25 mg and 100 mg tablet 
Clozapine

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

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

1. What is Clozapine Sandoz and what is it used for?

The active substance in Clozapine Sandoz is clozapine which belongs to a group of medicines called antipsychotic medicines. These are drugs used to treat specific mental illnesses such as psychosis.

Clozapine Sandoz is used to treating patients with schizophrenia where 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 medicines. One of these should be one of the newer so-called atypical antipsychotic drugs to treat schizophrenia and neither of these two drugs has worked satisfactorily or should have caused serious side effects that cannot be treated.

Clozapine Sandoz is also used to treat severe thoughts, feelings, and behavior disorders in people with Parkinson’s disease, where other drugs have not worked.

Clozapine contained in Clozapine Sandoz 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 Sandoz

Do not take Clozapine Sandoz if you:

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

Clozapine Sandoz 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 with Clozapine Sandoz, 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. Elevated blood sugar levels (sometimes very elevated) have occurred in both patients with previous diabetes and 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)
  • galactose intolerance, total lactase deficiency, or lack of glucose-galactose uptake
  • controlled epilepsy
  • colon disease
  • underwent any abdominal surgery
  • heart disease or if someone in your family has had disorders of the cardiac conduction system called “prolongation of the QT interval”
  • an increased risk of stroke, if you have high blood pressure, cardiovascular problems, or disease in the blood vessels of the brain, for example.

Tell your doctor immediately before taking the next Clozapine Sandoz 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.
  • has 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.
  • have rapid and irregular heartbeats, 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.
  • is nauseous, vomits, and/or has a lack of appetite. Then your doctor needs to check your liver.
  • have severe constipation. Your doctor will treat this to avoid later complications.
  • 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 Sandoz, 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 Sandoz.

  • Your doctor will carefully inform you when and where to go for a blood test. Clozapine Sandoz should only be taken if you have a normal number of blood cells.
  • Clozapine Sandoz 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 the number of white blood cells, you must stop Clozapine Sandoz treatment immediately. Your white blood cells will return to normal.
  • You will need to have blood tests for another 4 weeks after stopping Clozapine Sandoz 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 Sandoz.

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

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

If you already feel dizzy or if Clozapine Sandoz 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 Sandoz. 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 Sandoz, 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 Sandoz: 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 Sandoz

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 Sandoz with medicines that prevent the bone marrow from functioning normally and/or reduce 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 Sandoz with other medicines may affect how well Clozapine Sandoz 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 sleep disorders
  • drugs and other drugs that may affect breathing
  • drugs that control 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
  • digoxin, a drug used in heart problems
  • drugs used to treat fast or irregular heartbeat
  • some medicines used to treat stomach ulcers, such as omeprazole or cimetidine
  • some antibiotics, such as erythromycin and rifampicin
  • any drugs used to treat fungal infections (such as ketoconazole ) and viral infections (such as protease inhibitors, used to treat HIV – infection s)
  • atropine, a drug that can be used in certain eye drops or in cough and cold products
  • adrenaline, a drug used in emergencies
  • hormonal contraceptives.

This list is not complete. Your doctor and pharmacist should have more information about medicines that you should be careful about or avoid while taking Clozapine Sandoz. They also know if the drugs you are taking belong to the listed groups. Consult with them.

Clozapine Sandoz with food and drink

Do not drink alcohol during treatment with Clozapine Sandoz.

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 Clozapine Sandoz.

Pregnancy and breastfeeding

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 using 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 Clozapine Sandoz.

The following symptoms may occur in newborns of mothers who used Clozapine Sandoz during the last trimester (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 Sandoz. This means that you must use an effective method of contraception.

Do not breast-feed during treatment with Clozapine Sandoz. Clozapine, the active substance in Clozapine Sandoz, may pass into your breast milk and affect your baby.

Driving and using machines

Clozapine Sandoz can cause fatigue, drowsiness, and cramps, especially at the beginning of treatment. Do not drive or use any tools or machines while you have these symptoms.

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 Sandoz 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.

Clozapine Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Clozapine Sandoz

To reduce the risk of low blood pressure, seizures, and drowsiness, it is necessary for your doctor to increase the dose gradually. Always use 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 Sandoz without consulting your doctor first. 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 a lower dose and gradually increase it as you are at greater risk of developing any side effects(see section 2 “What you need to know before you take Clozapine Sandoz”).

Treatment of schizophrenia

The usual 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. If you tolerate this well, your doctor will gradually increase the dose one by one in steps of 25-50 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 steps of 50-100 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 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 Sandoz with good results for some period, your doctor may try a lower dose. You need to take Clozapine Sandoz 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. The doctor will then gradually increase the dose one in steps of 12.5 mg, not faster than 2 steps in a week, all the way 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, which is taken as an evening dose. 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.

Method of administration

Clozapine Sandoz is taken by mouth. Swallow the tablet with water. Clozapine Sandoz can be taken before, during, or after a meal. The tablet can be divided into equal parts.

If you take more Clozapine Sandoz then you should

The symptoms of overdose are:

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

If you forget to take Clozapine Sandoz

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 Sandoz for more than 48 hours.

If you stop taking Clozapine Sandoz

Do not stop taking Clozapine Sandoz 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 basic symptoms may return. A gradual reduction of one dose in steps of 12.5 mg over a period of 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 Sandoz quickly, you will need to be checked by a doctor.

If your doctor decides that you should start treatment with Clozapine Sandoz again and it has been over 48 hours since your last dose of Clozapine Sandoz, 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, this medicine can cause side effects, although not everybody gets them.

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

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

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

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

  • signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You will quickly need to take a blood test to check if your symptoms are related to your medicine.
  • seizures.
  • suddenly faints or loses consciousness at the same time as you become muscle weak ( syncope ).

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

  • 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):

  • signs of respiratory infection or pneumonia such as fever, cough, difficulty breathing, or wheezing.
  • severe, burning pain in the upper abdomen extending to the back as well as nausea and vomiting (due to inflammation of the pancreas).
  • faints or becomes muscle weak due to a sharp drop in blood pressure.
  • difficulty swallowing (which may cause you to put food in the trachea).
  • nausea, vomiting, and/or loss of appetite. Then your doctor needs to check your liver.
  • signs of becoming overweight or increasing obesity.
  • respiratory arrest with or without snoring during sleep.

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

  • rapid 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.

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

  • persistent painful erection of the penis, if you are a man. 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.
  • spontaneous bleeding or bruising, which may be a sign of decreased platelet count.
  • symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, stomach pain, increased thirst, urination abnormally, and often, confusion).
  • stomach pain, cramps, bloating, vomiting, constipation, and problems with gas in the gastrointestinal tract, which may be signs and symptoms of intestinal obstruction (intestinal obstruction).
  • poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness, and malaise. These symptoms may be a sign that you have started to develop a liver disease that can lead to cell death in the liver ( fulminant liver necrosis). 
  • nausea, vomiting, fatigue, weight loss that may be symptoms of inflammation of the kidneys.

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). Seek emergency medical treatment immediately.
  • pressure over the chest, heaviness, tightness, burning or suffocating sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your doctor will need to check your heart.
  • periodically “throbbing”, “throbbing” or “fluttering” feeling 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 control your heart.
  • symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual tiredness, cold and damp/sticky skin, or 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.
  • diagnosed or suspected infection together 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 cholinergic syndrome).
  • severely decreased urine production (signs of renal failure ).
  • allergic reaction (swelling mainly of the face, mouth, and throat, as well as the tongue, which may be itchy or painful).
  • poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness, and malaise. It can be a sign of a kind of liver disease which means that normal liver tissue is replaced with scar tissue. This leads to reduced liver function, including liver effects that have life-threatening consequences such as liver failure (which can lead to death), liver damage (damage to liver cells, bile duct in the liver, or both), and liver transplantation.
  • constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may indicate possible megacolon (enlargement of the intestines) or blood clot in the intestinal blood vessels (intestinal infarction/ischemia). 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.

If you get any of these side effects, talk to your doctor immediately before taking the next Clozapine Sandoz tablet.

Other side effects:

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

Drowsiness, dizziness, increased saliva flow.

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

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

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

A pronounced decrease in white blood cell count ( agranulocytosis ), speech difficulties (eg stuttering).

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

Decreased number of red blood cells ( anemia ), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle ( myocarditis ) or membranes surrounding the heart muscle (pericarditis), fluid accumulation around the pericardium (pericardial effusion), high blood sugar Mellitus, high blood sugar, blood clots in the lungs ( thromboembolism ), inflammation of the liver ( hepatitis ), a liver disease that causes yellowing of the skin / dark urine/itching, elevated levels of an enzyme called creatinine phosphokinase in the blood.

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

Increased platelet count with the risk of blood clots, involuntary twitching of mouth/tongue, legs, and arms, obsessions and obsessive-compulsive behaviors (signs of obsessive-compulsive disorder), skin reactions, swelling in front of the ear (enlargement of the parotid glands), difficulty breathing, very high levels of triglycerides or cholesterol in the blood, heart muscle disease ( cardiomyopathy ), cardiac arrest, 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 a meal, muscle weakness, muscle cramps, muscle aches, nasal congestion, nocturnal bedwetting, sudden, uncontrollable increase in blood pressure (pseudopheochromocytoma) (pleurothotonus), disturbed ejaculation in men which means that semen enters the bladder instead of ejaculation through the penis (dry orgasm or retrograde ejaculation), rash, purplish-red spots, fever or itching due to inflammation of blood vessels, inflammation in the large intestine causing diarrhea, abdominal pain, fever, changes in skin color, flushing, joint pain, muscle aches, fever and fatigue (lupus erythematosus), restless legs syndrome (compulsive need to move your legs or arms. This is usually accompanied by unpleasant sensations during emotional times of rest, especially in the evening or at night, and temporarily relieved by movement).

In the elderly with dementia, a small increase in the number of deaths has been reported for patients who have been treated with antipsychotics compared with those who have not been treated.

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 Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. or 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 of clozapine.

Each tablet contains 100 mg of clozapine.

The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, povidone (K25), microcrystalline cellulose, sodium starch glycolate (type A), and magnesium stearate.

What the medicine looks like and the contents of the pack

25 mg tablets are round, light yellow, scored and marked with “C 25”.

100 mg tablets are round and light yellow. They have a cloverleaf arrangement.

The tablets are packaged in blister cards or plastic jars with screw caps.

Pack sizes:

Blisters: 20, 28, 30, 40, 50, 60 (100 mg only), 84, 98, 100, 10 x 50 and 100 x 50.

10 x 50 and 100 x 50 tablets are for hospital use and dose dispensing only.

Jars (hospital use and dose dispensing):

100, 250, and 500.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1, 39179 Barleben, Germany

or

Lek SA, Ul. Domaniewska 50C, 02-672 Warsaw, Poland

or

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

Muhammad Nadeem

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