20 mg, 40 mg, 60 mg, 80 mg capsules, hard
ziprasidone
What Ziprasidone STADA is and what it is used for
Ziprasidone Stada belongs to the group of medicines called antipsychotics ( neuroleptics ).
Ziprasidone Stada 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 Stada 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 Stada 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 STADA
Do not use Ziprasidone STADA
- 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 difficulties
- if you have or have had heart problems or have recently had a heart attack
- if you use other medicines that affect the heart rhythm. See also the section “Use of other medicines” below.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ziprasidone Stada.
- 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 it 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.
Tell your doctor that you are taking Ziprasidone Stada before having any laboratory tests (eg blood, urine, liver function, pulse, etc.) as the medicine may affect the results.
Other medicines and Ziprasidone STADA
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
DO NOT TAKE ZIPRASIDONE STADA 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 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 medicine to treat:
- bacterial infection, these drugs are called antibiotics, e.g. macrolide antibiotics or rifampin
- 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, sertraline or natural 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 Stada” above.
Ziprasidone STADA with food, drink, and alcohol
The capsules SHOULD BE TAKEN WITH FOOD.
You should not drink alcohol during treatment with Ziprasidone Stada as it may increase the risk of side effects.
Pregnancy, breastfeeding, and fertility
Pregnancy:
You should not take Ziprasidone Stada capsules during pregnancy unless it has been prescribed by your doctor, as there is a risk that this medicine may harm your baby. Always use an effective birth control method. Tell your doctor if you become pregnant or plan to become pregnant while taking Ziprasidone Stada.
The following symptoms may occur in newborn babies of mothers who have used Ziprasidone Stada 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, you may need to see a doctor.
Breast-feeding
Do not breastfeed if you are taking Ziprasidone Stada capsules because small amounts of the medicine may pass into breast milk. If you plan to breastfeed, talk to your doctor before taking this medicine.
Driving ability and use of machinery
There is a risk that the treatment with Ziprasidone Stada will make you feel drowsy. If you feel this, do not drive or use machines.
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 STADA contains lactose and sodium
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Ziprasidone STADA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
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.
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.
Liver problems
If you have problems with your liver, you may need to take a lower dose of Ziprasidone Stada capsules. Your doctor will determine the right dose for you.
Mode of administration
To be swallowed.
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 Stada 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 (see the blister pack). You should take the medicine at the same time every day.
Use for children and adolescents
Use for 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 Stada in the treatment of children and adolescents with schizophrenia have not been established.
If you use too much Ziprasidone STADA
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.
If you have taken too much Ziprasidone Stada, you may experience drowsiness, tremors, convulsions, and involuntary movements of the head and neck.
If you forget to use Ziprasidone STADA
It is important to take the medicine 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 STADA
Your doctor will tell you how long to take Ziprasidone Stada capsules. You should not stop taking Ziprasidone Stada unless your doctor tells you to.
It is important to continue taking your 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. Most side effects are transient. It can often be difficult to distinguish the symptoms of your illness from those of side effects.
STOP taking Ziprasidone Stada and contact your doctor immediately if you experience any of the following symptoms:
Uncommon (may affect up to 1 in 100 users):
- Fast or irregular pulse and feeling dizzy when you stand up, may indicate abnormal heart function. These can be symptoms of a condition called postural hypotension.
- Involuntary/unusual movements, especially of the face or tongue.
Has been reported (occurring in an unknown number of 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 may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be life-threatening.
- Confusion, anxiety, increased temperature, sweating, difficulty coordinating muscles, and muscle twitching. These can be symptoms of a condition called serotonin syndrome.
- Fast, irregular pulse, 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.
Common (may affect up to 1 in 10 users):
- restlessness
- abnormal movements, including involuntary movements, muscle stiffness, slow movements, tremors, general weakness and tiredness, dizziness, abnormal need for sleep, headache
- constipation, nausea, vomiting and indigestion, dry mouth, or increased amount of saliva
- blurred vision
Uncommon (may affect up to 1 in 100 users):
- increased appetite
- difficulty controlling movements
- irritation, anxiety, the feeling of tightness in the throat, dream disturbances
- convulsions, involuntary eye movements to a certain position, clumsiness, slurred speech, numbness, tingling, reduced ability to concentrate, drooling, increased daytime sleepiness, fatigue
- palpitations, feeling faint when standing up, shortness of breath
- sensitivity to light, tinnitus
- sore throat, difficulty swallowing, swollen tongue, diarrhea, flatulence, stomach discomfort
- itchy rash, acne
- muscle cramps, stiff or swollen joints
- thirst, pain, chest discomfort, abnormal gait
Rare (may affect up to 1 in 1,000 users):
- Runny nose
- decreased calcium levels in the blood
- panic disorder, depression, slowness of thought, lack of emotions
- abnormal position of the head (slanted neck or torticollis ), immobility, “restless legs” (crawling in the legs with a numb, tingling sensation)
- total or partial loss of vision in one eye, itchy eyes, dry eyes, visual disturbances
- ear pain
- hiccup
- acid reflux
- loose stools
- hair loss, facial swelling, skin irritations
- inability to open the mouth
- difficulty urinating or holding tight, involuntary urination, pain when urinating, urinary retention (difficulty emptying the bladder)
- decreased or increased erection, decreased orgasm, abnormal breast milk production
- breast enlargement in both men and women
- the feeling of warmth, fever
- increase or decrease in white blood cells (in blood tests)
- abnormal results on liver function tests
- high blood pressure
- abnormal blood tests or abnormal heart rate
- patches of raised and inflamed skin covered in white flakes, also known as psoriasis
Has been reported (occurring in an unknown number of users)
- severe allergic reactions
- 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.
- difficulty sleeping, involuntary urination
- extremely high energy levels, abnormal thought patterns, and hyperactivity
- loss of consciousness
- large swellings with severe itching
- facial paralysis
- withdrawal symptoms in newborn babies.
How to store Ziprasidone STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton or the blister after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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
Ziprasidone Stada 20 mg capsules, hard
The active substance is ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 20 mg of ziprasidone.
Other ingredients
Lactose monohydrate
Microcrystalline cellulose
Pregelatinized corn starch
Croscarmellose sodium
Magnesium stearate
Capsule shell:
Gelatine
Titanium dioxide (E171)
Indigo carmine (E132)
Erythrosine (E127)
Black iron oxide (E172)
Ziprasidone Stada 40 mg capsules, hard
The active substance is ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 40 mg of ziprasidone.
Other ingredients
Lactose monohydrate
Microcrystalline cellulose
Pregelatinized corn starch
Croscarmellose sodium
Magnesium stearate
Capsule shell:
Gelatine
Titanium dioxide (E171)
Indigo carmine (E132)
Erythrosine (E127)
Black iron oxide (E172)
Ziprasidone Stada 60 mg capsules, hard
The active substance is ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 60 mg of ziprasidone.
Other ingredients
Lactose monohydrate
Microcrystalline cellulose
Pregelatinized corn starch
Croscarmellose sodium
Magnesium stearate
Capsule shell:
Gelatine
Titanium dioxide (E171)
Ziprasidone Stada 80 mg capsules, hard
The active substance is ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 80 mg of ziprasidone.
Other ingredients
Lactose monohydrate
Microcrystalline cellulose
Pregelatinized corn starch
Croscarmellose sodium
Magnesium stearate
Capsule shell:
Gelatine
Titanium dioxide (E171)
Indigo carmine (E132)
Erythrosine (E127)
Appearance and package sizes of the medicine
Ziprasidone STADA capsules are hard gelatin capsules.
Ziprasidone STADA 20 mg capsules, hard
Blue/white capsules, hard size no. 4, length approx. 14.3 mm
Ziprasidone STADA 40 mg capsules, hard
Blue capsules, hard size no. 3, length approx. 15.9 mm
Ziprasidone STADA 60 mg capsules, hard
White capsules, hard size no. 1, length approx. 19.4 mm
Ziprasidone STADA 80 mg capsules, hard
Blue/white capsules, hard size no. 0, length approx. 21.7 mm
Ziprasidone Stada 20 mg and 40 mg capsules, hard
Aluminum/aluminum blister in a carton containing 10, 14, 30, 56, or 100 capsules.
Ziprasidone Stada 60 mg and 80 capsules, hard
Aluminum/aluminum blister in a carton containing 30, 56, or 100 capsules.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local Representative
STADA Nordic Apps
Marielundvej 46 A
2730 Herlev
Denmark