that can affect your breathing.

- medications used to control epilepsy such as phenytoin and valproic acid.

- medications used to treat high or low blood pressure, such as adrenaline and noradrenaline.

- warfarin, a medication used to prevent blood clotting.

- antihistamines, medications used to treat colds and allergies such as hay fever (seasonal allergic rhinitis).

- anticholinergic medications, used to relieve stomach upset, spasms, and dizziness.

- medications used to treat Parkinson's disease.

- digoxin, a medication used to treat heart problems.

- medications used to treat rapid or irregular heart rate.

- some medications used to treat stomach ulcers, such as omeprazole or cimetidine.

- some antibiotics, such as erythromycin and rifampicin.

- some medications used to treat fungal or viral infections (such as protease inhibitors, used to treat HIV/AIDS).

- atropine, a medication that may be used in some eye drops or cough and cold preparations.

- adrenaline, a medication used in emergency situations.

- hormonal contraceptives (birth control pills).

This list is not exhaustive. Your doctor and pharmacist have more information about medications that should be taken with caution or avoided while taking Nemea. They also know if the medications you are taking belong to any of the listed groups. Inform them.

Taking Nemea with food and drinks

During treatment with Nemea, do not drink alcohol.

Inform your doctor if you smoke and how often you consume beverages containing caffeine (coffee, tea, cola drinks). Sudden changes in your smoking or caffeine consumption habits may also modify the effects of Nemea.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. Your doctor will discuss the benefits and potential risks of using this medication during pregnancy. Inform your doctor immediately if you become pregnant during treatment with Nemea.

The following symptoms may appear in newborn babies of mothers who used Nemea in the last trimester (the last three months of pregnancy): tremors, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you need to contact your doctor.

Some women taking medications for mental illnesses have irregular or no menstrual periods. If this has happened to you, your menstrual periods will return to normal when your medication is replaced by Nemea. This means you should use effective birth control.

During treatment with Nemea, do not breastfeed your baby. Clozapine, the active ingredient in Nemea, can pass into breast milk and affect the baby.

Driving and operating machinery

Nemea may cause drowsiness, dizziness, and seizures, especially at the beginning of treatment. Therefore, you should avoid driving or operating machinery while experiencing these symptoms.

Nemea may cause symptoms such as drowsiness, dizziness, or vision disturbances, and decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Nemea contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

To reduce the risk of seizures, drowsiness, or hypotension as much as possible, your doctor will need to gradually increase your dose.Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential not to change the dose or stop taking Clozapina without first asking your doctor. Continue taking Clozapina for the time your doctor has indicated.

If you are a patient 60 years of age or older, your doctor may start your treatment with a lower dose and gradually increase your dose more slowly, as you may be more susceptible to developing some unexpected adverse reactions. (See section 2 "What you need to know before starting to take Nemea").

If you cannot achieve the prescribed dose with this tablet presentation, other presentations of this medication are available to achieve the prescribed dose.

Schizophrenia treatment

Treatment begins with 12.5 mg (half of 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 the help of a glass of water. If you tolerate it well, your doctor will gradually increase the dose in amounts of 25 or 50 mg over 2 to 3 weeks to reach a daily dose of 300 mg. You may need to continue increasing the dose in amounts of 50 or 100 mg twice a week, or preferably once a week.

The usual daily dose of clozapine is between 200 and 450 mg, divided into several doses per day. Some people may need higher doses. Doses of up to 900 mg per day are allowed. At daily doses above 450 mg, adverse reactions may increase (particularly seizures). Always take the minimum dose that is effective for you. Most patients must take a part of the dose in the morning and another in the evening. Your doctor will tell you exactly how to divide your daily dose. If your daily dose does not exceed 200 mg, you can take it as a single dose at night. Once your clozapine treatment is working well for some time, your doctor will try the treatment with lower doses. You will need to take clozapine for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson's disease

The usual initial dose of clozapine is 12.5 mg (half of a 25 mg tablet) at night. Swallow the tablet with the help of a glass of water. Your doctor will gradually increase the dose in amounts of 12.5 mg, with a maximum of two increases per week, to reach a maximum dose of up to 50 mg by the end of the second week. Dose increases should be stopped or postponed if you feel weak, dizzy, or confused. To avoid such symptoms, your blood pressure will be measured during the first weeks of treatment.

The effective daily dose is between 25 and 37.5 mg, taken as a single dose at night. Only in exceptional cases can doses above 50 mg per day be increased. The maximum dose is 100 mg per day. Always take the minimum dose that is effective for you.

If you take moreNemeathan you should

If you think you have taken more Nemea than you should, or if someone has taken some of your tablets, inform your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of overdose are:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, numbness in the extremities, tremors in the hands, seizures, increased saliva production, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

If you forgot to take Nemea

If you forgot to take a dose, take the missed dose as soon as possible. If there is little time left for the next dose, do not take the missed dose and take the next dose at the time it is due. Do not take a double dose to compensate for the missed dose. If you have stopped taking clozapine for two or more days, do not start treatment without first consulting your doctor.

If you interrupt treatment withNemea

Do not stop treatment with clozapine without asking your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea (feeling dizzy), vomiting (feeling dizzy), and diarrhea.If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more severe symptoms unless you are treated immediately.Your initial symptoms may recur. If you have to interrupt treatment, it is recommended to gradually reduce your daily dose in amounts of 12.5 mg over a period of 1 to 2 weeks.Your doctor will give you instructions on how to reduce your daily dose. If you have to interrupt your treatment suddenly, your doctor should examine you.

If your doctor decides to restart treatment with clozapine and your last dose of clozapine was two days or more ago, you should start with the initial dose of 12.5 mg.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Some side effects can be serious and require immediate medical attention.Inform your doctor immediately before taking the next Nemea tablet if you experience any of the following circumstances:

Very common(affects more than 1 in 10 patients):

- severe constipation. Your doctor will need to treat you to prevent other complications.

- rapid heart rate.

Common(affects up to 1 in 10 patients):

- signs ofcommon 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 have are related to your medicine.

-seizures.

- sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

Uncommon(affects up to 1 in 100 patients):

- a sudden increase in body temperature, muscle stiffness that can lead to altered consciousness (neuroleptic malignant syndrome), as it may be a serious side effect that requires immediate treatment.

- mild headache, dizziness or weakness, when getting up from a sitting or lying position, as it may increase the risk of falling.

Rare(affects up to 1 in 1,000 patients):

- signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, wheezing (respiratory ruidous breathing).

- burning, intense pain in the upper abdomen that extends to the back accompanied by nausea and vomiting due to pancreatitis.

- fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).

- difficulty swallowing (which may cause inhalation of food).

-nausea (feeling sick), vomiting (being sick)and/orloss of appetite. Your doctor will need to examine your liver.

- signs of obesity or weight gain.

- interruption in breathing with or without snoring during sleep.

Rare(affects up to 1 in 1,000 patients)orvery rare(affects up to 1 in 10,000 patients):

- rapid and irregular heart rate, even when at rest,palpitations, breathing problems, chest painorunusual fatigue. Your doctor will need to check your heart and, if necessary, immediately refer you to a cardiologist.

Very rare(affects up to 1 in 10,000 patients):

- persistent and painful erections of the penis, if you are a man. This is called priapism. If you have an erection that lasts more than four hours, you may need immediate medical treatment to prevent further complications.

- spontaneous bleeding or bruising, which could be signs of a drop in platelet count 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, swollen abdomen, vomiting, constipation and lack of gas passage, which may be signs and symptoms of intestinal obstruction.

- loss of appetite, swollen abdomen, abdominal pain, yellowing of the skin, severe weakness and discomfort. These symptoms may be indicative of liver disease that can progress to sudden liver necrosis.

- nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Unknown(the frequency cannot be estimated from the available data):

- crushing chest pain, feeling of oppression, pressure or constriction (chest pain may radiate to the left arm, jaw, neck and upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting and palpitations (symptoms of a heart attack), which may cause death. Seek immediate medical treatment.

- chest pressure, heaviness, oppression, constriction, burning or asphyxia (signs of insufficient blood and oxygen flow to the heart), which may cause death. Your doctor will need to evaluate your heart function.

- intermittent chest pain in a "stinging", "accelerated" or "agitated" manner (palpitations).

- irregular heartbeats (atrial fibrillation). You may experience occasional heart palpitations, fainting, difficulty breathing or chest discomfort. Your doctor will need to check your heart.

- symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual fatigue, cold and moist skin or nausea.

- signs of blood clots in the veins, especially in the legs (symptoms that include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing.

- confirmed or suspected infection, accompanied by fever or low body temperature, rapid abnormal breathing, rapid heart rate, altered reaction and consciousness, decreased blood pressure (sepsis).

- excessive sweating, headache, nausea, vomiting and diarrhea (symptoms of cholinergic syndrome).

- sudden and drastic decrease in urine production (signs of kidney failure).

- allergic reaction (swelling mainly in the face, mouth and throat, as well as in the tongue that may cause itching or be painful).

- loss of appetite, swollen abdomen, abdominal pain, yellowing of the skin, severe weakness and discomfort. This may be indicative of possible liver damage that involves replacing normal liver tissue with scar tissue leading to loss of liver function, including those liver events that lead to life-threatening consequences such as liver insufficiency (which may lead to death), liver damage (damage to liver cells, bile ducts in the liver, or both) and liver transplant.

- burning pain in the upper abdomen, particularly between meals, early in the morning or after drinking acidic beverages; black, tar-like or bloody stools; swelling, acid reflux, nausea or vomiting, early feeling of fullness (intestinal ulceration of the stomach and/or intestine), which may lead to death.

- severe abdominal pain intensified by movement, nausea, vomiting, even vomiting blood (or liquid that looks like ground coffee); the abdomen becomes rigid with sensitivity (rebound) that extends from the perforation point through the abdomen; fever and/or chills (intestinal perforation of the stomach and/or intestine or intestinal rupture) that may lead to death.

- constipation, abdominal pain, abdominal sensitivity, fever, swelling, diarrhea with blood. This may be a symptom of possible megacolon (expansion of the intestines) or ischemia/intestinal infarction/necrosis, which may lead to death. Your doctor will need to examine you.

- appearance or increase of muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle damage (rhabdomyolysis). Your doctor will need to examine you.

- sudden and severe chest or abdominal pain with difficulty breathing with or without cough or fever.

During the use of Nemea, severe and intense skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS).The skin reaction may appear as rashes with or without blisters. Irritation of the skin, swelling and fever and flu-like symptoms may also occur. DRESS symptoms usually appear approximately 2 to 6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above cases apply to you, inform your doctor immediately before taking the next Nemea tablet.

Other side effects:

Very common(affects more than 1 in 10 patients):

Drowsiness, dizziness, increased saliva production.

Common(affects up to 1 in 10 patients):

High levels of white blood cells in the blood (leucocytosis), high levels of a certain type of white blood cell in the blood (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, restlessness, agitation, convulsions, involuntary movements, abnormal movements, inability to initiate movement, inability to remain still, changes in the heart's electrocardiogram (ECG), high blood pressure, weakness or mild headache after changing position, nausea (feeling of dizziness), vomiting (being dizzy), loss of appetite, dry mouth, minor abnormalities in liver function tests, loss of bladder control, difficulty urinating, fatigue, fever, increased sweating, elevated body temperature, minor speech disorders (e.g. dragged words).

Uncommon(affects up to 1 in 100 patients):

Low white blood cell count in the blood (agranulocytosis), speech disorder (e.g. stuttering).

Rare(affects up to 1 in 1,000 patients):

High red blood cell count in the blood (anemia), restlessness, agitation, confusion, delirium, irregular heart rate, inflammation of the heart muscle (myocarditis) or of the membrane that surrounds the heart muscle (pericarditis), accumulation of fluid around the heart (pericardial effusion), high blood sugar levels, diabetes mellitus, blood clotting in the lungs (pulmonary embolism), liver inflammation (hepatitis), liver disease that causes yellowing of the skin/ dark urine/itching, high levels of a certain enzyme in the blood called creatine phosphokinase.

Very rare(affects up to 1 in 10,000 patients):

Increased platelet count in the blood with possible blood vessel coagulation, involuntary movements of the mouth/tongue and lips, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, facial swelling (due to inflammation of the salivary glands), difficulty breathing, very high triglyceride or cholesterol levels in the blood, heart muscle disease (cardiomyopathy), cardiac arrest, sudden and unexpected death.

Unknown(the frequency cannot be estimated from the available data):

Changes in brain wave recording (electroencephalogram/EEG), diarrhea, stomach discomfort, burning, stomach discomfort after eating, weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), involuntary curvature of the body to one side (pleurototonos), if you are a man, sexual dysfunction, in which semen enters the bladder instead of ejaculating through the penis (dry orgasm or retrograde ejaculation), hives, red-purple spots, fever or itching due to inflammation of blood vessels, inflammation of the colon that causes diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move legs or arms, usually accompanied by uncomfortable sensations during periods of rest, especially in the afternoon or at night and temporarily relieved by movement).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through theSpanish System for PharmacovigilanceofHuman Medicines, website:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the case. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be thrown down the drain or in the trash.Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nemea

-The active principle is clozapine.

-The other components are: lactose monohydrate, magnesium stearate, talc, cornstarch, pregelatinized starch, povidone, and silicon dioxide.

Appearance of the product and contents of the package

Nemea 100 mg tablets are yellow, round, scored, and marked with “CPN 100” on one side.Each tablet contains 100 mg of clozapine.

They are presented in perforated unit-dose blisters contained in boxes of 40x1 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2nd floor

28023 Aravaca – Madrid, Spain

Tel.: +34 91 357 11 25

Fax: +34 91 307 09 70

e-mail:infoesp@adamed.com

Responsible for manufacturing

Synthon BV

Microweg 22

6545 CM Nijmegen, Netherlands

or

Synthon Hispania, S.L.

Castello, 1, Polígono ”Las Salinas”

08830 Sant Boi de Llobregat (Barcelona), Spain

or

G.L.PHARMA GMBH

Schlossplatz 1

Lannach 8502, Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Lanolept 25/50/100 mg – tablets

Italy:Clozapina Chiesi 25/50/100 mg tablets

Portugal:Clozapina Generis 25/100 mg tablets

Netherlands:Clozapine 25/50/100 mg, tablets

Spain:Nemea 25/100 mg tablets

Iceland:Clozapin Medical 25/100 mg tablets

Last review date of this leaflet: March 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.