Active ingredient
- clozapine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 32553/0007.
Zaponex Orodispersible tablets
Package leaflet: Information for the user
Zaponex® 12.5 mg orodispersible tablets
Zaponex® 25 mg orodispersible tablets
Zaponex® 50 mg orodispersible tablets
Zaponex® 100 mg orodispersible tablets
Zaponex® 200 mg orodispersible tablets
Clozapine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Zaponex is and what it is used for
2. What you need to know before you take Zaponex
3. How to take Zaponex
4. Possible side effects
5. How to store Zaponex
6. Contents of the pack and other information
1 What Zaponex is and what it is used for
The active substance of Zaponex is clozapine which belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis).
Zaponex is used to treat people with schizophrenia in whom other medicines have not worked. Schizophrenia is a mental illness which affects how you think, feel and behave. You should only use this medicine if you have already tried at least two other antipsychotic medicines, including one of the newer atypical antipsychotics, to treat schizophrenia, and these medicines did not work, or caused severe side effects that cannot be treated.
Zaponex is also used to treat severe disturbances in the thoughts, emotions and behaviour of people with Parkinson’s disease in whom other medicines have not worked.
2 What you need to know before you take Zaponex
Do not take Zaponex if you
If any of the above applies to you, tell your doctor and do not take Zaponex.
Zaponex must not be given to anyone who is unconscious or in a coma.
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.
Before you start treatment with Zaponex, tell your doctor if you have or ever had:
Tell your doctor immediately before taking the next Zaponex tablet if you:
Medical check-ups and blood tests
Before you start taking Zaponex, your doctor will ask about your medical history and do a blood test to ensure that your white blood cells count is normal. It is important to find this out, as your body needs white blood cells to fight infections.
Make sure that you have regular blood tests before you start treatment, during treatment and after you stop treatment with Zaponex.
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.
If you have a liver disorder you will have regular liver function tests as long as you continue to take Zaponex.
If you suffer from high levels of sugar in the blood (diabetes) your doctor may regularly check your level of sugar in the blood.
Zaponex may cause alteration in blood lipids. Zaponex may cause weight gain. Your doctor may monitor your weight and blood lipid level.
If you already suffer from or if Zaponex makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position as these 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 Zaponex. You may be at risk of thrombosis (blood clotting within a vein).
Children and adolescents under 16 years
If you are under 16 years of age you should not use Zaponex as there is not enough information on its use in that age group.
Elderly (aged 60 years and over)
Elderly (aged 60 years and over) may be more likely to have the following side effects during treatment with Zaponex: faintness or light-headedness after changing position, dizziness, fast heart beat, difficulty in passing urine, and constipation.
Tell your doctor or pharmacist if you suffer from a condition called dementia.
Other medicines and Zaponex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription or herbal therapies. You might need to take different amounts of your medicines or take different medicines.
Do not take Zaponex 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:
These medicines increase your risk of developing agranulocytosis (lack of white blood cells).
Taking Zaponex at the same time as another medicine may affect how well Zaponex 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:
This list is not complete. Your doctor and pharmacist have more information on medicines to be careful with or to avoid while taking Zaponex. They will also know if the medicines you are taking belong to the listed groups. Speak to them.
Zaponex with food, drink and alcohol
Do not drink alcohol during treatment with Zaponex.
Tell your doctor if you smoke and how often you have drinks containing caffeine (coffee, tea, cola). Sudden changes in your smoking habits or caffeine drinking habits can also change the effects of Zaponex.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy. Tell your doctor immediately if you become pregnant during treatment with Zaponex.
The following symptoms may occur in newborn babies, of mothers that have used Zaponex 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.
Some women taking some medicines to treat mental illnesses have irregular or no periods. If you have been affected in this way, your periods might return when your medicine is changed to Zaponex. This means you should use effective contraception.
Do not breast-feed during treatment with Zaponex. Clozapine, the active substance of Zaponex, may pass into your milk and affect your baby.
Driving and using machines
Zaponex might cause tiredness, drowsiness and seizures, especially at the beginning of treatment. You should not drive or operate machines while you have these symptoms.
Zaponex contains aspartame (E951)
Zaponex 12.5 mg orodispersible tablets contains 1.55 mg aspartame in each tablet which is equivalent to 18 mg/g.
Zaponex 25 mg orodispersible tablets contains 3.10 mg aspartame in each tablet which is equivalent to 18 mg/g.
Zaponex 50 mg orodispersible tablets contains 6.20 mg aspartame in each tablet which is equivalent to 18 mg/g.
Zaponex 100 mg orodispersible tablets contains 12.4 mg aspartame in each tablet which is equivalent to 18 mg/g.
Zaponex 200 mg orodispersible tablets contains 24.8 mg aspartame in each tablet which is equivalent to 18 mg/g.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3 How to take Zaponex
In order to minimise the risk of low blood pressure, seizures and drowsiness it is necessary that your doctor increases your dose gradually. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
It is important that you do not change your dose or stop taking Zaponex without asking your doctor first. Continue taking the tablets for as long as your doctor tells you. If you are 60 years or older, your doctor may start you on a lower dose and increase it more gradually because you might be more likely to develop some unwanted side effects (see section 2 “Before you take Zaponex”).
If the dose you are prescribed cannot be achieved with this strength tablet, other strengths of this medicinal product are available to achieve the dose.
Treatment of schizophrenia
The recommended starting dose is 12.5 mg once or twice on the first day followed by 25 mg once or twice on the second day.
Do not open the blister or the bottle until ready to administer. Immediately upon opening the blister or bottle, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid.
If tolerated well, your doctor will then gradually increase the dose in steps of 25-50 mg over the next 2-3 weeks until a dose up to 300 mg per day is reached. Thereafter, if necessary, the daily dose may be increased in steps of 50 to 100 mg half-weekly 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 people might need more. A daily dose of up to 900 mg is allowed. Increased side effects (in particular seizures) are possible at daily doses over 450 mg. Always take the lowest effective dose for you. Most people take part of their dose in the morning and part in the evening. Your doctor will tell you exactly how to divide your daily dose. If your daily dose is only 200 mg, then you can take this as a single dose in the evening. Once you have been taking Zaponex with successful results for some time, your doctor may try you on a lower dose. You will need to take Zaponex for at least 6 months.
Treatment of severe thought disturbances in patients with Parkinson’s disease
The recommended starting dose is 12.5 mg in the evening.
Do not open the blister or the bottle until ready to administer. Immediately upon opening the blister or bottle, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid.
Your doctor will then gradually increase the dose in steps of 12.5 mg, not faster than two steps a week, up to a maximum dose of 50 mg by the end of the second week. 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 measured during the first weeks of treatment.
The effective daily dose is usually between 25 mg and 37.5 mg, taken as one dose in the evening. Doses of 50 mg per day should only be exceeded in exceptional cases. The maximum daily dose is 100 mg. Always take the lowest effective dose for you.
If you take more Zaponex than you should
If you think that you may have taken too many tablets, or if anyone else takes any of your tablets, contact a doctor immediately or call for emergency medical help.
The symptoms of overdose are:
Drowsiness, tiredness, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff limbs, trembling hands, seizures (fits), increased production of saliva, widening of the black part of the eye, blurred vision, low blood pressure, collapse, fast or irregular heart beat, shallow or difficult breathing.
If you forget to take Zaponex
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, leave out the forgotten tablets and 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 any Zaponex for more than 48 hours.
If you stop taking Zaponex
Do not stop taking Zaponex without asking your doctor, 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 original symptoms might come back. A gradual reduction in dose in steps of 12.5 mg over one to two weeks is recommended, if you have to stop treatment. Your doctor will advise you on how to reduce your daily dose. If you have to stop Zaponex treatment suddenly, you will have to be checked by your doctor.
If your doctor decides to re-start the treatment with Zaponex and your last dose of Zaponex was over two days ago, this will be with the starting dose of 12.5 mg.
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.
Some side effects can be serious and need immediate medical attention. Tell your doctor immediately before taking the next Zaponex tablet if you experience any of the following:
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)
Rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
If any of the above applies to you, please tell your doctor immediately before taking the next Zaponex tablet.
Other side effects:
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)
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
5 How to store Zaponex
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 blister/bottle after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Zaponex contains
What Zaponex looks like and contents of the pack
Zaponex 12.5 mg are yellow, round, flat orodispersible tablets of approximately 6.5 mm of diameter. The tablets are debossed with “C7PN” on one side and “12.5” on the other.
Zaponex 25 mg are yellow, round, orodispersible flat tablets of approximately 8 mm of diameter. The tablets are debossed with “C7PN” on one side and “25” on the other.
Zaponex 50 mg are yellow, round, flat orodispersible tablets of approximately 10 mm of diameter. The tablets are debossed with “C7PN” on one side and “50” on the other.
Zaponex 100 mg are yellow, round, flat orodispersible tablets of approximately 13 mm of diameter. The tablets are debossed with “C7PN” on one side and “100” on the other.
Zaponex 200 mg are yellow, round, flat orodispersible tablets of approximately 16 mm of diameter. The tablets are debossed with “C7PN” on one side and “200” on the other.
Zaponex orodispersible tablets are available in PVC/PVDC/Al blister packs, PVC/PVDC/Al perforated unit-dose blister packs and HDPE bottles.
Blister packs contain 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, 100, 250, 300 or 500 tablets.
HDPE bottles contain 250 or 500 tablets Zaponex 12.5 mg, 25 mg, 50 mg and 100 mg orodispersable tablets and 250 or 275 tablets Zaponex 200 mg orodispersable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer(s)
National registration number:
Zaponex 12.5 mg orodispersible tablets PL 32553/0004
Zaponex 25 mg orodispersible tablets PL 32553/0005
Zaponex 50 mg orodispersible tablets PL 32553/0006
Zaponex 100 mg orodispersible tablets PL 32553/0007
Zaponex 200 mg orodispersible tablets PL 32553/0008
This leaflet was last revised in July 2020.
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