Ziprasidone Krka 40 mg hard capsules EFG

Package leaflet: Information for the user

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 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 and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ziprasidone Krka capsules is a medicine belonging to a group of medicines called antipsychotics.

Ziprasidone is indicated for the treatment of schizophrenia in adults, a mental illness characterized by the presence of one or more of the following symptoms: hearing, seeing, or feeling things that do not exist, believing things that are not true, having unusual suspicions, being withdrawn, having difficulty forming social relationships, nervousness, depression, or anxiety.

In addition, ziprasidone is used in adults and in children and adolescents aged 10 to 17 years for the treatment of moderate manic or mixed symptoms in bipolar disorder, which is a mental illness characterized by alternating phases of euphoric (mania) or depressed mood. During manic episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, reduced need for sleep, lack of concentration, hyperactivity, and repetitive engagement in risky behaviors.

2. What you need to know before taking Ziprasidona Krka

Do not take Ziprasidona Krka

• if you are allergic to ziprasidone (monohydrate hydrochloride) or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized by the appearance of skin rash, itching, swelling of the face or lips, or difficulty breathing.
• if you have or have had heart disease or have recently had a heart attack.
• if you are taking medicines for heart rhythm disorders (arrhythmias) or medicines that may affect heart rhythm. See section “Other medicines and Ziprasidona Krka” below.

Warnings and precautions

Talk to your doctor or pharmacist before starting ziprasidone

• if you or someone in your family has a history of blood clots, as this type of medicine has been associated with blood clot formation.
• if you have liver problems.
• if you have or have had seizures or epilepsy.
• if you are over 65 years of age and have dementia and are at high risk of stroke (cerebrovascular accident).
• if you have a significant decrease in resting heart rate and/or know that you may have low levels of blood salts as a result of prolonged severe diarrhoea and vomiting or due to the use of diuretics (which promote elimination of excess fluids).
• if you experience symptoms such as rapid or irregular heartbeat, fainting, syncope, or dizziness upon standing, as these may indicate abnormal heart rhythm.

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

• Severe skin reactions such as blistering rash, which may include mouth ulcers. Skin peeling, fever, and target-like spots on the skin could be symptoms of Stevens-Johnson syndrome. These skin reactions can be potentially life-threatening.
• Ziprasidona Krka may cause drowsiness, low blood pressure upon standing, dizziness, and gait disturbances, which may lead to falls. Caution should be exercised, especially if you are elderly or have any physical weakness.

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

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

DO NOT TAKE ZIPRASIDONA KRKA if you are taking medicines for heart rhythm disorders or medicines that may 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 medicines can alter heart rhythm by prolonging the QT interval. If you have any further questions about this effect, consult your doctor.

Talk to your doctor or pharmacist before starting Ziprasidona Krka.

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

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

See section “Do not take Ziprasidona Krka” above.

Taking Ziprasidona Krka with food and drinks

Ziprasidona Krka should be taken during main meals.

You should not drink 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Ziprasidona Krka during pregnancy unless your doctor specifically instructs you to do so, as there is a risk that this medicine may harm your baby. Always use an appropriate contraceptive method.

The following symptoms may occur in newborns of mothers who have used Ziprasidona Krka during the third trimester (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, you may need to contact your doctor.

Breastfeeding

You must not breastfeed while being treated with Ziprasidona Krka. This is because small amounts may pass into breast milk.

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

Contraception

If you are able to become pregnant, you should use an appropriate contraceptive method while taking this medicine.

Driving and using machines

Ziprasidona Krka may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Important information about some of the ingredients of Ziprasidona Krka

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ziprasidone Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 site in the intestine where the medicine is absorbed.

Ziprasidone should be taken twice daily—one capsule in the morning with a substantial breakfast and one in the evening with dinner. Try to take this medicine at the same time each day.

Adults

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

For long-term treatment, your doctor may adjust the dose. It is recommended not to exceed the maximum daily dose of 160 mg.

Children and adolescents with bipolar mania

The recommended starting dose is 20 mg once daily with food. Your doctor will then determine 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 has not been established.

Elderly patients over 65 years of age

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

Patients with liver problems

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

If you take more Ziprasidone Krka capsules than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20 immediately, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and patient information leaflet to the healthcare professional.

If you have taken too many capsules, symptoms such as drowsiness, tremor, seizures, and involuntary movements of the head and neck may occur.

If you forget to take Ziprasidone Krka

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

If you stop taking Ziprasidone Krka

Your doctor will advise you on how long you should take ziprasidone. Do not stop taking this medicine unless instructed by your doctor.

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

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

4. Possible adverse effects

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

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

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

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

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

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

• Rapid or irregular heartbeat, feeling dizzy 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 serious allergic reaction such as angioedema.

• Fever, rapid breathing, sweating, muscle rigidity, tremor, difficulty swallowing, and decreased consciousness. These could be symptoms of a disease known as neuroleptic malignant syndrome.

• Skin reactions, especially rash, fever, and swollen lymph nodes, which could be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.

• Confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.

• Rapid or irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as Torsades de Pointes.

• Abnormally persistent and painful erection of the penis.

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

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

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

• Difficulty sleeping
• Drowsiness or excessive daytime sleepiness
• Headache

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

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

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

• Elevated levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feeling nervous or depressed
• Decreased sexual desire
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech disturbance, numbness, tingling sensation, decreased ability to concentrate, drooling
• Palpitations, difficulty breathing
• Light sensitivity, dry eyes, ringing in the ears, ear pain
• Sore throat, flatulence, stomach discomfort
• Itchy skin rash, acne
• Muscle cramps, joint stiffness or swelling
• Thirst, pain, chest discomfort, change in walking pattern
• Acid reflux, stomach pain
• Hair loss
• Abnormal head positioning
• Urinary incontinence, pain or difficulty urinating
• Abnormal milk production
• 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 adverse effects (may affect up to 1 in 1,000 people):

• Decreased concentration of calcium in the blood
• Slowed thinking, absence of emotions
• Facial paralysis
• 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
• Withdrawal syndrome in newborns
• Reduced orgasm
• Feeling of warmth
• Decrease or increase in white blood cells (in blood tests). Raised, inflamed, red areas of skin covered with white scales, 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 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 may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.

Additional adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ziprasidone Krka

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

Do not store above 30°C.

Store in the original container to protect from moisture.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• Composition of Ziprasidone Krka
• The active substance 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 shell: titanium dioxide (E171), gelatin, indigo carmine (E132) and yellow iron oxide (E172). (See section 2 “Ziprasidone Krka contains lactose”)

Appearance of Ziprasidone Krka and contents of the pack

Hard capsules of 20 mg

The capsule cap is pastel green and the body is white. The capsule contains a powder ranging from slightly pinkish to brown in colour.

Hard capsules of 40 mg

The capsule cap is dark green and the body is pastel green. The capsule contains a powder ranging from slightly pinkish to brown in colour.

Hard capsules of 60 mg

The capsule cap is dark green and the body is white. The capsule contains a powder ranging from slightly pinkish to brown in colour.

Hard capsules of 60 mg

The capsule cap is pastel green and the body is white. The capsule contains a powder ranging from slightly pinkish to brown in colour.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For more information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: July 2024

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