25 mg, 100 mg  tablets 
clozapine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Clozapine Mylan is and what it is used for 
2. What you need to know before taking Clozapine Mylan 
3. How to take Clozapine Mylan 
4. Possible side effects 
5. How to store Clozapine Mylan 
6. Package contents and other information 

1. What Clozapine Mylan is and what it is used for

The active substance in Clozapine Mylan is clozapine which belongs to a group of medicines called antipsychotic medicines, which are used to treat specific mental conditions e.g. psychos.

Clozapine Mylan is used to treat patients with schizophrenia for whom other medicines have not worked satisfactorily.

Schizophrenia is a mental illness, which affects how you think, feel, and behave. You should only take this medicine if you have already tried at least two other antipsychotic drugs, including one of the newer so-called atypical antipsychotic drugs, to treat schizophrenia and none of these drugs have worked satisfactorily or caused serious untreatable side effects.

Clozapine Mylan is also used to treat severe thoughts, feelings, and behavioral disorders in people with Parkinson’s disease for whom other medicines have not worked.

Clozapine contained in Clozapine Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions

What you need to know before you take Clozapine Mylan

Do not take Clozapine Mylan:

  • if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6).
  • if you do not have the opportunity to participate in regular blood tests.
  • if you have previously been informed that you have a low white blood cell count (eg leukopenia or agranulocytosis ), especially if this has been caused by other medicines. This does not apply if you have low blood cell counts due to previous cancer treatment ( chemotherapy ).
  • if you have previously stopped taking clozapine due to serious side effects (eg agranulocytosis and heart problems).
  • if you are being treated with or have been treated with long-acting depot injections of antipsychotic drugs.
  • if you have or have had any disease that impairs bone marrow function or you are taking medicines that prevent your bone marrow from functioning normally.
  • if you have uncontrolled epilepsy (seizures and seizures).
  • if you have an acute mental illness caused by alcohol or drugs (eg drugs).
  • if you have impaired consciousness and pronounced drowsiness.
  • if you have experienced a collapse of the blood circulation, which may occur as a result of severe shock.
  • if you have severe kidney disease.
  • if you have any serious heart disease such as inflammation of the heart muscle ( myocarditis ).
  • if you have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, nausea, or poor appetite).
  • if you have any other serious liver disease.
  • if your bowel is not functioning normally and you have severe constipation (paralytic ileus ).
  • if you are taking any medicine that reduces the number of white blood cells in your blood.

If any of the above apply to you, tell your doctor and do not take Clozapine Mylan. Clozapine Mylan must not be given to anyone who is unconscious or in a coma.

Warnings and cautions

The safety precautions in this section are very important. You must follow them to minimize the risk of serious life-threatening side effects.

Before treatment  

Tell your doctor if you have or have had:

  • blood clots or if someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
  • glaucoma (increased pressure in the eye)
  • diabetes or if someone in your family has had diabetes. Elevated blood sugar level (sometimes very elevated), have occurred both in patients with preexisting diabetes or without previous diabetes (see section 4)
  • prostate problems or difficulty urinating
  • heart, kidney, or liver disease
  • chronic constipation or if you are taking medicines that can cause constipation (such as anticholinergics)
  • controlled epilepsy
  • colon disease

Also, tell your doctor if you

  • underwent any abdominal surgery
  • if you have had a heart condition or if someone in your family has had disorders of the cardiac conduction system called ” QT prolongation “,
  • if you have an increased risk of stroke, for example, if you have high blood pressure, cardiovascular problems, or disease of the blood vessels of the brain.

During treatment

Tell your doctor immediately before taking the next Clozapine Mylan tablet:

  • if you get signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. You will then immediately need to take a blood sample to check if your symptoms are related to your medicine.
  • if you have a sudden rapid rise in body temperature and stiff muscles that can lead to unconsciousness. It can be a serious side effect (malignant neuroleptic syndrome) that requires immediate treatment.
  • if you have a fast and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.
  • if you are sick, suffering from vomiting, and/or lack of appetite. Then your doctor needs to check your liver.
  • if you have severe constipation. Your doctor will treat this to avoid later complications.
  • if you have constipation, abdominal pain, abdominal pain, fever, bloating, and/or bloody diarrhea. Your doctor will need to examine you.

Medical and blood tests

Before starting treatment with Clozapine Mylan, your doctor will ask you about your medical history and take a blood test to make sure that your white blood cell count is normal. It is important to find out this because your body needs white blood cells to fight your infection.

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

  • Your doctor will carefully inform you when and where to take a blood test. Clozapine should only be taken if you have a normal number of blood cells.
  • Clozapine can cause a large decrease in the number of white blood cells in your blood ( agranulocytosis ). Only regular blood tests can tell your doctor if you are at risk of developing agranulocytosis.
  • During the first 18 weeks of treatment, blood tests are performed once a week. Later, blood tests are taken at least once a month.
  • If there is a decrease in white blood cell count , you must stop taking clozapine immediately. Your white blood cells will return to normal.
  • You will need to have a new blood test 4 weeks after stopping clozapine treatment.

Your doctor will also examine you before you start treatment. Your doctor may take an ECG to examine your heart, but only if it is considered necessary or if you have special concerns.

If you have impaired liver function, you will need regular liver function tests while you are taking clozapine.

If you suffer from high blood sugar levels ( diabetes ), your doctor may need to check your blood sugar levels regularly.

Clozapine can cause changes in blood fats. Clozapine may cause weight gain. Your doctor may need to check your weight and blood fats.

If you already feel dizzy or if clozapine makes you dizzy, dizzy, or faint, be careful when standing up from a sitting or lying position as these may increase the risk of falling.

If you need surgery or if for some reason you can not walk for a long time, discuss with your doctor the fact that you are taking clozapine. You are at risk of getting a blood clot in a vein ( thrombosis ).

Children and young people under 16 years of age

If you are under 16 years of age, do not take Clozapine Mylan, as there is not enough information on its use in this age group.

Elderly people (60 years and older)

Elderly people (60 years and older) are more likely to get the following side effects during treatment with clozapine: fainting or dizziness in the head after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

Tell your doctor or pharmacist if you suffer from dementia.

Other medicines and Clozapine Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and natural remedies. You may need to take a different amount of your medicine or take other medicines.

Do not take Clozapine Mylan with medicines that prevent bone marrow from functioning normally and/or reducing the number of blood cells produced by the body, such as:

  • carbamazepine, a medicine used to treat epilepsy
  • certain antibiotics: chloramphenicol, sulfonamide (eg co-triazole)
  • certain painkillers: pyrazolone analgesics such as phenylbutazone
  • penicillamine, a drug used to treat rheumatoid arthritis
  • cytotoxic agents, drugs used in chemotherapy
  • long-acting depot injections of antipsychotic drugs

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

Treatment with Clozapine Mylan with other medicines may affect how well Clozapine Mylan and/or the other medicines work. Tell your doctor if you are planning to take, if you are taking (even if your treatment is about to end) or if you have recently taken any of the following medicines:

  • drugs used to treat depression e.g. lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline
  • other antipsychotic drugs to treat mental illness, such as perazine
  • benzodiazepines and other medicines used to treat anxiety and difficulty sleeping
  • drugs and other drugs that may affect breathing
  • drugs such as epilepsy such as phenytoin and valproic acid
  • drugs used to treat high or low blood pressure such as adrenaline and norepinephrine
  • warfarin, a drug used to prevent blood clots
  • antihistamines, medicines used for allergies such as hay fever
  • anticholinergic drugs, which are used to relieve stomach cramps, spasms, and motion sickness
  • drugs used in Parkinson’s disease
  • drugs that inhibit certain enzymes such as caffeine (used as an analgesic), perazine (drugs used to treat mental illness), fluvoxamine (used to treat depression), ciprofloxacin ( antibiotic )
  • digoxin, a drug used in heart problems
  • drugs used to treat fast or irregular heartbeat
  • hormonal contraceptives ( birth control pills ), such as progesterone, or combined birth control pills such as progesterone and estrogen.
  • 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 (eg protease inhibitors, used to treat HIV infections)
  • atropine, a drug that can be used in certain eye drops or in cough and cold products
  • adrenaline, a drug used in emergencies

This list is not complete. Your doctor and pharmacist have more information about the medicines that you should be careful about or avoid when taking this medicine. They also know if the medicines you are currently taking belong to the medicines on the list.

Taking Clozapine Mylan with food and drink

Do not drink alcohol during treatment with Clozapine Mylan.

Tell your doctor if you smoke and how often you drink caffeinated beverages (coffee, tea, and Coca-cola). Sudden changes in your smoking or caffeine habits can also change the effect of this medicine.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss the benefits and possible risks for you of using this medicine during pregnancy. Tell your doctor immediately if you become pregnant during treatment with this medicine.

The following symptoms may occur in newborns of mothers who have used clozapine during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.

Some women who take medication to treat mental illness have irregular periods or none at all. If you have been affected in this way, your periods may return when you are treated with clozapine. This means that you must use an effective method of contraception.

Breast-feeding

Do not breast-feed during treatment with clozapine. Clozapine can pass into your breast milk and affect your baby.

Driving and using machines

Do not drive or use any tools or machines as Clozapine Mylan may cause fatigue, drowsiness, and cramps, especially at the beginning of treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Clozapine Mylan contains lactose

Clozapine Mylan contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Clozapine Mylan

To reduce the risk of low blood pressure, seizures, and drowsiness, it is necessary for your doctor to increase the dose gradually. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

It is important that you do not change your dose or stop taking Clozapine Mylan without first consulting your doctor. Keep taking the tablets for as long as your doctor tells you to. If you are 60 years of age or older, your doctor may start with the lower dose and gradually increase it as you are more likely to develop some side effects(See section 2 “What you need to know before taking Clozapine Mylan”).

Treatment of schizophrenia

The recommended starting dose is 12.5 mg (half a 25 mg tablet) once or twice on the first day followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If you tolerate this well, your doctor will gradually increase the dose one in steps of 25 mg-50 mg over the next 2-3 weeks until a dose of 300 mg per day is reached. Thereafter, if necessary, the daily dose may be increased in increments of 50 to 100 mg twice a week or preferably at weekly intervals.

The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses per day. Some patients may need a higher dose. A maximum daily dose of up to 900 mg is allowed. Increased side effects (especially seizures) may occur with daily doses above 450 mg. Always take the lowest dose that is effective for you. Most people take part of their dose in the morning and the other part in the evening. Your doctor will tell you exactly how to distribute the daily dose. About your daily dose only 200 mg, you can take it as a single dose in the evening. Once you have taken Clozapine Mylan with good results for some period, your doctor may try a lower dose. You need to take Clozapine Mylan for at least 6 months.

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

The usual starting dose is 12.5 mg (half a 25 mg tablet) in the evening. Swallow the tablet with water.

Your doctor will then gradually increase the dose one step by 12.5 mg, not faster than 2 steps in one week, all the way up to a maximum dose of 50 mg at the end of the second week. Increases in dosage one should be discontinued or postponed if you feel dizzy, dizzy, or confused. To avoid such symptoms, your blood pressure will be measured during the first few weeks of treatment.

The effective dose is usually between 25 mg and 37.5 mg, it is taken as a dose in the evening. Doses of 50 mg per day should only be exceeded in exceptional cases. The maximum daily dose is 100 mg. Always take the lowest dose that is effective for you.

The tablet can be divided into two equal doses.

Older

If you are older, your doctor will start treatment with a lower dose of 12.5 mg. Your doctor may gradually increase the dose to a maximum daily dose of 25 mg.

If you take more Clozapine Mylan then you should

The symptoms of overdose are:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff joints, trembling hands, increased or lack of reflexes, cramps (seizures), increased production of saliva, dilation of pupil one, increased sensitivity to heat, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing or heavy breathing.

If you forget to take Clozapine Mylan

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the forgotten tablets but take the next dose at the right time. Do not take a double dose to make up for a forgotten dose. Contact your doctor as soon as possible if you have not taken Clozapine Mylan in 48 hours.

If you stop taking Clozapine Mylan

Do not stop taking Clozapine Mylan without consulting your doctor, as you may experience withdrawal reactions. These reactions include sweating, headache, nausea, vomiting, and diarrhea. If you get any of these reactions, contact your doctor immediately. These reactions can be followed by more serious side effects if you are not treated immediately. Your underlying symptoms may return. A gradual dose reduction of 12.5 mg over one to two weeks is recommended if you need to stop treatment. Your doctor will advise you on how to reduce your daily dose. If you need to stop treatment with Clozapine Mylan quickly, you will need to be checked by your doctor.

If your doctor decides that you should start treatment with Clozapine Mylan again and it has been 48 hours since your last dose of Clozapine Mylan, the starting dose should be 12.5 mg.

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

4. Possible side effects

Like all medicines, Clozapine Mylan can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

Talk to your doctor immediately, or see your nearest emergency department, if you notice any of the following: 

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

  • seizures or muscle twitching.

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

  • signs of cold, fever, flu-like symptoms, sore throat, or any other infection. This can be a sign of a change in the number or type of white blood cells (which help fight infections ) that can lead to serious blood infections.
  • a sudden rapid increase in body temperature, stiff muscles, which can lead to unconsciousness (malignant neuroleptic syndrome) as this can be a serious side effect that requires immediate treatment.
  • dizzy, dizzy, or dizzy when standing up from a sitting or lying position as these may increase the risk of falling.

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

  • rapid and irregular heartbeat even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. These can be signs of changes in the heart rhythm (which can be seen on the ECG ) or enlargement of the heart muscle ( cardiomyopathy ) (very rare). They can also be signs of inflammation in the heart muscle ( myocarditis ), the membrane surrounding the heart muscle (pericarditis), or fluid accumulation around the heart (pericardial effusion). Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.
  • very slow, shallow breathing (frequent small breaths) or difficulty breathing, fainting and muscle weakness which may be associated with heart problems (circulatory collapse).
  • difficulty swallowing which can cause food to get stuck in the trachea.
  • extreme confusion that may be associated with hallucinations (seeing, feeling or hearing things that do not exist), increased or decreased activity and sleep problems ( delirium ).
  • inflammation of the pancreas leading to severe abdominal pain in the upper abdomen, which can reach around the back.
  • signs of becoming overweight or increasing obesity.
  • respiratory arrest with or without snoring during sleep.

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

  • unexplained bruising or if you bleed longer than normal. This may be a sign of a decrease in the number of platelets (which help the blood to coagulate). You need to take a blood test quickly to check if your symptoms are related to the medicine.
  • Obstacles or blockages in the small or large intestine. Your doctor will treat this to avoid further complications. Very rarely, this can lead to severe constipation or blockage in the intestine (paralytic ileus ).
  • persistent painful erection of the penis. This is called priapism. If you have an erection that lasts for more than 4 hours, immediate medical treatment may be necessary to avoid further complications.

Has been reported (occurs in an unknown number of users):

  • oppressive chest pain, feeling of tightness 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 (signs of heart attack), which can be life threatening. Seek emergency medical treatment immediately. In very rare cases, this can lead to cardiac arrest.
  • pressure over the chest, heaviness, tightness, pressing, burning, or suffocating sensation (signs of insufficient blood flow and oxygen to the heart muscle), which can be life-threatening. Your doctor will need to check your heart.
  • periodic “throbbing”, “throbbing” or “fluttering” sensation in the chest (palpitations).
  • rapid and irregular heartbeat ( atrial fibrillation ). It can cause symptoms such as temporary palpitations, fainting, shortness of breath, or chest pain. Your doctor will need to check your heart.
  • symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual tiredness, cold and damp/sticky skin, and nausea.
  • signs of blood clots in the veins, especially in the legs, (symptoms are swelling, pain, and redness of the legs), which can be transported via the blood vessels to the lungs and cause chest pain and difficulty breathing. This may be due to an increased number of platelets (which help the blood to coagulate)
  • diagnosed or suspected infection along with fever or low body temperature, abnormally fast breathing, fast heart rate, altered alertness, and consciousness, drop in blood pressure (symptoms of sepsis ).
  • heavy sweating, headache, nausea, vomiting, and diarrhea (symptoms of the cholinergic syndrome)
  • severely decreased urine production, blood in the urine, or pain in the lower back (signs of kidney failure ).
  • signs of an allergic reaction such as swelling of the face, lips, tongue, and throat which may cause difficulty breathing or difficulty swallowing.
  • rash that can appear on the face, neck, and scalp, joint pain, and fever which can all be signs of a problem with the body’s immune system (Systemic Lupus Erythematosus or SLE ).
  • a rare condition of rapidly increasing blood pressure which can lead to permanent damage to organs (other signs may be a faster heartbeat, difficulty breathing, dizziness, vomiting, blurred vision).
  • nausea, vomiting, and/or loss of appetite. These can be signs of liver problems where some can become serious such as inflammation of the liver, blockage of the bile duct, liver failure, and in some cases the need for a liver transplant.
  • burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages; tar-like, black, or bloody stools; bloating, heartburn, nausea or vomiting, early feeling of satiety (intestinal ulcers in the stomach and/or intestines), which can be life-threatening.
  • severe abdominal pain aggravated by movement; nausea, vomiting, including bloody vomiting (coffee-like); tense abdomen with residual tenderness spreading across the abdomen; fever and/or chills (broken stomach or intestines), which can be life-threatening.
  • nausea, vomiting, abdominal pain, increased thirst, excessive urination, disorientation, or confusion (signs of severe acid-base and glucose imbalance in the body that can lead to coma ).
  • constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may indicate possible megacolon (enlargement of the intestines) or a blood clot in the blood vessels of the intestines (intestinal infarction/ischemia/necrosis), which can be fatal. Your doctor will need to examine you.
  • sharp chest pain with shortness of breath with or without cough
  • increased or new muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle disease ( rhabdomyolysis ). Your doctor will need to examine you.
  • sharp chest or abdominal pain with shortness of breath and with or without cough or fever.
  • Extremely intense and severe skin reactions, such as drug rash with eosinophiliaand systemic symptoms (DRESS syndrome), have been reported with the use of clozapine. The side effect can manifest itself as a skin rash with or without blisters. Skin irritation, edema, fever, and flu-like symptoms may occur. Symptoms of DRESS syndrome usually occur about 2-6 weeks (possibly up to 8 weeks) after starting treatment.

Other side effects that may occur:

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

Drowsiness, constipation, dizziness, increased saliva flow, rapid heartbeat.

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

Increased white blood cell count ( leukocytosis ), increased number of white blood cell types ( eosinophilia ), weight gain, blurred vision, headache, tremors, stiffness, internal anxiety, abnormal movements, inability to initiate movement, inability to remain immobile, high blood pressure, fainting when getting up quickly, fainting, nausea, vomiting, loss of appetite, dry mouth, fever, slightly elevated values ​​in liver tests, urinary incontinence, difficulty urinating, fatigue, sweating, increased body temperature, speech difficulties (eg slurred speech).

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

Other speech difficulties (eg stuttering)

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

Decreased red blood cell count ( anemia ), restlessness, agitation, confusion, blood clots in the lungs ( thromboembolism ), hepatitis ( hepatitis ), liver disease causing yellowing of the skin or whites of the eyes, dark urine and itching, elevated levels of an enzyme called creatinine phosphokinase in blood. Decreased glucose tolerance may be due to the inability of the body to respond to a hormone called insulin. Diabetes with symptoms such as extreme thirst with simultaneous high urine production, that you feel tired or very hungry.

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

Involuntary twitching of the mouth, tongue, arms, and legs, obsessive thoughts and compulsive repetitive behavior (signs of obsessive-compulsive disorder), accumulation of hard stool in the rectum, which may be due to chronic constipation (fecal impaction), skin reactions, enlargement of the parotid gland, very high levels of triglyceride s or cholesterol in the blood, sudden unexplained death.

Has been reported (occurs in an unknown number of users) :

Changes in brain activity (seen on electroencephalogram / EEC), diarrhea, stomach pain, heartburn, stomach pain after meal, muscle weakness, muscle cramps, muscle aches, nasal congestion, nocturnal bedwetting, inflammation of blood vessels, inflammationin the colon (can be seen as blood in the stool and severe abdominal pain), changes in skin color, disturbed ejaculation in men. Uncontrolled muscle twitching affects the eyes, head, neck, and body and may be due to prolonged exposure to certain types of medicines called antipsychotics (medicines used to treat mental illnesses such as clozapine). Restless legs syndrome (compulsive need to move your legs or arms. This is usually accompanied by unpleasant sensations during times of rest, especially in the evening or at night, and is temporarily relieved by movement).

In elderly people with dementia who are treated with antipsychotic drugs, a small increase in the number of deaths has been reported compared with those who do not receive such treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Clozapine Mylan

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

Do not use Clozapine Mylan after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

6. Contents of the packaging and other information

Content declaration

  • The active substance is clozapine. Each tablet contains 25 mg clozapine and 100 mg clozapine, respectively.
  • The other ingredients are lactose monohydrate, corn starch, povidone, talc, colloidal anhydrous silica, and magnesium stearate.

What the medicine looks like and contents of the pack

Clozapine Mylan 25 mg tablets: light yellow, round, smooth tablets with beveled edges marked “CZ / 25” on one side and “G / G” on the other side.

Clozapine Mylan 100 mg tablets: light yellow, round, smooth tablets with beveled edges marked “CZ / 100” on one side and “G / G” on the other side.

Clozapine Mylan tablets are packaged in PVdC / PVC / Alu blisters containing 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

McDermott Laboratories Ltd. t / a Gerard Laboratories t / a Mylan Dublin

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1

2900 Komárom

Hungary

Muhammad Nadeem

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