APO-Ziprasidone
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
APO- ZIPRASIDONE
Contains the active ingredient ziprasidone hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What this medicine is used for
The name of your medicine is APO-Ziprasidone.It contains the active ingredient ziprasidone (as ziprasidone hydrochloride).
It is used to treat schizophrenia and bipolar disorder.
Ziprasidone belongs to a group of medicines called atypical antipsychotics/neuroleptics.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Ziprasidone is available only with a doctor’s prescription.
Schizophrenia
Schizophrenia is a mental illness.It varies from person to person, but can involve:
hallucinations: the person sees, hears, feels, smells or tastes something that is not actually there; most commonly a person may hear voices
delusions: a delusion is a false belief held by a person which is not held by others of the same cultural background
disturbed or disorganised thinking
poor memory and concentration
loss of emotion and expression
loss of motivation and energy
difficulty interacting with others, leading to social isolation.
Bipolar disorder
Bipolar disorder is a mental illness where a person cycles through:
‘manic’ phases – with symptoms such as over-activity, irritability, elation and limited need for sleep
‘depressive’ phases – with symptoms such as depressed mood, anxiety, difficulty making decisions, difficulty concentrating and hopelessness.
How it works
Schizophrenia
Researchers do not know exactly what causes schizophrenia, but they do know that many people with it have high levels of some brain chemicals – including dopamine and serotonin.
Ziprasidone is thought to work by helping to correct the imbalance of these chemicals, in turn, reducing the symptoms of schizophrenia.
Research has found ziprasidone can help reduce:
hallucinations
delusions
confused thoughts
social withdrawal
lack of motivation
Ziprasidone does not cure schizophrenia, but it can help manage the symptoms and help prevent further episodes.
Taking antipsychotic/neuroleptic medicines like ziprasidone can also allow you to try psychological therapies when recommended by your doctor. These may further help you manage your schizophrenia.
Bipolar disorder
Research has shown that there is a chemical imbalance in the brain in patients with bipolar disorder.
Ziprasidone does not cure bipolar disorder.It is used as a short-term treatment for the manic phases.It is not used to treat the depressive phases of bipolar disorder.
Controlling the manic phase of bipolar disorder with medicine can also allow you to try psychological therapies when recommended by your doctor.
Elderly patients
Ziprasidone is not recommended for the treatment of elderly patients with dementia-related psychosis.
It should be used with caution in elderly patients with risk factors for stroke.
Use in children
Ziprasidone is not recommended for children under 18 years of age as there is not enough information on its effects in this age group.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any medicine containing ziprasidone
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have or have had any of the following medical conditions:
a recent heart attack
heart failure that is not well- controlled
abnormal heart rhythm
any condition requiring medication to control your heart rhythm.
Do not take this medicine if you are taking any other medications known to lengthen your heart rhythm.
Do not take this medicine if you are pregnant.
Like most atypical antipsychotic/ neuroleptic medicines, ziprasidone is not recommended for use during pregnancy.
Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
For women of child-bearing age, an appropriate method of contraception is recommended.
Do not breastfeed if you are taking this medicine.
Do not take ziprasidone whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.It may pass into breastmilk
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
irregular heart rate
a condition requiring other drugs to control your heart rhythm
any heart or blood vessel problems
low blood levels of potassium or magnesium
a condition that may give you low blood pressure
seizures (fits)
liver problems
blood sugar level problems, e.g.diabetes
you are 65 years of age or over and have a condition known as ‘dementia-related psychosis’
if you have ever suffered or suffer from a condition called deep vein thrombosis (DVT). DVT is the formation of blood clots in one of the deep veins within the body, e.g. the leg or pelvis. The symptoms of DVT are pain and swelling in your legs. Sometimes the blood clot may break away from its original location and travel to the lungs. This condition is called pulmonary embolism (PE). Symptoms of PE may include sharp chest pain, shortness of breath or you may cough up blood
Tell your doctor if you have ever had any of the following reactions to this type of medicine:
Neuroleptic Malignant Syndrome (NMS) – symptoms include sudden fever, fast breathing, blood pressure changes, sweating, confusion, muscle stiffness and drowsiness or sleepiness
Tardive Dyskinesia (TD) – symptoms include unusual movements (mainly of the face and tongue), or uncontrollable twitching or jerking of the arms and legs
Tell your doctor if you are pregnant or plan to become pregnant or start breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell thembefore you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and ziprasidone may interfere with each other. These include:
lithium, used to treat bipolar disorders
medicines which act on the central nervous system (CNS), such as triptans, antipsychotics and antidepressants
alcohol
medicines used to control (lengthen or shorten) heart rhythm
ketoconazole, used to treat fungal infections
carbamazepine, used to treat epilepsy
rifampicin, an antibiotic used for the treatment of tuberculosis
a type of herbal medicine to treat depression called St John’s Wort (Hypericum perforatum)
These medicines may be affected by ziprasidone or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
Other medicines not listed above may also interact with ziprasidone.
How to take this medicine
Follow carefully all directions given to you by your doctor.
Their instructions may be different to the information in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much of this medicine you should take.This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Schizophrenia
The usual starting dose is one 40 mg capsule taken twice daily with food.
Your doctor may increase your dose up to one 80 mg capsule twice daily with food.
Allow at least 48 hours between changes to your dose unless otherwise instructed by your doctor.
You may reach the maximum dose of one 80 mg capsule twice daily with food on the third day from the start of your treatment.
Bipolar disorder
The usual starting dose is one 40 mg capsule twice daily with food.
Your doctor may adjust your dose up to one 80 mg capsule twice daily with food.
You may reach the maximum dose of one 80 mg capsule twice daily with food on the second day from the start of your treatment.
How to take it
Swallow the capsule(s) whole with a glass of water.
When to take it
Take your capsule(s) with food, so in the morning with breakfast and in the evening with your evening meal.
You need to take ziprasidone with food because it helps your body absorb the medicine better.If you do not take it with food, the medicine may have less effect.
Take this medicine at the same times each day. Taking it at the same times each day will have the best effect and will also help you remember when to take it.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much ziprasidone, you may feel drowsy and show signs of tremor and uncontrollable movements of the tongue, jaw, arms and legs.
While you are taking this medicine
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Talk to your doctor or mental health professional if you have thoughts or talk about death, suicide or self-harm.
These may be signs of changes or worsening in your mental illness.
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
If you feel drowsy or sleepy while taking ziprasidone, do not drive or operate machinery, or do things that could be dangerous if you are not alert.
Make sure you know how you react to ziprasidone before you drive a car, operate machinery or do anything else that could be dangerous if you are not alert.
Ziprasidone may also cause falls resulting in fractures or other injuries in some people.
Be careful when drinking alcohol while taking ziprasidone.
Combining ziprasidone and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with ziprasidone.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.
All medicines can have side effects.Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects.You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
headache
feeling sick (nausea)
vomiting
sleepiness or drowsiness
difficulty sleeping
dizziness on standing up, especially when getting up from a sitting or lying position, blackouts or feeling faint
dry mouth
too much saliva
indigestion
constipation
diarrhoea
restlessness
muscle stiffness
blurred vision
palpitations
weakness or loss of strength
anxiety or agitation
loss of control of your bladder
unusual secretion of breast milk
persistent painful erection of the penis without sexual arousal
male sexual dysfunction
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
any worm-like movements of the tongue
any other uncontrolled movements of the tongue, mouth, cheeks or jaw
any uncontrolled movements spreading to the arms and legs
sleepwalking
eating during sleepwalking
breathing stopping and starting while sleeping. Symptoms can be loud or frequent snoring, silent pauses in breathing, choking or gasping sounds
Some of these are symptoms of a condition called Tardive Dyskinesia (TD).
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
convulsions, fit or seizures
trembling and shaking of the hands and fingers
shuffling walk and stiffness of the arms and legs
sudden uncontrollable muscle spasms in the eyes, head, neck and body
sudden signs of allergy including skin rash, itching or hives; swelling of the face, lips or tongue, shortness of breath or difficulty breathing
pain and swelling in the large veins of your legs or hip
sharp chest pain, shortness of breath or and coughing up blood.
symptoms of a condition called Neuroleptic Malignant Syndrome (NMS), which include high fever, fast breathing, stiff muscles and confusion, drowsiness or sleepiness
These are very serious side effects and can also occur after you stop taking ziprasidone. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Storage and disposal
Storage
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What APO-Ziprasidone looks like
20 mg capsules:
Blue/White size ‘4’ hard gelatin capsules imprinted in black ink with “CL62” on the cap and “20 mg” on the body; filled with pale pink coloured powder. AUST R 201046. AUST R 201057.
40 mg capsules:
Blue/Blue size ‘2’ hard gelatin capsules imprinted in black ink with “CL63” on the cap and “40 mg” on the body; filled with pale pink coloured powder. AUST R 201053. AUST R 201058.
60 mg capsules:
White/White size ‘1’ hard gelatin capsules imprinted in black ink with “CL64” on the cap and “60 mg” on the body; filled with pale pink coloured powder. AUST R 201054. AUST R 201059.
80 mg capsules:
Blue/White size ‘0’ hard gelatin capsules imprinted in black ink with “CL65” on the cap and “80 mg” on the body; filled with pale pink coloured powder. AUST R 201055. AUST R 201060.
Available in:
Blister packs of 60 capsules.
Bottles of 300 capsules
Titration Pack: contains 6 capsules available in blister packs (2 × 40 mg capsules, 2 × 60 mg capsules, 2 × 80 mg capsules). AUST R 201087.
Ingredients
Each capsule contains ziprasidone hydrochloride as the active ingredient.
It also contains the following inactive ingredients:
sodium starch glycollate type B
macrogol 6000
lactose monohydrate
sucrose
ammonium chloride
sodium lauryl sulfate
gelatin (contains sulfites)
titanium dioxide
indigo carmine (20 mg, 40 mg and 80 mg capsules only)
TekPrint SW-9008 black ink
This medicine is gluten-free, tartrazine-free and free of other azo dyes.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie ParkNSW2113
APO is a registered trademark of Apotex Inc.
This leaflet was last updated May 2020.
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