20 mg, 40 mg, 60 mg, and 80 mg hard capsules
ziprasidone
What Ziprasidone Actavis is and what it is used for
Ziprasidone Actavis belongs to the group of medicines called antipsychotics.
Ziprasidone Actavis is used to treat adults with schizophrenia – a mental illness characterized by the following symptoms: hearing, seeing, and feeling things that are not there, believing something that is not true, feeling unusually suspicious, being absent, and having difficulty establishing social relationships, nervousness, depression or anxiety.
Ziprasidone Actavis is also used to treat manic or mixed states of manic-depressive (bipolar) disease in adults and children and adolescents aged 10 to 17 years – a mental illness characterized by alternating stages of euphoria (mania) or depression. During manic episodes, the most characteristic symptoms are elation, exaggerated self-esteem, increased energy, decreased need for sleep, lack of concentration or hyperactivity, and repeated instances of high risk-taking.
The ziprasidone contained in Ziprasidone Actavis may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Ziprasidone Actavis
Do not use Ziprasidone Actavis
- if you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself in a rash, itching, swelling of the face, swollen lips, or breathing problems.
- if you have or have had heart problems or have recently had a heart attack.
- if you use medicines for heart rhythm problems or medicines that affect the heart rhythm.
See also the section “Other medicines and Ziprasidone Actavis” below.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ziprasidone Actavis
- if you or someone in your family has had blood clots, as medicines like this are associated with the formation of blood clots
- if you have liver problems
- if you have or have had seizures or epilepsy
- if you are elderly (over 65) and have dementia and are at risk of having a stroke
- if you have a low resting heart rate and/or know that you may be salt-deficient as a result of prolonged severe diarrhea and vomiting or as a result of the use of diuretics (water tablets)
- if you experience a fast or irregular heartbeat, faint, collapse, or feel dizzy when you stand up, which may indicate an abnormal heart rate
Contact your doctor immediately if you experience any of the following:
- Serious skin reactions such as a blistering rash which may include mouth sores, peeling skin, fever, and round skin rashes which may be symptoms of Stevens-Johnson syndrome. These skin reactions can in some cases be life-threatening.
- Ziprasidone Actavis can cause drowsiness, a drop in blood pressure when standing up, dizziness, and difficulty walking, which can lead to falls. You should therefore be careful, especially if you are elderly or debilitated.
Tell your doctor that you are taking Ziprasidone Actavis before having laboratory tests (eg blood, urine, liver function, pulse, etc.) as the medicine may affect the results.
Children and young people
The safety and efficacy of ziprasidone in the treatment of schizophrenia have not been established in children and adolescents.
Other medicines and Ziprasidone Actavis
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Do not take Ziprasidone Actavis if you are taking medicines for heart rhythm problems or medicines that can affect heart rhythms, such as class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole or cisapride. These drugs affect the heart rhythm by extending the so-called QT interval et. If you have any questions about this, talk to your doctor.
Tell your doctor or pharmacist if you are taking or have recently taken medicines to treat:
- bacterial infections: these drugs are called antibiotics, e.g. macrolide antibiotics or rifampin
- mood swings (from depression to euphoria ), anxiety, and irritation: these drugs are called mood stabilizers, e.g. lithium, carbamazepine, valproate
- depression, including some serotonergic drugs, e.g. SSRI preparations such as fluoxetine, paroxetine, sertraline, or herbal medicines containing St. John’s wort
- epilepsy, e.g. phenytoin, phenobarbital, carbamazepine, ethosuximide
- Parkinson’s disease, e.g. levodopa, bromocriptine, ropinirole, pramipexole, or if you are using or have recently used the following medicines: verapamil, quinidine, itraconazole or ritonavir.
- See also the section “Do not use Ziprasidone Actavis” above.
Ziprasidone Actavis with food and alcohol
THE CAPSULES MUST BE TAKEN DURING THE MAIN MEAL.
You should not drink alcohol during treatment with Ziprasidone Actavis, as it increases the risk of side effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not use Ziprasidone Actavis during pregnancy unless it has been prescribed by your doctor, as there is a risk of this medicine harming your baby.
The following symptoms may occur in newborn babies of mothers who used Ziprasidone Actavis during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, restlessness, breathing problems, and difficulty eating. If your child shows any of these symptoms, contact a doctor.
Breast-feeding
Do not breastfeed while using Ziprasidone Actavis as small amounts of the medicine may pass into breast milk. If you plan to breastfeed, talk to your doctor before taking this medicine.
Contraceptive
If you could become pregnant, you must use an appropriate contraceptive method during treatment.
Driving ability and use of machinery
Using Ziprasidone Actavis may make you feel drowsy. If you experience this symptom, avoid driving, or using tools or machinery until the drowsiness disappears.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Ziprasidone Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost ‘sodium-free’.
How to use Ziprasidone Actavis
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The capsules must be swallowed whole, must not be chewed, and must be taken with meals. It is important not to chew the capsules as this can reduce the amount of medicine absorbed by the gut.
The capsules should be taken twice a day – one capsule in the morning in connection with a normal breakfast, and one capsule in the evening in connection with dinner or supper. You should take the medicine at the same time every day.
Adults
The recommended dose is 40–80 mg twice daily to be taken with meals.
In long-term treatment, the doctor can adjust the dose. You should not exceed the maximum dose of 160 mg per day.
Use in children and adolescents with bipolar mania
The recommended starting dose is 20 mg taken with a meal. Your doctor will then decide which dose is appropriate for you. The maximum single dose of 80 mg per day for children weighing 45 kg or less, or 160 mg per day for children weighing more than 45 kg should not be exceeded.
The safety and efficacy of Ziprasidone Actavis in the treatment of children and adolescents with schizophrenia have not been established.
Elderly (over 65 years)
If you are elderly, your doctor will determine an appropriate dose for you. Doses for people over 65 are sometimes lower than those used for younger people. The doctor will tell you which dose is suitable for you.
Patients with liver problems
If you have liver problems, you may need to take a lower dose of Ziprasidone Actavis. Your doctor will determine the right dose for you.
If you have taken too much Ziprasidone Actavis
Immediately contact a doctor or go to the nearest hospital. Take the pack of Ziprasidone Actavis with you.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. If you have taken too many Ziprasidone Actavis capsules, you may experience drowsiness, tremors, convulsions, and involuntary movements of the head and neck.
If you forget to take Ziprasidone Actavis
It is important to take the medicine regularly at the same time every day. If you have forgotten to take a dose, take it as soon as possible if it is not time for the next dose. Otherwise, skip the missed dose and instead take the next dose at the right time. Do not take a double dose to make up for a missed dose.
If you stop taking Ziprasidone Actavis
Your doctor will tell you how long to use Ziprasidone Actavis. You should not stop using Ziprasidone Actavis unless your doctor tells you to.
You must continue to use the medicine even if you feel better. If you stop the treatment too soon, the symptoms may return.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. However, most side effects are short-lived. It is often difficult to distinguish between the symptoms you get from the disease and the side effects.
Stop using Ziprasidone Actavis and contact your doctor immediately if you experience any of the following symptoms:
Common side effects ( may affect up to 1 in 10 users)
- involuntary/unusual movements, especially of the face or tongue.
Uncommon side effects ( may affect up to 1 in 100 users)
- fast or irregular pulse, and dizziness when standing up which may indicate abnormal heart function. These can be symptoms of a condition called postural hypotension.
Rare side effects ( may affect up to 1 in 1,000 users)
- swelling of the face, lips, tongue, or throat, difficulty swallowing, breathing problems, and hives. These may be symptoms of a serious allergic reaction such as angioedema.
- fever, shortness of breath, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased consciousness. These may be symptoms of a condition called a neuroleptic malignant syndrome.
- skin reactions, especially rash, fever, and swollen lymph nodes which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be life-threatening.
- confusion, restlessness, elevated temperature, sweating, difficulty coordinating muscles, and muscle twitching. These can be symptoms of a condition called serotonin syndrome.
- fast, irregular pulse, and fainting – these can be symptoms of a life-threatening condition called Torsades de Pointes.
- persistent, abnormal, and painful erection.
You may notice one or more of the side effects listed below. These side effects are usually mild or moderate and may go away with time. If any side effects get worse or last longer, contact your doctor.
Very common side effects ( may affect more than 1 in 10 users)
- sleep difficulties
- abnormal need for sleep or increased daytime sleepiness
- headache.
Common side effects ( may affect up to 1 in 10 users)
- Runny nose
- high energy levels, abnormal thought patterns, and hyperactivity, feelings of agitation and anxiety
- restlessness
- abnormal movements, including involuntary movements, muscle stiffness, slow movements
- dizziness
- drowsiness
- blurred vision or impaired vision
- high blood pressure
- constipation, diarrhea, nausea, vomiting and indigestion, dry mouth, or increased amount of saliva
- rash
- sexual problems in men
- fever
- pain
- weight loss or weight gain
- fatigue
- general malaise.
Uncommon side effects ( may affect up to 1 in 100 users)
- high prolactin levels in the blood
- increased appetite
- panic disorder
- nervousness or depression
- decreased sex drive
- unconsciousness
- difficulty controlling movements/involuntary movements
- restless legs
- tightness in the throat, nightmares
- convulsions, involuntary eye movements to a certain position, clumsiness, slurred speech, numbness, tingling, reduced ability to concentrate, diarrhea
- palpitations, shortness of breath
- sensitivity to light, dry eyes, tinnitus, earache
- sore throat, flatulence, discomfort in the stomach
- itchy rash, acne
- muscle cramps, stiff or swollen joints
- thirst, chest discomfort, abnormal gait
- acid reflux, stomach pain
- hair loss
- abnormal position of the head
- urinary incontinence, pain when urinating or difficulty urinating
- abnormal breast milk production
- breast augmentation in men
- cessation of menstruation
- abnormal results in cardiac examination or blood tests
- abnormal liver function tests
- dizziness
- a general feeling of weakness and tiredness.
Rare side effects (may affect up to 1 in 1,000 users)
- decreased calcium levels in the blood
- the slowness of thought, lack of emotion
- facial paralysis
- paralysis
- complete or partial loss of vision in one eye, itchy eyes
- difficulty speaking, hiccups
- loose stools
- skin irritations
- inability to open the mouth
- difficulty emptying the bladder
- withdrawal symptoms in newborn babies
- decreased orgasm
- feeling of warmth
- increase or decrease in white blood cells (in blood tests)
- patches of raised and inflamed skin covered in white scales also called psoriasis.
Has been reported (occurring in an unknown number of users)
- in elderly patients with dementia, a small number of deaths have been reported for patients using antipsychotics compared to those not using them.
- blood clots in the veins, especially the legs (symptoms include swelling, pain, and redness of the leg). These can travel via the blood vessels to the lungs, where they cause chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Ziprasidone Actavis
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton, blister, and can label. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ziprasidone. Each capsule contains 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone as ziprasidone hydrochloride.
- Other ingredients are Capsule content magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, and pregelatinized corn starch.Gelatin capsules20 mg: capsule : titanium dioxide (E171), gelatin top : indigo carmine (E132), titanium dioxide (E171), gelatin40 mg capsule and cap: indigo carmine (E132), titanium dioxide (E171), gelatin60 mg capsule and top : titanium dioxide (E171), gelatin80 mg: capsule: titanium dioxide (E171), gelatin top: indigo carmine (E132), titanium dioxide (E171), gelatin
Appearance and package sizes of the medicine
Capsule, hard.
20 mg capsules: Hard gelatin capsule size 4 with white cap and blue cap.
40 mg capsules: Hard gelatin capsule size 4 with blue cap and blue top.
60 mg capsules: Hard gelatin capsule size 3 with white capsule and white cap.
80 mg capsules: Hard gelatin capsule size 2 with white capsule and blue cap.
Ziprasidone Actavis is available in blister packs containing 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 hard capsules, as well as in tablet containers containing 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavik travel guide 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis Group PTC EHF.
Reykjavik travel guide 76-78
220 Hafnarfjordur
Iceland
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun
ZTN 3000 Malta MT
PharmaPath SA
28is Octovriou 1
Agia Varvara, 12351
Greece
Tjoapack Netherlands BV
Nieuwe Donk 9
4879 AC Etten-Leur
Netherlands