ZIPRASIDONE KRKA 80 mg HARD CAPSULES

Introduction

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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ziprasidone Krka and what is it used for
2. What you need to know before taking Ziprasidone Krka
3. How to take Ziprasidone Krka
4. Possible side effects
5. Storage of Ziprasidone Krka
6. Package Contents and Additional Information

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

Ziprasidone Krka capsules are a medication belonging to the group of medications called antipsychotics.

Ziprasidone is 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.

In addition, ziprasidone is used in adults and in children and adolescents from 10 to 17 years for the treatment of symptoms of mania or mixed moderate severity in bipolar disorder, which is a mental illness characterized by alternating phases of mood states, either euphoric (mania) or depressed. During episodes of mania, 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.

2. What you need to know before taking Ziprasidone Krka

Do not take Ziprasidone Krka

• if you are allergic to ziprasidone (monohydrate hydrochloride) or to any of the other components 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 recently had a heart attack.
• if you are taking medications for heart rhythm disorders (arrhythmias) or medications that can affect heart rhythm. See section "Other medications and Ziprasidone Krka" below.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take ziprasidone

• if you or someone in your family 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 suffer from dementia and have a high risk of suffering a stroke (cerebrovascular accident).
• if you have a significant decrease in resting heart rate and/or know that you may have low levels of salts in the blood as a result of having suffered from severe diarrhea and vomiting for a prolonged period or the use of diuretics (which promote the elimination of excess fluids).
• if you experience symptoms such as rapid or irregular heartbeats, fainting, syncope, or dizziness when standing up, as this may indicate abnormal heart rhythm function.

Contact your doctor immediately if you experience any of these symptoms:

• Severe skin reactions such as blistering rash, which may include ulcers in the mouth, skin peeling, fever, and target-like spots on the skin, which could be symptoms of Stevens-Johnson syndrome. These skin reactions can be potentially life-threatening.
• Ziprasidone Krka may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can lead to falls. You should be cautious, especially if you are an elderly patient or suffer from weakness.

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

Children and Adolescents

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

Other Medications and Ziprasidone Krka

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

DO NOT TAKE ZIPRASIDONE KRKAif you are taking medications for heart rhythm disorders or medications that can affect heart rhythm, such as:

• Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levometadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medications can alter the heart rhythm by prolonging the QT interval. If you have any further questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take Ziprasidone Krka.

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

• bacterial infections; these medications are known as antibiotics; for example, macrolide antibiotics or rifampicin.
• mood changes (from depressive mood to euphoria), agitation, and irritation; these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• depression, including some serotoninergic medications, for example, SSRIs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies that contain 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 recently taken the following medications: verapamil, quinidine, itraconazole, or ritonavir.

See section "Do not take Ziprasidone Krka" above.

Taking Ziprasidone Krka with Food and Drinks

Ziprasidone Krka should be taken during main meals.

You should not consume alcoholic beverages during treatment with Ziprasidone Krka, as this may increase the risk of side effects.

Pregnancy and Breastfeeding

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

Pregnancy

You should not take Ziprasidone Krka during pregnancy unless your doctor advises you to do so, as there is a risk that this medication may harm your baby. Always use an adequate contraceptive method.

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

Breastfeeding

You should not breastfeed your child if you are taking Ziprasidone Krka. This is because small amounts may pass into breast milk.

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

Contraception

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

Driving and Using Machines

Ziprasidone Krka may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce your reaction ability. These effects, as well as the underlying illness, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Important Information about Some of the Components of Ziprasidone Krka

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Ziprasidone Krka

Follow exactly the administration instructions for 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 them beforehand. It is important 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. Try 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.

Children and Adolescents with Bipolar Mania

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

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

Elderly Patients Over 65 Years

If you are over 65 years old, your doctor will decide the suitable dose for you. The dose for elderly patients is sometimes lower than that used in younger individuals. Your doctor will indicate the appropriate dose for you.

Patient 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 Take More Ziprasidone Krka Capsules Than You Should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested. It is recommended to bring the package and the package leaflet of the medication 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 You Forget to Take Ziprasidone Krka

It is important to take ziprasidone at the same time every day. If you forget to take a dose, take it as soon as possible. However, if it is close to the next dose, skip the missed dose and take the next one at the scheduled time. Do not take a double dose to make up for the missed doses.

If You Interrupt Treatment with Ziprasidone Krka

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

It is important to continue treatment even if you feel better. If you interrupt treatment too early, the symptoms may return.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

However, most adverse effects are transient. It is often difficult to distinguish the symptoms of your disease from the adverse effects.

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

Frequent adverse effects (may affect up to 1 in 10 people)

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

Infrequent adverse effects (may affect up to 1 in 100 people):

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

Rare adverse effects (may affect up to 1 in 1,000 people):

• Swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing, hives. These could be symptoms of a severe allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased consciousness. These could be symptoms of a disease known as neuroleptic malignant syndrome.
• Skin reactions, especially rash, fever, and lymph node inflammation, which could be symptoms of a disease called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.
• Confusion, agitation, fever, sweating, muscle coordination disorder, muscle spasms. These could be symptoms of a disease known as serotonin syndrome.
• Rapid, irregular heartbeats, fainting, which can be symptoms of a life-threatening disease known as Torsades de Pointes.
• Prolonged and painful erection of the penis.

You may experience some of the adverse effects mentioned below. These potential adverse effects are generally mild to moderate and may

disappear over time. However, if the adverse effect is severe or persistent, contact your doctor.

Very frequent adverse effects (may affect more than 1 in 10 people):

• Difficulty sleeping
• Somnolence or excessive daytime somnolence.
• Headache

Frequent adverse effects (may affect up to 1 in 10 people):

• Nasal secretion
• 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.
• Hypertension.
• Constipation, diarrhea, nausea, vomiting, and indigestion, dry mouth, increased salivation.
• Rash.
• Male sexual problems.
• Fever.
• Pain.
• Weight loss or gain.
• Exhaustion.
• General feeling of illness.

Infrequent adverse effects (may affect up to 1 in 100 people):

• High levels of prolactin in the blood.
• Increased appetite.
• Panic attacks.
• Nervous or depressive feelings.
• Decreased sexual desire.
• Loss of consciousness.
• Difficulty controlling movements / involuntary movements.
• Seizures, involuntary eye movements, clumsiness, speech impairment, numbness, tingling, decreased concentration, drooling
• Palpitations, difficulty breathing.
• Sensitivity to light, dry eyes, ear noises, ear pain.
• Sore throat, gas, stomach discomfort.
• Itchy skin rash, acne.
• Muscle cramps, stiffness, or joint swelling.
• Thirst, pain, chest discomfort, gait disturbance.
• Acid reflux, stomach pain
• Hair loss
• Abnormal head position
• Urinary incontinence, pain, or difficulty urinating
• Abnormal milk production
• Breast enlargement in men
• Absence of menstruation
• Abnormal heart or blood test results
• Abnormal liver function test results
• Vertigo
• Generalized weakness and fatigue

Rare adverse effects (may affect up to 1 in 1,000 people):

• Decreased calcium levels in the blood.
• Slow reasoning, lack 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.
• Neonatal withdrawal syndrome.
• Reduced orgasm.
• Feeling of heat.
• Decrease or increase in white blood cell count (in blood tests). Red, inflamed, scaly skin patches, known as psoriasis.

Frequency not known (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.
• Blood clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

Additional adverse effects in children and adolescents

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ziprasidona Krka

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

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

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

Hard capsules of 20 mg

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

Hard capsules of 40 mg

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

Hard capsules of 60 mg

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

Hard capsules of 80 mg

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

The other components (excipients) are:

• inside the capsule: lactose monohydrate, pregelatinized corn starch, povidone K-25, and magnesium stearate and
• capsule body: titanium dioxide (E171), gelatin, carmine indigo (E132), and yellow iron oxide (E172). (See section 2 "Ziprasidona Krka contains lactose")

Appearance ofZiprasidona Krkaand package contents

Hard capsules of 20 mg

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

Hard capsules of 40 mg

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

Hard capsules of 60 mg

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

Hard capsules of 60 mg

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 under the following names:

Date of last revision of this leaflet:July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.