ZIPRASIDONE CINFA 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ziprasidona Cinfa 80 mg Hard Capsules EFG

ziprasidone hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ziprasidona Cinfa capsules are a medicine belonging to a group of medicines called antipsychotics.

Ziprasidona is indicated for the treatment of schizophrenia in adults, a mental illness characterized by the appearance of some 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, ziprasidona is used in adults and in children and adolescents from 10 to 17 years for the treatment of symptoms of moderate severity mania in bipolar disorder, which is a mental illness characterized by alternating phases of euphoric (mania) or depressed mood. 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 you take Ziprasidona Cinfa

Do not take Ziprasidona Cinfa

• If you are allergic to ziprasidona or any of the other components of this medicine (included 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 "Taking Ziprasidona Cinfa with other medicines" below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ziprasidona Cinfa:

• 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 and prolonged diarrhea and vomiting 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, which may indicate abnormal heart rhythm.

Get in touch with your doctor immediately if you experience any of the following symptoms:

• Severe skin reactions such as, for example, rash with blisters that could be accompanied by ulcers in the mouth, skin peeling, fever, and skin spots with a target shape that could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially fatal.
• Ziprasidona may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. You should be cautious, especially if you are an elderly patient or suffer from some weakness.

Tell your doctor that you are taking Ziprasidona Cinfa 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 ziprasidona in the treatment of schizophrenia in children and adolescents have not been established.

Taking Ziprasidona Cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Do not take Ziprasidona Cinfaif 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 additional questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take Ziprasidona Cinfa.

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 serotonergic 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 Ziprasidona Cinfa" above.

Taking Ziprasidona Cinfa with food, drinks, and alcohol

Ziprasidona Cinfa capsules MUST BE TAKEN DURING MAIN MEALS.

You should not drink alcoholic beverages during treatment with Ziprasidona Cinfa capsules, 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 before using this medicine.

Pregnancy:

You should not take Ziprasidona Cinfa capsules during pregnancy unless your doctor tells you to, as there is a risk that this medicine may harm your baby. Always use an adequate contraceptive method.

The following symptoms may occur in newborn babies of mothers who have taken ziprasidona in the last trimester (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, sleepiness, agitation, respiratory problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding:

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

Contraception:

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

Driving and using machines

Ziprasidona may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce your reaction ability. These effects, as well as the underlying disease, 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 medicine.

Ziprasidona Cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Ziprasidona Cinfa

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

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

Ziprasidona Cinfa capsules should be taken twice a day, one capsule in the morning during a consistent breakfast and one in the evening during dinner (see blister). Try to take this medicine at the same time every day.

Adults

The recommended dose is 40 to 80 mg of ziprasidona 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 starting dose 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 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 ziprasidona in the treatment of schizophrenia in children and adolescents have not been established.

Over 65 years

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

If you take more Ziprasidona Cinfa than you should

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

If you have taken too much Ziprasidona Cinfa, you may experience drowsiness, tremors, convulsions, and involuntary movements of the head and neck.

If you forget to take Ziprasidona Cinfa

It is important that you take Ziprasidona 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 close to the next dose, skip the missed dose and take the next one at its time.

Do not take a double dose to make up for missed doses.

If you stop taking Ziprasidona Cinfa

Your doctor will indicate how long you should take Ziprasidona 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 soon, the symptoms may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

STOP taking Ziprasidona Cinfa 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/unusual movements, especially of the face or tongue.

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

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

Rare side 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 condition known as neuroleptic malignant syndrome.
• Severe skin reactions, especially rash, 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, uncoordinated muscle movements, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Rapid, irregular heartbeats, fainting, which can be symptoms of a life-threatening condition known as Torsades de Pointes.
• Prolonged and painful erection of the penis.

You may experience some of the side effects listed below. These potential side effects are generally mild to moderate and may disappear over time. However, if the side effect is severe or persistent, contact your doctor.

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

• Difficulty sleeping.
• Tendency to sleep or excessive daytime sleepiness.
• Headache.

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

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

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

• High 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.
• Restless legs.
• Feeling of pressure in the throat, nightmares.
• Seizures, involuntary eye movements, clumsiness, speech disturbances, numbness, feeling of muscle cramps, decreased concentration, drooling.
• Palpitations, difficulty breathing.
• Sensitivity to light, dry eyes, ringing in the ears, ear pain.
• Sore throat, gas, stomach discomfort.
• Itchy skin rash, acne.
• Muscle cramps, stiffness, or swelling of the joints.
• Thirst, chest discomfort, gait disturbances.
• Acid reflux, stomach pain.
• Hair loss.
• Unusual head position.
• Urinary incontinence, pain or difficulty urinating.
• Abnormal production of breast milk.
• Increased male breast size.
• Absence of menstruation.
• Abnormal blood tests and heart tests.
• Abnormal liver function tests.
• Dizziness.
• General weakness and fatigue.

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

• Decreased calcium levels in the blood.
• Slowness of thought, lack of emotional expressiveness.
• 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.
• Feeling of heat.
• Increased or decreased white blood cell count (in blood tests).
• Red, raised, and inflamed skin areas covered with white scales, known as psoriasis.

Frequency not known (cannot be estimated from the 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 blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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.

Shelf life after opening the package: 6 months

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ziprasidone Cinfa

• The active ingredient is ziprasidone. Each hard capsule contains 80 mg of ziprasidone in the form of ziprasidone hydrochloride.
• The other ingredients are: Capsule content:anhydrous colloidal silica, sodium croscarmellose, pregelatinized corn starch, magnesium stearate. Body and cap of the capsule:gelatin, titanium dioxide (E-171), indigo carmine (E-132).

Appearance of the Product and Package Contents

Ziprasidone Cinfa 80 mg hard capsules are presented in the form of hard gelatin capsules. The capsules are blue and white.

Package sizes:

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

HDPE plastic bottles containing 100 capsules.

Only some package 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, Krakow,

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Date of the Last Revision of this Leaflet:January 2025

Detailed and updated information on this medicine 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 updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80957/P_80957.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80957/P_80957.html