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Active substance(s): CLOZAPINE

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DENZAPINE® 50 mg/ml Oral Suspension

The use of DENZAPINE is restricted to those patients registered with the Denzapine Monitoring Services.
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet
1. What DENZAPINE is and what it is used for
2. Before you take DENZAPINE
3. How to take DENZAPINE

4. Possible side effects
5. How to store DENZAPINE
6. Further information

DENZAPINE is used:
- to treat schizophrenia when other antipsychotic medicines 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

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.
Also tell your doctor if you are taking any other antipsychotic medicines
(see section “Taking other medicines” below).
Or if you are taking any other medicines that are known to affect the heart.
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. Please tell your doctor if you develop any signs of infection, such
as fever, sore throat or flu-like symptoms.
If this medicine makes you feel dizzy, light-headed or faint, be careful
when getting up from a sitting or lying position. DENZAPINE may lower
your blood pressure, especially at the start of treatment. These
symptoms can usually be prevented by getting up slowly and flexing leg
muscles and toes to get the blood circulating. When getting out of bed,
dangle your legs over the side for a minute or two before standing up.
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.

diuretics (water tablets)
- Adrenaline (epinephrine), a medicine used in emergency
- 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)
Your doctor and pharmacist have more information on medicines to be
careful with or avoid while taking DENZAPINE.

DENZAPINE must not be given to anyone who is unconscious or in a coma.

- You are allergic (hypersensitive) to clozapine or to any of the other
ingredients of DENZAPINE Oral Suspension (see section 6, “Further
information”). 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 have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
- You are unable to undergo regular blood tests
- You have a low number of white cells in the blood
- You have ever had a low white blood cell count that was unexplained
or was caused by medicinal treatment (except anticancer treatment)
- You are receiving treatment with other medicines that can cause a fall
in the number of white blood cells
- You have suffered from a very low white blood cell count
(agranulocytosis) caused by previous treatment with DENZAPINE
You have any of the following diseases:
- Disorders of the bone marrow (when the bone marrow does not make
enough blood cells)
- Uncontrolled epilepsy (fits or seizures)
- Acute mental illness caused by alcohol, medicines or other substances
- Poisoning caused by other medicines
- Circulatory collapse (a very pronounced fall in blood pressure that
may lead to unconsciousness)
- Disorders affecting the brain that can lead to drowsiness or
- Severe kidney disease
- Heart disease (such as myocarditis, pericarditis or cardiomyopathy)
- Active liver disease with jaundice (yellow colouration of the skin and
eyes), feeling sick and loss of appetite
- Liver failure (very serious liver disease)
- Paralytic ileus (a disorder of the small intestine)

Take special care with DENZAPINE
Please tell your doctor 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 or any member of your family have changes on the heart trace
- Orthostatic hypotension (a fall in blood pressure on standing up)
- Epilepsy or fits, even if they are well controlled
- Liver disease
- Enlargement of the prostate
- Glaucoma (raised pressure in the eye)
- Constipation, paralytic ileus, disease of the large bowel or operations
on the abdomen
- Fever
- Neuroleptic Malignant Syndrome, a serious reaction to some antipsychotic 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.
- Diabetes
- Stroke (Risk factors of stroke e.g smoking, diabetes and high blood
- If you or someone else in your family has a history of blood clots, as

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

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Some medicines must NOT be used when you are taking DENZAPINE.
These include:
- 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,
- certain pain-killers (e.g. phenylbutazone, oxybutazone, antipyrine,
- 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 long-term treatment)
Other medicines can be affected by DENZAPINE or may affect how well
DENZAPINE works. Your doctor will tell you what medicines you can take
and their doses. Please also consult your doctor if you are taking any of
the medicines listed below:
- Medicines that can make you drowsy e.g. morphine (for pain),
benzodiazepines (sleeping pills) and antihistamines (for allergies)
such as loratadine, chlorpheniramine
- Anticholinergic medicines, which are used to relieve stomach cramps,
spasms and travel sickness
- Medicines used to treat high blood pressure, e.g. metoprolol, captopril,
- 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
- Medicines which may cause excessive salt loss, such as


DENZAPINE contains 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.

Taking DENZAPINE with food and drink
You can take DENZAPINE Suspension with or without food.
DENZAPINE Suspension may be mixed with water but not fruit juice or
any other liquid
DENZAPINE may increase the effect of alcohol. Therefore, you should
not drink alcohol during treatment.
Coffee can affect the levels of clozapine (the active substance of
DENZAPINE) in your blood. You may drink coffee. However, if you stop
drinking coffee suddenly, the levels of clozapine in your blood may fall.
This will make the medicine less effective. Equally, if you start drinking
coffee, the levels may rise, increasing the risk of side effects.

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.

DENZAPINE is not recommended for use in children.

Please tell your doctor if you have dementia or a family history of

Tell your doctor if you are or think you may be pregnant or if you are
planning to become pregnant.
There is limited information on the safety of DENZAPINE Suspension in
pregnancy. Your doctor will discuss with you the risks and benefits of
taking this medicine during pregnancy.
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.
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.

If you are breast-feeding, DENZAPINE can reach your baby through
your breast milk. DENZAPINE should not be used when breast-feeding.

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.

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.
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.
Continued over the page


How to use the oral Dispenser:

First, select the correct dispenser. The pack contains two oral
dispensers. If your dose is lower than 50 mg (1.0 ml), use the smaller
1.0 ml dispenser. If your dose is greater than 50 mg (1.0 ml), use the
larger 10 ml dispenser.
24 hours before first use only or after prolonged storage where there
is visible settling of the suspension, shake the bottle vigorously for 90
seconds. Stand the bottle for 24 hours. Immediately before the first
dose and each subsequent dose, shake the bottle for 10 seconds.
Remove the child-resistant cap from the bottle. Push the bottle
adaptor into the top of the bottle.
Ensure that the plunger is pressed down inside the barrel as far as it
will go and insert the dispenser into the bottle.
Hold the barrel of the pipette steady and slowly, pull the plunger up
until you see the liquid fill the barrel to the mark which matches the
number of ml of the suspension that you need to take.
Keeping hold of the barrel, withdraw the dispenser from the bottle.
The contents of the dispenser can be emptied directly into your
mouth to be swallowed.
If you prefer, the suspension may be diluted by emptying the contents
of the dispenser into a small glass containing approximately 50 ml of
water. Drink all the contents of the glass.
Do not mix the suspension with fruit juice or any other kind of liquid.


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 4 ml (200 mg), it is
not necessary to divide the dose. In this case, it is usually taken in the
Schizophrenic patients resistant to other treatments
When you first start taking DENZAPINE, the usual dose is 0.25 ml
(12.5 mg) taken once or twice on the first day, followed by 0.5 ml (25 mg)
or 1.0 ml (50 mg) taken on the second day. If this dose is well tolerated, it
may be increased gradually, usually to between 4 ml (200 mg) and 9 ml
(450 mg) per day.
However, some people may need a higher dose. The maximum permissible
dose is 18 ml (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.
Parkinsonian patients with psychotic disorders that do not respond to
standard treatment.
The initial dose is of 0.25 ml (12.5 mg) taken in the evening. The dose is

gradually increased to a maximum of 50 mg per day, taken in the evening.
The effective dose is usually between 0.5 ml to 0.75 ml (25 mg and 37.5
mg) of suspension. If the 1.0 ml (50 mg) dose is not effective, it can be
increased to 2 ml (100 mg) in some patients. This dose of 2ml (100 mg)
must not be exceeded.
Elderly patients:
DENZAPINE Suspension 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.

Tell all of the doctors and pharmacists who are treating you that you are
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.
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
should 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.

worsen if you suddenly stop taking it. Your doctor will gradually reduce
the amount you take each day before stopping the medicine
- Do not give DENZAPINE to anyone else even if they have the same
symptoms as you. It may harm them even if their condition seems
similar to yours.
- Do not use DENZAPINE to treat other complaints unless your doctor
tells you to.

If you take more DENZAPINE than you should
If you suspect that you or someone else has taken too much DENZAPINE
Suspension, 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
- light-headedness
- a fall in blood pressure
- collapse
- shallow or slow breathing or sometimes shortness of breath
- fast or irregular heartbeat
- dribbling
- fits.

If you forget to take DENZAPINE
If it is almost time for your next dose (within four hours), forget 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 the suspension 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 think the dose is too weak or too strong, talk to your doctor.
Taking the suspension at the same time each day will have the best
effect and will help you remember to take it.

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.

Things which I must not do
- Do not stop taking DENZAPINE or lower the dosage even if you are
feeling better, unless your doctor tells you to do so. Your condition may

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.
Like all medicines, DENZAPINE can cause side effects although not
everybody gets them. The frequency of side effects is based on the
Very common:
In more than 1 in 10 patients treated
In less than 1 in 10, but more than 1 in 100
patients treated
In less than 1 in 100, but more than 1 in 1,000
patients treated
In less than 1 in 1,000, but more than 1 in
10,000 patients treated
Very rare:
In less than 1 in 10,000 patients treated,
including single reports
The following side effects have been associated with DENZAPINE:

Very common:
A fast heart beat (tachycardia)
Hypersalivation (forming a large volume of saliva)

A fall in the number of white cells in the blood (leukopenia, neutropenia,
granulocytopenia, agranulocytosis) (see Section 3, “How to take
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)
Weight gain
Blurred vision
Stiffness of the limbs (rigidity)
Restlessness (akathisia)
Problems of coordination
Epileptic fits (localised or generalised)
Changes on the heart trace (ECG)
High blood pressure (hypertension)

A fall in blood pressure on standing up (orthostatic hypotension)
Nausea (feeling sick)
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)
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

Agranulocytosis (a very low number of white cells in the blood)
Neuroleptic malignant syndrome (fever, sweating, a fast heart beat,
muscle stiffness and changes in blood pressure)

Impaired glucose tolerance (excess sugar levels in the blood)
Diabetes mellitus
Restlessness (agitation)
Circulatory collapse (a very low blood pressure that can lead to
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 that may cause lung problems
Inhaling of food into the lungs (aspiration)
Difficulty swallowing (dysphagia)
Inflammation of the liver (hepatitis)
Jaundice (yellow colouration of the skin and eyes)
Inflammation of the pancreas (pancreatitis)
A rise in the CPK values (a blood test)

A low number of red blood cells (anaemia)
Chest infections and pneumonia

Very rare:
A fall in the number of platelets in the blood (thrombocytopenia)
Complications of excessive sugar in the blood (severe hyperglycaemia,
ketoacidosis, hyperosmolar coma)
Excessive fat in the blood (hypertriglyceridaemia)
Tardive dyskinesia (slow, abnormal movements of the face, tongue
and limbs)
Disease of the heart muscle (cardiomyopathy)
Cardiac arrest
Torsades de pointes (a life-threatening disorder of the heart. This is a
medical emergency.)
Very slow or shallow breathing (respiratory depression)
Absence of breathing (respiratory arrest)
Enlargement of the parotid glands (salivary glands)
Altered bowel movement (intestinal obstruction, paralytic ileus, faecal
Death of the liver (fulminant hepatic necrosis)
Skin reactions
Inflammation of the kidney (interstitial nephritis)
A persistent and possibly painful erection (priapism)
Sudden unexplained death
Obsessive thoughts and compulsive behaviours (obsessive compulsive
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.

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:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2.
Tel: +353 1 6764971. Fax: +353 1 6762517.
By reporting side effects you can help provide more information on the
safety of this medicine.

Keep DENZAPINE out of the reach and sight of children. A locked
cupboard at least one and a half metres from the ground is a good place
to store medicines.
Do not take DENZAPINE after the expiry date shown on the outer carton
or on the bottle label. The expiry date refers to the last day of that month.
Do not take DENZAPINE if the packaging is damaged or shows signs of

Do not use DENZAPINE Suspension later than 90 days after first opening
of the bottle.
Keep your medicine in the original container until it is time to take it. 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 the suspension appears to change in its appearance or
show any other apparent signs of deterioration, do not take it but
refer immediately to the pharmacist.
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.

What DENZAPINE contains
- The active substance is clozapine.
One ml of DENZAPINE 50 mg/ml Oral Suspension contains 50 mg
- The other ingredients are
– Glycerol (E422)
– Sodium dihydrogen phosphate dihydrate (E339(i))
– Sorbitol (E420)
– Xanthan gum (E415)

Povidone (E1201)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
Hydrochloric acid (for pH adjustment) (E507)
Sodium hydroxide (for pH adjustment) (E524)
Water, purified

What DENZAPINE looks like and contents of the pack
DENZAPINE Suspension is a free flowing yellow liquid, which is supplied
in bottles of 100 ml of suspension.

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: PL 04483/0071
This leaflet was last revised in April 2015.
9252644 XXXX



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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.