Ziprasidone CINFA 60 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ziprasidona cinfa 60 mg hard capsules EFG

ziprasidone hydrochloride

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 you should not give it to other people, even if they have the same symptoms as you, because 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.

Contents of the leaflet

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

1. What Ziprasidona cinfa is and what it is used for

Ziprasidona cinfa 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seeing, or sensing things that do not exist, believing in something that is not true, having unusual suspicions, being withdrawn and having difficulty establishing social relationships, nervousness, depression, or anxiety.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 severity manic symptoms in bipolar disorder, 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 repetition of risky behaviors.

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

Do not take ziprasidone cinfa

• If you are allergic to ziprasidone or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized by the appearance of a 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 “Taking ziprasidone cinfa with other medicines” below.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take ziprasidone cinfa:

• 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 you know you may have low levels of blood salts due to prolonged severe diarrhea 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, weakness, fainting, or dizziness upon standing, as these may indicate abnormal heart rhythm function.

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

• Severe skin reactions such as rash with blisters, which may be accompanied by mouth ulcers, skin peeling, fever, and skin spots with a target-like appearance, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could potentially be life-threatening.
• Ziprasidone 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 an elderly patient or suffer from any weakness.

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

Children and adolescents

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

Taking Ziprasidona cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Ziprasidona cinfa 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, levomethadyl 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 further questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting treatment with Ziprasidona cinfa.

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

• 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 certain 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 cinfa” above.

Taking ziprasidona cinfa with food, drinks, and alcohol

Ziprasidona cinfa capsules MUST BE TAKEN DURING MAIN MEALS.

You should not consume alcoholic beverages during treatment with ziprasidona cinfa capsules, as this may increase the risk of adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy:

You should not take ziprasidona cinfa capsules 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 whose mothers have taken ziprasidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, excessive sleepiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding:

You should not breastfeed while being treated with ziprasidona cinfa capsules. This is because small amounts of the medicine may pass into breast milk.

Contraception:

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

Driving and using machines

Ziprasidona may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles 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.

Ziprasidona cinfa contains sodium.

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

3. How to take ziprasidone cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole, without chewing, and must be taken with food. It is important not to chew the capsules, as this may affect the site where the medicine is absorbed in the intestine.

Ziprasidone cinfa capsules should be taken twice daily—one capsule in the morning with a substantial breakfast and one in the evening with dinner (see blister pack). 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. The maximum recommended dose based on weight is 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 of age

If you are over 65 years old, your doctor will decide the appropriate dose for you. The dose for patients over 65 may sometimes be 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 cinfa capsules. Your doctor will tell you what the correct dose is for you.

If you take more ziprasidone cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take ziprasidone cinfa

It is important to take ziprasidone cinfa capsules at the same time every day. If you forget to take a dose, take it as soon as possible. However, if it is almost time for the 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 cinfa

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

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 experiences them.

It may often be difficult to distinguish symptoms of your illness from adverse effects.

STOP taking ziprasidone cinfa 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 patients):

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

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

• Rapid or irregular heartbeat, dizziness upon standing, 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 patients):

• 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, 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 potentially be life-threatening.
• Confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These could be symptoms of a disease known as serotonin syndrome.
• Rapid or irregular heartbeat, fainting—these 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 one 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 patients):

• Difficulty sleeping.
• Drowsiness or excessive daytime sleepiness.
• Headache.

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

• Runny nose.
• Elevated mood, unusual thought patterns and hyperactivity, feeling restless or anxious.
• Restlessness.
• Abnormal movements including involuntary movements, muscle rigidity, slow movements.
• Dizziness.
• Sedation.
• Blurred or impaired vision.
• High blood pressure.
• Constipation, diarrhea, nausea, vomiting, indigestion, dry mouth, increased salivation.
• Rash.
• Male sexual problems.
• Fever.
• Pain.
• Weight loss or weight gain.
• Exhaustion.
• General feeling of being unwell.

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

• Elevated levels of prolactin in the blood.
• Increased appetite.
• Panic attacks.
• Feelings of nervousness or depression.
• Decreased libido.
• Loss of consciousness.
• Difficulty controlling movements/involuntary movements.
• Restless legs.
• Sensation of throat tightness, nightmares.
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech disturbance, numbness, tingling sensation, decreased concentration ability, 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, chest discomfort, altered gait.
• Acid reflux, stomach pain.
• Hair loss.
• Unusual head positioning.
• Urinary incontinence, pain or difficulty urinating.
• Abnormal production of breast milk.
• Enlargement of male breasts.
• Absence of menstruation.
• Abnormal blood tests and heart tests.
• Abnormal liver function tests.
• Dizziness.
• General weakness and fatigue.

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

• Decreased calcium concentration in the blood.
• Slowed thinking, lack of emotional expressiveness.
• Facial paralysis.
• Paralysis.
• Partial or complete vision loss in one eye, itchy eyes.
• Difficulty speaking, hiccups.
• Soft stools.
• Skin irritation.
• Inability to open the mouth.
• Difficulty emptying the bladder.
• Neonatal withdrawal syndrome.
• Reduced orgasm.
• Feeling of warmth.
• Increase or decrease 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 slight 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, consult your doctor immediately.

Reporting of adverse effects

If you experience any 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ziprasidone cinfa

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

Blister packs:

Do not store above 30°C.

Bottles:

Do not store above 30°C.

Period of validity after first opening the container: 6 months.

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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ziprasidone cinfa

• The active substance is ziprasidone. Each hard capsule contains 60 mg of ziprasidone as ziprasidone hydrochloride.
• The other components are:
  Capsule contents: anhydrous colloidal silica, sodium croscarmellose, pregelatinized corn starch, magnesium stearate.
  Capsule body and cap: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the product and pack contents

Ziprasidone cinfa 60 mg hard capsules are presented as hard gelatin capsules. The capsules are ivory-coloured.

Pack sizes:

Aluminum/aluminum blisters containing 14, 20, 30, 50, 56, 60 or 100 capsules.

HDPE plastic bottles containing 100 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków,
Poland

or

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80960/P_80960.html

QR code link: https://cima.aemps.es/cima/dochtml/p/80960/P_80960.html