20 mg, 40 mg capsules, hard
ziprasidone
What Ziprasidone Sandoz is and what it is used for
Ziprasidone Sandoz contains the active substance ziprasidone and belongs to the group of medicines called antipsychotics ( neuroleptics ).
Ziprasidone Sandoz is used to treating the following mental illnesses:
- Schizophrenia in adults. Schizophrenia is 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, as well as nervousness, depression, or anxiety.
- Manic or mixed episodes of moderate severity in bipolar (manic-depressive) illness in adults and children and adolescents aged 10 to 17 years. This mental illness is characterized by alternating stages of euphoria (mania) and 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.
Ziprasidone contained in Ziprasidone Sandoz 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 take Ziprasidone Sandoz
Do not take Ziprasidone Sandoz
- if you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction are rash, itching, swelling of the face, swollen lips, or difficulty breathing
- 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 can affect the heart rhythm.
See also the section “Other medicines and Ziprasidone Sandoz” below.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ziprasidone Sandoz
- 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
- 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, 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 Sandoz can cause drowsiness, a drop in blood pressure when standing up, dizziness, and gait disturbances, which can lead to fall accidents. You should therefore be careful, especially if you are elderly or debilitated.
Tell your doctor that you are taking Ziprasidone Sandoz 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 Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ziprasidone Sandoz 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 drugs affect the heart rhythm by extending the so-called QT interval et. If you have any questions about this, talk to your doctor.
Talk to your doctor or pharmacist before using Ziprasidone Sandoz.
Tell your doctor or pharmacist if you are taking or have recently taken medicines to treat:
- bacterial infections – these medicines are called antibiotics, e.g. macrolide antibiotics or rifampicin
- mood swings (from depression to euphoria ), excitement, and irritation – these are called mood-stabilizing drugs and include e.g. lithium, carbamazepine, and valproate
- depression, i.a. certain serotonergic drugs, e.g. SSRI preparations which include, among other things fluoxetine, paroxetine, and sertraline, or (traditional) herbal medicines containing St. John’s wort
- epilepsy, i.a. phenytoin, phenobarbital, carbamazepine, and ethosuximide
- Parkinson’s disease, i.a. 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 take Ziprasidone Sandoz” above.
Ziprasidone Sandoz with food, drink, and alcohol
Ziprasidone Sandoz MUST BE TAKEN WITH A MAIN MEAL.
You should not drink alcohol during treatment with Ziprasidone Sandoz as it may increase 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, consult your doctor before using this medicine.
- PregnancyYou should not take Ziprasidone Sandoz 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 of mothers who used Ziprasidone Sandoz during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or muscle weakness, sleepiness, agitation, breathing problems, and difficulty eating. If your child shows any of these symptoms, contact a doctor. - Breast-feeding does not breastfeed if you are taking Ziprasidone Sandoz because small amounts of the medicine may pass into breast milk.
- ContraceptiveIf you can become pregnant, you should use suitable contraception while taking this medicine.
Driving ability and use of machinery
There is a risk that the treatment with Ziprasidone Sandoz will make you feel drowsy. If you experience this symptom, you should not drive or use tools or machines until the drowsiness has disappeared.
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 Sandoz contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. it is almost “sodium-free”.
How to take Ziprasidone Sandoz
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The capsules should be swallowed whole (not chewed) and should be taken with a meal. It is important not to chew the capsules as this can affect the degree to which the medicine is absorbed by the intestine.
Ziprasidone Sandoz should be taken twice a day, one capsule in the morning in connection with a proper 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 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 for children and adolescents with bipolar mania
The usual starting dose is 20 mg taken with a meal. Your doctor will then decide which dose is appropriate 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 Sandoz in the treatment of children and adolescents with schizophrenia have not been established.
Elderly people (over 65 years old )
If you are elderly, your doctor will decide which dose is appropriate 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 liver problems, you may need to take a lower dose of Ziprasidone Sandoz. Your doctor will decide which dose is appropriate for you.
If you have taken too much Ziprasidone Sandoz
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. Take the packaging and any remaining capsules with you.
If you have taken too many capsules, you may feel drowsy or start to shake and have convulsions and involuntary movements of the head and neck.
If you forget to take Ziprasidone Sandoz
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 you remember unless it is time for the next dose. Then skip the forgotten capsule and instead take the next capsule at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Ziprasidone Sandoz
Your doctor will tell you how long to take Ziprasidone Sandoz. You should not stop using Ziprasidone Sandoz 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.
However, most side effects are short-lived. It is often difficult to distinguish between the symptoms you get from the disease and those caused by side effects.
STOP taking Ziprasidone Sandoz and contact your doctor immediately if you experience any of the following serious side effects:
Common (may affect up to 1 in 10 users):
- Involuntary/unusual movements, especially of the face or tongue.
Uncommon (may affect up to 1 in 100 users):
- Fast or irregular heart rate and feeling dizzy when you stand up, may indicate abnormal heart function. These can be symptoms of a condition called postural hypotension.
Rare (may affect up to 1 in 1,000 users):
- Swelling of the face, lips, tongue, or throat, difficulty swallowing, breathing problems, 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 and irregular heartbeats, fainting. These can be symptoms of a life-threatening condition called torsades de pointes.
- Persistent, abnormal, and painful erection.
Has been reported (occurring in an unknown number of users):
- Swelling, pain, and redness in the leg. These can be symptoms of blood clots in the veins, especially in the legs. The blood clots can travel through the blood vessels to the lungs and cause chest pain and difficulty breathing.
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 (may affect more than 1 in 10 users):
- Difficulty sleeping
- Drowsiness or increased daytime sleepiness
- Headache.
Common (may affect up to 1 in 10 users):
- Runny nose
- High energy level, abnormal thought patterns, and hyperactivity, feelings of agitation or anxiety
- Restlessness
- Abnormal movements, i.a. 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 (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
- Tight feeling in the throat, nightmares
- Seizures, involuntary eye movements to a certain position, clumsiness, slurred speech, numbness, crawling, impaired concentration, diarrhea
- Palpitations, shortness of breath
- Light sensitivity, dry eyes, tinnitus, earache
- Sore throat, flatulence, upset stomach
- Itchy rash, acne
- Muscle cramps, stiff or swollen joints
- Thirst, chest discomfort, gait disturbance
- Acid reflux, stomach pain
- Hair loss
- Unusual head position
- Urinary incontinence, pain when urinating or difficulty urinating
- Abnormal breast milk production
- Breast augmentation in men
- Absence of menstruation
- Abnormal results in cardiac examination or blood tests
- Abnormal liver function tests
- Dizziness
- A general feeling of weakness and tiredness.
Rare (may affect up to 1 in 1,000 users):
- Decreased calcium levels in the blood
- The inertness 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 children
- Decreased orgasm
- Feeling of warmth
- Increase or decrease in white blood cells (in blood tests)
- Patches of raised and inflamed, red skin covered with white scales, also called psoriasis.
Has been reported (occurring in an unknown number of users):
- In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotic drugs compared to those not taking these drugs.
How to store Ziprasidone Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister card, can, and carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 o C.
Cans
Shelf life after first opening: 6 months
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 hard capsule contains 20 mg ziprasidone (as ziprasidone hydrochloride monohydrate) Each hard capsule contains 40 mg ziprasidone (as ziprasidone hydrochloride monohydrate)
- Other ingredients are: Capsule content: lactose monohydrate, pregelatinized starch, magnesium stearateCapsule shell: indigo carmine (contains sodium ) (E132), titanium dioxide (E171), water and gelatin
Appearance and package sizes of the medicine
Ziprasidone Sandoz are gelatin capsules, hard
20 mg capsule, hard, size 4 (length: approx. 14.3 mm): opaque blue cap/opaque light blue body
40 mg capsule, hard, size 3 (length: approx. 15.7 mm): opaque blue cap/opaque blue body
Package sizes
Ziprasidone Sandoz is available in blister cards in cartons containing 10, 14, 20, 30, 50, 56, 60, 98, or 100 capsules.
Ziprasidone Sandoz is available in tins sealed with lids containing 200 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
SC Sandoz, SRL, Str. Livezeni no. 7A, RO-540472 Targu-Mures, Romania
or
Lek Pharmaceuticals dd, Trimlini 2D, 9220 Lendava, Slovenia