20 mg, 40 mg, 60 mg, 80 mg hard capsules
ziprasidone
What Ziprasidone Krka is and what it is used for
Ziprasidone Krka capsules are 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 Krka capsules are also used to treat manic or mixed states in 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 Krka may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
Ziprasidone Krka capsules belong to the group of medicines called antipsychotics ( neuroleptics ).
What you need to know before you use Ziprasidone Krka
Do not use Ziprasidone Krka
- 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 rashes, 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 are using medicines for the heart rhythm or which can affect the heart rhythm (see the section ” Other medicines and Ziprasidone Krka “ below).
Warnings and precautions
Talk to your doctor or pharmacist before using Ziprasidone Krka.
- 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 there is a particular risk that you may suffer a stroke
- if you have a low resting heart rate and/or you know that you are or may be salt deficient as a result of prolonged severe diarrhea and vomiting (nausea) or the use of diuretics (water tablets)
- if you feel 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, skin peeling, fever, and plaque-like patches on the skin may be symptoms of Stevens-Johnson syndrome. These skin reactions can be potentially life-threatening.
- Ziprasidone Krka 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 Krka before having any 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 Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
DO NOT TAKE Ziprasidone Krka if you are taking medicines for heart rhythm problems or medicines that can affect the heart rhythm, for example:
- class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medications affect the heart rhythm by prolonging the so-called QT interval. If you have any questions about this, talk to your doctor.
Talk to your doctor or pharmacist before using Ziprasidone Krka.
Tell your doctor or pharmacist if you are taking or have recently taken medicine to treat:
- bacterial infection er – these medicines are called antibiotics, e.g. macrolide antibiotics or rifampicin
- mood swings (from depression to euphoria ), agitation, and irritation – these are called mood-stabilizing drugs and include e.g. lithium, carbamazepine, and valproate.
- depression, including certain serotonergic drugs, for example, SSRI preparations which include e.g. fluoxetine, paroxetine, and sertraline, or natural remedies or herbal remedies containing St. John’s wort
- epilepsy, including phenytoin, phenobarbital, carbamazepine, and ethosuximide
- Parkinson’s disease, including levodopa, bromocriptine, ropinirole, and pramipexole
- or if you are taking or have recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.
See also the section ” Do not use Ziprasidone Krka ” above.
Ziprasidone Krka with food, drink, and alcohol
Ziprasidone Krka should be taken with the main meal.
You should not drink alcohol during treatment with Ziprasidone Krka because it can increase the risk of side effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
You should not take Ziprasidone Krka during pregnancy unless it has been prescribed by your doctor as there is a risk that this medicine may harm your baby.
The following symptoms may occur in newborn babies whose mothers have taken Ziprasidone Krka during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, restlessness, breathing problems, and difficulty eating. If your child develops any of these symptoms, contact a doctor.
Breast-feeding
Do not breastfeed if you are taking Ziprasidone Krka because small amounts of the medicine may pass into breast milk.
Contraceptive
If you can become pregnant, you should use suitable contraception while taking this medicine.
Ask your doctor or pharmacist before taking any medicine.
Driving ability and use of machinery
There is a risk that the treatment with Ziprasidone Krka will make you feel drowsy. If you feel this, you should not drive or use machines until the drowsiness has passed.
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 Krka contains excipients
Ziprasidone Krka contains lactose . If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Ziprasidone Krka
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The capsules should be swallowed whole and taken with food. It is important not to chew the capsules as this can affect the degree to which the medicine is absorbed by the gut.
Ziprasidone Krka should be taken twice a day, one capsule in the morning in connection with a normal breakfast and one 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 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.
Children and adolescents with bipolar disorder
The usual starting dose is 20 mg taken with a meal. Your doctor will then determine which dose is suitable for you. The maximum 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 in the treatment of children and adolescents with schizophrenia have not been established.
Elderly people (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. Your doctor will decide which dose is appropriate for you.
Patients with liver problems
If you have problems with your liver, you may need to take a lower dose of Ziprasidone Krka. Your doctor will determine the right dose for you.
If you have used too much Ziprasidone Krka
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take your pack of Ziprasidone Krka with you.
If you have taken too many capsules, you may experience drowsiness, tremors, convulsions, and involuntary head and neck movements.
If you forget to use Ziprasidone Krka
It is important to take Ziprasidone Krka regularly at the same time every day. If you forget to take your medicine, take it as soon as possible. However, if so much time has passed that it is almost time to take the next dose, then skip the forgotten capsule and instead take the next capsule at the right time. Do not take a double dose to make up for a missed dose.
If you stop using Ziprasidone Krka
Your doctor will tell you how long to take Ziprasidone Krka. You should not stop using Ziprasidone Krka unless your doctor tells you to.
It is important to continue taking your medication, 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 taking Ziprasidone Krka and contact your doctor immediately if you experience any of the following serious side effects:
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 feeling dizzy when you stand 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 in some cases be life-threatening.
- confusion, restlessness, elevated temperature, sweating, difficulty coordinating muscles, and muscle twitching. These may 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 or anxiety
- restlessness
- abnormal movements, including involuntary movements, muscle stiffness, slow movements
- dizziness
- sedation
- 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, dream disturbances
- 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 flakes, also known as psoriasis
Has been reported (occurring in an unknown number of users)
- in older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotic medications compared to those not taking these medications.
- blood clots in the veins, especially the legs (symptoms include swelling, pain, and redness of the leg). These can travel through the blood vessels to the lungs, where they cause chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
How to store Ziprasidone Krka
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 °C.
Store in the original packaging. Moisture sensitive.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacy 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.20 mg hard capsules each hard capsule contains 20 mg of ziprasidone as ziprasidone hydrogen sulfate.40 mg hard capsules each hard capsule contains 40 mg of ziprasidone as ziprasidone hydrogen sulfate.60 mg hard capsule rEach hard capsule contains 60 mg of ziprasidone as ziprasidone hydrogen sulfate.80 mg hard capsule rEach hard capsule contains 80 mg of ziprasidone as ziprasidone hydrogen sulfate.
- Other ingredients (excipients) are lactose monohydrate, pregelatinized starch (maize), povidone K-25 and magnesium stearate in the capsule core and titanium dioxide (E 171), gelatin, indigo carmine (E 132) and yellow iron oxide (E 172) in the capsule shell. See section 2 “Ziprasidone Krka contains lactose”.
Appearance and package sizes of the medicine
20 mg hard capsules:
The upper part of the capsule is pastel green, and the lower part of the capsule is white. The capsule contains a powder that is light pink to brown.
40 mg hard capsules:
The upper part of the capsule is dark green, and the lower part of the capsule is pastel green. The capsule contains a powder that is light pink to brown.
60 mg hard capsules:
The upper part of the capsule is dark green, and the lower part of the capsule is white. The capsule contains a powder that is light pink to brown.
80 mg hard capsules:
The upper part of the capsule is pastel green, and the lower part of the capsule is white. The capsule contains a powder that is light pink to brown.
For all strengths, cartons of 14, 20, 28, 30, 50, 56, 60, 90, and 100 hard capsules in blisters are available.
Not all pack sizes may be marketed.
KRKA dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia