Ziprasidone Aurovitas 60 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ziprasidone Aurovitas 60 mg Hard Capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it could 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.

Leaflet Contents

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

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

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

Ziprasidone is used in the treatment of schizophrenia in adults, a mental illness characterized by the presence of one or more of the following symptoms: hearing, seeing, or feeling things that do not exist, believing things that are not true, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression, or anxiety.

Ziprasidone is also used in adults and in children and adolescents aged 10 to 17 years for the treatment of moderate severity manic symptoms in bipolar disorder, which is 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, difficulty concentrating, hyperactivity, and recurring risk-taking behaviors.

2. What you need to know before taking Ziprasidona Aurovitas

Do not take Ziprasidona Aurovitas

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

See also the section “Other medicines and Ziprasidona Aurovitas” below.

Warnings and precautions

Talk to your doctor or pharmacist before taking ziprasidone:

• 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 slowing of resting heart rate and/or know that you may have low levels of blood salts due to prolonged severe diarrhoea and vomiting or due to the use of diuretics (which promote elimination of excess fluid).
• If you experience symptoms such as rapid or irregular heartbeat, fainting, syncope, 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 blistering rash possibly accompanied by mouth ulcers, skin peeling, fever, and target-like spots on the skin, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially life-threatening.
• Ziprasidone capsules 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 elderly or have any weakness.

Inform your doctor that you are taking ziprasidone before undergoing any diagnostic tests (such as blood or urine tests, liver function tests, heart rhythm tests, etc.), as it may affect 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 and Ziprasidona Aurovitas

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

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

Talk to your doctor or pharmacist before starting 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 irritability: these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• Depression, including some serotonergic medicines, such as SSRIs (Selective Serotonin Reuptake Inhibitors), such as fluoxetine, paroxetine, sertraline, or herbal remedies or natural medicines 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 the previous section “Do not take Ziprasidona Aurovitas”.

Taking Ziprasidona Aurovitas 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 adverse 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 specifically instructs you to do so, because there is a risk that this medicine may harm your baby.

Newborns of mothers who have used ziprasidone during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, 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 ziprasidone. This is because small amounts 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

Taking ziprasidone may cause drowsiness. If you experience this symptom, you should not drive or operate dangerous machinery until it resolves.

Ziprasidona Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Ziprasidona Aurovitas contains sodium

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

3. How to take Ziprasidone Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor. If in 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 extent to which the medicine is absorbed in the intestine.

Ziprasidone should be taken twice daily—one capsule in the morning with a substantial breakfast and one in the evening with dinner. 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. The maximum daily dose must not exceed 160 mg.

Children and adolescents with bipolar mania

The usual initial dose is 20 mg taken with food, after which your doctor will determine your optimal dose. The maximum daily dose must not exceed 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 (over 65 years of age)

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

If you take more Ziprasidone Aurovitas than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Take your pack of ziprasidone with you.

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

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

If you forget to take Ziprasidone Aurovitas

It is important to 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 time for your next dose. In that case, take only the next dose.

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

If you stop taking Ziprasidone Aurovitas

Your doctor will tell you how long you should take ziprasidone. 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 will experience them. It may often be difficult to distinguish symptoms of your illness from the adverse effects.

STOP taking ziprasidone and contact your doctor immediately if you experience any of the following serious adverse 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 heartbeat, 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 serious allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and reduced consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome.
• Skin reactions, especially rash, fever, and swollen lymph nodes, which could be symptoms of a disease called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.
• Confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Rapid or irregular heartbeat, fainting, which 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 some 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 (may affect more than 1 in 10 people):

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

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

• Runny nose.
• Elevated mood, unusual thought patterns, hyperactivity, feeling restless 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 weight gain.
• Exhaustion.
• General feeling of being unwell.

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

• Elevated levels of prolactin in the blood.
• Increased appetite.
• Panic attacks.
• Feelings of nervousness or depression.
• Decreased sex drive.
• Loss of consciousness.
• Difficulty controlling movements/involuntary movements.
• Restless legs.
• Feeling of tightness in the throat, nightmares.
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech disturbance, numbness, tingling sensation, reduced ability to concentrate, 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, changes in walking pattern.
• Acid reflux, stomach pain.
• Hair loss.
• Unusual head position.
• 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 concentration of calcium in the blood.
• Slowed thinking, 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 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 small 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ziprasidone 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 stated on the blister and the carton 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ziprasidone Aurovitas

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

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

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

Printing ink: shellac, black iron oxide (E172).

Appearance of the product and contents of the pack

Hard gelatin capsule of size “2”, with a whitish opaque cap and a whitish opaque body, printed with “F” on the cap and “39” on the body, both in black ink, filled with a granular cream to pale pink powder.

Ziprasidone Aurovitas is available in blister packs made of Polyamide/Aluminum/PVC/Aluminum containing 14, 30, and 56 hard capsules.

Only some pack sizes may be commercially available.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Ziprasidone Aurovitas 60 mg hard capsules EFG

Date of the most recent revision of this leaflet: June 2024

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