Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nemea 100 mg orodispersible tablets EFG

clozapine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Nemea is and what it is used for

Nemea contains the active substance clozapine.

Nemea belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders such as psychosis).

Nemea is used to treat patients with schizophrenia when other medications have not worked. Schizophrenia is a mental illness involving disturbances in thought, emotional reactions, and behavioural disorders. You can only use this medicine if you have already tried at least two other antipsychotic medicines, including one of the newer atypical antipsychotics for the treatment of schizophrenia, and these medicines either failed to work or caused serious adverse reactions that cannot be managed.

Nemea is also indicated for the treatment of severe disturbances in thinking, emotional reactions, and behavioural disorders occurring in Parkinson's disease, when other medications have not been effective.

2. What you need to know before taking Nemea

Do not take Nemea:

if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6).
if regular blood tests cannot be performed.
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 medicines. 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 due to serious adverse reactions (e.g. agranulocytosis or any heart problems).
if you are currently or have recently been treated with long-acting depot injections of antipsychotics.
if you have or have had any bone marrow disease.
if you have uncontrolled epilepsy (seizures or fits).
if you have had severe mental disorders caused by alcohol or other medicines (e.g. narcotics).
if you experience episodes of loss of consciousness and strong, uncontrollable drowsiness.
if you have circulatory collapse that may 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 any other serious heart disease.
if you have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, feeling unwell, and loss of appetite).
if you have severe liver disease.
if you have paralytic ileus (your intestine 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 your blood.

Inform your doctor and do not take Nemea if any of the above conditions apply to you.

Nemea must not be administered to anyone who is unconscious or in a coma.

Warnings and precautions

The safety measures described in this section are very important. You must follow them to minimize the risk of serious, potentially life-threatening adverse reactions.

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

blood clots or a family history of blood clots, as this type of medicine has been associated with blood clot formation.
glaucoma (increased pressure in the eye).
diabetes. Elevated blood glucose levels (sometimes markedly) have occurred in patients with or without a prior medical 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).
controlled epilepsy.
diseases of the large intestine.
abdominal surgery.
heart disease or a family history of abnormal heart conduction known as “QT interval prolongation”.
risk of stroke, for example, if you have very high blood pressure, cardiovascular problems, or cerebrovascular disease.

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

you have signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. You will need an urgent blood test to determine whether these symptoms are related to the medicine.
you experience a sudden increase in body temperature, muscle rigidity that may lead to altered consciousness (neuroleptic malignant syndrome), as this may be a serious adverse reaction requiring immediate treatment.
you have a rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unusual fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
you have nausea, vomiting, and/or loss of appetite. Your doctor should examine your liver.
you have severe constipation. Your doctor should treat you to prevent further complications.
you experience constipation, abdominal pain, abdominal tenderness, fever, abdominal distension, and/or bloody diarrhoea. Your doctor will need to examine you.

Medical examinations and blood tests

Before starting treatment with Nemea, your doctor will ask about your medical history and perform a blood test to ensure your white blood cell count is normal. This is important because you need white blood cells to fight infections.

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

Your doctor will inform you exactly when and where these tests will be performed. You may only take Nemea if you have a normal blood count.
Nemea may cause a severe decrease in white blood cells in your blood (agranulocytosis). Only regular blood tests can allow your doctor to detect if you are at risk of developing agranulocytosis (see section 4).
Blood tests must be performed weekly for the first 18 weeks of treatment, then at least once a month for the following 34 weeks.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then annually, if no decrease in white blood cell count is detected.
If your white blood cell count decreases, you must stop treatment with Nemea immediately. Your white blood cell count should return to normal levels.
You should continue to have blood tests for 4 weeks after stopping Nemea completely, if treatment is discontinued for haematological reasons (i.e. agranulocytosis), or if monitoring duration is less than 2 years, or if you have a history of neutropenia that did not lead to discontinuation of treatment.

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

If you have liver impairment, periodic liver function tests will be performed throughout treatment with Nemea.

If you have elevated blood glucose levels (diabetes), your doctor may periodically monitor your glucose levels.

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

If you feel dizzy, lightheaded, or faint, or if Nemea causes these symptoms, be careful when standing up from a sitting or lying position, as this may increase the risk of falls.

If you are scheduled for surgery or for any reason cannot walk for a prolonged period, inform your doctor that you are taking Nemea. You may be at risk of thrombosis (blood clot in a vein).

Children and adolescents under 16 years

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

Use in elderly patients (60 years and older)

Patients aged 60 years and older may be more susceptible to the following adverse effects during treatment with Nemea: fainting or dizziness after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

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

Other medicines and Nemea

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal remedies. You may need to take different doses or different medicines.

Do not take Nemea together with other 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 cotrimoxazole.
certain pain medicines: analgesics of the pyrazolone group such as phenylbutazone.
penicillamine, a medicine used to treat rheumatoid arthritis.
cytotoxic agents, medicines used in chemotherapy.
long-acting depot injections of antipsychotic medicines.

These medicines increase your risk of developing agranulocytosis (deficiency of white blood cells in the blood).

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

medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
other antipsychotic medicines used to treat mental illnesses, such as perazine.
benzodiazepines and other medicines used to treat anxiety or sleep disorders.
narcotics and other medicines that may affect your 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 clotting.
antihistamines, medicines used for colds and allergies, such as hay fever (seasonal allergic rhinitis).
anticholinergic medicines, used to relieve stomach cramps, spasms, and dizziness.
medicines used to treat Parkinson's disease.
digoxin, a medicine used to treat heart problems.
medicines used to treat rapid or irregular heartbeat.
some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
some antibiotics, such as erythromycin and rifampicin.
some medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors, used to treat HIV infections).
atropine, a medicine that may be used in certain eye drops or in cough and cold preparations.
adrenaline, a medicine used in emergency situations.
hormonal contraceptives (birth control pills).

This list is not exhaustive. Your doctor and pharmacist have more information about medicines that should be used with caution or avoided while taking Nemea. They also know whether the medicines you are taking belong to any of the groups listed above. Discuss this with them.

Taking Nemea with food and drinks

Do not drink alcohol during treatment with Nemea.

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

Pregnancy, breastfeeding, and fertility

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

The following symptoms may occur in newborn babies of mothers who took Nemea during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you must contact your doctor.

Some women who take certain medicines for mental illnesses experience irregular or absent menstrual periods. If this has happened to you, your menstrual cycle may return to normal when your medication is switched to Nemea. This means you should use effective contraception.

During treatment with Nemea, you must not breastfeed your baby. Clozapine, the active substance in Nemea, may pass into breast milk and affect the baby.

Driving and using machines

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

Nemea contains aspartame (E951)

This medicine contains 3.10 mg of aspartame per orodispersible tablet, equivalent to 18 mg/g.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

3. How to take Nemea

To minimize the risk of seizures, drowsiness, or hypotension as much as possible, your doctor must gradually increase the dose. Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important that you do not change the dose or stop taking Nemea without first asking your doctor. Continue taking Nemea for as long as your doctor has instructed.

If you are a patient aged 60 or older, your doctor may start you on a lower dose and increase it more gradually, as you may be more susceptible to developing 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 formulation, other formulations of this medicine are available to reach the prescribed dose.

Treatment of schizophrenia

Treatment starts with 12.5 mg once or twice on the first day, followed by 25 mg once or twice on the second day.

Do not open the blister pack until you are ready to take the tablet. Immediately after opening the blister or bottle, with dry hands, remove the tablet and place it on your tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid.

If well tolerated, your doctor will gradually increase the dose by increments of 25–50 mg over 2 to 3 weeks until reaching a daily dose of up to 300 mg. It may be necessary to continue increasing the dose by 50 to 100 mg twice weekly, or preferably once weekly.

The effective daily dose of clozapine ranges between 200 and 450 mg, divided into several doses per day. Some individuals may require higher doses. Doses up to 900 mg per day are permitted. At daily doses exceeding 450 mg, adverse reactions (particularly seizures) may increase. Always take the lowest effective dose for you. Most patients take part of the dose in the morning and part in the evening. Your doctor will tell you exactly how to divide your daily dose. If your daily dose is only 200 mg, you may take it as a single dose at night. Once Nemea treatment has been effective for you over a period of time, your doctor will consider trying lower doses. You will need to take Nemea 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 at night.

Your doctor will slowly increase the dose by 12.5 mg increments, with a maximum of two increases per week, until reaching a maximum dose of up to 50 mg by the end of the second week. Dose increases should be stopped or delayed if you feel weak, dizzy, or confused. To avoid such symptoms, your blood pressure will be monitored during the first weeks of treatment.

The effective daily dose usually ranges between 25 and 37.5 mg, taken as a single nightly dose. Doses above 50 mg per day may only be used in exceptional cases. The maximum dose is 100 mg per day. Always take the lowest effective dose for you.

If you take more Nemea than you should

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

Symptoms of overdose include:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, limb rigidity, hand tremors, seizures, increased salivation, pupil dilation, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

If you forget to take Nemea

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you have stopped taking Nemea for more than 48 hours, contact your doctor immediately.

If you stop taking Nemea

Do not stop treatment with Nemea without consulting your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea, vomiting, and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more serious ones unless you are treated promptly. Your initial symptoms may reappear. If you need to stop treatment with Nemea, it is recommended to gradually reduce the dose by 12.5 mg increments over a period of 1 to 2 weeks.

Your doctor will give you instructions on how to reduce your daily dose. If you need to stop treatment abruptly, your doctor should examine you.

If your doctor decides to restart Nemea treatment and your last dose of Nemea was two days or more ago, treatment should be restarted at the initial dose of 12.5 mg.

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

4. Possible adverse effects

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

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

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

severe constipation. Your doctor will need to treat this to prevent further complications.
fast heartbeat.

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

cold symptoms, fever, flu-like symptoms, sore throat, or any other infection. An urgent blood test will be needed to determine whether your symptoms are related to your medicine.
epileptic seizures.
sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

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

a sudden increase in body temperature, muscle rigidity that may lead to altered mental status (neuroleptic malignant syndrome), as this may be a serious adverse effect requiring immediate treatment.
dizziness, lightheadedness, 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 patients):

signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, wheezing (noisy breathing).
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 lead to inhalation of food).
nausea, vomiting and/or loss of appetite. Your doctor should examine your liver.
signs of obesity or worsening obesity.
interrupted breathing with or without snoring during sleep.

Rare (may affect up to 1 in 1,000 patients) or very rare (may affect up to 1 in 10,000 patients):

fast and irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unusual tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

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

persistent and painful penile erections, if you are a man. This is called priapism. If you have an erection lasting more than four hours, immediate medical treatment may be needed to avoid further complications.
spontaneous bleeding or bruising, which could be signs of a decrease in the number of platelets in the blood.
symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation, or confusion).
abdominal pain, cramps, bloated abdomen, vomiting, constipation, and inability to pass gas, which may be signs and symptoms of intestinal obstruction.
loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. These symptoms may indicate the onset of liver disease, which may progress to fulminant hepatic necrosis.
nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Frequency not known (frequency cannot be estimated from available data):

crushing pain in the chest, sensation of pressure, tightness, or constriction in the chest (chest pain may radiate to the left arm, jaw, neck, or upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting, and palpitations (symptoms of a heart attack) which may lead to death. Seek immediate emergency medical treatment.
pressure in the chest, heaviness, tightness, constriction, burning, or suffocation (signs of insufficient blood and oxygen flow to the heart) which may lead to death. Your doctor should evaluate your heart function.
intermittent sensation in the chest of "pounding," "hammering," or "fluttering" (palpitations).
rapid and irregular heartbeats (atrial fibrillation). There may be occasional heart palpitations, fainting, difficulty breathing, or chest discomfort. Your doctor will need to evaluate your heart function.
symptoms of low blood pressure such as dizziness, lightheadedness, fainting, blurred vision, unusual fatigue, cold and clammy skin, or nausea.
signs of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
confirmed infection or high suspicion of infection, accompanied by fever or abnormally low body temperature, rapid breathing, fast heartbeat, altered reaction capacity and consciousness, decreased blood pressure (sepsis).
excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
a drastic reduction in urine production (signs of kidney failure).
an allergic reaction (swelling mainly in the face, mouth, and throat, as well as the tongue, which may cause itching or be painful).
loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. This may indicate possible liver disturbances leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including life-threatening hepatic events such as liver failure (which may lead to death), liver damage (damage to liver cells, bile ducts in the liver, or both), and liver transplantation.
burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; bloating, heartburn, nausea or vomiting, early satiety (intestinal ulceration of the stomach and/or intestine) which may lead to death.
severe abdominal pain that worsens with movement, nausea, vomiting including vomiting of blood (or coffee-ground-like liquid); the 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 intestinal rupture) which may cause death.
constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may be a symptom of possible megacolon (intestinal dilation) or intestinal ischemia/infarction/necrosis which may lead to death. Your doctor will need to examine you.
sudden sharp chest pain with difficulty breathing, with or without cough.
onset or worsening of muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you.
sudden sharp chest or abdominal pain with difficulty breathing, with or without cough or fever.
during the use of clozapine, extremely severe and serious skin reactions have been reported, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). The adverse skin reaction may appear as rashes with or without blisters. Skin irritation, edema, fever, and flu-like symptoms may occur. DRESS syndrome symptoms usually appear approximately 2 to 6 weeks (possibly up to 8 weeks) after starting treatment.

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

Other adverse effects:

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

drowsiness, dizziness
increased saliva production

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

high levels of white blood cells in the blood (leukocytosis), high levels of a specific group of white blood cells in the blood (eosinophilia)
weight gain
blurred vision
headache, tremor, stiffness, restlessness, agitation, seizures, jerky movements, abnormal movements, inability to initiate movement, inability to remain still
changes in the heart electrocardiogram (ECG) test
high blood pressure, weakness, or mild headache after changing position
nausea, vomiting, loss of appetite, dry mouth
minor abnormalities in liver function tests
loss of bladder control, difficulty urinating
fatigue, fever, increased sweating, elevated body temperature
speech disorders (e.g., difficulty articulating words)

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

deficiency of white blood cells in the blood (agranulocytosis)
speech disorder (e.g., stuttering)

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

low levels of red blood cells in the blood (anemia)
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 clotting in the lungs (thromboembolism)
inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching
elevated levels in the blood of an enzyme called creatine phosphokinase

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

increased number of blood platelets with possible blood clotting in blood vessels
uncontrollable movements of the mouth/tongue and limbs, obsessive thoughts, and repetitive compulsive behaviors (obsessive-compulsive symptoms)
skin reactions
swelling in front of the ear (due to inflammation of the salivary glands)
difficulty breathing
very high levels of triglycerides or cholesterol in the blood
heart muscle disease (cardiomyopathy), cessation of heart rhythm (cardiac arrest)
unexpected sudden death.

Frequency not known (frequency cannot be estimated from available data):

changes in brain wave recordings (electroencephalogram/EEG), involuntary contractions causing curvature of the body to one side (pleurothotonus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by uncomfortable sensations during rest periods, especially in the afternoon or at night, and temporarily relieved by movement)
diarrhea, stomach discomfort, burning, stomach discomfort after eating, inflammation of the colon causing diarrhea, abdominal pain, fever
muscle weakness, muscle spasms, muscle pain, fever, and fatigue (lupus erythematosus)
nasal congestion
nocturnal enuresis
sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma)

-- if you are a man, ejaculation disorder, in which semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation)

rash, red-purple spots, facial rash in the shape of a "butterfly", joint pain, muscle pain
fever or itching due to inflammation of blood vessels
change in skin color

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nemea

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

Do not use this medicine after the expiry date stated on the blister pack/bottle and outer carton. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nemea

The active substance is clozapine. Each tablet contains 100 mg of clozapine.
The other components are: mannitol (E 421), microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), aspartame (E 951), mint flavour (containing maltodextrin, sodium octenyl succinate starch (E 1450) and glyceryl triacetate (E 1518)), yellow iron oxide (E 172), magnesium stearate.

Appearance of the product and contents of the pack

Nemea 100 mg orodispersible tablets are yellow, round, flat tablets, approximately 13 mm in diameter, engraved with "C7PN" on one side and "100" on the other.

They are available in:

PVC/PVDC/Al blisters available in packs containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.

Single-dose cut PVC/PVDC/Al blisters available in packs containing 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.

HDPE bottles containing 250 or 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Adamed Laboratorios, S.L.U.

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

28023 Madrid,

Spain

Manufacturers

Synthon BV

Microweg 22

6545 CM Nijmegen, The Netherlands

Synthon Hispania, S.L.

Castello, 1, Polígono "Las Salinas"

08830 Sant Boi de Llobregat (Barcelona), Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Netherlands: Ayupine 12.5 mg, orodispergeerbare tabletten

Ayupine 25 mg, orodispergeerbare tabletten

Ayupine 50 mg, orodispergeerbare tabletten

Ayupine 100 mg, orodispergeerbare tabletten

Ayupine 200 mg, orodispergeerbare tabletten

Spain: Nemea 25 mg orodispersible tablets EFG

Nemea 100 mg orodispersible tablets EFG

Nemea 200 mg orodispersible tablets

Croatia: ZANIQ 12.5 mg raspadljive tablete za usta

ZANIQ 25 mg raspadljive tablete za usta

ZANIQ 100 mg raspadljive tablete za usta

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

NeMea 100 mg orodispersible tablets EFG