Leaflet: information for the user

Ziprasidone Aurovitas 40 mg hard capsules EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Ziprasidone Aurovitas

3.How to take Ziprasidone Aurovitas

4.Possible side effects

5.Storage of Ziprasidone Aurovitas

6.Contents of the pack and additional information

Ziprasidoneis a medication belonging to the group of medications known as antipsychotics.

Ziprasidoneis used in 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.

Ziprasidone alsois used in adults and in children and adolescents from 10 to 17 years old for the treatment of symptoms of moderate severity mania in bipolar disorder, a mental illness characterized by alternating phases of euphoric mood states (mania) or depressed states. During mania episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, decreased need for sleep, lack of concentration or hyperactivity, and recurrent high-risk behaviors.

Do not takeZiprasidoneAurovitas

•If you are allergic to ziprasidone or any of the other components of this medication (listed in section 6).

•If you have or have had any heart disease or have had a recent heart attack.

•If you are taking medications for heart rhythm disturbances or that may affect heart rhythm.

See also the section “Other Medications andZiprasidoneAurovitas” further on.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take ziprasidone:

•If you or a family member 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 have dementia and are at high risk of having 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 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, dizziness, fainting, or dizziness when standing up, as this may indicate an abnormal heart rhythm.

Immediately contact your doctor if you experience any of the following symptoms:

•Severe skin reactions, such as blistering with blisters that may be accompanied by mouth ulcers, skin peeling, fever, and skin spots in the shape of a target, which may be symptoms of Stevens-Johnson syndrome. These skin reactions may be potentially fatal.

•Ziprasidonecapsules may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which may cause falls. You should be cautious, especially if you are an elderly patient or have any weakness.

Inform your doctor that you are taking ziprasidone before undergoing any diagnostic tests (such as blood tests, urine tests, liver function tests, heart rhythm tests, etc.) as it may alter the results.

Children and Adolescents

Ziprasidone has not been established as safe and effective for the treatment of schizophrenia in children and adolescents.

Other Medications andZiprasidoneAurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Do not take ziprasidoneif you are taking medications for heart rhythm disturbances or medications that may affect heart rhythm, such as:

•Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl acetate, mesoridazine, thioridazine, pimozide, esparfloxacine, gatifloxacine, moxifloxacine, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medications may prolong the QT interval and affect heart rhythm. If you have any additional questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take ziprasidone.

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

•Bacterial infections: these medications are known as antibiotics, such as macrolide antibiotics or rifampicin.

•Mood changes (from depressive mood to euphoria), agitation, and irritability: these medications are known as mood stabilizers, such as lithium, carbamazepine, or valproate.

•Depression, including some serotonin reuptake inhibitors, such as ISRSs (Selective Serotonin Reuptake Inhibitors), such as fluoxetine, paroxetine, sertraline, or herbal remedies or natural remedies containing St. John's Wort.

•Epilepsy, such as phenytoin, phenobarbital, carbamazepine, or ethosuximide.

•Parkinson's disease, such as levodopa, bromocriptine, ropinirole, or pramipexole.

•Or if you are taking or have taken recently the following medications: see the previous section “Do not take Ziprasidone Aurovitas”.

See the previous section “Do not take Ziprasidone Aurovitas”.

Ziprasidone Aurovitas with Food, Drinks, and Alcohol

Ziprasidonemust be taken during the main meals.

Do not consume alcoholic beverages during treatment with ziprasidone, as this may increase the risk of adverse effects.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Do not takeziprasidoneduring pregnancy unless your doctor tells you otherwise, as there is a risk that this medication may harm your baby.

Newborns of mothers who have usedziprasidonein the last trimester (last three months of pregnancy) may experience the following symptoms: tremors, stiffness, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding

Do not breastfeed your baby while takingziprasidone, as small amounts may pass into breast milk.

Contraception

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

Driving and Operating Machinery

The taking ofziprasidonemay cause drowsiness. If you experience this symptom, do not drive or operate hazardous machinery until it disappears.

Ziprasidone Aurovitas contains lactose

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

Ziprasidone Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 beforehand. It is essential not to chew, crush, or open the capsules, as this may affect the degree to 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. Make sure 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.

Your doctor may adjust the dose in long-term treatments. Do not exceed the maximum daily dose of 160 mg.

Children and adolescents with bipolar mania

The usual initial dose is 20 mg taken with food, after which your doctor will indicate your optimal dose. Do not exceed the maximum daily dose of 80 mg in children weighing 45 kg or less, or 160 mg in children weighing more than 45 kg.

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

Elderly patients (65 years or older)

If you are an elderly patient, your doctor will decide on the suitable dose for you. The dose for patients over 65 years may be lower than that used in younger individuals. 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 ziprasidone. Your doctor will indicate the correct dose for you.

If you take moreZiprasidone Aurovitas than you should

Consult your doctor immediately or go to the nearest hospital emergency room. Bring your ziprasidone box with you.

If you have taken too much ziprasidone, you may experience drowsiness, tremors, seizures, and involuntary head and neck movements.

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

If you forgot to takeZiprasidone Aurovitas

It is essential to take ziprasidone regularly at the same time every day. If you forgot to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, only take the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withZiprasidone Aurovitas

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

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them. It can often be difficult to distinguish the symptoms of your illness from side effects.

STOP taking ziprasidone and contact your doctor immediately if you experience any of the following severe side effects:

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

•Uncontrollable or involuntary movements, especially of the face or tongue.

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

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

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

•Swelling of the face, lips, tongue, or throat, 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 malignant neuroleptic syndrome.

•Skin reactions, especially hives, fever, and lymph node inflammation, 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, muscle coordination disorder, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.

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

•Persistent and painful erection of the penis.

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

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

•Difficulty sleeping.

•Excessive daytime sleepiness or drowsiness.

•Headache.

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

•Coughing.

•Exalted mood, strange thought patterns, and hyperactivity, feeling agitated 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, and indigestion, dry mouth, increased salivation.

•Rash.

•Male sexual problems.

•Fever.

•Pain.

•Weight loss or gain.

•Fatigue.

•General feeling of being unwell.

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

•Elevated levels of prolactin in the blood.

•Increased appetite.

•Panic attack.

•Feeling of nervousness or depression.

•Decreased libido.

•Loss of consciousness.

•Difficulty controlling movements/involuntary movements.

•Restless legs.

•Feeling of throat constriction, nightmares.

•Seizures, involuntary eye movements to a fixed position, clumsiness, speech alteration, numbness, tingling, decreased concentration, drooling.

•Palpitations, difficulty breathing.

•Light sensitivity, dry eyes, ear noises, ear pain.

•Throat pain, gas, stomach discomfort.

•Rash with itching, acne.

•Muscle cramps, stiffness, or swelling of the joints.

•Thirst, chest discomfort, altered gait.

•Acid reflux, stomach pain.

•Hair loss.

•Abnormal head position.

•Urinary incontinence, pain or difficulty urinating.

•Abnormal milk production.

•Male breast enlargement.

•Amenorrhea.

•Abnormal blood and heart function tests.

•Abnormal liver function tests.

•Dizziness.

•General weakness and fatigue.

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

•Decreased calcium levels in the blood.

•Slowed thinking, lack of emotional expression.

•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, inflamed skin patches covered with white scales, known as psoriasis.

Unknown frequency(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 may 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofZiprasidonaAurovitas

-The active ingredient is ziprasidona.Each hard capsule contains ziprasidona hydrochloride monohydrate, equivalent to 40 mg of ziprasidona.

-The other components:

Contents of the capsule:lactose monohydrate, ethylcellulose, pregelatinized cornstarch, magnesium stearate.

Capsule coating:indigo carmine (E132), titanium dioxide (E171), gelatin, sodium lauryl sulfate.

Printing ink:Shellac lacquer, iron oxide black (E172).

Appearance of the product and contents of the packaging

Hard gelatin capsule size “3”, with a blue opaque cap and a blue opaque body, with the impressions “F” on the cap and “38” on the body, both in black ink, and filled with a pale pink to cream-colored granular powder.

Ziprasidona Aurovitasis available in blister packs of Poliamida/Aluminio/PVC/Aluminio with 14, 30, and 56 hard capsules.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Ziprasidona Aurovitas 40 mg hard capsules EFG

Last review date of this leaflet: June 2024

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