Package Insert: Information for the Patient

Nemea 100 mg Bucodispersable Tablets EFG

Clozapine

Read this entire package insert carefully before taking 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.

Nemea contains the active ingredientclozapine.

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

Nemea is used for the treatment of patients with schizophrenia when the use of other medications has not been effective. Schizophrenia is a mental illness that involves disturbances of thought, emotional reactions, and behavioral disturbances. You can only use this medication if you have already tried at least two otherantipsychotic medications, including one of the new atypical antipsychotics for treating schizophrenia, and these medications were not effective, or caused severe adverse reactions that could not be treated.

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

Do not take Nemea:

• if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6).
• if it will not be possible to perform blood tests 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 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 because it caused severe side effects (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 fits).
• if you have had severe mental disorders caused by alcohol or other medicines (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 may occur as a result of a severe shock state.
• if you have severe kidney disease.
• if you have myocarditis (inflammation of the heart muscle).
• if you have 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 have any severe liver disease.
• if you have paralytic ileus (your intestine does not function correctly and you have severe constipation).
• if you are taking any medicine that prevents your bone marrow from functioning correctly.
• 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 circumstances apply.

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 side effects that may 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 medicine 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), high blood glucose levels (sometimes significantly) have been reported.

- 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.

- 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 very 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 medicine.

- you have a sudden increase in body temperature, muscle stiffness that can lead to altered consciousness (neuroleptic malignant syndrome), as this may be a severe side effect 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 examine your heart and, if necessary, refer you immediately to a cardiologist.

- you havenausea, vomiting and/orloss of appetite. Your doctor will examine your liver.

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

- you experience constipation, abdominal pain, abdominal sensitivity, fever, abdominal distension and/or bloody diarrhea. 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 will 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 before, during and after stopping 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 may 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 done weekly during the first 18 weeks of treatment and then 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 done for 4 weeks after stopping treatment with Nemea.

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 for you or if you have a special concern.

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

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

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

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

If you are to be operated on or if you are unable to walk for a long period for any reason, inform your doctor that you are taking Nemea. You may be at risk of developing thrombosis (blood clot 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 for its use in this age group.

Use in elderly patients (60 years and older)

Elderly patients (60 years and older) may be more susceptible to the following side effects during treatment with Nemea: dizziness or fainting after changing position, dizziness, rapid heart rate, difficulty urinating and constipation.

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

Other medicines and Nemea

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

Do not take Nemea with other medicines 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 medicine used to treat epilepsy.

- certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.

- certain painkillers: 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 antipsychotics.

These medicines increase your risk of developing agranulocytosis (low white blood cell count).

Taking Nemea at the same time as other medicines may affect the correct action of Nemea and/or the other medicines. 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 medicines:

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

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

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

- narcotics and other medicines that can 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 to treat colds and allergies, such as hay fever (seasonal allergic rhinitis).

- anticholinergic medicines, used to relieve stomach upset, 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 heart rate.

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

- atropine, a medicine that may be used in eye drops or in preparations for coughs and colds.

- 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 taken with caution or avoided while taking Nemea. They also know if the medicines you are taking belong to any of the groups listed above. Inform them.

Taking Nemea with food and drinks

Do not drink alcohol during treatment with Nemea.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 appear in newborn babies, of mothers who have used Nemea in the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

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

Do not breastfeed your baby during treatment with Nemea. Clozapine, the active substance in Nemea, may 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 contains aspartame (E951)

This medicine contains 3.10 mg of aspartame in each 18 mg/g buccal dispersible tablet.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

To reduce the risk of seizures, drowsiness, or hypotension as much as possible, your doctor will need to gradually increase the dose.Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential that you do not change the dose or stop taking Nemea without asking your doctor first. Continue taking Nemea for the time your doctor has indicated.

If you are a patient 60 years or older, your doctor may start the treatment with a lower dose and gradually increase it 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.

Treatment of schizophrenia

The 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 it. Immediately after opening the blister pack or bottle, with dry hands, remove the tablet and place it on the tongue. The tablet disintegrates quickly in the saliva. The buccodispersible tablet can be taken with or without liquid.

If you tolerate it well, your doctor will gradually increase the dose in amounts of 25-50 mg over 2-3 weeks to reach a dose of up to 300 mg per day. It may be necessary to continue increasing the dose in amounts of 50-100 mg twice a week, or preferably once a week.

The effective 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 take a portion of the daily 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 is only 200 mg, you can take it as a single dose at night. Once the treatment with Nemea is working well for you for some time, your doctor will try the treatment with 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.

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

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 usually ranges from 25 to 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. Phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose are:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, rigidity of the limbs, 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 Nemea for more than 48 hours, contact your doctor immediately.

If you interrupt the treatment withNemea

Do not stop taking Nemea without asking 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 severe symptoms unless you are treated immediately.Your initial symptoms may recur. If you have to interrupt the treatment with Nemea, it is recommended to gradually reduce the 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 the treatment with Nemea and your last dose of Nemea was more than two days ago, you should start with the initial dose of 12.5 mg.

If you have any other questions 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(may affect more than 1 in 10 patients):

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

- rapid heart rate.

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

- a sudden increase in your 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.

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

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

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

- severe, 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 food inhalation).

-nausea, vomiting 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(may affect up to 1 in 1,000 patients)orvery rare(may affect 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 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 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 inability to pass gas, 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 may progress to fulminant liver necrosis.

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

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

- crushing chest pain, feeling of oppression, pressure or constriction in the chest (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). Seek immediate medical treatment.

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

- intermittent sensation in the chest of “stabbing”, "beating" or "fluttering" (palpitations).

- rapid and irregular heartbeats (atrial fibrillation). You may have 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, 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, abnormal rapid breathing, rapid heart rate, altered reaction and consciousness, decreased blood pressure (sepsis).

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

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

- an 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 alterations that involve the replacement of normal liver tissue with scar tissue leading to liver function loss, including those 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.

- 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. Your doctor will need to examine you.

- acute pain in the chest with difficulty breathing and with or without coughing

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

- acute pain in the chest or abdomen with difficulty breathing with or without coughing or fever.

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

Other side 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 certain group of white blood cells in the blood (eosinophilia)

- weight gain

- blurred vision

- headache, tremor, stiffness, restlessness, agitation, convulsions, sudden movements, abnormal movements, inability to initiate movement, inability to stay still

- changes in the heart's electrocardiogram (ECG)

- 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):

- low white blood cell count in the blood (agranulocytosis)

- speech disorder (e.g., stuttering)

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

- low red blood cell count in the blood (anemia)

- restlessness, agitation

- confusion, delirium

- irregular heart rhythm, inflammation of the heart muscle (myocarditis) or of the membrane surrounding 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/urine darkening/itching

- high levels in the blood of an enzyme called creatine phosphokinase

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

- increased platelet count in the blood with possible clotting in blood vessels

- uncontrolled movements of the mouth/tongue and limbs, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms)

- skin reactions

- swelling in the 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), cardiac arrest

- sudden unexpected death.

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

- changes in the brain wave recording (electroencephalogram/EEG), involuntary contraction that causes curvature of the body to one side (pleurotónos), restless legs syndrome (irresistible impulse to move the legs or arms, usually accompanied by uncomfortable sensations during periods of rest, especially in the afternoon or at night and that temporarily improves with movement)

- diarrhea, stomach discomfort, burning, stomach discomfort after eating, inflammation of the colon that causes 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 ejaculating through the penis (dry orgasm or retrograde ejaculation)

- hives, red-purple spots, hives on the face in the shape of “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 cases of death in patients taking antipsychotics compared to those not taking them has been reported.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point of 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 ingredient 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), peppermint aroma (contains maltodextrin, octenyl succinate sodium starch (E 1450) and triacetin glycerol (E 1518)), yellow iron oxide (E 172), magnesium stearate.

Appearanceof the productand contentsof the package

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

They are available in:

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

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

HDPE bottles may contain 250 or 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

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

28023 Madrid, Spain

Responsible Manufacturers

Synthon BV

Microweg 22

6545 CMNijmegen, Netherlands

or

Synthon Hispania, S.L.

Castello, 1, Polígono ”Las Salinas”

08830 Sant Boi de Llobregat (Barcelona), Spain

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

Germany:Ayupine 12.5 mg Schmelztabletten

Ayupine 25 mg Schmelztabletten

Ayupine 50 mg Schmelztabletten

Ayupine 100 mg Schmelztabletten

Ayupine 200 mg Schmelztabletten

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 buccal dispersible tablets EFG

Nemea 100 mg buccal dispersible tablets EFG

Nemea 200 mg buccal dispersible tablets

France:Ayupile 12.5 mg, comprimé orodispersible

Ayupile 25 mg, comprimé orodispersible

Ayupile 100 mg, comprimé orodispersible

Croatia:ZANIQ 12.5 mg raspadljive tablete za usta

ZANIQ 25 mg raspadljive tablete za usta

ZANIQ 100 mg raspadljive tablete za usta

Poland:Ayupil

Last review date of this leaflet: March 2023

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/