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DENZAPINE 100MG TABLETS

Active substance(s): CLOZAPINE / CLOZAPINE / CLOZAPINE

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Package leaflet: Information for the user
DENZAPINE® 25, 50, 100, 200 mg Tablets
Clozapine
The use of Denzapine is restricted to those patients registered with the Denzapine Monitoring
Service.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep 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 pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
What Denzapine is and what is it used for
2.
What you need to know before you take Denzapine
3.
How to take Denzapine
4.
Possible side effects
5.
How to store Denzapine
6.
Contents of the pack and other information

1.

What Denzapine is and what it is used for

Denzapine contains the active substance clozapine, which belongs to a group of medicines called
atypical antipsychotics. Antipsychotics are mainly used to treat schizophrenia. Schizophrenia is a
psychiatric disorder that affects the way a person thinks and behaves.
Denzapine is used:
-

to treat schizophrenia when at least two other antipsychotic medicines, including one of the
newer atypical antipsychotics, have not worked or have caused severe side effects
to treat psychotic disorders occurring in patients with Parkinson’s disease, when standard
treatment has failed.

Denzapine is available only with a doctor’s prescription. Ask your doctor if you have any
questions about why this medicine has been prescribed for you.

2.

What you need to know before you take Denzapine

Denzapine must not be given to anyone who is unconscious or in a coma.
Do not take Denzapine:
-

if you are allergic to clozapine or to any of the other ingredients of this medicine (listed in
section 6). It is important to tell your doctor if you think you have ever had an allergic
reaction to any of these ingredients. Symptoms of an allergic reaction can include:
- swelling of the face and mouth
- itchy skin rashes or hives

-

difficulty breathing
faintness.

-

if you are unable to digest lactose (milk sugar), due to one of the following conditions:
- galactose intolerance
- Lapp-lactase deficiency
- glucose-galactose malabsorption.

-

if you are unable to undergo regular blood tests
if you have a low number of white cells in the blood
(leucopenia/granulocytopenia/agranulocytosis) especially if this was caused by medicines.
This does not apply if you have had low white blood cell count caused by previous
chemotherapy.
if you are receiving treatment with other medicines that can cause a fall in the number of
white blood cells
if you are being treated or have been treated with long-acting depot injections of
antipsychotics.
if you have suffered from a very low white blood cell count (agranulocytosis) caused by
previous treatment with clozapine.

-

Do not take Denzapine if you have any of the following diseases:
- Disorders of the bone marrow (when the bone marrow does not make enough blood cells) or
have ever suffered from bone marrow disease.
- Uncontrolled epilepsy (fits or seizures)
- Acute mental illness caused by alcohol, medicines or other substances (e.g. narcotics)
- Poisoning caused by other medicines
- Circulatory collapse (a very pronounced fall in the blood pressure that may lead to
unconsciousness)
- Disorders affecting the brain that can lead to severe drowsiness, reduced consciousness or
unconsciousness
- Severe kidney disease
- Heart disease (such as myocarditis (inflammation of heart muscle), pericarditis or
cardiomyopathy (weakness of heart muscle))
- Active liver disease with jaundice (yellow colouration of the skin and eyes), feeling sick and
loss of appetite
- Liver failure (very serious liver disease) or any other severe liver disease
- Paralytic ileus (a disorder of the small intestine).
- If you use any medicine that stops your bone marrow from working properly.
Warnings and precautions
The safety measures mentioned in this section are very important. You must comply with
them to minimise the risk of serious life-threatening side effects.
Talk to your doctor or pharmacist before taking Denzapine if you have or have had any medical
conditions or illnesses, especially the following:
-

Low number of white blood cells (leukopenia, neutropenia, granulocytopenia,
agranulocytosis)
High number of a certain type of white blood cells called eosinophil granulocytes
(eosinophilia)
Low number of platelets in the blood (thrombocytopenia)
Pericarditis or pericardial effusion (inflammation of the membranes around the heart)
If you have had a heart disease or family history of abnormal conduction in the heart called
“prolongation of the QT interval”.
Orthostatic hypotension (a fall in the blood pressure on standing up)
Epilepsy or fits, even if they are well controlled

-

Any heart, kidney, or liver disease
Enlargement of the prostate or difficulty urinating
Glaucoma (raised pressure in the eye)
Chronic constipation or if you are taking medicines which cause constipation (such as
anticholinergics).
Tell your doctor if you have ever had abdominal surgery.
Constipation, paralytic ileus, disease of the large bowel or operations on the abdomen
Diabetes. Increased blood sugar levels have occurred in patients with or without diabetes
mellitus in their medical history (see section 4).
Stroke (risk factors of stroke e.g. smoking, diabetes and high blood pressure).
If you or someone else in your family has a history of blood clots, as medicines like these
have been associated with formation of blood clots. If you are not mobile you are at increased
risk of developing blood clots while taking Denzapine.

Talk to your doctor or pharmacist immediately
if you experience an elevated temperature (fever). This may be caused by Neuroleptic
Malignant Syndrome - a serious reaction to some anti-psychotic medicines. Symptoms include a
sudden increase in body temperature, sweating, a fast heart beat, muscle stiffness and a
fluctuating blood pressure. It can lead to coma. Stop taking Denzapine immediately if your
doctor or pharmacist tells you.
- if you get signs of a cold, fever, flu-like symptoms, sore throat or any other infection.
You will have to have an urgent blood test to check if your symptoms are related to your
medicine.
- if you have fast and irregular heart beat, even when you are at rest, palpitations,
breathing problems, chest pain or unexplained tiredness. Your doctor will need to
check your heart and if necessary refer you to a cardiologist immediately.
- if you experience nausea (feeling sick), vomiting (being sick) and/or loss of appetite.
Your doctor will need to check your liver.
- if you have severe constipation. Your doctor will have to treat this in order to avoid
further complications.
Tell your doctor if you are taking any other antipsychotic medicines (see section “Taking other
medicines” below).
Tell your doctor if you are taking any other medicines that are known to affect the heart.
Medical check-ups and blood tests
Denzapine may lower the number of your white blood cells, making you more prone to infections.
Before and during your treatment with Denzapine, your doctor will monitor your blood count
closely to make sure that the number of your white blood cells do not fall under a certain level.
Tell your doctor immediately if you develop any signs of infection, such as fever, sore throat or
flu-like symptoms.
Your doctor will tell you exactly when and where to have the tests. Denzapine may only be taken
if you have a normal blood count.
Denzapine can cause agranulocytosis. In this condition, the number of white blood cells (which
are necessary to fight infection) is too low. If this occurs, you are at risk of suffering infections
which may be life-threatening. Warning signs include flu-like symptoms, a sore throat or fever. If
you develop these or any other signs suggestive of infection, you must contact your doctor
immediately.
There is no way of knowing who is at risk of developing agranulocytosis. Deaths have occurred in
severe cases of agranulocytosis, although with regular blood tests, agranulocytosis can be detected
early. If Denzapine is stopped as soon as a problem is detected, the white blood cell numbers
should return to normal. You must understand the importance of regular blood tests by your doctor
while taking Denzapine.

After starting treatment with Denzapine, you will have a blood test once a week for the first 18
weeks. The risk of agranulocytosis is highest in this period. For the rest of the first year of
treatment, blood tests will be performed every 2 weeks. After the first year, tests will be
performed every 4 weeks for as long as you continue to take Denzapine. Tests will also be
performed for one month after stopping the medicine. These tests will tell the doctor if there is any
problem with the number of white cells in your blood. There are some situations where you may
need to have blood tests more often (e.g. twice a week). Your doctor will talk to you about this.
If the number of your white blood cells falls below a critical level, Denzapine must be stopped
immediately and you must never take any medicines containing clozapine again.
You will need to have blood tests for another 4 weeks after the end of Denzapine treatment.
Your doctor will also do a physical examination before starting treatment. Your doctor may do an
electrocardiogram (ECG) to check your heart, but only if this is necessary for you, or if you have
any special concerns.
Denzapine may cause alteration in blood lipids (fats), and may cause weight gain. Your doctor
may monitor your weight and blood lipid level.
If you have a liver disorder you will need regular liver function tests for as long as you continue to
take Denzapine.
If Denzapine makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting
or lying position.
If you have to undergo surgery or if for some reason you are unable to walk around for a long
time, discuss with your doctor the fact that you are taking Denzapine. You may be at risk of
thrombosis (blood clotting within a vein).
Be careful when drinking alcohol or when taking antihistamines (medicines used for hay fever,
allergies or colds), sleeping tablets or tablets to relieve pain while taking this medicine.
Denzapine can increase drowsiness caused by alcohol and by medicines affecting your nervous
system.
Denzapine may affect the way your body controls temperature, and it may prevent sweating even
in very hot weather. Exercise, hot baths or saunas may make you feel dizzy or faint while you are
taking this medicine.

Children and adolescents
Do not use Denzapine if you are under 16 years of age because there is not enough information
about its use in this age group.
Older people (aged 60 years and over)
Some side effects are more common in older people: feeling dizzy or faint when you stand up or
change position, fast heart beat, difficulty passing urine, and constipation.
Tell your doctor or pharmacist if you suffer from Dementia.
Other medicines and Denzapine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not take Denzapine together with medicines that stop the bone marrow from working
properly and/or decrease the number of blood cells produced by the body, such as:
- Medicines that affect the bone marrow. These can decrease the number of blood cells
produced by the bone marrow. They include:

-

some antibiotics (e.g. co-trimoxazole, chloramphenicol, sulphonamides)
certain pain-killers (e.g. phenylbutazone, oxybutazone, antipyrine, dipyrone)
penicillamine (for rheumatoid arthritis)
carbamazepine (for epilepsy and for neuralgic pain)
cytotoxic (anticancer) medicines
other antipsychotic medicines (neuroleptics), especially when given as a depot (for longterm treatment).

Taking Denzapine at the same time as another medicine may affect how well Denzapine
and/or the other medicine works. Tell your doctor if you plan to take, if you are
taking (even if the course of treatment is about to end) or if you have recently had to
stop taking any of the following medicines:
- Medicines that can make you drowsy e.g. morphine (for pain), benzodiazepines (for anxiety
or as sleeping pills) and antihistamines (for allergies or colds) such as loratadine,
chlorpheniramine
Other antipsychotic medicines used to treat mental illnesses such as perazine
- Anticholinergic medicines, which are used to relieve stomach cramps, spasms and travel
sickness
- Medicines used to treat high blood pressure, e.g. metoprolol, captopril, enalapril.
- Medicines used to treat a fast or irregular heart beat (antiarrhythmics, e.g. flecainide,
pilsicainide)
- Medicines that can cause changes on the heart trace (ECG). Your doctor will know which
medicines these are
- Medicines that can cause constipation, particularly certain medicines to treat psychosis,
depression or Parkinson’s disease. Your doctor will know which medicines these are
- Atropine, a medicine which may be used in some eye drops or cough preparations
- Medicines which may cause excessive salt loss, such as diuretics (water tablets)
- Adrenaline (epinephrine), a medicine used in emergency situations
- Warfarin, a medicine to prevent blood clots
- Digoxin (for heart diseases)
- Cimetidine, used for stomach ulcers
- Erythromycin and rifampicin (antibiotics)
- Medicines to treat fungal infections, such as ketoconazole, itraconazole and miconazole
- Medicines to treat epilepsy e.g. phenytoin, carbamazepine, valproic acid
- Medicines for depression, such as fluvoxamine, fluoxetine, paroxetine, sertraline, citalopram,
amitriptyline, phenelzine, moclobemide, chlorpromazine, mesoridazine or fluphenazine
- Lithium (for mental disorders)
- Medicines which affect how your body eliminates clozapine. Your doctor will know which
medicines these are.
- Omeprazole (a drug used to treat excess stomach acid)
- Ciprofloxacin (a drug used to treat infections)
- Hormonal contraceptives (birth control tablets)
- Medicines used to treat viral infections such as protease inhibitors used to treat HIV infection.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while
taking Denzapine.
Denzapine with food, drink, and alcohol
You can take your Denzapine tablets with or without food.
Do not drink alcohol during treatment with Denzapine.
Caffeine can affect the levels of clozapine (the active substance of Denzapine) in your blood.

You may drink coffee, tea, cola and other drinks containing caffeine. However, if you stop
drinking caffeine suddenly, the levels of clozapine in your blood may fall. This will make the
medicine less effective. Equally, if you start drinking caffeine, the levels may rise, increasing the
risk of side effects.
Smoking
Smoking can affect the levels of clozapine in your blood. If you stop smoking suddenly, the levels
of clozapine in your blood may rise. This may increase the risk of side effects.
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. There is limited information on the safety
of Denzapine tablets in pregnancy. Your doctor will discuss with you the risks and benefits of
taking this medicine during pregnancy.
The following symptoms may occur in newborn babies, of mothers that have used Denzapine in
the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or
weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.
Breast-feeding
Do not breast-feed when using Denzapine because the active ingredient, clozapine, can reach your
baby through your breast milk.
Fertility
Some women taking antipsychotic medicines have irregular or no periods. If you have been
affected in this way, your periods may return when your medication is changed to Denzapine.
In these circumstances you should be sure to take adequate contraceptive precautions.
Driving and using machines
You may feel tired, drowsy, dizzy or you may feel faint while taking Denzapine, especially during
the early stages of treatment. If you have any of these symptoms, do not drive, operate machinery
or do any tasks where you need to be alert.
Denzapine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. How to take Denzapine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Your dose of Denzapine has been determined by your doctor. The dose will depend on how well
you respond to the medicine. It will also depend on the other medicines you are taking and other
medical conditions you may have. The dose may be altered from time to time.
Do not use Denzapine to treat other complaints unless your doctor tells you to.
If you have heart, kidney or liver disease, epilepsy or are elderly, or if you are taking any other
medicines that may affect the way Denzapine works, your doctor may start you on a lower dose to
prevent unwanted effects. The dose will be increased slowly.
When changing from a previous antipsychotic treatment to Denzapine, the first treatment should
be gradually withdrawn before starting Denzapine.

Carefully follow all the instructions given to you by your doctor and pharmacist. Their
instructions may differ from the information contained in this leaflet. If you do not understand the
instructions on the label, ask your doctor or pharmacist for help. Take Denzapine exactly as
prescribed by your doctor to prevent unwanted side effects.
Do not take more or less Denzapine than your doctor has prescribed. If you think the dose is too
weak or too strong, talk to your doctor.
Recommended dose
The total amount of Denzapine you take each day is usually divided into two doses. If you have to
divide your dose, you should take the larger dose at bed time. However, if your total daily dose is
not over 200 mg, it is not necessary to divide the dose. In this case, it is usually taken in the
evening.
Swallow Denzapine tablets with a full glass of water or other liquid. Taking the tablets at the same
time each day will have the best effect and will help you remember to take them.
Patients with schizophrenia that is resistant to other treatments
When you first start taking Denzapine, the usual dose is half a 25 mg tablet (12.5 mg) taken once
or twice on the first day, followed by one or two 25 mg tablets taken on the second day. If this
dose is well tolerated, it may be increased gradually, usually to between 200 mg and 450 mg per
day.
However, some people may need a higher dose. The maximum permissible dose is 900 mg per
day. Once the maximum benefit is achieved, your doctor may reduce the dose gradually to a lower
level. Your doctor will determine the most appropriate dose for you.
Treatment of severe thought disturbances in patients with Parkinson’s disease
The initial dose is of 12.5 mg (half a 25 mg tablet) taken in the evening. The dose is gradually
increased to a maximum of 50 mg per day, taken in the evening. Increases in the dosage should be
stopped or postponed if you feel faint, light-headed or confused. In order to avoid such symptoms
your blood pressure will be monitored during the first weeks’ treatment.
The effective dose is usually between 25 mg and 37.5 mg (one to one-and-a-half 25 mg tablets). If
the 50 mg dose is not effective, it can be increased to 100 mg in some patients. This dose (100 mg)
must not be exceeded. Always take the lowest effective dose for you.
Patients with liver problems:
If you have a liver disorder you will need regular liver function tests for as long as you continue to
take Denzapine.
Use in children and adolescents:
Denzapine is not recommended for use in children and adolescents.
Elderly patients:
Denzapine tablets can be used in the elderly (over 65 years of age). Treatment usually begins with
a lower dose (e.g. 12.5 mg daily), which is then gradually increased.
Duration of treatment:
You should take Denzapine for at least 6 months. Do not stop taking this medicine without first
talking to your doctor.
While taking Denzapine
Tell all of the doctors and pharmacists who are treating you that you are taking Denzapine. You
must have regular blood tests while taking Denzapine.
Blood tests
Before starting Denzapine you will have a blood test to make sure that you can take this medicine.

If you take more Denzapine than you should
If you suspect that you or someone else has taken too many Denzapine tablets, contact a doctor
immediately or go to the Accident and Emergency Department at your nearest hospital. Do this
even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep the telephone numbers for these places handy.
The most common signs and symptoms of overdose include:
- drowsiness
- confusion and coma
- delirium
- agitation
- lack of energy,
- light-headedness
- Hallucinations
- a fall in the blood pressure
- collapse
- widening of the black part of the eye, blurred vision
- shallow or slow breathing or sometimes shortness of breath
- fast or irregular heart beat
- dribbling
- fits.
If you forget to take Denzapine
If it is almost time for your next dose (within four hours), leave out the dose you missed and take
your next dose at its normal time. Otherwise take it as soon as you remember, and then go back to
taking your tablets as you would normally.
If you miss a dose of Denzapine do not take a double dose to make up for the missed dose.
If you have stopped taking Denzapine for more than two days, you must contact your doctor
before starting to take it again. In this case, the medicine must be started again at a low dose and
then increased.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you stop taking Denzapine
Do not stop taking Denzapine or lower the dosage even if you are feeling better, unless your
doctor tells you to do so because you might get withdrawal reactions. These reactions include
sweating, headache, nausea (feeling sick), vomiting (being sick) and diarrhoea. If you have any of
the above signs, tell your doctor straight away. These signs may be followed by more serious
side effects unless you are treated immediately. Your condition may worsen if you suddenly
stop taking it. Your doctor will gradually reduce the amount you take each day before stopping the
medicine completely.
If your doctor tells you to stop taking Denzapine
If the medicine needs to be stopped abruptly due to side effects, you will be monitored closely for
psychotic symptoms. Other symptoms can also arise, including increased sweating, headache,
nausea (feeling sick), vomiting and diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects can be serious and need immediate medical attention:

Very common (may affect more than 1 in 10 people):
- a fast heart beat (tachycardia).
Common (may affect up to 1 in 10 people):
- a fall in the number of white cells in the blood (leukopenia, neutropenia, granulocytopenia,
agranulocytosis) (see Section 3, “How to take Denzapine”)
- eosinophilia (an increase in the number of a certain type of white blood cells called eosinophil
granulocytes)
- leukocytosis (an increase in the number of white blood cells).
Your blood must be monitored to detect these conditions.
- signs of a cold, fever, flu-like symptoms, sore throat or any other infection, tell your doctor
immediately.
- changes on the heart trace (ECG)
- epileptic fits (localised or generalised)
- a fall in the blood pressure on standing up (orthostatic hypotension)
- fainting
Uncommon (may affect up to 1 in 100 people):
- a very low number of white cells in the blood (agranulocytosis)
- neuroleptic malignant syndrome (fever, sweating, a fast heart beat, muscle stiffness and
changes in the blood pressure)
Rare (may affect up to 1 in 1,000 people):
- impaired glucose tolerance (excess sugar levels in the blood)
- diabetes mellitus, or worsening of existing diabetes
- circulatory collapse (a very low blood pressure that can lead to unconsciousness)
- irregular heart beat (arrhythmia)
- ventricular arrhythmias (life-threatening disorders of the heart. These are medical
emergencies.)
- inflammation of the heart muscle (myocarditis)
- pericarditis (inflammation of the membranes around the heart)
- pericardial effusion (a collection of liquid in the membranes around the heart)
- blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in
the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty
in breathing. If you notice any of these symptoms seek medical advice immediately.
- jaundice (yellow colouration of the skin and eyes). If you notice these symptoms stop taking
Denzapine immediately and seek medical advice.
- nausea (feeling sick), vomiting (being sick) and/or loss of appetite. Your doctor will need to
check your liver.
- inflammation of the liver (hepatitis)
- inflammation of the pancreas (pancreatitis)
- signs of a respiratory tract infection or pneumonia such as fever, coughing, difficulty
breathing, wheezing
Very rare (may affect up to 1 in 10,000 people):
- tardive dyskinesia (slow, abnormal movements of the face, tongue and limbs)
- cardiac arrest
- disease of the heart muscle (cardiomyopathy)
- abnormality of electrocardiogram (ECG) called QT prolongation
- torsades de pointes (a life-threatening disorder of the heart. This is a medical emergency)
- sudden unexplained death
- very slow or shallow breathing (respiratory depression)
- absence of breathing (respiratory arrest)
- altered bowel movement (intestinal obstruction, paralytic ileus, faecal impaction)
- death of the liver (fulminant hepatic necrosis)
- inflammation of the kidney (interstitial nephritis)

-

-

in elderly people with dementia, a small increase in the number of people dying has been
reported for patients taking antipsychotics compared with those not taking antipsychotics
a persistent and possibly painful erection (priapism). If you have an erection which lasts more
than 4 hours immediate medical treatment may be needed in order to avoid further
complications.
a change in the number of platelets in the blood outside the normal range (thrombocytopenia,
thrombocythaemia),
complications of excessive sugar in the blood (severe hyperglycaemia, ketoacidosis,
hyperosmolar coma)

Not known (frequency cannot be estimated from the available data):
- changes in normal patterns of brain activity detected (EEG)
- heart attack
- chest pain, including pain which spreads to the arms and shoulders
- blood clots in the veins
- death of parts of the liver
- damage to the liver caused by chemicals
- failure of the liver to heal correctly (hepatic fibrosis, hepatic cirrhosis)
- other liver disorders which may result in death or require liver transplant
- kidney failure
- allergic reaction (swelling mainly of the face, mouth and throat, as well as the tongue, which
may be itchy or painful)
- profuse sweating, headache, nausea, vomiting and diarrhoea (symptoms of cholinergic
syndrome).
The following side effects have also been associated with Denzapine:
Very common (may affect more than 1 in 10 people):
constipation – if you have severe constipation your doctor will have to treat this in order to avoid
further complications, hypersalivation (forming a large volume of saliva), drowsiness, dizziness.
Common (may affect up to 1 in 10 people):
fatigue, weight gain, blurred vision, headache, tremor, stiffness of the limbs (rigidity), restlessness
(akathisia), problems of coordination, high blood pressure (hypertension), nausea (feeling sick),
vomiting, loss of appetite (anorexia), dry mouth, changes in the blood tests that assess how the
liver is working, urinary incontinence, urinary retention (the inability to pass urine)fever, benign
hyperthermia (drug fever; changes in body temperature caused by certain medicines), alterations
in the body’s control of temperature, alterations of sweating, slurring of words, abnormal
movements, inability to initiate movement, inability to remain motionless, sudden loss of
consciousness.
Uncommon (may affect up to 1 in 100 people):
stammering.
Rare (may affect up to 1 in 1,000 people):
restlessness, agitation, confusion, delirium, inhaling of food into the lungs (aspiration), difficulty
swallowing (dysphagia), a rise in the CPK values (a blood test), a low number of red blood cells
(anaemia), serious chest infection.
Very rare (may affect up to 1 in 10,000 people):
excessive fat in the blood (hypertriglyceridaemia, hypercholesterolaemia), enlargement of the
parotid glands (salivary glands), skin reactions, obsessive thoughts and compulsive behaviours
(obsessive compulsive symptoms).
Not known (frequency cannot be estimated from the available data):
blocked nose, diarrhoea, stomach discomfort, heartburn, indigestion, accumulation of fat in the
liver, muscle weakness, or spasms, or pain, bedwetting while asleep, sudden uncontrollable

increase in blood pressure (pseudophaeochromocytoma), uncontrolled bending of the body to one
side (pleurothotonus),ejaculatory disorder, rash, purplish-red spots, fever or itching due to
inflammation of blood vessel, change in skin colour, “butterfly” facial rash, joint pain, muscle
pain, fever and fatigue (lupus erythematous).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
The Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Denzapine
Keep this medicine out of the sight and reach of children.
A locked cupboard at least one and a half metres from the ground is a good place to store
medicines.
Do not use this medicine after the expiry date which is stated on the outer carton or on the blister
strip. The expiry date refers to the last day of that month.
Do not take Denzapine if the packaging is damaged or shows signs of tampering.
Store Denzapine at a temperature at or below 30°C. Store in the original packaging. Keep in the
outer carton to protect from light. Keep your tablets in the original container until it is time to take
them.
Do not store Denzapine or any medicine in the bathroom or near a sink.
Do not leave it in a car or on a window sill.
Heat and dampness can destroy medicines. If your tablets appear to change in their appearance or
show any other apparent signs of deterioration, do not take the tablets but refer immediately to the
pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Denzapine contains
-

The active substance is clozapine.

One Denzapine 25 mg tablet contains 25 mg clozapine.
One Denzapine 50 mg tablet contains 50 mg clozapine.
One Denzapine 100 mg tablet contains 100 mg clozapine.
One Denzapine 200 mg tablet contains 200 mg clozapine.
- The other ingredients are:
Microcrystalline cellulose
Lactose monohydrate
Povidone
Sodium starch glycolate
Magnesium stearate.

What Denzapine looks like and contents of the pack
Denzapine 25 mg tablets are small, round, yellow tablets with “25” embossed over a breakline on
one face, the other side is plain.
Denzapine 50 mg tablets are small, round, yellow tablets with “50” embossed over a breakline on
one face, the other side is plain.
Denzapine 100 mg tablets are small, round, yellow tablets with “100” embossed over a breakline
on one face, the other side is plain.
Denzapine 200 mg tablets are large, oval shaped, yellow tablets with “200” on one side and a
breakline on the other side.
The breakline allows the tablet to be broken for easier swallowing.
Denzapine 25 and 100 mg tablets are supplied in bottles of 100 tablets and in blister packs
containing 28 or 84 tablets.
Denzapine 50 mg tablets are supplied in bottles of 50 or 100 tablets and in blister packs containing
20, 50, or 100 tablets.
Denzapine 200 mg tablets are supplied in blister packs containing 20 or 50 tablets.
Not all pack sizes may be marketed.
The quantity provided to you by the pharmacy will be determined by your doctor.

The Marketing Authorisation holder and manufacturer:
Britannia Pharmaceuticals Ltd.
200 Longwater Avenue, Green Park, Reading, Berkshire, RG2 6GP, UK
If you have any further questions about your medicine or are unsure about any of the advice in this
leaflet, ask your doctor or pharmacist.
Marketing Authorisation number:
Denzapine 25 mg tablets PL 04483/0067
Denzapine 50 mg tablets PL 04483/0068
Denzapine 100 mg tablets PL 04483/0069
Denzapine 200 mg tablets PL 04483/0070
This leaflet was last revised in May 2017

DENZAPINE® is a registered trademark.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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