ZIPRASIDONE AUROVITAS 60 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ziprasidone Aurovitas 60 mg Hard Capsules EFG

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

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

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

Ziprasidone is used to treat schizophrenia in adults, a mental illness characterized by the occurrence 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.

Ziprasidone is also 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 mood states, either euphoric (mania) or depressed. 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 recurrent risk behaviors.

2. What you need to know before you take Ziprasidone Aurovitas

Do not takeZiprasidoneAurovitas

• If you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had any heart disease or have recently had a heart attack.
• If you are taking medicines for heart rhythm disorders or that may affect heart rhythm.

See also the section “Other medicines andZiprasidoneAurovitas” later.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ziprasidone:

• If you or someone in your family has a history of blood clots, as this type of medicine 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 of age 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, as they 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 that may be accompanied by ulcers in the mouth, skin peeling, fever, and skin spots with a target shape, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially fatal.
• Ziprasidone capsules may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. Caution should be exercised, especially if you are an elderly patient or suffer from weakness.

Tell 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

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

Other medicines andZiprasidoneAurovitas

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

Do not take ziprasidoneif 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 may alter the heart rhythm by prolonging the QT interval. If you have any further questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take ziprasidone.

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 irritation: these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• Depression, including some serotoninergic medicines, such as selective serotonin reuptake inhibitors (SSRIs), 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 medicines: verapamil, quinidine, itraconazole, or ritonavir.

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

TakingZiprasidoneAurovitas with food, drinks, and alcohol

Ziprasidone MUST BE TAKEN DURING MAIN MEALS.

You should not drink alcoholic beverages during treatment with ziprasidone, as this may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

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

You should not take ziprasidone during pregnancy unless your doctor advises you to do so, as there is a risk that this medicine may harm your baby.

Newborns of mothers who have used ziprasidone in the last trimester (last three months of pregnancy) may exhibit the following symptoms: tremor, stiffness, and/or muscle weakness, drowsiness, 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 ziprasidone. 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

Taking ziprasidone may cause drowsiness. If you experience this symptom, do not drive or operate hazardous machinery until it disappears.

Ziprasidone Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ziprasidone Aurovitas contains sodium

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

3. How to take Ziprasidone Aurovitas

Follow the instructions for administration of this medicine exactly 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 them beforehand. It is important not to chew, crush, or open the capsules as this may affect the degree to which the medicine 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. Try to take this medicine at the same time each day.

Adults

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

In long-term treatments, your doctor may adjust the dose. Do not exceed the maximum dose of 160 mg per day.

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 dose of 80 mg per day in children with a weight of 45 kg or less or 160 mg in children with a weight over 45 kg.

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

Elderly patients (over 65 years of age)

If you are an elderly patient, your doctor will decide the suitable dose for you. The dose for patients over 65 years of age is sometimes lower than that used in younger people. Your doctor will indicate the appropriate dose for you.

Patient 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 moreZiprasidoneAurovitas than you should

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

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

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 forget to takeZiprasidoneAurovitas

It is important that you take ziprasidone regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is close to the next dose. In this case, only take the next dose.

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

If you stop takingZiprasidoneAurovitas

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

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

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

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

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

• Rapid or irregular heartbeats, dizziness when standing up, which may indicate 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 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 following side effects. 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 (may affect more than 1 in 10 people):

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

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

• Rhinorrhea.
• Elevated mood, unusual thought patterns, and hyperactivity, feeling of agitation or anxiety.
• 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 (may affect up to 1 in 100 people):

• High levels of prolactin in the blood.
• Increased appetite.
• Panic attacks.
• Feeling of nervousness or depression.
• 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 disturbance, numbness, tingling, 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 disturbance.
• Acid reflux, stomach pain.
• Hair loss.
• Unusual position of the head.
• Urinary incontinence, pain or difficulty urinating.
• Abnormal production of breast milk.
• Enlargement of male breast tissue.
• Absence of menstruation.
• Abnormal blood tests and heart 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.
• Slowness of thought, lack of emotional expressiveness.
• 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 heat.
• Increased or decreased white blood cell count (in blood tests).
• Red, raised, and inflamed areas of skin 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 who were 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, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ziprasidona Aurovitas

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

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofZiprasidonaAurovitas

• The active substance is ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate, equivalent to 60 mg of ziprasidone.
• The other ingredients are:

Capsule content:lactose monohydrate, ethylcellulose, pregelatinized corn starch, magnesium stearate.

Capsule shell:titanium dioxide (E171), gelatin, sodium lauryl sulfate.

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

Appearance of the Product and Package Contents

Hard gelatin capsule of size “2”, with a white opaque cap and a white opaque body, with the prints “F” on the cap and “39” on the body, both with black ink, and filled with a granulated powder of cream to pale pink color.

Ziprasidona Aurovitas is available in blister packs of Polyamide/Aluminum/PVC/Aluminum with 14, 30, and 56 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 under the following names:

Spain: Ziprasidona Aurovitas 60 mg hard capsules EFG

Date of the last revision of this leaflet: June 2024

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