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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04483/0071.
Denzapine 50mg/ml Oral Suspension
DENZAPINE® 50 mg/ml Oral Suspension
Clozapine
The use of Denzapine is restricted to those patients registered with the Denzapine Monitoring Service.
1. What Denzapine is and what it is 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
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:
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.
Denzapine must not be given to anyone who is unconscious or in a coma.
Do not take Denzapine if you have any of the following diseases:
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:
Talk to your doctor or pharmacist immediately
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.
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, or if you already suffer from these feelings, be careful when getting up from a sitting or lying position as this may increase the possibility of falling.
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.
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.
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.
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:
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:
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Denzapine.
You can take Denzapine Suspension with or without food.
Denzapine Suspension may be mixed with water but not fruit juice or any other liquid.
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 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.
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 Suspension 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.
Do not breast-feed when using Denzapine because the active ingredient, clozapine, can reach your baby through your breast milk.
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.
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 oral suspension contains Sodium methyl parahydroxybenzoate (E219) and Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed)
Denzapine oral suspension contains Sorbitol (E420)
This medicine contains 150 mg sorbitol in each ml of Oral Suspension.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
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.
Taking the suspension at the same time each day will have the best effect and will help you remember to take it.
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 evening.
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.
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. 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 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. Always take the lowest effective dose for you.
If you have a liver disorder you will need regular liver function tests for as long as you continue to take Denzapine.
Denzapine is not recommended for use in children and adolescents.
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.
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 taking Denzapine. You must have regular blood tests while taking Denzapine.
Before starting Denzapine you will have a blood test to make sure that you can take this medicine.
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:
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 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.
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 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.
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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
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), chest infections and pneumonia.
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), restless legs syndrome (irresistible urge to move your legs or arms, usually accompanied by uncomfortable sensations during periods of rest, especially in the evening or at night and temporarily relieved by movement).
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
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 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 tampering.
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.
Do not throw away 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.
One ml of Denzapine 50 mg/ml Oral Suspension contains 50 mg clozapine.
Denzapine Suspension is a free flowing yellow liquid, which is supplied in bottles of 100 ml of suspension.
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 February 2019
DENZAPINE® is a registered trademark.