Prospect: information for the user

Ziprasidone Sandoz 20 mg hard capsules EFG

Ziprasidone Sandoz 40 mg hard capsules EFG

Ziprasidone Sandoz 60 mg hard capsules EFG

Ziprasidone Sandoz 80 mg hard capsules EFG

Ziprasidone (hydrochloride monohydrate)

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Ziprasidone Sandoz

3.How to take Ziprasidone Sandoz

4.Possible adverse effects

5Storage of Ziprasidone Sandoz

6.Contents of the pack and additional information

Ziprasidona Sandoz contains the active ingredient ziprasidone and belongs to a group of medicines called antipsychotics.

Ziprasidone isindicated in the treatmentof the following mental illnesses:

• Schizophreniain adults.

Schizophrenia is characterized by the following symptoms: hearing, seeing or feeling things that do not exist, believing in something that is not true, having unusual suspicions, being absent and having difficulty establishing social relationships, nervousness, depression or anxiety.

• Moderate severity manic or mixed episodesinbipolar disorderin adults and in children and adolescents from10 to17 years.

It is a mental illness characterized by alternating phases of euphoric mood states (mania) or depressed states. During manic episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, decreased need for sleep, lack of concentration or hyperactivity and repetition of risky behaviors.

Do not take Ziprasidona Sandoz

• if you are allergic to ziprasidona or any of the other ingredients of this medication (listed in section 6). The signs of an allergic reaction are the appearance of a skin rash, itching, swollen face or lips, difficulty breathing,
• if you have or have had any heart disease or have had a recent heart attack,
• if you are taking medications for heart rhythm disturbances or medications that can affect heart rhythm.

Also see the section "Taking Ziprasidona Sandoz with other medications" below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ziprasidona:

• if you or a family member has a history of blood clots, as this type of medication has been associated with the formation of blood clots,
• if you have liver problems,
• if you have or have had seizures or epilepsy,
• if you are an elderly person (over 65 years old) and suffer from dementia and have a high risk of stroke,
• if you have a significant decrease in resting heart rate, and/or know that you may have low blood salt levels as a result of prolonged diarrhea and vomiting or the use of diuretics (which promote the elimination of excess fluids)
• if you experience symptoms such as rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, as this may indicate abnormal heart rhythm.

Immediately contact your doctor if you experience any of the following symptoms:

• Severe skin reactions such as, rash with blisters that may be accompanied by mouth ulcers, skin peeling, fever, and skin spots in the shape of a target that may be symptoms of Stevens-Johnson syndrome. These skin reactions may be potentially fatal.
• Ziprasidona may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which may cause falls. You should be cautious, especially if you are an elderly person or have weakness.

Inform your doctor that you are taking ziprasidona before undergoing any diagnostic tests (including blood tests, urine tests, liver function tests, heart rhythm tests, etc.) as it may alter the test results.

Children and adolescents

The safety and efficacy of ziprasidona in the treatment of schizophrenia in children and adolescents have not been established.

Taking Ziprasidona Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Do not takeZiprasidonaSandozif you are taking medications for heart rhythm disturbances or medications 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 medications may prolong the QT interval and alter heart rhythm. If you have any additional questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take ziprasidona.

Inform your doctor or pharmacist if you are using or have used recently medications for the treatment of:

• bacterial infections; these medications are known as antibiotics; e.g., macrolide antibiotics or rifampicin;
• mood changes (from depressive mood to euphoria), agitation, and irritability; these medications are known as mood stabilizers, e.g., lithium, carbamazepine, valproate;
• depression, including some selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies 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 taking or have taken recently the following medications: verapamil, quinidine, itraconazole, or ritonavir.

See section “Do not take Ziprasidona Sandoz” above.

Taking Ziprasidona Sandoz with food, drinks, and alcohol

Ziprasidona Sandoz MUST BE TAKEN DURING MAIN MEALS.

Do not consume alcoholic beverages during treatment with ziprasidona, as this may increase the risk of adverse effects.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

Do not take ziprasidona during pregnancy unless your doctor tells you to, as this medication may harm your baby.

The following symptoms may occur in newborn babies of mothers who have taken ziprasidona in the last trimester (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

• Lactation

Do not breastfeed while taking ziprasidona. This is because small amounts of this medication may pass into breast milk.

• Contraception

If you can become pregnant, you should use an appropriate contraceptive method while taking this medication.

Driving and operating machinery

The taking of ziprasidona may cause drowsiness. If you experience this symptom, refrain from driving and operating hazardous machinery until the drowsiness disappears.

Ziprasidona Sandoz contains lactose and sodium

Ziprasidona Sandoz contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

20 mg, 40 mg, and 80 mg hard capsules:

This medication contains less than 23 mg of sodium (1 mmol) per hard capsule; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole, without chewing, and should be taken with food. It is essential not to chew the capsules, as this may affect the point at which the medication is absorbed in the intestine.

Ziprasidone should be taken twice a day, one capsule in the morning during a consistent "breakfast" and one at night during "dinner". Make sure to take this medication at the same time every day.

Adults

The recommended dose is 40 to 80 mg of ziprasidone twice a day with food.

In long-term treatments, your doctor may adjust the dose. It is recommended not to exceed the maximum dose of 160 mg per day.

Use in children and adolescents with bipolar mania

The recommended starting dose for treatment is 20 mg per day in a single dose with food, after which your doctor will indicate your optimal dose. It is recommended not to exceed the maximum dose established by weight range of 80 mg per day in children weighing less than 45 kg and 160 mg per day in children weighing 45 kg or more.

The safety and efficacy of ziprasidone in the treatment of schizophrenia in children and adolescents have not been established.

Older adults (65 years and older)

If you are an older adult, your doctor will decide on the suitable dose for you. The dose for those over 65 years old is sometimes lower than that used in younger people. Your doctor will indicate the appropriate dose for you.

Patients with liver problems

If you have liver problems, you may need to take a lower dose of ziprasidone capsules. Your doctor will indicate the correct dose for you.

If you take more Ziprasidone Sandoz than you should

If you have taken more Ziprasidone than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you have taken many Ziprasidone Sandoz capsules, you may experience drowsiness, tremors, convulsions, and involuntary head and neck movements.

If you forget to take Ziprasidone Sandoz

It is essential to take ziprasidone at the same time every day. If you forget to take a dose, take it as soon as you remember. However, if it is close to the next dose, skip the missed dose and take the next one at its scheduled time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ziprasidone Sandoz

Your doctor will indicate for how long you should take ziprasidone. Do not stop taking this medication unless your doctor tells you to.

It is essential to continue treatment even if you feel better. If you stop treatment too soon, symptoms may return.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

However, most side effects are transient.It may often be difficult to distinguish the symptoms of your illness from side effects.

STOP taking Ziprasidona Sandoz and consult your doctor immediately if you experience any of the following severe side effects:

Frequent side effects (can affect up to 1 in 10 people):

• involuntary or uncontrolled movements, especially of your face or tongue.

Less frequent side effects (can affect up to 1 in 100 people):

• rapid or irregular heartbeat, feeling of dizziness when standing, which may indicate an altered heart function. These may be symptoms of a condition known as postural hypotension.

Rare side effects(can affect up to 1 in 1,000 people):

• swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing, urticaria. These may be symptoms of a severe allergic reaction such as angioedema,
• fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and decreased consciousness. These may be symptoms of a condition known as malignant neuroleptic syndrome,
• skin reactions, particularly skin rash, fever, and inflamed lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be potentially fatal,
• confusion, agitation, fever, sweating, muscle movement disorder, muscle spasms. These may be symptoms of a condition known as serotonin syndrome,
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes,
• abnormal and painful erection.

Side effects of unknown frequency (cannot be estimated from available data):

• swelling, pain, and redness in the leg. These may be symptoms of blood clots in the veins, especially in the legs, which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing.

You may experience some of the side effects mentioned below. These potential side effects are generally mild to moderate in nature and may disappear over time. However, if the side effect is severe or persistent, contact your doctor.

Very frequent side effects(can affect more than 1 in 10 people):

• difficulty sleeping,
• excessive daytime somnolence or sleepiness,
• headache.

Frequent side effects (can affect up to 1 in 10 people):

• sneezing,
• increased mood, strange thought patterns, and hyperactivity, feeling agitated or anxious,
• restlessness,
• movement disorders, including involuntary movements, muscle stiffness, slowness of movement,
• dizziness,
• sedation,
• blurred or impaired vision,
• high blood pressure,
• constipation, diarrhea, nausea, vomiting, and indigestion, dry mouth, increased salivation,
• skin rash,
• male sexual problems,
• fever,
• pain,
• weight loss or gain,
• fatigue,
• general feeling of illness.

Less frequent side effects (can affect up to 1 in 100 people):

• high levels of prolactin in the blood,
• increased appetite,
• panic attack,
• feeling nervous or depressed,
• decreased libido,
• loss of consciousness,
• difficulty controlling movements/involuntary movements,
• restless legs,
• throat constriction, nightmares,
• convulsions, involuntary eye movements to a fixed position, clumsiness, speech disorder, numbness, tingling, and pins and needles, decreased ability to concentrate, drooling,
• palpitations, shortness of breath,
• light sensitivity, dry eyes, tinnitus, ear pain,
• throat pain, wind, stomach discomfort,
• skin rash with itching, acne,
• muscle cramps, stiff or swollen joints,
• thirst, chest discomfort, abnormal gait,
• acid reflux, stomach pain,
• hair loss,
• abnormal head position,
• urinary incontinence, pain or difficulty urinating,
• abnormal milk production,
• male breast enlargement,
• absence of menstruation,
• abnormal results from cardiac or blood tests,
• abnormal results from liver function tests,
• dizziness,
• general weakness and fatigue.

Rare side effects (can affect up to 1 in 1,000 people):

• decreased levels of calcium in the blood,
• slow thinking, lack of emotions,
• facial drooping,
• paralysis,
• partial or complete loss of vision in one eye, eye itching,
• difficulty speaking, hiccups,
• loose stools,
• skin irritation,
• inability to open the mouth,

difficulty emptying the bladder,

• drug withdrawal syndrome in newborn babies,
• reduced orgasm,
• sensation of heat,
• decreased or increased white blood cell count (in blood tests),
• red, inflamed patches of skin covered with a white scale known as psoriasis.

Unknown frequency (cannot be estimated from available data):

• in elderly patients with dementia, a small increase in the number of deaths has been observed in those patients treated with antipsychotics compared to those not taking antipsychotics.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister pack; bottle and packagingafter “EXP”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Bottles:after the first opening: 6 months.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ziprasidone Sandoz

• The active ingredient 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:

Ziprasidone Sandoz 20, 40 and 80 mg hard capsules:

Caplet content: lactose monohydrate, pregelatinized starch, magnesium stearate.

Caplet: indigo carmine (contains sodium) (E132), titanium dioxide (E171), gelatin and water.

Ziprasidone Sandoz 60 mg hard capsules:

Caplet content: lactose monohydrate, pregelatinized starch, magnesium stearate.

Caplet: titanium dioxide (E171), gelatin and water.

Appearance of the product and contents of the package

Ziprasidone Sandoz are hard gelatin capsules.

• Ziprasidone Sandoz 20 mg: hard capsules of size 4 (height: 14.3 mm), cap of the capsule opaque blue and body opaque light blue.
• Ziprasidone Sandoz 40 mg: hard capsules of size 3 (height: 15.7 mm), cap of the capsule opaque blue and body opaque light blue.
• Ziprasidone Sandoz 60 mg: hard capsules of size 2 (height: 17.6 mm), cap of the capsule opaque white and body opaque white.
• Ziprasidone Sandoz 80 mg: hard capsules of size 1 (height: 19.4 mm), cap of the capsule opaque blue and body opaque light blue.

Pack sizes

Ziprasidone Sandoz is presented in blisters in carton containers containing: 10, 14, 20, 30, 50, 56, 60, 98, 100 hard capsules.

Ziprasidone Sandoz is presented in closed bottles with caps containing: 200 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovškova 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.

Lendava Site. Trimlini 2d

SI-9220 Lendava

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyZiprasidon – 1 A Pharma 20 mg Hartkapseln

Ziprasidon – 1 A Pharma 40 mg Hartkapseln

Ziprasidon – 1 A Pharma 60 mg Hartkapseln

Ziprasidon – 1 A Pharma 80 mg Hartkapseln

DenmarkZiprasidone Sandoz

ItalyZIPRASIDONE SANDOZ

SpainZiprasidona Sandoz 20 mg cápsulas duras EFG,

Ziprasidona Sandoz 40 mg cápsulas duras EFG,

Ziprasidona Sandoz 60 mg cápsulas duras EFG,

Ziprasidona Sandoz 80 mg cápsulas duras EFG

SwedenZiprasidone Sandoz 20 mg kapslar, hårda,

Ziprasidone Sandoz 40 mg kapslar, hårda,

Last revision date of this leaflet: April 2020

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)(AEMPS)http://www.aemps.gob.es/