Package Leaflet: Information for the Patient

Ziprasidone Krka 20 mg Hard Capsules EFG

Ziprasidone Krka 40 mg Hard Capsules EFG

Ziprasidone Krka 60 mg Hard Capsules EFG

Ziprasidone Krka 80 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4

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

2. What you need to know before you start taking Ziprasidone Krka

3. How to take Ziprasidone Krka

4. Possible side effects

5. Storage of Ziprasidone Krka

6. Contents of the pack and additional information

Ziprasidona Krkacapsules are a medication belonging to the group of medications known as antipsychotics.

Ziprasidonais indicated for the treatment of schizophrenia in adults, a mental illness characterized by the appearance of one or more of 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.

Furthermore,ziprasidonais used in adults and in children and adolescents from 10 to 17 years old for the treatment of symptoms of moderate severity mania or mixed in bipolar disorder, a mental illness characterized by alternating phases of euphoric mood states (mania) or depressed. During mania 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 Krka

• if you are allergic to ziprasidona (hydrochloride monohydrate) or any of the other ingredients of this medication (listed in section 6). An allergic reaction can be recognized by 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 (arrhythmias) or medications that can affect heart rhythm. See the section “Other medications and Ziprasidona Krka” later.

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 over 65 years old and have dementia and are at high risk of suffering a stroke (cerebrovascular accident)
• if you experience symptoms such as rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, as this may indicate abnormal heart rhythm function.

Contact your doctor immediately if you experience any of the following symptoms:

• severe skin reactions such as blistering rash that may include mouth ulcers. Skin shedding, fever, and skin dots that may be symptoms of Stevens-Johnson syndrome. These skin reactions can be potentially fatal.
• Ziprasidona Krka may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. Be cautious, especially if you are an elderly patient or have weakness.

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

Children and adolescents

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

Other medications and Ziprasidona Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those purchased without a prescription.

DO NOT TAKE ZIPRASIDONA KRKAif 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, sparflloxacin, 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 Krka.

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

• bacterial infections; these medications are known as antibiotics; for example, macrolide antibiotics or rifampicin
• mood changes (from depressive mood to euphoria), agitation, and irritability; these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate;
• depression, including some serotonin reuptake inhibitors (SSRIs) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies containing St. John's Wort
• epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole.
• or if you are taking or have taken recently the following medications: see the section “Do not take Ziprasidona Krka” earlier.

See the section “Do not take Ziprasidona Krka” earlier.

Ziprasidona Krka with food and drinks

Ziprasidona Krka should be taken during main meals.

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

Pregnancy and breastfeeding

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 Krka during pregnancy unless your doctor tells you to, as this medication may harm your baby. Always use a suitable contraceptive method.

The following symptoms may occur in newborns, from mothers who have used Ziprasidona Krka in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. If your baby experiences any of these symptoms, you may need to contact your doctor.

Breastfeeding

Do not breastfeed your baby while taking Ziprasidona Krka, as small amounts may pass into breast milk.

If you plan to breastfeed your baby, inform your doctor before taking this medication.

Contraception

If you can become pregnant, you should use a suitable contraceptive method while taking this medication.

Driving and use of machines

Ziprasidona Krka may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor evaluates your response to this medication.

Important information about some of the components of Ziprasidona Krka

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

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

The capsules should be taken with food and swallowed whole, without chewing, crushing, or opening beforehand. It is essential not to chew, crush, or open 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 in the evening 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.

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

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, 160 mg per day for children weighing 45 kg or more, and 80 mg per day for children weighing less than 45 kg.

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

Patients over 65 years old

If you are over 65 years old, your doctor will decide on the suitable dose for you. The dose for patients 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. Your doctor will indicate the correct dose for you.

If you takemultiple Ziprasidone Krka capsules

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you have taken too many capsules, you may experience drowsiness, tremors, seizures, and involuntary movements of the head and neck.

If youforgot to take Ziprasidone Krka

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 the treatment with Ziprasidone Krka

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 can often be difficult to distinguish the symptoms of your illness from side effects.

STOP taking Ziprasidona Krka capsules and contact your doctor immediately if you experience any of the following serious side effects:

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

• Uncontrollable or involuntary movements, especially in your face or tongue.

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

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

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

• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and decreased consciousness. These could be symptoms of a condition known as malignant neuroleptic syndrome.
• Skin reactions, especially hives, fever, and inflammation of the lymph nodes, which could be symptoms of a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially fatal.
• Confusion, agitation, fever, sweating, muscle movement disorder, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Fast or irregular heartbeat, dizziness, which may be symptoms of a life-threatening condition known as Torsades de Pointes.
• Persistent and painful erection of the penis.

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
• Drowsiness or excessive daytime somnolence.
• Headache

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

• Runny nose
• Euphoric mood, strange thought patterns, and hyperactivity, agitation, anxiety
• Restlessness.
• Abnormal movements, including involuntary movements, muscle rigidity, slow movements.
• Dizziness.
• Sedation.
• Blurred or altered vision.
• High blood pressure.
• Constipation, diarrhea, nausea, vomiting, and indigestion, dry mouth, increased salivation.
• Rash.
• Male sexual problems.
• Fever.
• Pain.
• Weight loss or gain.
• Generalized fatigue.
• General feeling of illness.

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

• Elevated levels of prolactin in the blood.
• Increased appetite.
• Panic attack.
• Nervous or depressive feeling.
• Decreased libido.
• Loss of consciousness.
• Difficulty controlling movements/involuntary movements.
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech disorder, numbness, muscle cramps, decreased concentration ability, drooling
• Palpitations, difficulty breathing.
• Sensitivity to light, dry eyes, ear noises, ear pain.
• Throat pain, gas, stomach discomfort.
• Rash on the skin that often itches, acne.
• Muscle cramps, stiffness, or swelling of the joints.
• Thirst, pain, chest discomfort, altered gait.
• Acid reflux, stomach pain
• Hair loss
• Abnormal head position
• Urinary incontinence, pain or difficulty urinating
• Abnormal milk production
• Enlarged breasts in men
• Absence of menstruation
• Abnormal results in heart or blood tests
• Abnormal results in liver function tests
• Dizziness
• Generalized weakness and fatigue

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

• Decreased calcium levels in the blood.
• Slow reasoning, absence of emotions
• Facial paralysis
• Paralysis
• Partial or complete loss of vision in one eye, eye itching
• Difficulty speaking, hiccups
• Soft stools.
• Skin irritation.
• Inability to open the mouth.
• Difficulty emptying the bladder.
• Withdrawal syndrome in newborns.
• Reduced orgasm.
• Sensation of heat.
• Decreased or increased white blood cells (in blood tests).Red, raised, and inflamed skin areas covered with white scales, 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.
• Clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

Additional side effects in children and adolescents

In clinical trials with children and adolescents, side effects were generally similar to those of adults (see above), except for sedation and somnolence, which were more frequent in children. The most common side effects in children and adolescents were sedation, somnolence, headache, fatigue, nausea, dizziness, vomiting, decreased appetite, and movement disorders.

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 Medicinal Products for Human Use Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

Do not store above 30°C.

Store in the original packaging to protect from humidity.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

• Composition of Ziprasidone Krka
• The active ingredient is ziprasidone.

Hard capsules of 20 mg

Each hard capsule contains 20 mg of ziprasidone as ziprasidone hydrochloride.

Hard capsules of 40 mg

Each hard capsule contains 40 mg of ziprasidone as ziprasidone hydrochloride.

Hard capsules of 60 mg

Each hard capsule contains 60 mg of ziprasidone as ziprasidone hydrochloride.

Hard capsules of 80 mg

Each hard capsule contains 80 mg of ziprasidone as ziprasidone hydrochloride.

The other components (excipients) are:

- inside the capsule: lactose monohydrate, pregelatinized maize starch, povidone K-25 and magnesium stearate and

- capsule body: titanium dioxide (E171), gelatin, indigo carmine (E132) andyellow iron oxide (E172). (See section 2 “Ziprasidone Krka contains lactose”)

Appearance ofZiprasidone Krkaand contents of the package

Hard capsules of 20 mg

The cap of the capsule is pale green and the capsule body is white. The capsule contains a slightly pink to brown powder.

Hard capsules of 40 mg

The cap of the capsule is dark green and the capsule body is pale green. The capsule contains a slightly pink to brown powder.

Hard capsules of 60 mg

The cap of the capsule is dark green and the capsule body is white. The capsule contains a slightly pink to brown powder.

Hard capsules of 60 mg

The cap of the capsule is pale green and the capsule body is white. The capsule contains a slightly pink to brown powder.

Packages of 14, 20, 28, 30, 50, 56, 60, 90 and 100 hard capsules in blisters are available.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Date of the last review of this leaflet:July 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.