Zipsila

Leaflet accompanying the packaging: patient information

Zypsila, 20 mg, hard capsules

Zypsila, 40 mg, hard capsules

Zypsila, 60 mg, hard capsules

Zypsila, 80 mg, hard capsules

Ziprasidone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zypsila and what is it used for
• 2. Important information before taking Zypsila
• 3. How to take Zypsila
• 4. Possible side effects
• 5. How to store Zypsila
• 6. Contents of the packaging and other information

1. What is Zypsila and what is it used for

Zypsila belongs to a group of medicines called antipsychotics.
Zypsila is used to treat schizophrenia in adults - a mental disorder characterized by the following symptoms: seeing, hearing, or feeling things that do not exist, believing in unreal things, excessive suspiciousness, withdrawal or difficulty in contacting others, nervousness, depression, or anxiety.
Zypsila is also used in adults and children and adolescents aged 10-17 years for the treatment of manic or mixed episodes of moderate severity in bipolar affective disorders - mental disorders characterized by variable states of elevated (mania) or lowered (depression) mood. The most characteristic symptoms of a manic episode are: excessive excitement, elevated self-esteem, increased energy, decreased need for sleep, difficulty concentrating, or hyperactivity and repetitive behaviors with high risk.

2. Important information before taking Zypsila

When not to take Zypsila

Warnings and precautions

Before starting treatment with Zypsila, you should discuss it with your doctor or pharmacist.

You should contact your doctor immediately if you experience any of the following symptoms:

• severe skin reactions, such as rash with blisters, including blisters in the mouth, skin peeling, fever, spots on the skin, which may be symptoms of Stevens-Johnson syndrome. These reactions can be life-threatening.
• Zypsila may cause drowsiness, a drop in blood pressure when standing up, dizziness, and gait disturbances, which can lead to falls. You should be careful, especially if you are an elderly or weakened person.

If the patient is to undergo laboratory tests (such as blood or urine tests, liver or heart function tests, etc.), they should inform their doctor about taking Zypsila, as it may affect the results of these tests.

Children and adolescents

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

Zypsila and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
DO NOT TAKE Zypsilaif you are taking medicines used to treat heart rhythm disorders or that may affect heart function, such as:

• antiarrhythmic drugs class IA and III, arsenic trioxide, halofantrine, levomethadyl acetate, mezoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindol, or cyzapride. These medicines may affect heart function due to prolongation of the QT interval. If you have any further doubts, you should consult your doctor.

Before starting treatment with Zypsila, you should discuss it with your doctor or pharmacist.
You should tell your doctor or pharmacist about any medicines you are currently taking or have recently taken, including:

• bacterial infections; these medicines are called antibiotics; e.g., macrolide antibiotics or rifampicin;
• mood changes (from depressive mood to elevated mood), excitement, and irritability. These medicines are called mood stabilizers; e.g., lithium, carbamazepine, valproate;
• depression, including some serotoninergic medicines, e.g., selective serotonin reuptake inhibitors, such as fluoxetine, paroxetine, sertraline; or herbal preparations, herbal products containing St. John's Wort;
• epilepsy, e.g., phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, e.g., levodopa, bromocriptine, ropinirole, pramipexole;
• and about taking any of the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

See also the section "When not to take Zypsila".

Taking Zypsila with food and drink

Zypsila SHOULD BE TAKEN WITH MAIN MEALS.
You should not drink alcohol while taking Zypsila, as it increases the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Pregnancy
Zypsila should not be taken during pregnancy, unless your doctor advises otherwise, as there is a risk of fetal harm.
In newborns whose mothers take Zypsila in the last 3 months of pregnancy, the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, feeding difficulties. If your baby experiences any of these symptoms, you should contact your doctor immediately.
Breastfeeding
You should not breastfeed while taking Zypsila, as small amounts of the medicine may be excreted in breast milk.
Contraception
If you can become pregnant while taking this medicine, you should use effective contraception.

Driving and using machines

Zypsila may cause drowsiness. If you experience drowsiness, you should not drive, operate machinery, or perform other potentially hazardous activities until it resolves.

Zypsila contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Zypsila

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The capsules should be taken with food and swallowed whole, without chewing, crushing, or opening. It is important not to chew, crush, or open the capsules, as this may affect the amount of medicine absorbed in the gut.
Zypsila should be taken twice a day - one capsule in the morning, with a hearty breakfast, and one capsule in the evening, with dinner. The medicine should be taken at the same time every day.

Adults

The recommended dose is 40 to 80 mg, twice a day, taken with food.
In the case of long-term treatment, your doctor may adjust the dose of the medicine. Do not exceed the maximum dose of 160 mg per day.

Children and adolescents with bipolar affective disorder

The recommended initial dose is 20 mg, taken with food. Then, your doctor will determine the optimal dose for your child. Do not exceed the maximum dose of 80 mg per day in children with a body weight of less than 45 kg or 160 mg per day in children with a body weight of 45 kg or more.
The safety and efficacy of ziprasidone in the treatment of schizophrenia in children and adolescents have not been established.

Elderly patients (over 65 years old)

In elderly patients, your doctor will determine the dose suitable for you. In patients over 65 years old, the doses of the medicine are often lower than those used in younger patients. Your doctor will inform you about the dose that is right for you.

Patients with liver function disorders

In patients with liver function disorders, it may be necessary to use a lower dose of Zypsila. Your doctor will determine the suitable dose for you.

Taking a higher dose of Zypsila than recommended

You should contact your doctor or go to the nearest hospital emergency department immediately. You should take the packaging of Zypsila with you.
If you take a higher dose of Zypsila than recommended, you may experience symptoms such as drowsiness, trembling, seizures, and involuntary movements of the head and neck.

Missing a dose of Zypsila

It is important to take Zypsila regularly, at the same time every day. If you forget to take a dose, you should take it as soon as you remember, unless it is time for your next dose. In this case, you should take the next dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Zypsila

Your doctor will inform you about how long you should take Zypsila. You should not stop taking Zypsila unless your doctor decides to.
It is important to continue taking the medicine, even if you feel better. If treatment is stopped too early, the symptoms of the disease may return.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are temporary. Sometimes it can be difficult to distinguish the symptoms of the disease itself from the side effects.

YOU SHOULD STOP TAKING Zypsila AND CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF THE FOLLOWING SERIOUS SIDE EFFECTS:

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

• Involuntary or abnormal movements, mainly in the face or tongue.

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

• Rapid or irregular heartbeat, dizziness when standing up, which may indicate abnormal heart function. These may be symptoms of a condition called orthostatic hypotension.

Rare side effects (may affect up to 1 in 1000 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, trembling, difficulty swallowing, and changes in consciousness. These may be symptoms of a condition called neuroleptic malignant syndrome.
• Skin reactions, including mainly rash, fever, and swollen lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be life-threatening.
• Confusion, excitement, high body temperature, excessive sweating, lack of coordination, muscle trembling. These may be symptoms of a condition called serotonin syndrome.
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes.
• Priapism (prolonged, painful erection).

The following side effects may occur. These side effects are usually mild to moderate and may resolve over time. If the side effect is severe or does not resolve, you should contact your doctor.

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

• Difficulty sleeping
• Drowsiness or excessive drowsiness during the day
• Headache.

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

• Cold
• Extremely elevated, euphoric mood, strange thinking patterns, and excessive restlessness, feeling of excitement or anxiety
• Restlessness
• Abnormal movements, including involuntary movements, muscle stiffness, slow movements
• Dizziness
• Calmness
• Blurred vision or vision disturbances
• High blood pressure
• Constipation, diarrhea, nausea, vomiting, and indigestion, dry mouth, increased salivation
• Rash
• Sexual disturbances in men
• Fever
• Pain
• Weight gain or loss
• Fatigue.

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

• High prolactin levels in the blood
• Increased appetite
• Panic attacks
• Feeling of agitation or depression
• Decreased sexual desire
• Loss of consciousness
• Difficulty controlling movements or involuntary movements
• Restless legs syndrome
• Throat tightness, nightmares
• Seizures, uncontrolled eye movements in a fixed position, clumsiness, speech disturbances, feeling of numbness and tingling, decreased ability to concentrate, drooling
• Palpitations, shortness of breath
• Sensitivity to light, dry eyes, ringing in the ears, ear pain
• Sore throat, gas, feeling of discomfort in the abdomen
• Itchy skin rash, acne
• Muscle cramps, stiffness, or swelling of the joints
• Thirst, discomfort in the chest, abnormal gait
• Acid reflux, stomach pain
• Hair loss
• Abnormal head position (torticollis or neck stiffness)
• Urinary incontinence, pain or difficulty urinating
• Abnormal milk production in the breasts
• Breast enlargement in men
• Absence of menstruation
• Abnormalities in blood tests or heart function tests
• Abnormalities in liver function tests
• Dizziness of labyrinthine origin
• General weakness and fatigue.

Rare side effects (may affect up to 1 in 1000 people):

• Decreased calcium levels in the blood
• Slowed thinking, lack of emotions
• Facial drooping
• Paralysis
• Partial or complete loss of vision in one eye, eye itching
• Speech disturbances, hiccups
• Diarrhea
• Skin irritation
• Inability to open the mouth
• Difficulty in completely emptying the bladder
• Withdrawal syndrome in newborns
• Decreased orgasm
• Feeling of heat
• Decreased or increased white blood cell count (detected in blood tests)
• Red, raised skin patches with inflammatory changes, covered with a white scale, called psoriasis.

Unknown frequency (cannot be estimated from the available data):

• A slight increase in the number of deaths in elderly patients with dementia taking antipsychotic medicines (compared to patients who do not take this type of medicine)
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). These clots can move with the blood to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, you should contact your doctor immediately.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zypsila

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zypsila contains

• The active substance of the medicine is ziprasidone. 20 mg, hard capsules Each hard capsule contains 20 mg of ziprasidone in the form of ziprasidone hydrochloride. 40 mg, hard capsules Each hard capsule contains 40 mg of ziprasidone in the form of ziprasidone hydrochloride. 60 mg, hard capsules Each hard capsule contains 60 mg of ziprasidone in the form of ziprasidone hydrochloride. 80 mg, hard capsules Each hard capsule contains 80 mg of ziprasidone in the form of ziprasidone hydrochloride.
• Other ingredients (excipients) are: lactose monohydrate, cornstarch, povidone K-25, and magnesium stearate in the capsule core, and titanium dioxide (E 171), gelatin, indigo carmine (E 132), and iron oxide yellow (E 172) in the capsule shell. See section 2 "Zypsila contains lactose".

What Zypsila looks like and contents of the packaging

20 mg, hard capsules
The capsule cap is pale green, and the capsule body is white. The capsule contains a powder that is pinkish-brown in color.
40 mg, hard capsules
The capsule cap is dark green, and the capsule body is pale green. The capsule contains a powder that is pinkish-brown in color.
60 mg, hard capsules
The capsule cap is dark green, and the capsule body is white. The capsule contains a powder that is pinkish-brown in color.
80 mg, hard capsules
The capsule cap is pale green, and the capsule body is white. The capsule contains a powder that is pinkish-brown in color.
Pack sizes: 28, 30, 56, 60, or 90 hard capsules in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 20.07.2024