Ziprasidone Sandoz

In track changes the changes relating to R001
Highlight in yellow the changes relating to variation 017

Package Leaflet: Information for the Patient

Ziprasidone Sandoz 20 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules, 80 mg hard capsules

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ziprasidone Sandoz is and what it is used for
2. What you need to know before taking Ziprasidone Sandoz
3. How to take Ziprasidone Sandoz
4. Possible side effects
5. How to store Ziprasidone Sandoz
6. Contents of the pack and other information

1. What Ziprasidone Sandoz is and what it is used for

Ziprasidone Sandoz contains the active substance ziprasidone and belongs to a group of medicines
called antipsychotics.
Ziprasidone Sandoz is used to treat the following mental disorders:

• schizophrenia in adults. Schizophrenia is characterized by the following symptoms: hearing, seeing and feeling things that do not exist, believing in something unreal, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression or anxiety
• moderate manic or mixed episodes in bipolar disorder in adults and in children and adolescents aged 10 to 17 years. This mental illness is characterized by alternating phases of euphoric (manic) or depressive states. During manic episodes, the most characteristic symptoms are: euphoric behaviour, excessive self-esteem, increased energy, reduced need for sleep, lack of concentration or hyperactivity, and repeated high-risk behaviours.

2. What you need to know before taking Ziprasidone Sandoz

Do not take Ziprasidone Sandoz

• if you are allergic to ziprasidone or to any of the other ingredients of this medicine (listed in section 6). Signs of allergic reactions include rash, itching, swelling of the face or lips, difficulty breathing.
• if you have or have ever had heart problems or have recently had a heart attack
• if you are taking medicines for heart rhythm disorders or medicines that can affect heart rhythm.

See also the section below “Other medicines and Ziprasidone Sandoz”.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ziprasidone Sandoz

• if you or a family member has a history of blood clots, as this type of medicine may be associated with blood clot formation
• if you have liver problems
• if you have or have ever had seizures or epilepsy
• if you are elderly (over 65 years) and have dementia and are at risk of stroke
• if you have a slow resting heart rate and/or are aware that you may be prone to salt depletion following severe and prolonged diarrhoea and vomiting (due to illness) or due to use of diuretics (tablets)
• if you have ever had irregular or rapid heartbeat, fainting, collapse or dizziness when standing, which may indicate abnormal heart rhythm.

Contact your doctor immediately if any of the following occur:

• severe skin reactions such as rashes with blisters, which may include mouth ulcers, skin peeling, fever, and target-like spots on the skin, which may be symptoms of Stevens-Johnson syndrome. These skin reactions can potentially be life-threatening.
• Ziprasidone Sandoz may cause drowsiness, low blood pressure when standing up, dizziness and gait disturbances, which may lead to falls. Use caution, especially if you are elderly or frail.

Inform your doctor that you are taking Ziprasidone Sandoz before undergoing laboratory tests
(such as blood, urine, liver function, heart rate tests, etc.), as this medicine may alter test results.
Children and adolescents
The safety and efficacy of ziprasidone in the treatment of schizophrenia in children and adolescents have not been established.
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 disorders or medicines that can affect heart rhythm 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 medicines can affect heart rhythm by prolonging the QT interval.
Ask your doctor or pharmacist if you need further information.
Talk to your doctor or pharmacist before taking Ziprasidone Sandoz.
Tell your doctor or pharmacist if you are taking or have recently taken medicines for:

• bacterial infections; these medicines are known as antibiotics; for example macrolide antibiotics or rifampicin.
• mood disorders (from depression to euphoria), agitation and irritability; these medicines are known as mood stabilizers, e.g. lithium, carbamazepine, valproate;
• depression, including certain serotonergic medicines, for example SSRIs such as fluoxetine,

paroxetine, sertraline; or herbal or natural remedies containing St. John’s wort (Hypericum perforatum)

• Epilepsy, for example phenytoin, phenobarbital, carbamazepine, ethosuximide.
• Parkinson’s disease, for example levodopa, bromocriptine, ropinirole, pramipexole.
• If you are taking or have recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

See also the section above “Do not take Ziprasidone Sandoz”
Ziprasidone Sandoz with food, drinks and alcohol
Ziprasidone Sandoz MUST BE TAKEN DURING MAIN MEALS.
Alcohol consumption should be avoided during treatment with Ziprasidone Sandoz, as it may increase the risk of adverse effects.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

• Pregnancy You must not take Ziprasidone Sandoz during pregnancy unless specifically instructed by your doctor, as this medicine may harm the unborn baby.

The following symptoms have been observed in newborns whose mothers took Ziprasidone Sandoz during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If your baby shows any of these symptoms, contact your doctor.

• Breastfeeding Do not breastfeed while taking Ziprasidone Sandoz. This is because small amounts of the medicine may pass into breast milk.
• Contraception If you are of childbearing age, you must use an adequate method of contraception while taking this medicine.

Driving and using machines
Taking Ziprasidone Sandoz may cause drowsiness. If you experience this symptom, do not drive or operate tools or machinery until drowsiness subsides.
Ziprasidone Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
20 mg, 40 mg and 80 mg hard capsules:
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially ‘sodium-free’.

3. How to take Ziprasidone Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The capsules must be swallowed whole, not chewed, and should be taken with meals.
It is important not to chew the capsules, as this may affect the rate of absorption
of the medicine in the intestine.
Ziprasidone Sandoz should be taken twice daily: one capsule in the morning with a substantial breakfast and one in the evening with the evening meal. Take this medicine every day at the same time.
Adults
The recommended dose is 40–80 mg twice daily, taken with food.
For long-term treatment, your doctor may adjust the dose. Do not exceed the maximum daily dose of 160 mg.
Children and adolescents with bipolar mania
The usual starting dose is 20 mg taken with food. Your doctor will then advise you on the optimal dose suitable for you. The maximum daily dose must not exceed 80 mg in children weighing equal to or less than 45 kg, or 160 mg in children weighing more than 45 kg.
The safety and efficacy of Ziprasidone Sandoz in the treatment of schizophrenia in children and adolescents have not been established.
Elderly (over 65 years of age)
If you are elderly, your doctor will decide the appropriate dose for you. For patients over 65 years of age, the dose is sometimes lower than in younger patients. Your doctor will advise you on the correct dose.
Patients with hepatic impairment
If you have liver problems, you may need to take a lower dose of Ziprasidone
Sandoz capsules. Your doctor will determine the appropriate dose for you.
If you take more Ziprasidone Sandoz than you should
In case of overdose, contact your doctor or pharmacist immediately and make the packaging and any remaining capsules available.
If you have taken too many capsules, you may experience drowsiness, tremor, seizures, and involuntary movements of the head and neck.
If you forget to take Ziprasidone Sandoz
It is important to take the capsules regularly, at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
In this case, take only the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Ziprasidone Sandoz
Your doctor will tell you how long to take Ziprasidone Sandoz capsules. Do not stop treatment unless your doctor advises you to do so.
It is important to continue treatment even if you feel better. If you stop treatment too early, symptoms may return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most side effects are temporary in nature. It is often difficult to distinguish symptoms of the illness from those of side effects.
If you experience any of the following serious side effects, STOP taking
Ziprasidone Sandoz and contact your doctor immediately:

Common side effects, may affect up to 1 in 10 people:

• Involuntary/unusual movements, especially of the face or tongue.

Uncommon side effects, may affect up to 1 in 100 people:

• Fast or irregular heartbeat, dizziness upon standing, which may indicate abnormal heart function. These may be symptoms of a condition known as postural hypotension.

Rare side effects, may affect up to 1 in 1,000 people:

• Swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, hives. These may be symptoms of a severe allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing and reduced level of consciousness. These may be symptoms of a disorder known as neuroleptic malignant syndrome.
• Skin reactions, particularly rashes, fever and swollen lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions may potentially be life-threatening.
• Confusion, agitation, high body temperature, sweating, lack of muscle coordination, muscle spasms. These may be symptoms of a disorder known as serotonin syndrome.
• Fast and irregular heartbeat and fainting, which may be symptoms of a potentially fatal disorder known as Torsades de Pointes.
• Abnormal, persistent and painful erection of the penis.

Not known, frequency cannot be estimated from available data:

• Swelling, pain and redness in the legs. These may be symptoms of blood clots in the veins, particularly those in the legs, which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties.

You may experience any of the following side effects. These
potential side effects are generally mild to moderate in severity and may
resolve over time. However, if the side effect is severe or persistent, you should
contact your doctor.

Very common side effects, may affect more than 1 in 10 people:

• Difficulty sleeping
• Drowsiness or excessive daytime sleepiness
• Headache

Common side effects, may affect up to 1 in 10 people:

• Runny nose
• Extremely elevated mood, bizarre thought patterns, hyperactivity, agitation or anxiety
• Restlessness
• Abnormal movements including involuntary movements, muscle stiffness, slowness of movement
• Dizziness
• Sedation
• Blurred or impaired vision
• High blood pressure
• Constipation, diarrhoea, nausea, vomiting and indigestion, dry mouth, increased salivation
• Rash
• Male sexual problems
• Fever
• Pain
• Weight loss or weight gain
• Weakness
• General feeling of being unwell

Uncommon side effects, may affect up to 1 in 100 people:

• Elevated levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feelings of nervousness or depression
• Decreased sexual desire
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Tightness in the throat, nightmares
• Seizures, involuntary eye movements when staring, clumsiness, speech disorders, numbness, tingling sensations, reduced ability to concentrate, increased salivation
• Palpitations, shortness of breath
• Light sensitivity, dry eyes, ringing in the ears, ear pain
• Sore throat, bloating, stomach discomfort
• Itchy rash, acne
• Muscle cramps, swollen or stiff joints
• Thirst, chest discomfort, abnormal gait
• Acid reflux, stomach pain
• Hair loss
• Abnormal head positioning
• Urinary incontinence, pain or difficulty urinating
• Abnormal production of breast milk
• Breast enlargement in males
• Absence of menstruation
• Abnormal results in heart or blood tests
• Abnormal liver function test results
• Dizziness
• Generalized weakness and fatigue

Rare side effects, may affect up to 1 in 1,000 people:

• Decreased levels of calcium in the blood
• Slowed thinking, lack of emotions
• Facial slackness
• Paralysis
• Partial or complete loss of vision in one eye, itchy eyes
• Difficulty speaking, hiccups
• Soft stools
• Skin irritation
• Inability to open the mouth
• Difficulty emptying the bladder
• Drug withdrawal syndrome in the newborn
• Reduced orgasm
• Feeling of warmth
• Decrease or increase in white blood cells (blood tests)
• Reddish, raised patches of skin covered with white scales, known as psoriasis

Not known, frequency cannot be estimated from available data:

• In elderly patients with dementia, a slight increase in the number of deaths has been reported in patients taking antipsychotics compared to those not taking them.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ziprasidone Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Bottles:
Validity after first opening: 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ziprasidone Sandoz contains

• The active substance is ziprasidone. Each hard capsule contains 20 mg of ziprasidone (as ziprasidone hydrochloride monohydrate). Each hard capsule contains 40 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

Each hard capsule contains 60 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).
Each hard capsule contains 80 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

• The other components are:
  Capsule contents: lactose monohydrate, pregelatinized starch, magnesium stearate.
  Capsules of 20, 40 and 80 mg:
  Capsule shell: indigo carmine (contains sodium) (E132), titanium dioxide (E171), water and gelatin.
  Capsules of 60 mg:
  Capsule shell: titanium dioxide (E171), water and gelatin.

Description of the appearance of Ziprasidone Sandoz and package contents
Ziprasidone Sandoz is available as hard gelatin capsules.
Hard capsules 20 mg, size 4 (length: approximately 14.3 mm): capsules with opaque blue cap/opaque blue body.
Hard capsules 40 mg, size 3 (length: approximately 15.7 mm): capsules with opaque blue cap/opaque blue body.
Hard capsules 60 mg, size 2 (length: approximately 17.6 mm): capsules with opaque white cap/opaque white body.
Hard capsules 80 mg, size 1 (length: approximately 19.4 mm): capsules with opaque blue cap/opaque blue body.

Pack sizes:
Ziprasidone Sandoz is packaged in blisters in cardboard boxes containing 10, 14, 20, 30, 50, 56, 60, 98 or 100 capsules.
Ziprasidone Sandoz is also available in bottles with closures containing 200 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:

Germany
Ziprasidon – 1 A Pharma 20 mg Hard Capsules
Ziprasidon – 1 A Pharma 40 mg Hard Capsules
Ziprasidon – 1 A Pharma 60 mg Hard Capsules
Ziprasidon – 1 A Pharma 80 mg Hard Capsules

Denmark
Ziprasidone Sandoz

Italy
Ziprasidone Sandoz

Spain
Ziprasidona Sandoz 20 mg hard capsules EFG,
Ziprasidona Sandoz 40 mg hard capsules EFG,
Ziprasidona Sandoz 60 mg hard capsules EFG,
Ziprasidona Sandoz 80 mg hard capsules EFG

Sweden
Ziprasidone Sandoz 20 mg hard capsules,
Ziprasidone Sandoz 40 mg hard capsules